POPULARITY
Dr. John Sweetenham and Dr. Erika Hamilton highlight key abstracts that were presented at ASCO25, including advances in breast and pancreatic cancers as well as remarkable data from the use of structured exercise programs in cancer care. Transcript Dr. Sweetenham: Hello, and welcome to the ASCO Daily News Podcast. I'm your host, Dr. John Sweetenham. Today, we'll be discussing some of the key advances and novel approaches in cancer care that were presented at the 2025 ASCO Annual Meeting. I'm delighted to be joined again by the chair of the Meeting's Scientific Program, Dr. Erika Hamilton. She is a medical oncologist and director of breast cancer and gynecologic cancer research at the Sarah Cannon Research Institute in Nashville, Tennessee. Our full disclosures are available in the transcript of this episode. Dr. Hamilton, congratulations on a fantastic meeting. From the practice-changing science to the world-renowned speakers at this year's Meeting, ASCO25 really reflected the amazing progress we're seeing in oncology today and the enormous opportunities that lie ahead of us. And thanks for coming back on to the podcast today to discuss some of these advances. Dr. Hamilton: Thanks, Dr. Sweetenham. I'm happy to join you today. It really was an impactful ASCO Annual Meeting. I probably am biased, but some great research was presented this year, and I heard lots of great conversations happening while we were there. Dr. Sweetenham: Yeah, absolutely. There was a lot of buzz, as well as a lot of media buzz around the meeting this year, and I think that's probably a good place to start. So I'd like to dive into abstract number LBA3510. This was the CHALLENGE trial, which created a lot of buzz at the meeting and subsequently in the media. This is the study that was led by the NCI Canada Clinical Trials Group, which was the first randomized phase 3 trial in patients with stage III and high-risk stage II colon cancer, which demonstrated that a post-treatment structured exercise program is both feasible and effective in improving disease-free survival in this patient group. The study was performed over a long period of time and in many respects is quite remarkable. So, I wonder if you could give us your thoughts about this study and whether you think that this means that our futures are going to be full of structured exercise programs for those patients who may benefit. Dr. Hamilton: It's a fantastic question. I think that this abstract did create a lot of buzz. We were very excited when we read it. It was highlighted in one of the Clinical Science Symposium sessions. But briefly, this was a phase 3 randomized trial. It was conducted at 55 centers, so really a broad experience, and patients that had resected colon cancer who completed adjuvant therapy were allowed to participate. There were essentially 2 groups: a structured exercise program, called ‘the exercise group,' or health education materials alone, so that was called just ‘the health education group.' And this was a 3-year intervention, so very high quality. The primary end point, as you mentioned, was disease-free survival. This actually accrued from 2009 to 2024, so quite a lift, and almost 900 patients underwent randomization to the exercise group or the health education group. And at almost 8 years of follow-up, we saw that the disease-free survival was significantly longer in the exercise group than the health education group. This was essentially 80.3% of patients were disease-free in exercise and 73.9% in the health education group. So a difference of over 6 percentage points, which, you know, at least in the breast cancer world, we make decisions about whether to do chemotherapy or not based on these kind of data. We also looked at overall survival in the exercise group and health education group, and the 8-year overall survival was 90.3% in the exercise group and 83.2% in the health education group. So this was a difference of 7.1%. Still statistically significant. I think this was really a fantastic effort over more than a decade at over 50 institutions with almost 900 patients, really done in a very systematic, high-intervention way that showed a fantastic result. Absolutely generalizable for patients with colon cancer. We have hints in other cancers that this is beneficial, and frankly, for our patients for other comorbidities, such as cardiovascular, etc., I really think that this is an abstract that deserved the press that it received. Dr. Sweetenham: Yeah, absolutely, and it is going to be very interesting, I think, over the next 2 or 3 years to see how much impact this particular study might have on programs across the country and across the world actually, in terms of what they do in this kind of adjuvant setting for structured exercise. Dr. Hamilton: Absolutely. So let's move on to Abstract 3006. This was an NCI-led effort comparing genomic testing using ctDNA and tissue from patients with less common cancers who were enrolled in but not eligible for a treatment arm of the NCI-MATCH trial. Tell us about your takeaways from this study. Dr. Sweetenham: Yeah, so I thought this was a really interesting study based, as you said, on NCI-MATCH. And many of the listeners will probably remember that the original NCI-MATCH study screened almost 6,000 patients to assess eligibility for those who had an actionable mutation. And it turned out that about 60% of the patients who went on to the study had less common tumors, which were defined as anything other than colon, rectum, breast, non–small cell lung cancer, or prostate cancer. And most of those patients lacked an eligible mutation of interest and so didn't get onto a trial therapy. But with a great deal of foresight, the study group had actually collected plasma samples from these patients so that they would have the opportunity to look at circulating tumor DNA profiles with the potential being that this might be another way for testing for clinically relevant mutations in some of these less common cancer types. So initially, they tested more than 2,000 patients, and to make a somewhat complicated story short, there was a subset of five histologies with a larger representation in terms of sample size. And these were cholangiocarcinoma, small cell lung cancer, esophageal cancer, pancreatic, and salivary gland cancer. And in those particular tumors, when they compared the ctDNA sequencing with the original tumor, there was a concordance there of around 84%, 85%. And in the presentation, the investigators go on to list the specific mutated genes that were identified in each of those tumors. But I think that the other compelling part of this study from my perspective was not just that concordance, which suggests that there's an opportunity there for the use of ctDNA instead of tumor biopsies in some of these situations, but what was also interesting was the fact that there were several clinically relevant mutations which were detected only in the circulating tumor DNA. And a couple of examples of those included IDH1 for cholangiocarcinoma, BRAF and p53 in several histologies, and microsatellite instability was most prevalent in small cell lung cancer in the ctDNA. So I think that what this demonstrates is that liquid biopsy is certainly a viable screening option for patients who are being assessed for matching for targeted therapies in clinical trials. The fact that some of these mutations were only seen in the ctDNA and not in the primary tumor specimen certainly suggests that there's some tumor heterogeneity. But I think that for me, the most compelling part of this study was the fact that many of these mutations were only picked up in the plasma. And so, as the authors concluded, they believe that a comprehensive gene profiling with circulating tumor DNA probably should be included as a primary screening modality in future trials of targeted therapy of this type. Dr. Hamilton: Yeah, I think that that's really interesting and mirrors a lot of data that we've been seeing. At least in breast cancer, you know, we still do a biopsy up front to make sure that our markers, we're still treating the right disease that we think we are. But it really speaks to the utility of using ctDNA for serial monitoring and the emergence of mutations. Dr. Sweetenham: Absolutely. And you mentioned breast cancer, and so I'd like to dwell on that for a moment here because obviously, there was a huge amount of exciting breast cancer data presented at the meeting this year. And in particular, I'd like to ask you about LBA1008, the DESTINY-Breast09 clinical trial, which I think has the potential to establish a new first-line standard of care for metastatic HER2+ breast cancer. And that's an area where we haven't seen a whole lot of innovation for around a decade now. So can you give us some of the highlights of this trial and what your thinking is, having seen the results? Dr. Hamilton: Yeah, absolutely. So this was a trial in the first-line metastatic HER2 setting. So this was looking at trastuzumab deruxtecan. We certainly have had no shortage of reports around this drug, initially approved for later lines. DESTINY-Breast03 brought it into our second-line setting for HER2+ disease and we're now looking at DESTINY-Breast09 in first-line. So this actually was a 3-arm trial where patients were randomized 1:1:1 against standard taxane/trastuzumab/pertuzumab in one arm; trastuzumab deruxtecan with pertuzumab in another arm; and then a third arm, trastuzumab deruxtecan alone. And what we did not see reported was that trastuzumab deruxtecan-alone arm. But we did have reports from the trastuzumab deruxtecan plus pertuzumab versus the chemo/trastuzumab/pertuzumab. And what we saw was a statistically significant improvement in median progression-free survival, 26.9 months up to 40.7, so an improvement of 13.8 months, over a year in PFS. Not to mention that we're now in the 40-month range for PFS in first-line disease. Really, across all subgroups, we really weren't able to pick out a subset of patients that did not benefit. We did see about a 12% ILD rate with trastuzumab deruxtecan. That really is on par with what we've seen in other studies, around 10%-15%. I think that this is going to become a new standard of care in the first-line. I think it did leave some unanswered questions. We saw some data from the PATINA trial this past San Antonio Breast, looking at the addition of endocrine therapy with or without a CDK4/6 inhibitor, palbociclib, for those patients that also have ER+ disease, after taxane has dropped out in the first-line setting. So how we're going to kind of merge all this together is, I suspect that there are going to be patients that we or they just don't have the appetite to continue 3 to 4 years of trastuzumab deruxtecan. And so we're probably going to be looking at a maintenance-type strategy for them, maybe integrating the PATINA data there. But how we really put this into practice in the first-line setting and if or when we think about de-escalating down from trastuzumab deruxtecan to antibody therapy are some lingering questions. Dr. Sweetenham: Okay, so certainly is going to influence practice, but watch this space for a little bit longer, it sounds as though that's what you're saying. Dr. Hamilton: Absolutely. So let's move on to GI cancer. Abstract 4006 reported preliminary results from the randomized phase 2 study of elraglusib in combination with gemcitabine/nab-paclitaxel versus the chemo gemcitabine/nab-paclitaxel alone in patients with previously untreated metastatic pancreatic cancer. Can you tell us more about this study? Dr. Sweetenham: Yeah, absolutely. As you mentioned, elraglusib is actually a first-in-class inhibitor of GSK3-beta, which has multiple potential actions in pancreatic cancer. But the drug itself may be involved in mediating drug resistance as well as in some tumor immune response modulation. Some of that's not clearly understood, I believe, right now. But certainly, preclinical data suggests that the drug may be effective in preclinical models and may also be effective in combination with chemotherapy and potentially with immune-modulating agents as well. So this particular study, as you said, was an open-label, randomized phase 2 study in which patients with pancreatic cancer were randomized 2:1 in favor of the elraglusib plus GMP—gemcitabine and nab-paclitaxel—versus the chemotherapy alone. And upon completion of the study, which is not right now, median overall survival was the primary end point, but there are a number of other end points which I'll talk about in just a moment. But the sample size was planned to be around 207 patients. The primary analysis included 155 patients in the combination arm versus 78 patients in the gemcitabine/nab-paclitaxel arm. Overall, the 1-year overall survival rate was 44.1% for the patients in the elraglusib-containing arm versus 23.0% in the patients receiving gemcitabine/nab-paclitaxel only. When they look at the median overall survival, it was 9.3 months for the experimental arm versus 7.2 months for chemotherapy alone. So put another way, there's around a 37% reduction in the risk of death with the use of this combination arm. The treatment was overall well-tolerated. There were some issues with grade 1 to 2 transient visual impairment in a large proportion of the patients. The most common treatment-related adverse effects with the elraglusib/GMP combination was transient visual impairment, which affected around 60% of the patients. Most of the more serious treatment-related adverse events included neutropenia, anemia, and fatigue in 50%, 25%, and 16% of the patients, respectively. So the early results from this study show a significant benefit for 1-year overall survival and for median overall survival with, as I mentioned above, a significant reduction in the risk of death. The authors went on to mention that the median overall survival for the control arm in this study is somewhat lower than in other comparable trials, but they think that this may be related to a more advanced disease burden in this particular study. Of interest to me was that right now: there is no apparent difference in progression-free survival between the 2 arms of this study. The authors described this as potentially indicating that this may be related in some way to immune modulation and immune effects on the tumor, which, if I'm completely honest, I don't totally understand. And so, the improvement in overall survival, as far as I can see at the moment, is not matched by an improvement in progression-free survival. So I think we probably need to wait for more time to elapse to see what happens with the study. And so, I think it certainly is an interesting study, and the results are intriguing, but I think it's probably a little early for it to actually shift the treatment paradigm in this disease. Dr. Hamilton: Fantastic. I think we've been waiting for advances in pancreatic cancer for a long time, but this, not unlike others, we learn more and then learn more we don't realize, so. Dr. Sweetenham: Right. Let's shift gears at this point and talk about a couple of other abstracts in kind of a very different space. Let's start out with symptom management for older adults with cancer. We know that undertreated symptoms are common among the older patient population, and Abstract 11002 reported on a randomized trial that demonstrated the effects of remote monitoring for older patients with cancer in terms of kind of symptoms and so on. Can you tell us a little bit about this study and whether you think this approach will potentially improve care for older patients? Dr. Hamilton: Yeah, I really liked this abstract. It was conducted through the Veterans Affairs, and it was based in California, which I'm telling you that because it's going to have a little bit of an implication later on. But essentially, adults that were 75 years or older who were Medicare Advantage beneficiaries were eligible to participate. Forty-three clinics in Southern California and Arizona, and patients were randomized either into a control group of usual clinic care alone, or an intervention group, which was usual care plus a lay health worker-led proactive telephone-based weekly symptom assessment, and this was for 12 months using the validated Edmonton Symptom Assessment System. So, there was a planned enrollment of at least 200 patients in each group. They successfully met that. And this lay health worker reviewed assessments with a physician assistant, who conducted follow-up for symptoms that changed by 2 points from a prior assessment or were rated 4 or greater. So almost a triage system to figure out who needed to be reached out to and to kind of work on symptoms. What I thought was fantastic about this was it was very representative of where it enrolled. There were actually about 50% of patients enrolled here that were Hispanic or Latinos. So some of our underserved populations and really across a wide variety of tumor types. They found that the intervention group had 53% lower odds of emergency room use, 68% lower odds of hospital use than the control group. And when they translated this to actual total cost of care, this was a savings of about $12,000 U.S. per participant and 75% lower odds of a death in an acute care facility. So I thought this was really interesting for a variety of reasons. One, certainly health care utilization and cost, but even more so, I think any of our patients would want to prevent hospitalizations and ER visits. Normally, that's not a fantastic experience having to feel poorly enough that you're in the emergency room or the hospital. And really showing in kind of concrete metrics that we were able to decrease this with this intervention. In terms of sustainability and scalability, I think the question is really the workforce to do this. Obviously, you know, this is going to take dedicated employees to have the ability to reach out to these patients, etc., but I think in value-based care, there's definitely a possibility of having reimbursement and having the funds to institute a program like this. So, definitely thought-provoking, and I hope it leads to more interventions. Dr. Sweetenham: Yeah, we've seen, over several years now, many of these studies which have looked at remote symptom monitoring and so on in this patient population, and many of them do show benefits for that in kinds of end points, not the least in this study being hospitalization and emergency room avoidance. But I think the scalability and personnel issue is a huge one, and I do wonder at some level whether we may see some AI-based platforms coming along that could actually help with this and provide interactions with these patients outside of actual real people, or at least in combination with real people. Dr. Hamilton: Yeah, that's a fantastic point. So let's talk a little bit about clinical trials. So eligibility assessment for oncology clinical trials, or prescreening, really relies on manual review of unstructured clinical notes. It's time-consuming, it's prone to errors, and Abstract 1508 reported on the final analysis of a randomized trial that looked at the effect of human-AI teams prescreening for clinical trial eligibility versus human-only or AI-only prescreening. So give us more good news about AI. What did the study find? Dr. Sweetenham: Yeah, this is a really, a really interesting study. And of course, any of us who have ever been involved in clinical trials will know that accrual is always a problem. And I think most centers have attempted, and some quite successfully managed to develop prescreening programs so that patients are screened by a health care provider or health care worker prior to being seen in the clinic, and the clinical investigator will then already know whether they're going to be eligible for a trial or not. But as you've already said, it's a slow process. It's typically somewhat inefficient and requires a lot of time on the part of the health care workers to actually do this in a successful way. And so, this was a study from Emory University where they took three models of ways in which they could assess the accuracy of the prescreening of charts for patients who are going to be considered for clinical trials. One of these was essentially the regular way of having two research coordinators physically abstract the charts. The second one was an AI platform which would extract longitudinal EHR data. And then the third one was a combination of the two. So the AI would be augmented by the research coordinator or the other way around. As a gold standard, they had three independent oncology reviewers who went through all of these charts to provide what they regarded as being the benchmark for accuracy. In a way, it's not a surprise to me because I think that a number of other systems which have used this combination of human verification of AI-based tools, it actually ultimately concluded that the combination of the two in terms of chart accuracy was for the most part better than either one individually, either the research coordinator or the AI alone. So I'll give you just a few examples of where specifically that mattered. The human plus AI platform was more accurate in terms of tumor staging, in terms of identifying biomarker testing and biomarker results, as well as biomarker interpretation, and was also superior in terms of listing medications. There are one or two other areas where either the AI alone was somewhat more accurate, but the significant differences were very much in favor of a combination of human + AI screening of these patient charts. So, in full disclosure, this didn't save time, but what the authors reported was that there were definite efficiency gains, and presumably this would actually become even more improved once the research coordinators were somewhat more comfortable and at home with the AI tool. So, I thought it was an interesting way of trying to enhance clinical trial accrual up front by this combination of humans and technology, and I think it's going to be interesting to see if this gets adopted at other centers in the future. Dr. Hamilton: Yeah, I think it's really fascinating, all the different places that we can be using AI, and I love the takeaway that AI and humans together are better than either individually. Dr. Sweetenham: Absolutely. Thanks once again, Dr. Hamilton, for sharing your insights with us today and for all of the incredible work you did to build a robust program. And also, congratulations on what was, I think, a really remarkable ASCO this year, one of the most exciting for some time, I think. So thank you again for that. Dr. Hamilton: Thanks so much. It was really a pleasure to work on ASCO 2025 this year. Dr. Sweetenham: And thank you to our listeners for joining us today. You'll find links to all the abstracts we discussed today in the transcript of this episode. Be sure to catch up on all of our coverage from the Annual Meeting. You can catch up on my daily reports that were published each day of the Annual Meeting, featuring the key science and innovations presented. And we'll have wrap-up episodes publishing in June, covering the full spectrum of malignancies from ASCO25. If you value the insights you hear on the ASCO Daily News Podcast, please remember to rate, review, and subscribe wherever you get your podcasts. Disclaimer: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement. More on today's speakers: Dr. John Sweetenham Dr. Erika Hamilton @erikahamilton9 Follow ASCO on social media: @ASCO on Twitter ASCO on Bluesky ASCO on Facebook ASCO on LinkedIn Disclosures: Dr. John Sweetenham: No relationships to disclose Dr. Erika Hamilton: Consulting or Advisory Role (Inst): Pfizer, Genentech/Roche, Lilly, Daiichi Sankyo, Mersana, AstraZeneca, Novartis, Ellipses Pharma, Olema Pharmaceuticals, Stemline Therapeutics, Tubulis, Verascity Science, Theratechnologies, Accutar Biotechnology, Entos, Fosun Pharma, Gilead Sciences, Jazz Pharmaceuticals, Medical Pharma Services, Hosun Pharma, Zentalis Pharmaceuticals, Jefferies, Tempus Labs, Arvinas, Circle Pharma, Janssen, Johnson and Johnson Research Funding (Inst): AstraZeneca, Hutchison MediPharma, OncoMed, MedImmune, Stem CentRx, Genentech/Roche, Curis, Verastem, Zymeworks, Syndax, Lycera, Rgenix, Novartis, Millenium, TapImmune, Inc., Lilly, Pfizer, Lilly, Pfizer, Tesaro, Boehringer Ingelheim, H3 Biomedicine, Radius Health, Acerta Pharma, Macrogenics, Abbvie, Immunomedics, Fujifilm, eFFECTOR Therapeutics, Merus, Nucana, Regeneron, Leap Therapeutics, Taiho Pharmaceuticals, EMD Serono, Daiichi Sankyo, ArQule, Syros Pharmaceuticals, Clovis Oncology, CytomX Therapeutics, InventisBio, Deciphera, Sermonix Pharmaceuticals, Zenith Epigentics, Arvinas, Harpoon, Black Diamond, Orinove, Molecular Templates, Seattle Genetics, Compugen, GI Therapeutics, Karyopharm Therapeutics, Dana-Farber Cancer Hospital, Shattuck Labs, PharmaMar, Olema Pharmaceuticals, Immunogen, Plexxikon, Amgen, Akesobio Australia, ADC Therapeutics, AtlasMedx, Aravive, Ellipses Pharma, Incyte, MabSpace Biosciences, ORIC Pharmaceuticals, Pieris Pharmaceuticals, Pieris Pharmaceuticals, Pionyr, Repetoire Immune Medicines, Treadwell Therapeutics, Accutar Biotech, Artios, Bliss Biopharmaceutical, Cascadian Therapeutics, Dantari, Duality Biologics, Elucida Oncology, Infinity Pharmaceuticals, Relay Therapeutics, Tolmar, Torque, BeiGene, Context Therapeutics, K-Group Beta, Kind Pharmaceuticals, Loxo Oncology, Oncothyreon, Orum Therapeutics, Prelude Therapeutics, Profound Bio, Cullinan Oncology, Bristol-Myers Squib, Eisai, Fochon Pharmaceuticals, Gilead Sciences, Inspirna, Myriad Genetics, Silverback Therapeutics, Stemline Therapeutics
Audio roundup of selected biopharma industry content from Scrip over the business week ended 13 June 2025. In this episode: breaking down big pharma's executive pay; US vaccine panel upheaval; Merck's RSV approval; MFN and Japan; and the future of Pfizer and Arvinas's partnership. https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-BC44NPMNMNGMXP5X4STR4ZAFU4/ This episode was produced with the help of AI text-to-voice and voice emulation tools. Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things
The words of the week so far in biopharma are “deals” and “cancer”—or, more specifically, money being invested in cancer and other key therapeutic areas. With the American Society of Clinical Oncology's annual conference underway in Chicago, Bristol Myers Squibb got in the PD-1/PD-L1xVEGF game, paying potentially more than $11 billion to co-develop BioNTech's solid tumor bispecific BNT327. Elsewhere, Sanofi nabbed the year's second-biggest buyout, picking up Blueprint for $9.5 billion, expanding its rare disease portfolio. And Regeneron plunked down up to $2 billion to license a dual GLP-1/GIP receptor agonist from Chinese biopharma Hansoh Pharmaceuticals Group. Back in Chicago, presentations by AstraZeneca, Gilead and Amgen drew rave reviews from investor analysts, while Pfizer and Arvinas elaborated on mixed data from a PROTAC that showed positive results in only a subsection of breast cancer patients, failing to impress Wall Street. Meanwhile, Bicara's solid survival stats in head and neck cancer weren't enough to clear the high bar set by rival Merus. At the meeting, BioSpace's own Dan Samorodnitsky sat down with Jazz Pharmaceuticals' CMO Rob Iannone to discuss the company's recently acquired pediatric glioma drug, and talked AI strategy with AstraZeneca's head of U.S. oncology for lung cancer Arun Krishna. Dan recaps his ASCO experience here. Speaking of buzzy therapeutic spaces, there was more action on the vaccines front last week as Health and Human Services Secretary RFK Jr. announced that healthy children and healthy pregnant women would no longer be advised to get vaccinated against COVID-19. However, as of publication, the CDC still recommends a COVID vaccine for healthy children but instead of a universal recommendation advises that the decision should be made between parents and healthcare providers. Against this backdrop, the FDA signed off on Moderna's next-gen COVID-19 vaccine, mNEXSPIKE, for a limited population in line with its new guidelines. This was a much-needed win for Moderna, which last week had a $760 million-plus government contract for its mRNA-based bird flu vaccine terminated. Also on the policy front, the Trump administration released its Make America Healthy Again report last week to much scrutiny after reports found studies and references that did not exist.
Dr. John Sweetenham and Dr. Erika Hamilton discuss top abstracts that will be presented at the 2025 ASCO Annual Meeting, including research on tech innovations that could shape the future of oncology. Transcript Dr. John Sweetenham: Hello, and welcome to the ASCO Daily News Podcast. I'm your host, Dr. John Sweetenham, and I'm delighted to be joined today by Dr. Erika Hamilton, a medical oncologist and director of breast cancer and gynecologic cancer research at the Sarah Cannon Research Institute in Nashville, Tennessee. Dr. Hamilton is also the chair of the 2025 ASCO Annual Meeting Scientific Program, and she's here to tell us about some of the key abstracts, hot topics, and novel approaches in cancer care that will be featured at this year's Annual Meeting. Our full disclosures are available in the transcript of this episode. Dr. Hamilton, it's great to have you on the podcast today, and thanks so much for being here. Dr. Erika Hamilton: Thanks, Dr. Sweetenham. I'm glad to be here. Dr. John Sweetenham: Dr. Hamilton, the Presidential Theme of the Annual Meeting this year is ‘Driving Knowledge to Action: Building a Better Future,' and that's reflected in many of the sessions that will focus on action-oriented guidance to improve care for our patients. And as always, there'll be great presentations on practice-changing abstracts that will change treatment paradigms and transform care. Can you tell us about some of the hot topics this year and what you're particularly excited about? Dr. Erika Hamilton: You're right. Dr. Robin Zon's theme is ‘Driving Knowledge to Action: Building a Better Future,' and you're going to see that theme really interlaced throughout the ASCO program this year. We had a record number of submissions. Over 5,000 abstracts will be published, and there'll be about 3,000 presentations, either in oral format or poster presentations. We have 200 dynamic sessions. Many of the discussants will be highlighting key takeaways and how we can translate action-oriented guidance to better treat our patients to build a better future. Our state-of-the-art science will include a Plenary Session. This will feature presentations as well as discussion of each of the presentations for clinical late-breaking abstracts. We have Clinical Science Symposia that I'm particularly excited about this year. These will feature key abstracts as well as discussions and a foundational talk around the subject. We're covering novel antibody-drug conjugate targets, turning “cold” tumors “hot” to include CAR T, as well as the future of cancer detection. There'll be rapid oral abstracts, case-based panels, and this will also feature interactive audience polling and case discussions. I also want to highlight the community connection opportunities. There will be 13 Communities of Practice that will be meeting on-site during ASCO, and there's also really a plethora of networking opportunities for trainees and early-career professionals, a Women's Networking Center, a patient advocate space, and I'm happy to report there will also be live music out on the terrace this year at ASCO. Dr. John Sweetenham: Well, that's going to be a really great addition. I have to say, I think this is always a special time of year because excitement starts to mount as the meeting gets closer and closer. And once the abstracts are out there, I certainly personally feel that the excitement builds. Talking of abstracts, let's dive into some of the key abstracts for this year's meeting. I'd like to start out by asking you about Abstract 505. This reports on 15-year outcomes for women with premenopausal hormone receptor-positive early breast cancer in the SOFT and TEXT trials. It assesses the benefits of adjuvant exemestane and ovarian function suppression or tamoxifen and ovarian function suppression. So, could you talk us through this and tell us what you think the key takeaways from this abstract are? Dr. Erika Hamilton: Absolutely. This is essentially the SOFT and TEXT trials. They are trials that we've been following for quite some time, evidenced by the 15-year outcome. And I think it really answers two very important questions for us regarding adjuvant endocrine therapy for patients that are facing hormone receptor-positive disease. The benefit of ovarian function suppression for one, and then second, the benefit of exemestane over tamoxifen, which is our SERM [selective estrogen receptor modulator]. So, in terms of the SOFT trial, when we talk about distance recurrence-free interval, which I really think is probably the most meaningful because secondary cancers, et cetera, are not really what we're getting at here. But in terms of distant recurrence-free interval, certainly with tamoxifen, using tamoxifen plus ovarian function suppression adds a little bit. But where we really get additional benefits are by moving to exemestane, an aromatase inhibitor with the ovarian function suppression. So, for example, in SOFT, for distant recurrence-free interval for patients that have received prior chemotherapy, the distance recurrence-free interval was 73.5% with tamoxifen, bumped up just a tiny bit to 73.8% with ovarian function suppression. But when we used both ovarian function suppression and switched to that aromatase inhibitor, we're now talking about 77.6%. It may seem like these are small numbers, but when we talk about an absolute benefit of 4%, these are the type of decisions that we decide whether to offer chemotherapy based on. So, really just optimizing endocrine therapy really can provide additional benefits for these patients. Just briefly, when we turn to TEXT, similarly, when we look at distance recurrence-free interval for our patients that are at highest risk and receive chemotherapy, tamoxifen and ovarian function suppression, 79%; 81% with exemestane and ovarian function suppression. And when we talk about our patients that did not receive chemotherapy, it increased from 91.6% up to 94.6%—very similar that 3% to 4% number. So, I think that this is just very important information when counseling our patients about the decisions that they're going to make for themselves in the adjuvant setting and how much we want to optimize endocrine therapy. Dr. John Sweetenham: Thanks so much for your insight into that. Dr. Erika Hamilton: Yeah, absolutely. So, let's turn to hematologic malignancies. Abstract 6506 reports exciting results on the new agent ziftomenib in relapsed/refractory NPM1-mutant acute myeloid leukemia. This is a phase 1b clinical activity study and safety results. This was the pivotal KOMET-001 study. And my question is, will this new agent fulfill an unmet need in this NPM1 space? Dr. John Sweetenham: Yeah, great question. And I think the answer is almost certainly ‘yes'. So, just as some brief background, NPM1 mutation is known to be a driver of leukemogenesis in around 30% of patients with AML, and it's a poor prognostic factor. And typically, about 50% of these patients will relapse within a year of their first-line therapy, and only around 10% of them will get a subsequent complete remission with salvage therapy. Menin inhibitors, which disrupt the interaction between menin and KMT2A, are known to be active in NPM1-mutated as well as in KMT2A-rearranged AML. And ziftomenib is a selective oral menin inhibitor, which in this study was evaluated at a dose of 600 mg once a day, as you mentioned, a phase 1b/2 study, which is multicenter and presented by Dr. Eunice Wang from Roswell Park. It's a relatively large study of 112 patients who were treated with this standard dose with relatively short median follow-up at this time. The median age was 69 years, and median prior therapies were two, but with a range of one to seven. And I think very importantly, 60% of these patients had previously been treated with venetoclax, and 23% of them had had a prior transplant. Looking at the results overall for this study, the overall response rate was 35%, which is actually quite impressive. Specifically for those patients in the phase 2 part of the study, around 23% achieved a CR [complete remission] or CRh [complete remission with partial hematologic recovery]. What's very interesting in my mind is that the response rates were comparable in venetoclax-naive and venetoclax-exposed patients. And the drug was very well tolerated, with only 3% of patients having to discontinue because of treatment-related adverse events. And I think the authors appropriately conclude that, first of all, the phase 2 primary endpoint in the study was met, and that ziftomenib achieved deep and durable responses in relapsed and refractory NPM1-mutated AML, regardless of prior venetoclax, with good tolerance of the drug. And so, I think putting all of this together, undoubtedly, these data do support the potential use of this agent as monotherapy and as a new option for those patients who have relapsed or refractory NPM1-mutated acute myeloid leukemia. So, let's move on a little bit more now and change the subject and change gears completely and talk about circulating tumor DNA [ctDNA]. This has been a hot topic over a number of years now, and at this year's meeting, there are quite a few impactful studies on the use of ctDNA. We have time to focus on just one of these, and I wanted to get your thoughts on Abstract 4503. This is from the NIAGARA trial, which looks at ctDNA in patients with muscle-invasive bladder cancer who receive perioperative durvalumab. Could you tell us a little bit about this study? Dr. Erika Hamilton: So, this was the phase 3 NIAGARA trial, and this is literally looking for patients with muscle-invasive bladder cancer that are cisplatin-eligible, and the addition of durvalumab to neoadjuvant chemotherapy. So here, this is a planned exploratory analysis of ctDNA and the association with clinical outcomes from NIAGARA. So, this is really the type of study that helps us determine which of our patients are more likely to have a good outcome and which of our patients are more likely not to. There were 1,000 randomized patients in this study, and 462 comprised the biomarker-evaluable population. There were about half in the control arm and half in the durvalumab arm. And overall, the ctDNA-positive rate at baseline was about 57%, or a little over half, and that had decreased to about 22% after neoadjuvant treatment. ctDNA clearance rates from baseline to pre-radical cystectomy was about 41% among those with durvalumab and 31% among those in control. And the non-pCR rate was 97% among patients with pre-cystectomy ctDNA-positive status. So, this really gives us some information about predicting who is going to have better outcomes here. We did see a disease-free survival benefit with perioperative durvalumab, and this was observed in post-cystectomy ctDNA-positive as well as the ctDNA-negative groups. Shifting gears now to GI cancer, Abstract 3506 is a long-term safety and efficacy study of sotorasib plus panitumumab and FOLFIRI for previously treated KRAS G12C-mutated metastatic colorectal cancer. And this is the CodeBreaK-101 study. What are your thoughts on this study? Dr. John Sweetenham: Yeah, thanks. A very interesting study, and this abstract builds upon the phase 3 CodeBreaK-300 trial, which I think has just been published in the Journal of Clinical Oncology. This showed that the combination of sotorasib and panitumumab improved clinical outcomes in patients with chemorefractory KRAS G12C-mutated metastatic colorectal cancer. The current abstract, as you mentioned, reports the CodeBreaK-101 trial. And this was a phase 1b trial where FOLFIRI therapy was added to sotorasib and panitumumab in previously treated patients with KRAS G12C-mutated metastatic colorectal cancer. The abstract reports the overall and progression-free survival results, as well as some updated safety and response data. So, in this study, patients with this particular mutation who had received at least one prior systemic treatment but were KRAS G12C inhibitor-naive were enrolled into an expansion cohort of the CodeBreaK-101 protocol. And these patients received what apparently now recommended as the standard phase 2 dose of sotorasib of 960 mg daily, plus panitumumab and a standard dose of FOLFIRI. And the primary endpoint of the study was safety, and secondary endpoints included confirmed response, overall response, and progression-free survival, as assessed by the investigator. And by November of last year, 40 patients had been enrolled into this study. Common treatment-related adverse events were cutaneous; some patients developed neutropenia, and stomatitis was fairly widespread. Discontinuation of sotorasib because of adverse events was only seen in 1% of patients, although patients did have to discontinue because of toxicity from some of the other agents in the combination. Looking at the results of this study, the updated objective response rate was 57.5%, and the disease control rate was estimated at 92%, going on 93%, with a median time to response of 1.6 months and a median response duration of 6 months. After a median follow-up of 29.2 months, the median progression-free survival was 8.2 months, and the overall survival 17.9 months. So, the authors have concluded that this combination, including sotorasib, panitumumab, and FOLFIRI, does appear to show quite promising long-term efficacy in pretreated patients with this specific mutation. The ongoing phase 3 study they mentioned, CodeBreaK-301, is aiming to evaluate this combination against the standard of care in the first-line setting for patients with KRAS G12C-mutated colorectal cancer. So, promising results, and we'd be very interested to see how this particular combination performs in the frontline. Dr. Erika Hamilton: Fantastic. Thanks so much for sharing that. Let's shift gears again and really talk about digital technology. I feel that we're all going to have to get much better with this, and really, there are a lot of promises for our patients coming here. There are a lot of abstracts at ASCO that are focusing on innovations in digital technology, including a really interesting psychosocial digital application for caregivers of patients that are undergoing hematopoietic stem cell transplantation. Can you tell us a little bit about this? It's Abstract 11000. Dr. John Sweetenham: Yeah, absolutely. This abstract certainly caught my eye, and I think it's intriguing for a number of reasons, partly because it's app-based, and partly also because it specifically addresses caregiver burden and caregiver needs in the oncology setting, which I think is especially important. And although the context, the clinical context of this study, is hematopoietic stem cell transplantation, I think it has potential applications way beyond that. We all know that caregivers of patients undergoing stem cell transplantation have significant quality-of-life struggles. They are well-documented to have significant psychological and emotional strain before, during, and after stem cell transplantation. And this abstract describes an application called BMT-CARE, which is aimed at improving caregivers' quality of life, caregiver burden, mood symptoms, and coping skills, and so on. So, this was a single-center, randomized trial from MGH [Massachusetts General Hospital] of this app for stem cell transplant caregivers, compared with usual care in those individuals. And the eligible patients, or eligible individuals, were adults caring for patients with heme malignancy undergoing either an autologous or an allogeneic stem cell transplant. Patients were randomly assigned either to use the app or for usual care. And the app itself—and I think it'll be interesting to actually see this at the meeting and visualize it and see how user-friendly and so on it is—but it comprises five modules, which integrate psychoeducation, behavior change, stress management, and they're delivered through a kind of interactive platform of educational games and videos. And then participants were self-reporting at baseline and then 60 days after transplant. So, around 125 patients were enrolled in this study, of around 174 who were initially approached. So, just over 70% uptake from caregivers, which is, I think, relatively high, and evenly distributed between the two randomized arms. And the majority of the participants were spouses. And at 60 days post-stem cell transplant, the intervention participants reported a better quality of life compared with those who received usual care. If you break this down a little bit more, these participants reported lower caregiving burden, lower incidence of depression, fewer PTSD symptoms, and overall better coping skills. So, the authors conclude that this particular app, a digital health intervention, led to pretty substantial improvements in quality of life for these caregivers. So, intriguing. As I said, it'll be particularly interesting to see how this thing looks during the meeting. But if these kind of results can be reproduced, I think this sort of application has potential uses way beyond the stem cell transplant setting. Dr. Erika Hamilton: Yeah, I find that just so fascinating and very needed. I think that the caregiving role is often underestimated in how important that is for the patient and the whole family, and really giving our caregivers more tools in their toolbox certainly is quite helpful. Dr. John Sweetenham: Absolutely. Well, the meeting is getting closer, and as I mentioned earlier, I think anticipation is mounting. And I wanted to say thanks so much to you for chatting with me today about some of the interesting advances in oncology that we're going to see at this year's meeting. There is a great deal more to come. Our listeners can access links to the studies we've discussed today in the transcript of this episode. I'm also looking forward, Dr. Hamilton, to having you back on the podcast after the Annual Meeting to dive into some of the late-breaking abstracts and some of the other key science that's captured the headlines this year. So, thanks once again for joining me today. Dr. Erika Hamilton: Thanks so much for having me. Pleasure. Dr. John Sweetenham: And thank you to our listeners for joining us today. Be sure to catch my “Top Takeaways from ASCO25.” These are short episodes that will drop each day of the meeting at 5:30 p.m. Eastern Time. So, subscribe to the ASCO Daily News Podcast wherever you prefer to listen, and join me for concise analyses of the meeting's key abstracts. Disclaimer: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement. More on today's speakers: Dr. John Sweetenham Dr. Erika Hamilton @erikahamilton9 Follow ASCO on social media: @ASCO on Twitter ASCO on Bluesky ASCO on Facebook ASCO on LinkedIn Disclosures: Dr. John Sweetenham: No relationships to disclose Dr. Erika Hamilton: Consulting or Advisory Role (Inst): Pfizer, Genentech/Roche, Lilly, Daiichi Sankyo, Mersana, AstraZeneca, Novartis, Ellipses Pharma, Olema Pharmaceuticals, Stemline Therapeutics, Tubulis, Verascity Science, Theratechnologies, Accutar Biotechnology, Entos, Fosun Pharma, Gilead Sciences, Jazz Pharmaceuticals, Medical Pharma Services, Hosun Pharma, Zentalis Pharmaceuticals, Jefferies, Tempus Labs, Arvinas, Circle Pharma, Janssen, Johnson and Johnson Research Funding (Inst): AstraZeneca, Hutchison MediPharma, OncoMed, MedImmune, Stem CentRx, Genentech/Roche, Curis, Verastem, Zymeworks, Syndax, Lycera, Rgenix, Novartis, Millenium, TapImmune, Inc., Lilly, Pfizer, Lilly, Pfizer, Tesaro, Boehringer Ingelheim, H3 Biomedicine, Radius Health, Acerta Pharma, Macrogenics, Abbvie, Immunomedics, Fujifilm, eFFECTOR Therapeutics, Merus, Nucana, Regeneron, Leap Therapeutics, Taiho Pharmaceuticals, EMD Serono, Daiichi Sankyo, ArQule, Syros Pharmaceuticals, Clovis Oncology, CytomX Therapeutics, InventisBio, Deciphera, Sermonix Pharmaceuticals, Zenith Epigentics, Arvinas, Harpoon, Black Diamond, Orinove, Molecular Templates, Seattle Genetics, Compugen, GI Therapeutics, Karyopharm Therapeutics, Dana-Farber Cancer Hospital, Shattuck Labs, PharmaMar, Olema Pharmaceuticals, Immunogen, Plexxikon, Amgen, Akesobio Australia, ADC Therapeutics, AtlasMedx, Aravive, Ellipses Pharma, Incyte, MabSpace Biosciences, ORIC Pharmaceuticals, Pieris Pharmaceuticals, Pieris Pharmaceuticals, Pionyr, Repetoire Immune Medicines, Treadwell Therapeutics, Accutar Biotech, Artios, Bliss Biopharmaceutical, Cascadian Therapeutics, Dantari, Duality Biologics, Elucida Oncology, Infinity Pharmaceuticals, Relay Therapeutics, Tolmar, Torque, BeiGene, Context Therapeutics, K-Group Beta, Kind Pharmaceuticals, Loxo Oncology, Oncothyreon, Orum Therapeutics, Prelude Therapeutics, Profound Bio, Cullinan Oncology, Bristol-Myers Squib, Eisai, Fochon Pharmaceuticals, Gilead Sciences, Inspirna, Myriad Genetics, Silverback Therapeutics, Stemline Therapeutics
This Oncology PER®Spectives™ podcast explores the role of EZH2 in metastatic castration-resistant prostate cancer (mCRPC) progression and its synergy with androgen receptor inhibitors. In this podcast, experts Neeraj Agarwal, MD, FASCO; Himisha Beltran, MD; and Maha Hussain, MD, FACP, FASCO, discuss the management of mCRPC. Acknowledgment of Educational Grant Support This activity is supported by an educational grant from Pfizer Inc. Accreditation/Credit Designation Physicians' Education Resource®, LLC, is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians. Physicians' Education Resource®, LLC, designates this enduring material for a maximum of 1.5 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity. Physicians' Education Resource®, LLC is approved by the California Board of Registered Nursing, Provider #16669, for 1.5 Contact Hours. Instructions on How to Receive Credit Listen to this podcast in its entirety. Go to gotoper.com/credit and enter code: 6947 Answer the evaluation questions. Request credit using the drop-down menu. You may immediately download your certificate. Today's faculty are: Neeraj Agarwal, MD, FASCO Professor of Medicine Senior Director for Clinical Research HCI Presidential Endowed Chair of Cancer Research Director, Center of Investigational Therapeutics Director, Genitourinary Oncology Program Huntsman Cancer Institute, University of Utah (NCI-CCC) Salt Lake City, UT Disclosures: Grant/Research Support (paid to institution): Arvinas, Astellas, AstraZeneca, Bayer, Bristol Myers Squibb, Calithera, Celldex, Clovis, Crispr, Eisai, Eli Lilly, EMD Serono, Exelixis, Genentech, Gilead, GlaxoSmithKline, Immunomedics, Janssen, Lava, Merck, Nektar, Neoleukin, Novartis, Oric, Pfizer, Roche, Sanofi, Seagen, Takeda, Tra-con Himisha Beltran, MD Associate Professor of Medicine Director of Translational Research Within Medical Oncology Harvard Medical School Lank Center for Genitourinary Oncology and the Division of Molecular and Cellular Oncology Dana Farber Cancer Institute Boston, MA Disclosures: Grant/Research Support: Circle Pharma, Daiichi Sankyo, Novartis; Adviser: Amgen, AstraZeneca, Daiichi Sankyo, Novartis Maha Hussain, MD, FACP, FASCO Genevieve E. Teuton Professor of Medicine Professor, Medicine (Hematology/Oncology) Deputy Director Robert H. Lurie Comprehensive Cancer Center Northwestern University Feinberg School of Medicine Chicago, IL Disclosures: Advisory Board: AstraZeneca, Bayer, Convergent Therapeutics, Honoraria: AstraZeneca, Bayer The staff of Physicians' Education Resource®, LLC, have no relevant financial relationships with ineligible companies. PER® mitigated all COI for faculty, staff, and planners prior to the start of this activity by using a multistep process. Off-Label Disclosure and Disclaimer This activity may or may not discuss investigational, unapproved, or off-label use of drugs. Learners are advised to consult prescribing information for any products discussed. The information provided in this accredited activity is for continuing education purposes only and is not meant to substitute for the independent clinical judgment of a health care professional relative to diagnostic, treatment, or management options for a specific patient's medical condition. The opinions expressed in the content are solely those of the individual faculty members and do not reflect those of PER® or any company that provided commercial support for this activity. Release Date May 14, 2025 Expiration Date May 14, 2026
Audio roundup of selected biopharma industry content from Scrip over the business week ended 14 March 2025. In this episode: Roche's big new obesity deal; J&J opts out of next-gen Darzalex; Arvinas and Pfizer's protein degrader misses Phase III endpoint; Kelun wins first TROP2 ADC approval in lung cancer; and big name brands poised to lose US exclusivity. https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-QOIAKBVZ2FDQ7NL2SFMWK66HP4/ This episode was produced using AI text-to-voice and voice emulation software. Let me know your views: ian.haydock@citeline.com. Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things
In this episode of Life Science Success, my guest is John Houston, Ph.D., the Chairperson, Chief Executive Officer, and President of Arvinas. With over three decades of experience in drug discovery and development, Dr. Houston brings valuable insights into pioneering protein degradation therapeutics and the challenges of leading a cutting-edge biotech company. 00:00 Introduction to Life Science Success Podcast 00:46 Sponsor Message from D3 Digital Media Marketing 01:25 Meet John Houston: CEO of Arvinas 03:07 Transition from Big Pharma to Biotech 04:40 Remote Work and Company Growth 06:46 Impact of BMS Experience on Arvinas 10:57 Innovations in Protein Degradation 17:39 Collaborations and Partnerships 30:26 Challenges and Future of Biotech 35:06 Personal Insights and Leadership Advice 42:57 Conclusion and Final Thought
Arvinas is a biotech company dedicated to improving the lives of patients suffering from debilitating and life-threatening diseases. In this podcast episode, Dr. Randy Teel discusses the company's PROTAC protein degrader technology platform and its pipeline of clinical-stage assets, with a focus on vepdegestrant, the company's lead asset that is being co-developed together with partner Pfizer, for the treatment of women with early and locally advanced or metastatic ER+/HER2- breast cancer.
Dr. Lillian Siu and Dr. Melvin Chua discuss the new technologies and novel therapeutics that were featured at the 2024 ASCO Breakthrough meeting. TRANSCRIPT Dr. Lillian Siu: Hello and welcome to the ASCO Daily News Podcast. I'm Dr. Lillian Siu, a medical oncologist and director of the Phase 1 Trials Program at the Princess Margaret Cancer Center in Toronto, Canada, and a professor of medicine at the University of Toronto. On today's episode, we'll be discussing key takeaways from the 2024 ASCO Breakthrough meeting in Yokohama, Japan. Joining me for this discussion is Dr. Melvin Chua, who served as the chair of Breakthrough's Program Committee. Dr. Chua is the head of the Department for Head, Neck and Thoracic Cancers in the Division of Radiation Oncology at the National Cancer Center in Singapore. Our full disclosures are available in the transcript of this episode. Dr. Chua, it's great to be speaking with you today and congratulations on a very successful Breakthrough meeting. Dr. Melvin Chua: Thanks Dr. Siu. It was really inspiring to come together again to showcase the innovative work of world-renowned experts, clinicians, researchers, med-tech pioneers, and drug developers from around the globe. Our theme this year was inclusivity and thus it was important to bring people together again in the Asia Pacific region and to foster international collaborations that are so important in advancing cancer care. This year, we invited 65 international faculty, of which 55% were from Asia. Also, importantly, we achieved approximately a 50-50 split for male to female representation. These are remarkable statistics for the meeting, and we really hope to retain this for future Breakthrough [meetings]. Dr. Lillian Siu: The meeting featured renowned keynote speakers who shared great insights on new technologies and therapies that are shaping the future of drug development and care delivery. Let's first talk about artificial intelligence and the keynote address by Dr. Andrew Trister. He gave a very interesting talk titled, “Plaiting the Golden Braid: How Artificial Intelligence Informs the Learning Health System.” What are the key messages from his talk? Dr. Melvin Chua: Couldn't agree with you more, Dr. Siu. Dr. Trister is the chief medical and scientific officer of Verily, a precision health company. He previously worked in digital health and AI at The Bill and Melinda Gates Foundation, and worked at Apple where he led clinical research and machine learning with Apple partners. But perhaps it was really his background and training as a radiation oncologist that was most pertinent as he was able to weave both the components of new AI models and the applications and pitfalls in the clinic to the audience. Dr. Trister provided a very high-level view through the history of AI and showcased the progression of the different AI models and he basically explained between deep and shallow methods as well as deductive logic versus inductive probabilistic methods. He then provided several clinical examples where these models have shown their utility in the clinic, for example, pathology and so forth. At the same time, he illustrated several pitfalls with these models. So overall, I think Dr. Trister's talk was very well received by the audience with several key messages, including the importance of [using] high-quality data as the basis of a good AI model. AI was also addressed in an Education Session that looked at Artificial Intelligence in the Cancer Clinic. And we had a panel of experts that highlighted current progress and successes with AI in the clinic, advances with AI assisted pathology for clinical research and precision medicine, large language models (LLMs) for applications in the clinic, and how we could leverage AI in precision oncology. And from this session, I had several key takeaways. Dr. Alexander Pearson [of the University of Chicago] gave a very illustrative talk on how multimodal information across clinical omics, radiological information and multi omics could be used to improve diagnostic tasks and clinical prediction across different cancers. And Dr. Joe Yeong [of Singapore General Hospital] gave a very good talk on how AI can be applied in digital pathology to accelerate research in immunology and help in the development of immunotherapies. Dr. Danielle Bitterman [of Brigham and Women's Hospital] shared very good examples of how LLMs could be used in a clinic. And I think the example that really stood out for me was how LLMs could be deployed to create responses to patient queries. And of course, the big question in the room was: How could AI eventually encapsulate compassion in their response? I think this again showcased how LLMs could really help to accelerate our clinical work going forward. And ultimately circling back to data, Dr. Caroline Chung [of MD Anderson] gave a very poignant description on the importance of data quality and how poor-quality data could eventually lead to underperforming AI models. So all in all, I think this was a great session. And what do you think, Dr. Siu? Dr. Lillian Siu: Melvin, I totally agree with you. I like all your comments and I really enjoyed the keynote as well as the session on AI in the cancer clinic chaired by Dr. Pearson. I think all these sessions were really informative. Discussions on the latest AI and machine learning, algorithms and technologies on digital pathology, LLMs and big data, as you said, really enables the attendees, especially clinicians like me, to gain a deep understanding of how AI can be translated to practical applications. Dr. Melvin Chua: Great. So, Dr. Siu, let's talk about some of the novel therapeutics that were featured at the meeting. Again, this was an important session for Breakthrough, and it's always been there. So could you share some highlights from the sessions on novel drug development from your perspective? Dr. Lillian Siu: Yes, indeed. Drug development is such an exciting aspect of this meeting. On Day 3 of the meeting, we had a keynote by Dr. Shimon Sakaguchi of Osaka University, who discussed “Targeting Regulatory T cells (Tregs) in Cancer: The Science, Trials, and Future.” And he talked about T cells, especially Treg biology, the role of Tregs in immune regulation, new developments in Treg immuno-oncology drugs, and how we can actually target Tregs to treat early cancers, etc. This talk is particularly exciting because there are now anti CCR8 antibodies in the clinic that specifically target Tregs, and some early signals of anti-tumor activities are already being observed. Dr. Sakaguchi also emphasized the importance of combination sequence and timing of drugs for the successful use of cancer immunotherapeutic agents. I also want to emphasize the Education Session that followed, titled, “The Future of Immunotherapy, New Drugs and New Ideas.” In that particular session, we heard about engineering T-cell immunity to eradicate tumors. We heard about CAR T-cell therapy in GI cancers, novel immunotherapeutic combinations, and T-cell engagers, which are bispecifics in cancer. While success with some of these immunotherapeutic modalities, such as cell therapies and T-cell engagers have been largely seen in hematological malignancies, we are beginning to observe efficacy signals in solid tumors. For example, the CAR T targeting Claudin18.2 in gastrointestinal cancers and the recently approved FDA-approved DLL3/CD3 bispecific T-cell engager, tarlatamab, in small cell lung cancer are really exciting examples. We also heard from investigators who are exploring neoadjuvant therapies in the neoadjuvant therapy session, and the key takeaway from that session is that we have growing interest in using neoadjuvant therapy or perioperative therapy. In other words, neoadjuvant plus adjuvant therapy in different cancers. In the neoadjuvant session, there were updates provided by different experts on the roles of neoadjuvant therapy in melanoma, liver cancer, bladder cancer, and nasopharyngeal cancer. Increasingly, there is randomized trial evidence to support the use of neoadjuvant therapy or perioperative immunotherapy in several cancer types with survival-based endpoints. Very exciting indeed. Dr. Melvin Chua: Indeed, I couldn't agree with you more. I think one of the things that went into designing the case-based discussions this year was that we wanted to talk about cancers that were relevant to this part of the world and hence we again showcased lung cancers, gastric cancers and melanomas, and whereby we have again perspectives from an expert from the West coupled to an expert from the East, thereby showcasing the diversity of practice around the world. The other thing that we did this year was we decided to pair the case-based discussions with the keynotes and the Education Sessions as well. For example, on Day 3, we had Dr. Sakaguchi speak on Tregs, as you mentioned. And this was followed by an in-depth session on new immunotherapies, and then followed by a case-based discussion on different melanoma cases on the role of neoadjuvant immunotherapy in this disease, and the strikingly relevance of response to prognostication. This is an important trait that we're seeing now that seems to pan out across different cancers, where we find that neoadjuvant response to combination systemic therapies and/or radiotherapy is a strong prognosticator. Dr. Lillian Siu: So, Dr. Chua, we've discussed some breakthrough treatments and promising advances in cancer care, and we've touched upon some barriers to success in cancer treatment. I would like to ask you about the keynote address by Dr. Raffaella Casolino of the World Health Organization, who spoke passionately about efforts by the WHO and its partners to build equity in cancer care. Can you share some highlights with us? Dr. Melvin Chua: Absolutely, Dr. Siu. In spite of the tremendous advances we've seen in recent years in oncology, there are still major disparities in cancer care, such as cost and access, which affect patients worldwide. I think Dr. Casolino's talk was a very nice overview whereby she showed, first of all, the WHO's impact in terms of the WHO Cancer Resolution initiative that was implemented in 2017, where through this initiative, WHO has impacted 100 countries, invested $1 billion in funds, and that has led to millions of lives saved. But she then really drilled down to some of the key examples of the focus of the WHO in terms of equalizing care in cancer. I think one which struck me was the appreciation of the disparities in the clinical trials landscape. I think it is clear that there's still a huge barrier to clinical trials between the high- and middle-income countries and the low- and middle-income countries, and the majority of clinical trials these days are industry sponsored and we really need to look at leveling the playing field in this regard. Then she highlighted the WHO's work on trying to lower the barriers to precision oncology. And I think there are several issues in that sense, but I think what the WHO has really worked hard on is promoting education for genomic medicine, where they've done several reviews with experts around the world to educate the field across the world on how we interpret and apply genomics in the clinic. So all in all, it was very interesting to hear Dr. Casolino's insights from a policy perspective, and again, this emphasizes that there's so much work to be done at the end of the day and the dialogue needs to continue. We also heard about policy, academic and industry perspectives in the context of clinical trials, and that led to a discussion on real-world evidence generation for regulatory approvals. It was very nice that we had a session on that at the end of Breakthrough 2024 (Real-World Evidence and Clinical Trials: Beyond the Ivory Tower). And in that session, we heard from Dr. Shaalan Beg [of the NIH], and Dr. Janet Dancey [of Queen's University] who represented views from academia and Dr. Hidetoshi Hayashi [of Kindai University Hospital] shared perspectives on decentralized trials. I'd like to encourage our listeners to watch these sessions if they were unable to attend. The content is very rich, and I'm sure they'll learn from it. Dr. Lillian Siu: Thank you so much, Dr. Chua. Is there anything else you would like to cover before we wrap up the podcast today? Dr. Melvin Chua: Thank you, Dr. Siu. The thing I really want to emphasize is, apart from all these Educational Sessions and having very eminent keynote speakers, one of the key points that we really want to bring out for Breakthrough is to showcase the high-quality research. This year we had 300 abstracts submitted and they were all high quality, cutting across trials, omics research, AI and technology, and eventually we selected 235 of them and we were able to showcase some of them across three oral sessions over three days. I think this is an important component of Breakthrough that we really wish to continue building upon where people are now excited to use this forum to present their work. Dr. Lillian Siu: Thank you so much, Dr. Chua. I really enjoyed our discussions today. I look forward to seeing how the Breakthrough meeting will continue to grow in future years. Dr. Melvin Chua: Thank you again, Dr. Siu. Thank you for all your leadership and efforts in making Breakthrough a successful meeting series the past few years. Dr. Lillian Siu: Thank you to our listeners for your time today. You'll find links to the session discussed today in the transcript of this episode. Finally, if you value the insights that you hear on the ASCO Daily News Podcast, please take a moment to rate, review and subscribe wherever you get your podcast. Thank you. Disclaimer: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement. Find out more about today's speakers: Dr. Lilian Siu @lillian_siu Dr. Melvin Chua @DrMLChua Follow ASCO on social media: @ASCO on Twitter ASCO on Facebook ASCO on LinkedIn Disclosures: Dr. Lillian Siu: Leadership (Immediate family member): Treadwell Therapeutics Stock and Other Ownership Interests (Immediate family member): Agios Consulting or Advisory Role: Merck, AstraZeneca/MedImmune, Roche, Voronoi Inc., Oncorus, GSK, Seattle Genetics, Arvinas, Navire, Janpix, Relay Therapeutics, Daiichi Sankyo/UCB Japan, Janssen, Research Funding (Institution): Bristol-Myers Squibb, Genentech/Roche, GlaxoSmithKline, Merck, Novartis, Pfizer, AstraZeneca, Boehringer Ingelheim, Bayer, Amgen, Astellas Pharma, Shattuck Labs, Symphogen, Avid, Mirati Therapeutics, Karyopharm Therapeutics, Amgen Dr. Melvin Chua: Leadership, Stock and Other Ownership Interests: Digital Life Line Honoraria: Janssen Oncology, Varian Consulting or Advisory Role: Janssen Oncology, Merck Sharp & Dohme, ImmunoSCAPE, Telix Pharmaceuticals, IQVIA, BeiGene Speakers' Bureau: AstraZeneca, Bayer, Pfizer, Janssen Research Funding: PVmed, Decipher Biosciences, EVYD Technology, MVision, BeiGene, EVYD Technology, MVision, BeiGene Patents, Royalties, Other Intellectual Property: High Sensitivity Lateral Flow Immunoassay for Detection of Analyte in Samples (10202107837T), Singapore. (Danny Jian Hang Tng, Chua Lee Kiang Melvin, Zhang Yong, Jenny Low, Ooi Eng Eong, Soo Khee Chee)
Dr. Allison Zibelli and Dr. Erika Hamilton discuss the results of the DESTINY-Breast06 trial in HR+, HER2-low and HER2-ultralow metastatic breast cancer and the A-BRAVE trial in early triple-negative breast cancer, the results of which were both presented at the 2024 ASCO Annual Meeting. TRANSCRIPT Dr. Allison Zibelli: Hello, I'm Dr. Allison Zibelli, your guest host of the ASCO Daily News Podcast. I'm an associate professor of medicine and breast medical oncologist at the Sidney Kimmel Cancer Center of Jefferson Health in Philadelphia. My guest today is Dr. Erika Hamilton, a medical oncologist and director of breast cancer research at the Sarah Cannon Research Institute. We'll be discussing the DESTINY-Breast06 trial, which showed a progression-free advantage with the antibody-drug conjugate trastuzumab deruxtecan (T-DXd) compared to chemotherapy in hormone receptor-positive HER2-low or HER2-ultralow metastatic breast cancer. We'll address the implications of this study for the community, including the importance of expanding pathology assessments to include all established subgroups with HER2 expression, and the promise of expanding eligibility for antibody-drug conjugates. We'll also highlight advances in triple-negative breast cancer, focusing on the A-BRAVE trial, the first study reporting data on an immune checkpoint inhibitor avelumab in patients with triple-negative breast cancer with invasive residual disease after neoadjuvant chemotherapy. Our full disclosures are available in the transcript of this episode. Erika, it's great to have you on the podcast today. Dr. Erika Hamilton: Thanks so much, Allison. Happy to join. Dr. Allison Zibelli: Antibody-drug conjugates are rapidly changing the treatment landscape in breast cancer. The data from the DESTINY-Breast06 trial suggests that trastuzumab deruxtecan may become a preferred first-line treatment option for most patients with HER2-low or HER2-ultralow metastatic breast cancer after progression on endocrine therapy. First, could you remind our listeners, what's the definition of HER2-ultralow and what were the findings of this trial? Dr. Erika Hamilton: Yeah, those are fantastic questions. Ultralow really has never been talked about before. Ultralow is part of a subset of the IHC zeros. So it's those patients that have HER2-tumor staining that's less than 10% and incomplete but isn't absolutely zero. It's even below that +1 or +2 IHC that we have classified as HER2-low. Now, I think what's important to remember about D-B06, if you recall, D-B04 (DESTINY-Breast04) was our trial looking at HER2-low, is that D-B06 now included HER2-low as well as this HER2-ultralow category that you asked about. And it also moved trastuzumab deruxtecan up into the frontline. If you recall, D-B04 was after 1 line of cytotoxic therapy. So now this is really after exhausting endocrine therapy before patients have received other chemotherapy. And what we saw was an improvement in progression-free survival that was pretty significant: 13.2 months versus 8.1 months, it was a hazard ratio of 0.62. And you can ask yourself, “well, was it mainly those HER2-low patients that kind of drove that benefit? What about the ultralow category?” And when we look at ultralow, it was no different: 13.2 months versus 8.3 months, hazard ratio, again, highly significant. So I think it's really encouraging data and gives us some information about using this drug earlier for our patients with hormone receptor-positive but HER2-negative disease. Dr. Allison Zibelli: I thought this study was really interesting because it's a patient population that I find very difficult to treat, the hormone receptor-positive metastatic patient that's not responding to endocrine therapy anymore. But it's important to mention that T-DXd resulted in more serious toxicities compared to traditional chemotherapy in this study. So how do you choose which patients to offer this to? Dr. Erika Hamilton: Yeah, those are both great points. So you're right, this is after endocrine therapy. And in fact, about 85% of these patients had received at least 2 prior lines of endocrine therapy. So I have some people kind of asking, “Well, if endocrine therapy really isn't benefiting everyone in the second-line setting post-CDK, should we just move to the ADCs?” And, no, probably we should really make sure that we're exhausting endocrine therapies for those patients that are going to benefit. And once we determine somebody has endocrine-resistant disease, that's when we would think about switching. In terms of the side effects, I think you're right. It's mainly ILD that's probably the more serious side effect that we worry about a little bit with trastuzumab deruxtecan. The good news is, through multiple trials, we've gotten a little bit better at managing this. We've pretty much all but eliminated any fatal cases of ILD, definitely less than 1% now. ILD rates, depending on what study you look for, kind of ranges in that 10% to 15% range. Any grade ILD on D-B06 was 11.3%. So really kind of making sure that we look for ILD at scans, making sure that patients are educated to tell us about any new pulmonary symptoms: cough, exertional dyspnea, shortness of breath at rest, etc. But I think the most common side effects that we really deal with on a daily basis with trastuzumab deruxtecan, luckily, is nausea, which we've gotten better at managing with the 2- or 3-drug antiemetic regimen, and probably a little bit of fatigue as well. Dr. Allison Zibelli: Thank you. So, I think for most people in the community, the sticking point here will be expanding pathology assessments to include all of the subgroups, including the ultralow. Most patients in the community are not testing for HER2-low and HER2-ultralow now. Dr. Erika Hamilton: Historically, we kind of all did HER2 IHC, right? And then as FISH became available, there were a lot of institutions that moved to FISH and maybe didn't have IHC anymore. And now, at least in my institution, we do both. But I think it's a very important point that you made that IHC was really designed to pick out those patients that have HER2-high, the 3 pluses or the FISH amplified cases. It was not to tell the difference between a 1+ or a 2+ or a 0 that's not quite a 0 and a 1+. So I think you're right. I think this is tough. I probably have a little bit more of an interesting take on this than some people will. But data from ASCO, not this year but in 2023, there was actually a pretty eloquent study presented where they looked at serial biopsies in patients, and essentially, if you got up to 4 or 5 biopsies, you were guaranteed to have a HER2-low result. Now, this didn't even include ultralow, which is even easier. If we know we include ultralow, we're really talking about probably 85% to 90% of our patients now that have some HER2 expression. But if we biopsy enough, we're guaranteed to get a HER2 low. And so I think the question really is, if we know IHC wasn't really designed to pick out these ultralows, and we know kind of greater than 90% of patients are going to have some expression, did we kind of develop this drug a little bit backwards? Because we thought we understood HER2, and the reality is this drug is a little bit more like a sacituzumab govitecan, where we don't test for the TROP2. Should we really be kind of serial biopsying these patients or should maybe most patients have access to at least trying this drug? Dr. Allison Zibelli: So I don't think that most of my patients will really be happy to sign up for serial biopsies. Dr. Erika Hamilton: Agreed. Dr. Allison Zibelli: Do we have any emerging technologies for detecting low levels of HER2? You talked about how the IHC test isn't really designed to detect low levels of HER2. Do you think newer detection techniques such as immunofluorescence will make a difference, or will we have liquid biopsy testing for this? Dr. Erika Hamilton: Yeah, I think liquid biopsy may be a little bit hard, just because some of those circulating tumor cells are more of a mesenchymal-type phenotype and don't necessarily express all of the same receptors. Normally, if they're cytokeratin-positive, they do, but certainly there is a lot out there looking at more sensitive measures. You mentioned immunofluorescence, there are some even more quantitative measures looking at lower levels of HER2. I definitely think there will be. I guess, ultimately, with even the IHC zeros that are the less than 10% incomplete staining, having a PFS that was absolutely no different than the HER2 low, I guess the question is, how low can we really go? We know that even the IHC zeros doesn't mean that there's no HER2 expression on the cell surface. It just means that maybe there's a couple of thousand as opposed to 10,000 or 100,000 copies of HER2. And so it really appears that perhaps this drug really is wedded to having a lot of HER2 expression. So ultimately, I wonder how much we're going to have to use those tests, especially with what we know about tumor heterogeneity. We know that if we biopsy 1 lesion in the liver, biopsy a lymph node, or even another lesion in the liver, that the HER2 results can have some heterogeneity. And so ultimately, my guess is that most people have some HER2 expression on their breast cancer cells. Dr. Allison Zibelli: So maybe we're going to be using this for everybody in the future. Dr. Erika Hamilton: It certainly seems like we keep peeling back the onion and including more and more patients into the category that are eligible to receive this. I agree. Dr. Allison Zibelli: Let's move on to triple-negative breast cancer, namely the A-BRAVE trial. This was an interesting trial for patients that did not get neoadjuvant immunotherapy and testing 2 groups. The first group was those with residual disease after neoadjuvant conventional chemotherapy. The second group was people with high-risk disease identified upfront that had upfront surgery. The study found that adjuvant avelumab did not improve disease-free survival versus observation, which was the study's primary endpoint. But interestingly, there was a significant improvement in 3-year overall survival and distant disease-free survival. Can you give us your thoughts on that? Dr. Erika Hamilton: Yeah, I think this study was really interesting. Right now, the standard for our patients with larger or node-positive triple-negative cancers is KEYNOTE-522. It's a pretty tough regimen. It's kind of 2 sequential uses of 2 chemotherapies, so 4 chemotherapy agents total with pembrolizumab. But you're right, this study looked at those that had residual disease after neoadjuvant that didn't include immunotherapy, or those patients that didn't get neoadjuvant therapy, went to surgery, and then were receiving chemotherapy on the back end. I'm going to give you the numbers, because you're right. The 3-year disease-free survival rates were not statistically significant. It was 68.3% among those that had avelumab, 63.2% with those that had observation only. So the difference was 5.1% in favor of avelumab, but it wasn't statistically significant. A p value of 0.1, essentially. But when we looked at the 3-year overall survival rates, we saw the same pattern, those patients with the avelumab doing better, but it was 84.8% overall survival and not, unfortunately, dying, versus 76.3%. So the magnitude of benefit there was 8.5%, so about 3% higher than we saw for disease-free survival, and this was statistically significant. So is this going to change practice for most patients? I probably don't think so. I think for our patients that have larger tumors that's recognized upfront or have node positivity, we're probably going to want to use neoadjuvant chemo. Being able to get a PCR is very prognostic for our patients and enables us to offer things on the back end, such as PARP inhibitors or further chemotherapy of a different type of chemotherapy. But for our patients that go to surgery and maybe the extent of their disease just isn't recognized initially, this could be an option. Dr. Allison Zibelli: I agree. I think this will be a really useful regimen for patients where we get the surprise lymph node that we weren't expecting, or somebody who comes to us, maybe without seeing the medical oncologist, who got upfront surgery. So I thought this was really interesting. What kind of translational studies do you think we're going to do to try and understand which patients would benefit from avelumab? Dr. Erika Hamilton: Yeah, I think that's a great question, and honestly, it's a question that we haven't really answered in the neoadjuvant setting either. Immunotherapy in breast cancer is just a little bit different than it is in some other diseases. We have a benefit for those patients that are PD-L1 positive in the first line. We really haven't seen benefit for metastatic outside of first line. And then in neoadjuvant, it was among all comers. We don't have to test for PD-L1. And now we have this avelumab data from A-BRAVE. I think the question is, is there's probably a subset of patients that are really getting benefit and a subset that aren't. And I don't know that PD-L1 testing is the right test. We know a lot of people are looking at TILs, so kind of lymphocytes that are infiltrating the tumor, a variety of other kind of immunologic markers. But my guess is that eventually we're going to get smart enough to tease out who actually needs the immunotherapy versus who isn't going to benefit. But we're not quite there yet. Dr. Allison Zibelli: Thank you, Erika, for sharing your valuable insights with us on the ASCO Daily News Podcast today. Dr. Erika Hamilton: Thanks so much for having me. Dr. Allison Zibelli: And thank you to our listeners for joining us. You'll find the links to all the abstracts discussed today in the transcript of this episode. Finally, if you like this podcast and you value our insights, please take a moment to rate, review, and subscribe wherever you get your podcasts. It really helps other people to find us. So thank you very much for listening today. Disclaimer: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement. Find out more about today's speakers: Dr. Allison Zibelli Dr. Erika Hamilton @ErikaHamilton9 Follow ASCO on social media: @ASCO on Twitter ASCO on Facebook ASCO on LinkedIn Disclosures: Dr. Allison Zibelli: None Disclosed Dr. Erika Hamilton: Consulting or Advisory Role (Inst): Pfizer, Genentech/Roche, Lilly, Daiichi Sankyo, Mersana, AstraZeneca, Novartis, Ellipses Pharma, Olema Pharmaceuticals, Stemline Therapeutics, Tubulis, Verascity Science, Theratechnologies, Accutar Biotechnology, Entos, Fosun Pharma, Gilead Sciences, Jazz Pharmaceuticals, Medical Pharma Services, Hosun Pharma, Zentalis Pharmaceuticals, Jefferies, Tempus Labs, Arvinas, Circle Pharma, Janssen, Johnson and Johnson Research Funding (Inst): AstraZeneca, Hutchison MediPharma, OncoMed, MedImmune, Stem CentRx, Genentech/Roche, Curis, Verastem, Zymeworks, Syndax, Lycera, Rgenix, Novartis, Millenium, TapImmune, Inc., Lilly, Pfizer, Lilly, Pfizer, Tesaro, Boehringer Ingelheim, H3 Biomedicine, Radius Health, Acerta Pharma, Macrogenics, Abbvie, Immunomedics, Fujifilm, eFFECTOR Therapeutics, Merus, Nucana, Regeneron, Leap Therapeutics, Taiho Pharmaceuticals, EMD Serono, Daiichi Sankyo, ArQule, Syros Pharmaceuticals, Clovis Oncology, CytomX Therapeutics, InventisBio, Deciphera, Sermonix Pharmaceuticals, Zenith Epigentics, Arvinas, Harpoon, Black Diamond, Orinove, Molecular Templates, Seattle Genetics, Compugen, GI Therapeutics, Karyopharm Therapeutics, Dana-Farber Cancer Hospital, Shattuck Labs, PharmaMar, Olema Pharmaceuticals, Immunogen, Plexxikon, Amgen, Akesobio Australia, ADC Therapeutics, AtlasMedx, Aravive, Ellipses Pharma, Incyte, MabSpace Biosciences, ORIC Pharmaceuticals, Pieris Pharmaceuticals, Pieris Pharmaceuticals, Pionyr, Repetoire Immune Medicines, Treadwell Therapeutics, Accutar Biotech, Artios, Bliss Biopharmaceutical, Cascadian Therapeutics, Dantari, Duality Biologics, Elucida Oncology, Infinity Pharmaceuticals, Relay Therapeutics, Tolmar, Torque, BeiGene, Context Therapeutics, K-Group Beta, Kind Pharmaceuticals, Loxo Oncology, Oncothyreon, Orum Therapeutics, Prelude Therapeutics, Profound Bio, Cullinan Oncology, Bristol-Myers Squib, Eisai, Fochon Pharmaceuticals, Gilead Sciences, Inspirna, Myriad Genetics, Silverback Therapeutics, Stemline Therapeutics
Dr. Pedro Barata and Dr. Lillian Siu discuss recent advances in cancer vaccines and biomarkers, including the potential of the neoantigen and immune modulatory vaccines and the challenges surrounding cancer vaccine development. TRANSCRIPT Dr. Pedro Barata: Hello, I'm Dr. Pedro Barata, your guest host for the ASCO Daily News Podcast today. I'm a GU medical oncologist at the University Hospitals Seidman Cancer Center in Cleveland, Ohio, and an associate professor of medicine at Case Western Reserve University School of Medicine. I'm also an associate editor of the ASCO Educational Book. And today we'll be discussing a timely article that was recently published in the Educational Book titled, “State-Of-The-Art Advancements on Cancer Vaccines and Biomarkers.” I'm delighted to welcome one of the article's co-authors and a world-renowned oncologist, Dr. Lillian Siu. She is a senior medical oncologist and director of the Phase 1 Program at the Princess Margaret Cancer Center and a professor of medicine at the University of Toronto. Welcome, Dr. Siu. Dr. Lillian Siu: Thank you, Dr. Barata; it's great to be here. Dr. Pedro Barata: Wonderful. Dr. Siu will discuss new tools for cancer vaccine development, strategies for combating the immunosuppressive and tumor microenvironment. She will also address cancer vaccine guidelines and patient recruitment strategies to optimize patient selection and access to cancer vaccine trials. I should say that Dr. Siu and her co-authors also addressed this topic during an Education Session at the ASCO 2024 Annual Meeting. Finally, our full disclosures are available in the transcript of this episode. So again, Dr. Siu, great to be speaking with you today. I'm looking forward to our discussion. Dr. Lillian Siu: Thank you, Dr. Barata. And before I begin, I want to acknowledge Dr. Jeffrey Weber and Dr. Inge Marie Svane, who both presented during the ASCO session you mentioned. They gave excellent presentations related to the topic of neoantigen vaccines and immune-modulatory vaccines, which we will talk about later. Dr. Pedro Barata: Wonderful. So let's get started. Cancer vaccines are among the most promising frontiers for breakthrough innovations and new strategies in the fight against cancer. The successes in vaccine development during the COVID-19 pandemic, I think, inspired further research in this area. Why do you think it's important that we harness these recent successes and technological advances to really accelerate progress in vaccine development? Dr. Lillian Siu: Absolutely. I think all of us who have lived through COVID really appreciated how important the COVID vaccine development was to all of us. It saved millions of lives. And I think we witnessed a paradigm change in drug development that none of us thought was possible, that we're able to actually bring a concept to a drug from bench to bedside within an extremely short time. That timeline is not something we would ever imagine to have happened, and it did. And I think it gives us hope that perhaps this is not just limited to the COVID vaccine; it's also extrapolatable to other therapeutics – that we can bring promising medicines to our patients in a really expedited timeline, obviously without compromising their safety. We now know that cancer vaccines have entered a new, or maybe I should say, renewed era of promise. And it's holding promise on many fronts, Pedro, if I may. It's very exciting in the area of molecular residual disease. In other words, a setting where the cancer is treated definitively by surgery or radiation, plus adjuvant treatment. And we know some patients will relapse because we know they're at high risk. And now we also have different ways to detect these microscopic risks, such as by ctDNA, circulating tumor DNA, or biomarkers. And we know that having some therapeutic that can eradicate these cancers at such microscopic levels would be very attractive, especially with low toxicity, and I think cancer vaccine is such a candidate. And of course, we can even look further into the future of using such treatment in cancer prevention, especially in those with high risk of developing cancer, for example, those with hereditary syndromes like lynch syndrome. We're not there yet, but I think it holds that promise. So I think, going back to your original question, if we can develop such a therapeutic that is showing promise in a very short period of time, it brings the timeline and the hope to a much shorter timeframe to really deliver to our patients in a very timely manner while safeguarding all the important parts, such as safety and tolerability. Dr. Pedro Barata: Wow, those are such important points. I couldn't agree with you, more. It's really exciting. As I think through this, and as I was reading through your piece, I was thinking it would be great if you could highlight some of the novel approaches to personalized neoantigen vaccine development that are driving progress in this space. Dr. Lillian Siu: Absolutely. And during the session, Dr. Weber spoke about the neoantigen vaccine, and he's a pioneer in this space. So I can only try to iterate some of the points he had delivered during his talk. Neoantigen is a very exciting space for immunologists because we know that tumors express these neoantigens. Many of these are unique antigens that are only expressed in tumors, so-called tumor specific antigens, that we can use as our targets, including vaccines, but not limited to vaccines. And with these altered sequences in DNA in different forms, they could be mutations and splice alterations, etc. We expect that we have modified proteins that are expressed by tumor cells, and these become targets for our drug development of vaccines. And now we can have very specific strategies, very sophisticated algorithms to figure out which neoantigens are more so called immunogenic, more likely to stimulate or activate the immune system, and they can be recognized by T cells. So leveraging this knowledge and technology, we have been able to develop especially mRNA vaccines that are deliverable to our patients through different mechanisms, for example, in lipopeptides, etc., so that we can deliver to the patients in a safe way, such that we can use it to deliver vaccines, such as in the MRD setting that I mentioned earlier, as well as in the advanced disease setting. So Dr. Weber, in his presentation, highlighted one of such vaccines that have been tested in a randomized controlled trial that is KEYNOTE-942, which randomized 157 patients to the mRNA vaccine plus pembrolizumab versus pembrolizumab alone in patients with advanced melanoma. This is a vaccine against 34 mutated neoantigens, and it showed a significant difference in the recurrence free survival with a hazard ratio of 0.56. And if you look at the 18-month relapse free survival rate, it was 78.6% versus 62.2%. Obviously, these are still fairly early data and numbers are still small. I think we would definitely look forward to the randomized phase 3 study of neoantigen vaccine in melanoma and other cancers. Dr. Pedro Barata: No, absolutely. And I agree, it's really exciting. Dr. Weber did a fantastic job going through some of that data. So let me ask you Dr. Siu, as you think about this cancer vaccine field, what are the limitations that you'd highlight when you think about cancer vaccine development? What challenges do you encounter, obstacles do you encounter? Dr. Lillian Siu: There are many, many potential challenges. And to some extent, that's probably why cancer vaccine development has been somewhat slow for the many decades until more recently. We know first of all; the target has to be recognized. So we need immunogenic targets. So I think a lot of the effort has been put into trying to understand which antigens expressed by cancer cells are immunogenic, able to activate the immune system. They're obviously assay based methods. You're going to try and see if you can ex vivo stimulate immune cells on dishes and models, etc. But we need to also develop in silico computerized algorithms, and now with AI, I think that makes it even more tangible and exciting that we can actually understand through a large number of neoantigens or other antigens, whether we can choose the ones that are most likely going to actually stimulate T cells to be activated. And I think that is one area that there is a lot of interest in development, how to really develop ways to select out the most attractive antigens. I would also want to highlight that the platforms, which is how we deliver the vaccine, can also pose significant challenges. For example, vaccines can be delivered using peptide-based formulation, cell-based formulation, nucleic acids and viral vectors. For some of these formulations, for example, the peptides very often are restricted to HLA. They can be rapidly degraded in the body, such that they become not really visible to the T cells anymore. Some of the formulations can be very complex. For example, the cell-base; it may need to have cells isolated from patients, cultured, stored and transported to the site of delivery, which can be very complex. For some of the nucleic acid vaccines, they can have very low transfection efficiency. It could be at risk for also having, for example, DNA vaccines integrated into the host genome. And then lastly, there's also the immune suppressive environment in the TME, such that it does not really have the effect when you give it repeatedly. It becomes attenuated and no longer effective. So these are some of the challenges associated with cancer vaccines. Dr. Pedro Barata: Thank you for that summary. I think it's really important for folks out there, including researchers getting into this field, to be aware of potential obstacles they might encounter. So let me ask you the opposite question as we see more compelling preclinical and clinical data emerging in this field of vaccine development, what is really exciting you the most about the newest technologies that are shaping the future of cancer vaccines, in your opinion? Dr. Lillian Siu: I think one I want to highlight is the immune-modulatory vaccine that Dr. Svane, Dr. Inge Marie Svane had presented during the presentation at ASCO. This is a completely different strategy from the neoantigen vaccine. It targets antigens in the tumor microenvironment. And we know that in the tumor microenvironment, we have tumor cells, we have immune cells, and there are many types of cell types, including, for example, macrophages, cancer associated fibroblasts, regulatory T cells, etc. And using these particular cell types, we know that we can really develop vaccines that can stimulate the body's immune system to attenuate, to downgrade some of the negative factors in the tumor microenvironment. And this is what Dr. Svane and her group is trying to do. For example, they have an IDO vaccine that is able to actually target these antigens in the tumor microenvironment, and by that, not just suppressing the negative forces, so to speak, but also activate T cells to help attack cancer cells. I think that's a very interesting area. Very early promise has been seen already in non-small cell lung cancer in early phase trials using the immune-modulatory vaccine. But going back to your question, what kind of advances; I mentioned earlier about having novel ways to select our antigens that are most immunogenic. There are many algorithms that are being developed, and I think we can try and leverage that kind of knowledge from artificial intelligence, machine learning. So I think that's definitely very exciting. There are also new vaccine platforms coming out. For example, there's recent data using modification of peptides, so called amphiphile vaccines, that already show very early promise in colorectal cancer, microsatellite status, colorectal cancer, as well as in pancreatic cancer in the molecular residual disease setting, where these long peptide vaccines targeting KRAS mutants together with adjuvant oligonucleotide DNA, combined together, can actually be given to patients and reduce the chance of cancer relapse in patients with resected colorectal cancer, as well as pancreatic cancer, with endpoints such as ctDNA or biomarker being downregulated. I think that's a very exciting example. Another very exciting example is cell-based vaccines that are being developed in Europe by the NKI Netherlands Cancer Institute Group, where they are looking at plasmacytoid dendritic cells that are loaded with peptides from different tumor associated antigens and then given to patients, which, again, in non-small cell lung cancer, together with pembrolizumab, has yielded very high response rate. And we will almost certainly see more trials coming out using that particular platform with the dendritic cells. So that's just some of the examples of exciting things that are happening in the vaccine field. Dr. Pedro Barata: Thank you. I'm wondering if you can share with our listeners about what really are the existing guidelines for using these new tools for discovery, methods of treatment, and perhaps optimizing patient selection to access trials. Dr. Lillian Siu: To be honest, the latest guideline that was published from the FDA that I can find is almost 13 years ago in 2011. So I think it is time for a new guidance, or at least a draft guidance, to give some additional support and guidance in terms of what to do with these new treatments from the FDA and perhaps other regulatory agencies as well. I think we're now entering a very exciting time that cancer vaccines are no longer an ineffective therapeutic. It is now showing evidence of efficacy, not just in the advanced setting, but also in the molecular residual disease setting. There're so many questions to be answered, like how to develop these trials in early disease; what's the end point? Can we incorporate them into the neoadjuvant setting, and if so, how do we give these drugs before surgery, and do we give them maintenance after surgery? I think guidance from the regulatory authorities would be extremely helpful and informative to guide academic groups as well as the pharmaceutical sector to develop these agents in the right way. Dr. Pedro Barata: Dr. Siu, this is a fantastic summary, and we certainly are on the cusp of a new dawn of discovery and development in cancer vaccines, and super interesting to hear from you talking about it. Before letting you go, do you have any final thoughts that you'd like to share with the listeners, with all of us about this topic? Dr. Lillian Siu: I think as a drug developer like you are, I'm extremely excited because we now have yet another way to leverage the host immunity as a cancer therapeutic, and it is going to be opening a new door to combination therapy because we can imagine combining these treatments with other immunotherapeutics such as bispecific molecules such as CAR Ts and even vaccine plus vaccine combination is feasible. That came up actually during the session as a question from the audience. Can we combine neoantigen vaccines and immune-modulatory vaccines together? And both of our speakers who presented felt that it was possible. Obviously, we have to understand the sequence question and the endpoints question, but the fact that it opens a new door to combinatorial therapy, not just with immunotherapeutics, but perhaps with other therapeutics as well, antibody drug conjugates, etc., really, I think, is very exciting for this field to become further explored. I mentioned earlier in the podcast that the whole area of cancer prevention is something that we have not been tapping into for the last decade with vaccines because it has not been very effective. Viral vaccines, of course, HPV and other vaccines targeting viruses, but targeting cancer cells is not something we have been successful using vaccines to prevent cancer from developing. I think we would be very interested to see if this will become a reality in the next decade. I think we would start off with patients with high risk of developing cancers such as, as I mentioned earlier, those with lynch syndrome, those harboring BRCA alterations, for example. Can we use these vaccines to actually prevent the cancers from developing in such high-risk individuals? I think the field is definitely open to that consideration. Dr. Pedro Barata: Definitely. And I'd like to thank you, Dr. Siu, for sharing these great insights with us today on the ASCO Daily News Podcast. Dr. Lillian Siu: Thank you so much for your time. Dr. Pedro Barata: And thank you to all the listeners for your time today. You'll find a link to the article discussed today in the transcript of this episode, and I encourage you to check out the 2024 ASCO Educational Book. Finally, if you value the insights that you hear on the podcast, please take a moment to rate, review, and subscribe wherever you get your podcasts. So again, thank you so much for your time and see you soon. Disclaimer: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement. Follow today's speakers: Dr. Pedro Barata @PBarataMD Dr. Lillian Siu @lillian_siu Follow ASCO on social media: @ASCO on Twitter ASCO on Facebook ASCO on LinkedIn Disclosures: Dr. Pedro Barata: Honoraria: UroToday Consulting or Advisory Role: Bayer, BMS, Pfizer, EMD Serono, Eisai, Caris Life Sciences, AstraZeneca, Exelixis, AVEO, Dendreon Speakers' Bureau (Inst): Caris Life Sciences, Bayer, Pfizer/Astellas Research Funding (Inst.): Blueearth, AVEO, Pfizer, Merck Dr. Lillian Siu: Leadership (Immediate family member): Treadwell Therapeutics Stock and Other Ownership Interests (Immediate family member): Agios Consulting or Advisory Role: Merck, AstraZeneca/MedImmune, Roche, Voronoi Inc., Oncorus, GSK, Seattle Genetics, Arvinas, Navire, Janpix, Relay Therapeutics, Daiichi Sankyo/UCB Japan, Janssen, Research Funding (Institution): Bristol-Myers Squibb, Genentech/Roche, GlaxoSmithKline, Merck, Novartis, Pfizer, AstraZeneca, Boehringer Ingelheim, Bayer, Amgen, Astellas Pharma, Shattuck Labs, Symphogen, Avid, Mirati Therapeutics, Karyopharm Therapeutics, Amgen
On this week's episode of Biotech Hangout, hosts Brad Loncar, Daphne Zohar, Luba Greenwood and Eric Schmidt kick off the discussion with Vertex's plans to acquire Alpine Immune Sciences for almost $5 billion in cash, making it the largest deal for the sector in 2024. The hosts also discuss inflation effects on biotech stocks and M&A, macro takeaways from AACR and more fallout from the BioSecurity Act and implications for the industry. The group covers the US Department of Justice's complaint filed against Regeneron related to its eye drug, Eylea, and the unfortunate impact on the industry's reputation around drug pricing. The hosts also discuss Novartis' deal to pay $150 million for Arvinas's prostate cancer therapy and e-therapeutics CEO Ali Mortazavi joins the panel to discuss the London Stock Exchange challenges and his company's plans to delist from the LSE's junior market, AIM. *This episode aired on April 12, 2024.
This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, downloadable Practice Aids, slides, and complete CME/MOC/NCPD/CPE/AAPA/IPCE information, and to apply for credit, please visit us at PeerView.com/KBV865. CME/MOC/NCPD/CPE/AAPA/IPCE credit will be available until February 17, 2025.Simplifying the Complicated: An Algorithmic Guide for Clinical Decision-Making in HR+, HER2- EBC and MBC In support of improving patient care, PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported by an educational grant from Lilly.Disclosure PolicyAll relevant conflicts of interest have been mitigated prior to the commencement of the activity.Faculty/Planner DisclosuresChair/PlannerErika Hamilton, MD, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for Arcus Biosciences, Inc.; Arvinas, Inc.; AstraZeneca; Daiichi Sankyo, Inc.; Deciphera Pharmaceuticals, Inc.; Ellipses Pharma; F. Hoffmann-La Roche Ltd/Genentech, Inc.; Greenwich LifeSciences, Inc.; iTeos Therapeutics; Janssen Pharmaceuticals, Inc.; Lilly; Loxo Oncology; Mersana Therapeutics; Novartis Pharmaceuticals Corporation; Orum Therapeutics; Pfizer; Relay Therapeutics; Seagen Inc.; and Verascity Science (all paid to institution).Grant/Research Support from AbbVie Inc.; Accutar Biotechnology Inc; Acerta Pharma; ADC Therapeutics SA; Akeso Biopharma Co., Ltd.; Amgen Inc.; Aravive; Artios Pharma; Arvinas, Inc.; AstraZeneca; AtlasMedx, Inc.; BeiGene, Inc.; Black Diamond Therapeutics, Inc.; Bliss Biopharmaceutical (Hangzhou) Co., Ltd.; Boehringer Ingelheim Pharmaceuticals, Inc.; Cascadian Therapeutics; Clovis Oncology; Compugen; Cullinan Oncology, Inc.; Curis, Inc.; CytomX Therapeutics, Inc.; Daiichi Sankyo, Inc.; Dana-Farber Cancer Institute; Dantari; Deciphera Pharmaceuticals, Inc.; Duality Biologics; eFFECTOR Therapeutics, Inc.; Ellipses Pharma; Elucida Oncology, Inc.; EMD Serono, Inc.; F. Hoffmann-La Roche Ltd/Genentech, Inc.; FUJIFILM Pharmaceuticals U.S.A., Inc.; G1 Therapeutics, Inc.; H3 Biomedicine Inc.; Harpoon Therapeutics; HUTCHMED (China) Limited; ImmunoGen, Inc.; Immunomedics, Inc.; Incyte; Infinity Pharmaceuticals, Inc.; InvestisBio; Jacobio Pharmaceuticals Group Co., Ltd.; K-Group Beta, Inc.; Karyopharm; Lilly; Loxo Oncology; Lycera; MabSpace Biosciences Co., Ltd.; MacroGenics, Inc.; MedImmune, LLC; Mersana Therapeutics; Merus; Millennium Pharmaceuticals, Inc.; Molecular Templates, Inc.; Novartis Pharmaceuticals Corporation; Nucana; Olema Oncology; OncoMed Pharmaceuticals, Inc.; Onconova Therapeutics; Oncothyreon; ORIC Pharmaceuticals, Inc.; Orinove Inc.; Pfizer; PharmaMar; Pieris Pharmaceuticals, Inc.; Pionyr Immunotherapeutics; Plexxikon; Radius Health, Inc.; Regeneron Pharmaceuticals Inc.; Relay Therapeutics; Repertoire Immune Medicines; Rgenix Inc.; Seagen Inc.; Sermonix Pharmaceuticals; Shattuck Labs Inc.; Stemcentrx, Inc.; Sutro Biopharma, Inc.; Syndax; Syros Pharmaceuticals, Inc.; Taiho Oncology, Inc.; TapImmune Inc; TESARO, Inc.; Tolmar Pharmaceuticals, Inc.; Torque Therapeutics, Inc.; Treadwell Therapeutics; Verastem, Inc.; Vincerx Pharma; zenithepigenetics; and Zymeworks Inc. (all paid to institution).Faculty/PlannerKomal Jhaveri, MD, FACP, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for AbbVie Inc.; AstraZeneca; Blueprint Medicines; Bristol Myers Squibb; Daiichi Sankyo, Inc.; Eisai Inc.; F. Hoffmann-La Roche Ltd/Genentech, Inc.; Jounce Therapeutics, Inc.; Lilly/Loxo Oncology; Menarini Group/Stemline Therapeutics; Novartis Pharmaceuticals Corporation; Pfizer; Scorpion Therapeutics; Seattle Genetics, Inc. (Seagen Inc.); Sun Pharma Advanced Research Company; and Taiho Oncology, Inc.Grant/Research Support from ADC Therapeutics SA; AstraZeneca; Blueprint Medicines; Debiopharm; Genentech, Inc.; Gilead Sciences, Inc.; Lilly; Merck & Co., Inc.; Novartis Pharmaceuticals Corporation; Novita Pharmaceuticals, Inc.; Pfizer; Puma Biotechnology, Inc.; Scorpion Therapeutics; and Zymeworks Inc.Faculty/PlannerProfessor Stephen Johnston, MA, PhD, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for AstraZeneca; Lilly; Novartis Pharmaceuticals Corporation; Pfizer; Puma Biotechnology, Inc.; and Sanofi.Grant/Research Support from AstraZeneca; F. Hoffmann-La Roche Ltd/Genentech, Inc.; Lilly; Novartis Pharmaceuticals Corporation; Pfizer; and Puma Biotechnology, Inc.Speakers Bureau participant with AstraZeneca; Eisai Inc.; F. Hoffmann-La Roche Ltd/Genentech, Inc.; and Pfizer.Planning Committee and Reviewer DisclosuresPlanners, independent reviewers, and staff of PVI, PeerView Institute for Medical Education, do not have any relevant financial relationships related to this CE activity unless listed below.
This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, downloadable Practice Aids, slides, and complete CME/MOC/NCPD/CPE/AAPA/IPCE information, and to apply for credit, please visit us at PeerView.com/KBV865. CME/MOC/NCPD/CPE/AAPA/IPCE credit will be available until February 17, 2025.Simplifying the Complicated: An Algorithmic Guide for Clinical Decision-Making in HR+, HER2- EBC and MBC In support of improving patient care, PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported by an educational grant from Lilly.Disclosure PolicyAll relevant conflicts of interest have been mitigated prior to the commencement of the activity.Faculty/Planner DisclosuresChair/PlannerErika Hamilton, MD, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for Arcus Biosciences, Inc.; Arvinas, Inc.; AstraZeneca; Daiichi Sankyo, Inc.; Deciphera Pharmaceuticals, Inc.; Ellipses Pharma; F. Hoffmann-La Roche Ltd/Genentech, Inc.; Greenwich LifeSciences, Inc.; iTeos Therapeutics; Janssen Pharmaceuticals, Inc.; Lilly; Loxo Oncology; Mersana Therapeutics; Novartis Pharmaceuticals Corporation; Orum Therapeutics; Pfizer; Relay Therapeutics; Seagen Inc.; and Verascity Science (all paid to institution).Grant/Research Support from AbbVie Inc.; Accutar Biotechnology Inc; Acerta Pharma; ADC Therapeutics SA; Akeso Biopharma Co., Ltd.; Amgen Inc.; Aravive; Artios Pharma; Arvinas, Inc.; AstraZeneca; AtlasMedx, Inc.; BeiGene, Inc.; Black Diamond Therapeutics, Inc.; Bliss Biopharmaceutical (Hangzhou) Co., Ltd.; Boehringer Ingelheim Pharmaceuticals, Inc.; Cascadian Therapeutics; Clovis Oncology; Compugen; Cullinan Oncology, Inc.; Curis, Inc.; CytomX Therapeutics, Inc.; Daiichi Sankyo, Inc.; Dana-Farber Cancer Institute; Dantari; Deciphera Pharmaceuticals, Inc.; Duality Biologics; eFFECTOR Therapeutics, Inc.; Ellipses Pharma; Elucida Oncology, Inc.; EMD Serono, Inc.; F. Hoffmann-La Roche Ltd/Genentech, Inc.; FUJIFILM Pharmaceuticals U.S.A., Inc.; G1 Therapeutics, Inc.; H3 Biomedicine Inc.; Harpoon Therapeutics; HUTCHMED (China) Limited; ImmunoGen, Inc.; Immunomedics, Inc.; Incyte; Infinity Pharmaceuticals, Inc.; InvestisBio; Jacobio Pharmaceuticals Group Co., Ltd.; K-Group Beta, Inc.; Karyopharm; Lilly; Loxo Oncology; Lycera; MabSpace Biosciences Co., Ltd.; MacroGenics, Inc.; MedImmune, LLC; Mersana Therapeutics; Merus; Millennium Pharmaceuticals, Inc.; Molecular Templates, Inc.; Novartis Pharmaceuticals Corporation; Nucana; Olema Oncology; OncoMed Pharmaceuticals, Inc.; Onconova Therapeutics; Oncothyreon; ORIC Pharmaceuticals, Inc.; Orinove Inc.; Pfizer; PharmaMar; Pieris Pharmaceuticals, Inc.; Pionyr Immunotherapeutics; Plexxikon; Radius Health, Inc.; Regeneron Pharmaceuticals Inc.; Relay Therapeutics; Repertoire Immune Medicines; Rgenix Inc.; Seagen Inc.; Sermonix Pharmaceuticals; Shattuck Labs Inc.; Stemcentrx, Inc.; Sutro Biopharma, Inc.; Syndax; Syros Pharmaceuticals, Inc.; Taiho Oncology, Inc.; TapImmune Inc; TESARO, Inc.; Tolmar Pharmaceuticals, Inc.; Torque Therapeutics, Inc.; Treadwell Therapeutics; Verastem, Inc.; Vincerx Pharma; zenithepigenetics; and Zymeworks Inc. (all paid to institution).Faculty/PlannerKomal Jhaveri, MD, FACP, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for AbbVie Inc.; AstraZeneca; Blueprint Medicines; Bristol Myers Squibb; Daiichi Sankyo, Inc.; Eisai Inc.; F. Hoffmann-La Roche Ltd/Genentech, Inc.; Jounce Therapeutics, Inc.; Lilly/Loxo Oncology; Menarini Group/Stemline Therapeutics; Novartis Pharmaceuticals Corporation; Pfizer; Scorpion Therapeutics; Seattle Genetics, Inc. (Seagen Inc.); Sun Pharma Advanced Research Company; and Taiho Oncology, Inc.Grant/Research Support from ADC Therapeutics SA; AstraZeneca; Blueprint Medicines; Debiopharm; Genentech, Inc.; Gilead Sciences, Inc.; Lilly; Merck & Co., Inc.; Novartis Pharmaceuticals Corporation; Novita Pharmaceuticals, Inc.; Pfizer; Puma Biotechnology, Inc.; Scorpion Therapeutics; and Zymeworks Inc.Faculty/PlannerProfessor Stephen Johnston, MA, PhD, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for AstraZeneca; Lilly; Novartis Pharmaceuticals Corporation; Pfizer; Puma Biotechnology, Inc.; and Sanofi.Grant/Research Support from AstraZeneca; F. Hoffmann-La Roche Ltd/Genentech, Inc.; Lilly; Novartis Pharmaceuticals Corporation; Pfizer; and Puma Biotechnology, Inc.Speakers Bureau participant with AstraZeneca; Eisai Inc.; F. Hoffmann-La Roche Ltd/Genentech, Inc.; and Pfizer.Planning Committee and Reviewer DisclosuresPlanners, independent reviewers, and staff of PVI, PeerView Institute for Medical Education, do not have any relevant financial relationships related to this CE activity unless listed below.
This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, downloadable Practice Aids, slides, and complete CME/MOC/NCPD/CPE/AAPA/IPCE information, and to apply for credit, please visit us at PeerView.com/KBV865. CME/MOC/NCPD/CPE/AAPA/IPCE credit will be available until February 17, 2025.Simplifying the Complicated: An Algorithmic Guide for Clinical Decision-Making in HR+, HER2- EBC and MBC In support of improving patient care, PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported by an educational grant from Lilly.Disclosure PolicyAll relevant conflicts of interest have been mitigated prior to the commencement of the activity.Faculty/Planner DisclosuresChair/PlannerErika Hamilton, MD, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for Arcus Biosciences, Inc.; Arvinas, Inc.; AstraZeneca; Daiichi Sankyo, Inc.; Deciphera Pharmaceuticals, Inc.; Ellipses Pharma; F. Hoffmann-La Roche Ltd/Genentech, Inc.; Greenwich LifeSciences, Inc.; iTeos Therapeutics; Janssen Pharmaceuticals, Inc.; Lilly; Loxo Oncology; Mersana Therapeutics; Novartis Pharmaceuticals Corporation; Orum Therapeutics; Pfizer; Relay Therapeutics; Seagen Inc.; and Verascity Science (all paid to institution).Grant/Research Support from AbbVie Inc.; Accutar Biotechnology Inc; Acerta Pharma; ADC Therapeutics SA; Akeso Biopharma Co., Ltd.; Amgen Inc.; Aravive; Artios Pharma; Arvinas, Inc.; AstraZeneca; AtlasMedx, Inc.; BeiGene, Inc.; Black Diamond Therapeutics, Inc.; Bliss Biopharmaceutical (Hangzhou) Co., Ltd.; Boehringer Ingelheim Pharmaceuticals, Inc.; Cascadian Therapeutics; Clovis Oncology; Compugen; Cullinan Oncology, Inc.; Curis, Inc.; CytomX Therapeutics, Inc.; Daiichi Sankyo, Inc.; Dana-Farber Cancer Institute; Dantari; Deciphera Pharmaceuticals, Inc.; Duality Biologics; eFFECTOR Therapeutics, Inc.; Ellipses Pharma; Elucida Oncology, Inc.; EMD Serono, Inc.; F. Hoffmann-La Roche Ltd/Genentech, Inc.; FUJIFILM Pharmaceuticals U.S.A., Inc.; G1 Therapeutics, Inc.; H3 Biomedicine Inc.; Harpoon Therapeutics; HUTCHMED (China) Limited; ImmunoGen, Inc.; Immunomedics, Inc.; Incyte; Infinity Pharmaceuticals, Inc.; InvestisBio; Jacobio Pharmaceuticals Group Co., Ltd.; K-Group Beta, Inc.; Karyopharm; Lilly; Loxo Oncology; Lycera; MabSpace Biosciences Co., Ltd.; MacroGenics, Inc.; MedImmune, LLC; Mersana Therapeutics; Merus; Millennium Pharmaceuticals, Inc.; Molecular Templates, Inc.; Novartis Pharmaceuticals Corporation; Nucana; Olema Oncology; OncoMed Pharmaceuticals, Inc.; Onconova Therapeutics; Oncothyreon; ORIC Pharmaceuticals, Inc.; Orinove Inc.; Pfizer; PharmaMar; Pieris Pharmaceuticals, Inc.; Pionyr Immunotherapeutics; Plexxikon; Radius Health, Inc.; Regeneron Pharmaceuticals Inc.; Relay Therapeutics; Repertoire Immune Medicines; Rgenix Inc.; Seagen Inc.; Sermonix Pharmaceuticals; Shattuck Labs Inc.; Stemcentrx, Inc.; Sutro Biopharma, Inc.; Syndax; Syros Pharmaceuticals, Inc.; Taiho Oncology, Inc.; TapImmune Inc; TESARO, Inc.; Tolmar Pharmaceuticals, Inc.; Torque Therapeutics, Inc.; Treadwell Therapeutics; Verastem, Inc.; Vincerx Pharma; zenithepigenetics; and Zymeworks Inc. (all paid to institution).Faculty/PlannerKomal Jhaveri, MD, FACP, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for AbbVie Inc.; AstraZeneca; Blueprint Medicines; Bristol Myers Squibb; Daiichi Sankyo, Inc.; Eisai Inc.; F. Hoffmann-La Roche Ltd/Genentech, Inc.; Jounce Therapeutics, Inc.; Lilly/Loxo Oncology; Menarini Group/Stemline Therapeutics; Novartis Pharmaceuticals Corporation; Pfizer; Scorpion Therapeutics; Seattle Genetics, Inc. (Seagen Inc.); Sun Pharma Advanced Research Company; and Taiho Oncology, Inc.Grant/Research Support from ADC Therapeutics SA; AstraZeneca; Blueprint Medicines; Debiopharm; Genentech, Inc.; Gilead Sciences, Inc.; Lilly; Merck & Co., Inc.; Novartis Pharmaceuticals Corporation; Novita Pharmaceuticals, Inc.; Pfizer; Puma Biotechnology, Inc.; Scorpion Therapeutics; and Zymeworks Inc.Faculty/PlannerProfessor Stephen Johnston, MA, PhD, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for AstraZeneca; Lilly; Novartis Pharmaceuticals Corporation; Pfizer; Puma Biotechnology, Inc.; and Sanofi.Grant/Research Support from AstraZeneca; F. Hoffmann-La Roche Ltd/Genentech, Inc.; Lilly; Novartis Pharmaceuticals Corporation; Pfizer; and Puma Biotechnology, Inc.Speakers Bureau participant with AstraZeneca; Eisai Inc.; F. Hoffmann-La Roche Ltd/Genentech, Inc.; and Pfizer.Planning Committee and Reviewer DisclosuresPlanners, independent reviewers, and staff of PVI, PeerView Institute for Medical Education, do not have any relevant financial relationships related to this CE activity unless listed below.
This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, downloadable Practice Aids, slides, and complete CME/MOC/NCPD/CPE/AAPA/IPCE information, and to apply for credit, please visit us at PeerView.com/KBV865. CME/MOC/NCPD/CPE/AAPA/IPCE credit will be available until February 17, 2025.Simplifying the Complicated: An Algorithmic Guide for Clinical Decision-Making in HR+, HER2- EBC and MBC In support of improving patient care, PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported by an educational grant from Lilly.Disclosure PolicyAll relevant conflicts of interest have been mitigated prior to the commencement of the activity.Faculty/Planner DisclosuresChair/PlannerErika Hamilton, MD, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for Arcus Biosciences, Inc.; Arvinas, Inc.; AstraZeneca; Daiichi Sankyo, Inc.; Deciphera Pharmaceuticals, Inc.; Ellipses Pharma; F. Hoffmann-La Roche Ltd/Genentech, Inc.; Greenwich LifeSciences, Inc.; iTeos Therapeutics; Janssen Pharmaceuticals, Inc.; Lilly; Loxo Oncology; Mersana Therapeutics; Novartis Pharmaceuticals Corporation; Orum Therapeutics; Pfizer; Relay Therapeutics; Seagen Inc.; and Verascity Science (all paid to institution).Grant/Research Support from AbbVie Inc.; Accutar Biotechnology Inc; Acerta Pharma; ADC Therapeutics SA; Akeso Biopharma Co., Ltd.; Amgen Inc.; Aravive; Artios Pharma; Arvinas, Inc.; AstraZeneca; AtlasMedx, Inc.; BeiGene, Inc.; Black Diamond Therapeutics, Inc.; Bliss Biopharmaceutical (Hangzhou) Co., Ltd.; Boehringer Ingelheim Pharmaceuticals, Inc.; Cascadian Therapeutics; Clovis Oncology; Compugen; Cullinan Oncology, Inc.; Curis, Inc.; CytomX Therapeutics, Inc.; Daiichi Sankyo, Inc.; Dana-Farber Cancer Institute; Dantari; Deciphera Pharmaceuticals, Inc.; Duality Biologics; eFFECTOR Therapeutics, Inc.; Ellipses Pharma; Elucida Oncology, Inc.; EMD Serono, Inc.; F. Hoffmann-La Roche Ltd/Genentech, Inc.; FUJIFILM Pharmaceuticals U.S.A., Inc.; G1 Therapeutics, Inc.; H3 Biomedicine Inc.; Harpoon Therapeutics; HUTCHMED (China) Limited; ImmunoGen, Inc.; Immunomedics, Inc.; Incyte; Infinity Pharmaceuticals, Inc.; InvestisBio; Jacobio Pharmaceuticals Group Co., Ltd.; K-Group Beta, Inc.; Karyopharm; Lilly; Loxo Oncology; Lycera; MabSpace Biosciences Co., Ltd.; MacroGenics, Inc.; MedImmune, LLC; Mersana Therapeutics; Merus; Millennium Pharmaceuticals, Inc.; Molecular Templates, Inc.; Novartis Pharmaceuticals Corporation; Nucana; Olema Oncology; OncoMed Pharmaceuticals, Inc.; Onconova Therapeutics; Oncothyreon; ORIC Pharmaceuticals, Inc.; Orinove Inc.; Pfizer; PharmaMar; Pieris Pharmaceuticals, Inc.; Pionyr Immunotherapeutics; Plexxikon; Radius Health, Inc.; Regeneron Pharmaceuticals Inc.; Relay Therapeutics; Repertoire Immune Medicines; Rgenix Inc.; Seagen Inc.; Sermonix Pharmaceuticals; Shattuck Labs Inc.; Stemcentrx, Inc.; Sutro Biopharma, Inc.; Syndax; Syros Pharmaceuticals, Inc.; Taiho Oncology, Inc.; TapImmune Inc; TESARO, Inc.; Tolmar Pharmaceuticals, Inc.; Torque Therapeutics, Inc.; Treadwell Therapeutics; Verastem, Inc.; Vincerx Pharma; zenithepigenetics; and Zymeworks Inc. (all paid to institution).Faculty/PlannerKomal Jhaveri, MD, FACP, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for AbbVie Inc.; AstraZeneca; Blueprint Medicines; Bristol Myers Squibb; Daiichi Sankyo, Inc.; Eisai Inc.; F. Hoffmann-La Roche Ltd/Genentech, Inc.; Jounce Therapeutics, Inc.; Lilly/Loxo Oncology; Menarini Group/Stemline Therapeutics; Novartis Pharmaceuticals Corporation; Pfizer; Scorpion Therapeutics; Seattle Genetics, Inc. (Seagen Inc.); Sun Pharma Advanced Research Company; and Taiho Oncology, Inc.Grant/Research Support from ADC Therapeutics SA; AstraZeneca; Blueprint Medicines; Debiopharm; Genentech, Inc.; Gilead Sciences, Inc.; Lilly; Merck & Co., Inc.; Novartis Pharmaceuticals Corporation; Novita Pharmaceuticals, Inc.; Pfizer; Puma Biotechnology, Inc.; Scorpion Therapeutics; and Zymeworks Inc.Faculty/PlannerProfessor Stephen Johnston, MA, PhD, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for AstraZeneca; Lilly; Novartis Pharmaceuticals Corporation; Pfizer; Puma Biotechnology, Inc.; and Sanofi.Grant/Research Support from AstraZeneca; F. Hoffmann-La Roche Ltd/Genentech, Inc.; Lilly; Novartis Pharmaceuticals Corporation; Pfizer; and Puma Biotechnology, Inc.Speakers Bureau participant with AstraZeneca; Eisai Inc.; F. Hoffmann-La Roche Ltd/Genentech, Inc.; and Pfizer.Planning Committee and Reviewer DisclosuresPlanners, independent reviewers, and staff of PVI, PeerView Institute for Medical Education, do not have any relevant financial relationships related to this CE activity unless listed below.
This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, downloadable Practice Aids, slides, and complete CME/MOC/AAPA information, and to apply for credit, please visit us at PeerView.com/GHA865. CME/MOC/AAPA credit will be available until January 6, 2025.Mastering the Art of Precision in the Treatment of HR+ Early and Metastatic Breast Cancer: Risk Assessment, Prognostic Testing, and Selection and Sequencing of Therapies In support of improving patient care, this activity has been planned and implemented by PVI, PeerView Institute for Medical Education, GRASP, and Living Beyond Breast Cancer. PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported by independent educational grants from AstraZeneca, Lilly, and Olema Pharmaceuticals.Disclosure PolicyAll relevant conflicts of interest have been mitigated prior to the commencement of the activity.Faculty/Planner DisclosuresChair/PlannerErika Hamilton, MD, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for Arcus Biosciences, Inc.; Arvinas, Inc.; AstraZeneca; Daiichi Sankyo, Inc.; Deciphera Pharmaceuticals, Inc.; Ellipses Pharma; F. Hoffmann-La Roche Ltd/Genentech, Inc.; Greenwich LifeSciences, Inc.; iTeos Therapeutics; Janssen Pharmaceuticals, Inc.; Lilly; Loxo Oncology; Mersana Therapeutics; Novartis Pharmaceuticals Corporation; Orum Therapeutics; Pfizer; Relay Therapeutics; Seagen Inc.; and Verascity Science (all paid to institution).Grant/Research Support from AbbVie Inc.; Accutar Biotechnology Inc; Acerta Pharma; ADC Therapeutics SA; Akeso Biopharma Co., Ltd.; Amgen Inc.; Aravive; Artios Pharma; Arvinas, Inc.; AstraZeneca; AtlasMedx, Inc.; BeiGene, Inc.; Black Diamond Therapeutics, Inc.; Bliss Biopharmaceutical (Hangzhou) Co., Ltd.; Boehringer Ingelheim Pharmaceuticals, Inc.; Cascadian Therapeutics; Clovis Oncology; Compugen; Cullinan Oncology, Inc.; Curis, Inc.; CytomX Therapeutics, Inc.; Daiichi Sankyo, Inc.; Dana-Farber Cancer Institute; Dantari; Deciphera Pharmaceuticals, Inc.; Duality Biologics; eFFECTOR Therapeutics, Inc.; Ellipses Pharma; Elucida Oncology, Inc.; EMD Serono, Inc.; F. Hoffmann-La Roche Ltd/Genentech, Inc.; FUJIFILM Pharmaceuticals U.S.A., Inc.; G1 Therapeutics, Inc.; H3 Biomedicine Inc.; Harpoon Therapeutics; HUTCHMED (China) Limited; ImmunoGen, Inc.; Immunomedics, Inc.; Incyte; Infinity Pharmaceuticals, Inc.; InvestisBio; Jacobio Pharmaceuticals Group Co., Ltd.; K-Group Beta, Inc.; Karyopharm; Lilly; Loxo Oncology; Lycera; MabSpace Biosciences Co., Ltd.; MacroGenics, Inc.; MedImmune, LLC; Mersana Therapeutics; Merus; Millennium Pharmaceuticals, Inc.; Molecular Templates, Inc.; Novartis Pharmaceuticals Corporation; Nucana; Olema Oncology; OncoMed Pharmaceuticals, Inc.; Onconova Therapeutics; Oncothyreon; ORIC Pharmaceuticals, Inc.; Orinove Inc.; Pfizer; PharmaMar; Pieris Pharmaceuticals, Inc.; Pionyr Immunotherapeutics; Plexxikon; Radius Health, Inc.; Regeneron Pharmaceuticals Inc.; Relay Therapeutics; Repertoire Immune Medicines; Rgenix Inc.; Seagen Inc.; Sermonix Pharmaceuticals; Shattuck Labs Inc.; Stemcentrx, Inc.; Sutro Biopharma, Inc.; Syndax; Syros Pharmaceuticals, Inc.; Taiho Oncology, Inc.; TapImmune Inc; TESARO, Inc.; Tolmar Pharmaceuticals, Inc.; Torque Therapeutics, Inc.; Treadwell Therapeutics; Verastem, Inc.; Vincerx Pharma; zenithepigenetics; and Zymeworks Inc. (all paid to institution).Faculty/PlannerKomal Jhaveri, MD, FACP, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for AbbVie Inc.; AstraZeneca; Blueprint Medicines; Bristol Myers Squibb; Daiichi Sankyo, Inc.; Eisai Inc.; F. Hoffmann-La Roche Ltd/Genentech, Inc.; Jounce Therapeutics, Inc.; Lilly/Loxo Oncology; Menarini Group/Stemline Therapeutics; Novartis Pharmaceuticals Corporation; Pfizer; Scorpion Therapeutics; Seattle Genetics, Inc. (Seagen Inc.); Sun Pharma Advanced Research Company; and Taiho Oncology, Inc.Grant/Research Support from ADC Therapeutics SA; AstraZeneca; Blueprint Medicines; Debiopharm; Genentech, Inc.; Gilead Sciences, Inc.; Lilly; Merck & Co., Inc.; Novartis Pharmaceuticals Corporation; Novita Pharmaceuticals, Inc.; Pfizer; Puma Biotechnology, Inc.; Scorpion Therapeutics; and Zymeworks Inc.Faculty/PlannerHope S. Rugo, MD, FASCO, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for Daiichi Sankyo, Inc.; Mylan/Viatris Inc.; Napo Pharmaceuticals, Inc.; and Puma Biotechnology, Inc.Grant/Research Support from AstraZeneca; Daiichi Sankyo, Inc.; F. Hoffmann-La Roche Ltd/Genentech, Inc.; Gilead Sciences, Inc.; Lilly; Merck & Co., Inc.; Novartis Pharmaceuticals Corporation; OBI Pharma, Inc.; Pfizer; Pionyr Immunotherapeutics; Sermonix Pharmaceuticals; and Stemline Therapeutics.Faculty/PlannerPaolo Tarantino, MD, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for AstraZeneca; Daiichi Sankyo, Inc.; Gilead Sciences, Inc.; and Lilly.Grant/Research Support from AstraZeneca.Planning Committee and Reviewer DisclosuresPlanners, independent reviewers, and staff of PVI, PeerView Institute for Medical Education, do not have any relevant financial relationships related to this CE activity unless listed below.
This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, downloadable Practice Aids, slides, and complete CME/MOC/AAPA information, and to apply for credit, please visit us at PeerView.com/GHA865. CME/MOC/AAPA credit will be available until January 6, 2025.Mastering the Art of Precision in the Treatment of HR+ Early and Metastatic Breast Cancer: Risk Assessment, Prognostic Testing, and Selection and Sequencing of Therapies In support of improving patient care, this activity has been planned and implemented by PVI, PeerView Institute for Medical Education, GRASP, and Living Beyond Breast Cancer. PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported by independent educational grants from AstraZeneca, Lilly, and Olema Pharmaceuticals.Disclosure PolicyAll relevant conflicts of interest have been mitigated prior to the commencement of the activity.Faculty/Planner DisclosuresChair/PlannerErika Hamilton, MD, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for Arcus Biosciences, Inc.; Arvinas, Inc.; AstraZeneca; Daiichi Sankyo, Inc.; Deciphera Pharmaceuticals, Inc.; Ellipses Pharma; F. Hoffmann-La Roche Ltd/Genentech, Inc.; Greenwich LifeSciences, Inc.; iTeos Therapeutics; Janssen Pharmaceuticals, Inc.; Lilly; Loxo Oncology; Mersana Therapeutics; Novartis Pharmaceuticals Corporation; Orum Therapeutics; Pfizer; Relay Therapeutics; Seagen Inc.; and Verascity Science (all paid to institution).Grant/Research Support from AbbVie Inc.; Accutar Biotechnology Inc; Acerta Pharma; ADC Therapeutics SA; Akeso Biopharma Co., Ltd.; Amgen Inc.; Aravive; Artios Pharma; Arvinas, Inc.; AstraZeneca; AtlasMedx, Inc.; BeiGene, Inc.; Black Diamond Therapeutics, Inc.; Bliss Biopharmaceutical (Hangzhou) Co., Ltd.; Boehringer Ingelheim Pharmaceuticals, Inc.; Cascadian Therapeutics; Clovis Oncology; Compugen; Cullinan Oncology, Inc.; Curis, Inc.; CytomX Therapeutics, Inc.; Daiichi Sankyo, Inc.; Dana-Farber Cancer Institute; Dantari; Deciphera Pharmaceuticals, Inc.; Duality Biologics; eFFECTOR Therapeutics, Inc.; Ellipses Pharma; Elucida Oncology, Inc.; EMD Serono, Inc.; F. Hoffmann-La Roche Ltd/Genentech, Inc.; FUJIFILM Pharmaceuticals U.S.A., Inc.; G1 Therapeutics, Inc.; H3 Biomedicine Inc.; Harpoon Therapeutics; HUTCHMED (China) Limited; ImmunoGen, Inc.; Immunomedics, Inc.; Incyte; Infinity Pharmaceuticals, Inc.; InvestisBio; Jacobio Pharmaceuticals Group Co., Ltd.; K-Group Beta, Inc.; Karyopharm; Lilly; Loxo Oncology; Lycera; MabSpace Biosciences Co., Ltd.; MacroGenics, Inc.; MedImmune, LLC; Mersana Therapeutics; Merus; Millennium Pharmaceuticals, Inc.; Molecular Templates, Inc.; Novartis Pharmaceuticals Corporation; Nucana; Olema Oncology; OncoMed Pharmaceuticals, Inc.; Onconova Therapeutics; Oncothyreon; ORIC Pharmaceuticals, Inc.; Orinove Inc.; Pfizer; PharmaMar; Pieris Pharmaceuticals, Inc.; Pionyr Immunotherapeutics; Plexxikon; Radius Health, Inc.; Regeneron Pharmaceuticals Inc.; Relay Therapeutics; Repertoire Immune Medicines; Rgenix Inc.; Seagen Inc.; Sermonix Pharmaceuticals; Shattuck Labs Inc.; Stemcentrx, Inc.; Sutro Biopharma, Inc.; Syndax; Syros Pharmaceuticals, Inc.; Taiho Oncology, Inc.; TapImmune Inc; TESARO, Inc.; Tolmar Pharmaceuticals, Inc.; Torque Therapeutics, Inc.; Treadwell Therapeutics; Verastem, Inc.; Vincerx Pharma; zenithepigenetics; and Zymeworks Inc. (all paid to institution).Faculty/PlannerKomal Jhaveri, MD, FACP, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for AbbVie Inc.; AstraZeneca; Blueprint Medicines; Bristol Myers Squibb; Daiichi Sankyo, Inc.; Eisai Inc.; F. Hoffmann-La Roche Ltd/Genentech, Inc.; Jounce Therapeutics, Inc.; Lilly/Loxo Oncology; Menarini Group/Stemline Therapeutics; Novartis Pharmaceuticals Corporation; Pfizer; Scorpion Therapeutics; Seattle Genetics, Inc. (Seagen Inc.); Sun Pharma Advanced Research Company; and Taiho Oncology, Inc.Grant/Research Support from ADC Therapeutics SA; AstraZeneca; Blueprint Medicines; Debiopharm; Genentech, Inc.; Gilead Sciences, Inc.; Lilly; Merck & Co., Inc.; Novartis Pharmaceuticals Corporation; Novita Pharmaceuticals, Inc.; Pfizer; Puma Biotechnology, Inc.; Scorpion Therapeutics; and Zymeworks Inc.Faculty/PlannerHope S. Rugo, MD, FASCO, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for Daiichi Sankyo, Inc.; Mylan/Viatris Inc.; Napo Pharmaceuticals, Inc.; and Puma Biotechnology, Inc.Grant/Research Support from AstraZeneca; Daiichi Sankyo, Inc.; F. Hoffmann-La Roche Ltd/Genentech, Inc.; Gilead Sciences, Inc.; Lilly; Merck & Co., Inc.; Novartis Pharmaceuticals Corporation; OBI Pharma, Inc.; Pfizer; Pionyr Immunotherapeutics; Sermonix Pharmaceuticals; and Stemline Therapeutics.Faculty/PlannerPaolo Tarantino, MD, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for AstraZeneca; Daiichi Sankyo, Inc.; Gilead Sciences, Inc.; and Lilly.Grant/Research Support from AstraZeneca.Planning Committee and Reviewer DisclosuresPlanners, independent reviewers, and staff of PVI, PeerView Institute for Medical Education, do not have any relevant financial relationships related to this CE activity unless listed below.
This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, downloadable Practice Aids, slides, and complete CME/MOC/AAPA information, and to apply for credit, please visit us at PeerView.com/GHA865. CME/MOC/AAPA credit will be available until January 6, 2025.Mastering the Art of Precision in the Treatment of HR+ Early and Metastatic Breast Cancer: Risk Assessment, Prognostic Testing, and Selection and Sequencing of Therapies In support of improving patient care, this activity has been planned and implemented by PVI, PeerView Institute for Medical Education, GRASP, and Living Beyond Breast Cancer. PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported by independent educational grants from AstraZeneca, Lilly, and Olema Pharmaceuticals.Disclosure PolicyAll relevant conflicts of interest have been mitigated prior to the commencement of the activity.Faculty/Planner DisclosuresChair/PlannerErika Hamilton, MD, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for Arcus Biosciences, Inc.; Arvinas, Inc.; AstraZeneca; Daiichi Sankyo, Inc.; Deciphera Pharmaceuticals, Inc.; Ellipses Pharma; F. Hoffmann-La Roche Ltd/Genentech, Inc.; Greenwich LifeSciences, Inc.; iTeos Therapeutics; Janssen Pharmaceuticals, Inc.; Lilly; Loxo Oncology; Mersana Therapeutics; Novartis Pharmaceuticals Corporation; Orum Therapeutics; Pfizer; Relay Therapeutics; Seagen Inc.; and Verascity Science (all paid to institution).Grant/Research Support from AbbVie Inc.; Accutar Biotechnology Inc; Acerta Pharma; ADC Therapeutics SA; Akeso Biopharma Co., Ltd.; Amgen Inc.; Aravive; Artios Pharma; Arvinas, Inc.; AstraZeneca; AtlasMedx, Inc.; BeiGene, Inc.; Black Diamond Therapeutics, Inc.; Bliss Biopharmaceutical (Hangzhou) Co., Ltd.; Boehringer Ingelheim Pharmaceuticals, Inc.; Cascadian Therapeutics; Clovis Oncology; Compugen; Cullinan Oncology, Inc.; Curis, Inc.; CytomX Therapeutics, Inc.; Daiichi Sankyo, Inc.; Dana-Farber Cancer Institute; Dantari; Deciphera Pharmaceuticals, Inc.; Duality Biologics; eFFECTOR Therapeutics, Inc.; Ellipses Pharma; Elucida Oncology, Inc.; EMD Serono, Inc.; F. Hoffmann-La Roche Ltd/Genentech, Inc.; FUJIFILM Pharmaceuticals U.S.A., Inc.; G1 Therapeutics, Inc.; H3 Biomedicine Inc.; Harpoon Therapeutics; HUTCHMED (China) Limited; ImmunoGen, Inc.; Immunomedics, Inc.; Incyte; Infinity Pharmaceuticals, Inc.; InvestisBio; Jacobio Pharmaceuticals Group Co., Ltd.; K-Group Beta, Inc.; Karyopharm; Lilly; Loxo Oncology; Lycera; MabSpace Biosciences Co., Ltd.; MacroGenics, Inc.; MedImmune, LLC; Mersana Therapeutics; Merus; Millennium Pharmaceuticals, Inc.; Molecular Templates, Inc.; Novartis Pharmaceuticals Corporation; Nucana; Olema Oncology; OncoMed Pharmaceuticals, Inc.; Onconova Therapeutics; Oncothyreon; ORIC Pharmaceuticals, Inc.; Orinove Inc.; Pfizer; PharmaMar; Pieris Pharmaceuticals, Inc.; Pionyr Immunotherapeutics; Plexxikon; Radius Health, Inc.; Regeneron Pharmaceuticals Inc.; Relay Therapeutics; Repertoire Immune Medicines; Rgenix Inc.; Seagen Inc.; Sermonix Pharmaceuticals; Shattuck Labs Inc.; Stemcentrx, Inc.; Sutro Biopharma, Inc.; Syndax; Syros Pharmaceuticals, Inc.; Taiho Oncology, Inc.; TapImmune Inc; TESARO, Inc.; Tolmar Pharmaceuticals, Inc.; Torque Therapeutics, Inc.; Treadwell Therapeutics; Verastem, Inc.; Vincerx Pharma; zenithepigenetics; and Zymeworks Inc. (all paid to institution).Faculty/PlannerKomal Jhaveri, MD, FACP, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for AbbVie Inc.; AstraZeneca; Blueprint Medicines; Bristol Myers Squibb; Daiichi Sankyo, Inc.; Eisai Inc.; F. Hoffmann-La Roche Ltd/Genentech, Inc.; Jounce Therapeutics, Inc.; Lilly/Loxo Oncology; Menarini Group/Stemline Therapeutics; Novartis Pharmaceuticals Corporation; Pfizer; Scorpion Therapeutics; Seattle Genetics, Inc. (Seagen Inc.); Sun Pharma Advanced Research Company; and Taiho Oncology, Inc.Grant/Research Support from ADC Therapeutics SA; AstraZeneca; Blueprint Medicines; Debiopharm; Genentech, Inc.; Gilead Sciences, Inc.; Lilly; Merck & Co., Inc.; Novartis Pharmaceuticals Corporation; Novita Pharmaceuticals, Inc.; Pfizer; Puma Biotechnology, Inc.; Scorpion Therapeutics; and Zymeworks Inc.Faculty/PlannerHope S. Rugo, MD, FASCO, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for Daiichi Sankyo, Inc.; Mylan/Viatris Inc.; Napo Pharmaceuticals, Inc.; and Puma Biotechnology, Inc.Grant/Research Support from AstraZeneca; Daiichi Sankyo, Inc.; F. Hoffmann-La Roche Ltd/Genentech, Inc.; Gilead Sciences, Inc.; Lilly; Merck & Co., Inc.; Novartis Pharmaceuticals Corporation; OBI Pharma, Inc.; Pfizer; Pionyr Immunotherapeutics; Sermonix Pharmaceuticals; and Stemline Therapeutics.Faculty/PlannerPaolo Tarantino, MD, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for AstraZeneca; Daiichi Sankyo, Inc.; Gilead Sciences, Inc.; and Lilly.Grant/Research Support from AstraZeneca.Planning Committee and Reviewer DisclosuresPlanners, independent reviewers, and staff of PVI, PeerView Institute for Medical Education, do not have any relevant financial relationships related to this CE activity unless listed below.
This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, downloadable Practice Aids, slides, and complete CME/MOC/AAPA information, and to apply for credit, please visit us at PeerView.com/GHA865. CME/MOC/AAPA credit will be available until January 6, 2025.Mastering the Art of Precision in the Treatment of HR+ Early and Metastatic Breast Cancer: Risk Assessment, Prognostic Testing, and Selection and Sequencing of Therapies In support of improving patient care, this activity has been planned and implemented by PVI, PeerView Institute for Medical Education, GRASP, and Living Beyond Breast Cancer. PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported by independent educational grants from AstraZeneca, Lilly, and Olema Pharmaceuticals.Disclosure PolicyAll relevant conflicts of interest have been mitigated prior to the commencement of the activity.Faculty/Planner DisclosuresChair/PlannerErika Hamilton, MD, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for Arcus Biosciences, Inc.; Arvinas, Inc.; AstraZeneca; Daiichi Sankyo, Inc.; Deciphera Pharmaceuticals, Inc.; Ellipses Pharma; F. Hoffmann-La Roche Ltd/Genentech, Inc.; Greenwich LifeSciences, Inc.; iTeos Therapeutics; Janssen Pharmaceuticals, Inc.; Lilly; Loxo Oncology; Mersana Therapeutics; Novartis Pharmaceuticals Corporation; Orum Therapeutics; Pfizer; Relay Therapeutics; Seagen Inc.; and Verascity Science (all paid to institution).Grant/Research Support from AbbVie Inc.; Accutar Biotechnology Inc; Acerta Pharma; ADC Therapeutics SA; Akeso Biopharma Co., Ltd.; Amgen Inc.; Aravive; Artios Pharma; Arvinas, Inc.; AstraZeneca; AtlasMedx, Inc.; BeiGene, Inc.; Black Diamond Therapeutics, Inc.; Bliss Biopharmaceutical (Hangzhou) Co., Ltd.; Boehringer Ingelheim Pharmaceuticals, Inc.; Cascadian Therapeutics; Clovis Oncology; Compugen; Cullinan Oncology, Inc.; Curis, Inc.; CytomX Therapeutics, Inc.; Daiichi Sankyo, Inc.; Dana-Farber Cancer Institute; Dantari; Deciphera Pharmaceuticals, Inc.; Duality Biologics; eFFECTOR Therapeutics, Inc.; Ellipses Pharma; Elucida Oncology, Inc.; EMD Serono, Inc.; F. Hoffmann-La Roche Ltd/Genentech, Inc.; FUJIFILM Pharmaceuticals U.S.A., Inc.; G1 Therapeutics, Inc.; H3 Biomedicine Inc.; Harpoon Therapeutics; HUTCHMED (China) Limited; ImmunoGen, Inc.; Immunomedics, Inc.; Incyte; Infinity Pharmaceuticals, Inc.; InvestisBio; Jacobio Pharmaceuticals Group Co., Ltd.; K-Group Beta, Inc.; Karyopharm; Lilly; Loxo Oncology; Lycera; MabSpace Biosciences Co., Ltd.; MacroGenics, Inc.; MedImmune, LLC; Mersana Therapeutics; Merus; Millennium Pharmaceuticals, Inc.; Molecular Templates, Inc.; Novartis Pharmaceuticals Corporation; Nucana; Olema Oncology; OncoMed Pharmaceuticals, Inc.; Onconova Therapeutics; Oncothyreon; ORIC Pharmaceuticals, Inc.; Orinove Inc.; Pfizer; PharmaMar; Pieris Pharmaceuticals, Inc.; Pionyr Immunotherapeutics; Plexxikon; Radius Health, Inc.; Regeneron Pharmaceuticals Inc.; Relay Therapeutics; Repertoire Immune Medicines; Rgenix Inc.; Seagen Inc.; Sermonix Pharmaceuticals; Shattuck Labs Inc.; Stemcentrx, Inc.; Sutro Biopharma, Inc.; Syndax; Syros Pharmaceuticals, Inc.; Taiho Oncology, Inc.; TapImmune Inc; TESARO, Inc.; Tolmar Pharmaceuticals, Inc.; Torque Therapeutics, Inc.; Treadwell Therapeutics; Verastem, Inc.; Vincerx Pharma; zenithepigenetics; and Zymeworks Inc. (all paid to institution).Faculty/PlannerKomal Jhaveri, MD, FACP, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for AbbVie Inc.; AstraZeneca; Blueprint Medicines; Bristol Myers Squibb; Daiichi Sankyo, Inc.; Eisai Inc.; F. Hoffmann-La Roche Ltd/Genentech, Inc.; Jounce Therapeutics, Inc.; Lilly/Loxo Oncology; Menarini Group/Stemline Therapeutics; Novartis Pharmaceuticals Corporation; Pfizer; Scorpion Therapeutics; Seattle Genetics, Inc. (Seagen Inc.); Sun Pharma Advanced Research Company; and Taiho Oncology, Inc.Grant/Research Support from ADC Therapeutics SA; AstraZeneca; Blueprint Medicines; Debiopharm; Genentech, Inc.; Gilead Sciences, Inc.; Lilly; Merck & Co., Inc.; Novartis Pharmaceuticals Corporation; Novita Pharmaceuticals, Inc.; Pfizer; Puma Biotechnology, Inc.; Scorpion Therapeutics; and Zymeworks Inc.Faculty/PlannerHope S. Rugo, MD, FASCO, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for Daiichi Sankyo, Inc.; Mylan/Viatris Inc.; Napo Pharmaceuticals, Inc.; and Puma Biotechnology, Inc.Grant/Research Support from AstraZeneca; Daiichi Sankyo, Inc.; F. Hoffmann-La Roche Ltd/Genentech, Inc.; Gilead Sciences, Inc.; Lilly; Merck & Co., Inc.; Novartis Pharmaceuticals Corporation; OBI Pharma, Inc.; Pfizer; Pionyr Immunotherapeutics; Sermonix Pharmaceuticals; and Stemline Therapeutics.Faculty/PlannerPaolo Tarantino, MD, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for AstraZeneca; Daiichi Sankyo, Inc.; Gilead Sciences, Inc.; and Lilly.Grant/Research Support from AstraZeneca.Planning Committee and Reviewer DisclosuresPlanners, independent reviewers, and staff of PVI, PeerView Institute for Medical Education, do not have any relevant financial relationships related to this CE activity unless listed below.
This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, downloadable Practice Aids, slides, and complete CME/MOC/AAPA information, and to apply for credit, please visit us at PeerView.com/GHA865. CME/MOC/AAPA credit will be available until January 6, 2025.Mastering the Art of Precision in the Treatment of HR+ Early and Metastatic Breast Cancer: Risk Assessment, Prognostic Testing, and Selection and Sequencing of Therapies In support of improving patient care, this activity has been planned and implemented by PVI, PeerView Institute for Medical Education, GRASP, and Living Beyond Breast Cancer. PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported by independent educational grants from AstraZeneca, Lilly, and Olema Pharmaceuticals.Disclosure PolicyAll relevant conflicts of interest have been mitigated prior to the commencement of the activity.Faculty/Planner DisclosuresChair/PlannerErika Hamilton, MD, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for Arcus Biosciences, Inc.; Arvinas, Inc.; AstraZeneca; Daiichi Sankyo, Inc.; Deciphera Pharmaceuticals, Inc.; Ellipses Pharma; F. Hoffmann-La Roche Ltd/Genentech, Inc.; Greenwich LifeSciences, Inc.; iTeos Therapeutics; Janssen Pharmaceuticals, Inc.; Lilly; Loxo Oncology; Mersana Therapeutics; Novartis Pharmaceuticals Corporation; Orum Therapeutics; Pfizer; Relay Therapeutics; Seagen Inc.; and Verascity Science (all paid to institution).Grant/Research Support from AbbVie Inc.; Accutar Biotechnology Inc; Acerta Pharma; ADC Therapeutics SA; Akeso Biopharma Co., Ltd.; Amgen Inc.; Aravive; Artios Pharma; Arvinas, Inc.; AstraZeneca; AtlasMedx, Inc.; BeiGene, Inc.; Black Diamond Therapeutics, Inc.; Bliss Biopharmaceutical (Hangzhou) Co., Ltd.; Boehringer Ingelheim Pharmaceuticals, Inc.; Cascadian Therapeutics; Clovis Oncology; Compugen; Cullinan Oncology, Inc.; Curis, Inc.; CytomX Therapeutics, Inc.; Daiichi Sankyo, Inc.; Dana-Farber Cancer Institute; Dantari; Deciphera Pharmaceuticals, Inc.; Duality Biologics; eFFECTOR Therapeutics, Inc.; Ellipses Pharma; Elucida Oncology, Inc.; EMD Serono, Inc.; F. Hoffmann-La Roche Ltd/Genentech, Inc.; FUJIFILM Pharmaceuticals U.S.A., Inc.; G1 Therapeutics, Inc.; H3 Biomedicine Inc.; Harpoon Therapeutics; HUTCHMED (China) Limited; ImmunoGen, Inc.; Immunomedics, Inc.; Incyte; Infinity Pharmaceuticals, Inc.; InvestisBio; Jacobio Pharmaceuticals Group Co., Ltd.; K-Group Beta, Inc.; Karyopharm; Lilly; Loxo Oncology; Lycera; MabSpace Biosciences Co., Ltd.; MacroGenics, Inc.; MedImmune, LLC; Mersana Therapeutics; Merus; Millennium Pharmaceuticals, Inc.; Molecular Templates, Inc.; Novartis Pharmaceuticals Corporation; Nucana; Olema Oncology; OncoMed Pharmaceuticals, Inc.; Onconova Therapeutics; Oncothyreon; ORIC Pharmaceuticals, Inc.; Orinove Inc.; Pfizer; PharmaMar; Pieris Pharmaceuticals, Inc.; Pionyr Immunotherapeutics; Plexxikon; Radius Health, Inc.; Regeneron Pharmaceuticals Inc.; Relay Therapeutics; Repertoire Immune Medicines; Rgenix Inc.; Seagen Inc.; Sermonix Pharmaceuticals; Shattuck Labs Inc.; Stemcentrx, Inc.; Sutro Biopharma, Inc.; Syndax; Syros Pharmaceuticals, Inc.; Taiho Oncology, Inc.; TapImmune Inc; TESARO, Inc.; Tolmar Pharmaceuticals, Inc.; Torque Therapeutics, Inc.; Treadwell Therapeutics; Verastem, Inc.; Vincerx Pharma; zenithepigenetics; and Zymeworks Inc. (all paid to institution).Faculty/PlannerKomal Jhaveri, MD, FACP, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for AbbVie Inc.; AstraZeneca; Blueprint Medicines; Bristol Myers Squibb; Daiichi Sankyo, Inc.; Eisai Inc.; F. Hoffmann-La Roche Ltd/Genentech, Inc.; Jounce Therapeutics, Inc.; Lilly/Loxo Oncology; Menarini Group/Stemline Therapeutics; Novartis Pharmaceuticals Corporation; Pfizer; Scorpion Therapeutics; Seattle Genetics, Inc. (Seagen Inc.); Sun Pharma Advanced Research Company; and Taiho Oncology, Inc.Grant/Research Support from ADC Therapeutics SA; AstraZeneca; Blueprint Medicines; Debiopharm; Genentech, Inc.; Gilead Sciences, Inc.; Lilly; Merck & Co., Inc.; Novartis Pharmaceuticals Corporation; Novita Pharmaceuticals, Inc.; Pfizer; Puma Biotechnology, Inc.; Scorpion Therapeutics; and Zymeworks Inc.Faculty/PlannerHope S. Rugo, MD, FASCO, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for Daiichi Sankyo, Inc.; Mylan/Viatris Inc.; Napo Pharmaceuticals, Inc.; and Puma Biotechnology, Inc.Grant/Research Support from AstraZeneca; Daiichi Sankyo, Inc.; F. Hoffmann-La Roche Ltd/Genentech, Inc.; Gilead Sciences, Inc.; Lilly; Merck & Co., Inc.; Novartis Pharmaceuticals Corporation; OBI Pharma, Inc.; Pfizer; Pionyr Immunotherapeutics; Sermonix Pharmaceuticals; and Stemline Therapeutics.Faculty/PlannerPaolo Tarantino, MD, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for AstraZeneca; Daiichi Sankyo, Inc.; Gilead Sciences, Inc.; and Lilly.Grant/Research Support from AstraZeneca.Planning Committee and Reviewer DisclosuresPlanners, independent reviewers, and staff of PVI, PeerView Institute for Medical Education, do not have any relevant financial relationships related to this CE activity unless listed below.
This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, downloadable Practice Aids, slides, and complete CME/MOC/AAPA information, and to apply for credit, please visit us at PeerView.com/GHA865. CME/MOC/AAPA credit will be available until January 6, 2025.Mastering the Art of Precision in the Treatment of HR+ Early and Metastatic Breast Cancer: Risk Assessment, Prognostic Testing, and Selection and Sequencing of Therapies In support of improving patient care, this activity has been planned and implemented by PVI, PeerView Institute for Medical Education, GRASP, and Living Beyond Breast Cancer. PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported by independent educational grants from AstraZeneca, Lilly, and Olema Pharmaceuticals.Disclosure PolicyAll relevant conflicts of interest have been mitigated prior to the commencement of the activity.Faculty/Planner DisclosuresChair/PlannerErika Hamilton, MD, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for Arcus Biosciences, Inc.; Arvinas, Inc.; AstraZeneca; Daiichi Sankyo, Inc.; Deciphera Pharmaceuticals, Inc.; Ellipses Pharma; F. Hoffmann-La Roche Ltd/Genentech, Inc.; Greenwich LifeSciences, Inc.; iTeos Therapeutics; Janssen Pharmaceuticals, Inc.; Lilly; Loxo Oncology; Mersana Therapeutics; Novartis Pharmaceuticals Corporation; Orum Therapeutics; Pfizer; Relay Therapeutics; Seagen Inc.; and Verascity Science (all paid to institution).Grant/Research Support from AbbVie Inc.; Accutar Biotechnology Inc; Acerta Pharma; ADC Therapeutics SA; Akeso Biopharma Co., Ltd.; Amgen Inc.; Aravive; Artios Pharma; Arvinas, Inc.; AstraZeneca; AtlasMedx, Inc.; BeiGene, Inc.; Black Diamond Therapeutics, Inc.; Bliss Biopharmaceutical (Hangzhou) Co., Ltd.; Boehringer Ingelheim Pharmaceuticals, Inc.; Cascadian Therapeutics; Clovis Oncology; Compugen; Cullinan Oncology, Inc.; Curis, Inc.; CytomX Therapeutics, Inc.; Daiichi Sankyo, Inc.; Dana-Farber Cancer Institute; Dantari; Deciphera Pharmaceuticals, Inc.; Duality Biologics; eFFECTOR Therapeutics, Inc.; Ellipses Pharma; Elucida Oncology, Inc.; EMD Serono, Inc.; F. Hoffmann-La Roche Ltd/Genentech, Inc.; FUJIFILM Pharmaceuticals U.S.A., Inc.; G1 Therapeutics, Inc.; H3 Biomedicine Inc.; Harpoon Therapeutics; HUTCHMED (China) Limited; ImmunoGen, Inc.; Immunomedics, Inc.; Incyte; Infinity Pharmaceuticals, Inc.; InvestisBio; Jacobio Pharmaceuticals Group Co., Ltd.; K-Group Beta, Inc.; Karyopharm; Lilly; Loxo Oncology; Lycera; MabSpace Biosciences Co., Ltd.; MacroGenics, Inc.; MedImmune, LLC; Mersana Therapeutics; Merus; Millennium Pharmaceuticals, Inc.; Molecular Templates, Inc.; Novartis Pharmaceuticals Corporation; Nucana; Olema Oncology; OncoMed Pharmaceuticals, Inc.; Onconova Therapeutics; Oncothyreon; ORIC Pharmaceuticals, Inc.; Orinove Inc.; Pfizer; PharmaMar; Pieris Pharmaceuticals, Inc.; Pionyr Immunotherapeutics; Plexxikon; Radius Health, Inc.; Regeneron Pharmaceuticals Inc.; Relay Therapeutics; Repertoire Immune Medicines; Rgenix Inc.; Seagen Inc.; Sermonix Pharmaceuticals; Shattuck Labs Inc.; Stemcentrx, Inc.; Sutro Biopharma, Inc.; Syndax; Syros Pharmaceuticals, Inc.; Taiho Oncology, Inc.; TapImmune Inc; TESARO, Inc.; Tolmar Pharmaceuticals, Inc.; Torque Therapeutics, Inc.; Treadwell Therapeutics; Verastem, Inc.; Vincerx Pharma; zenithepigenetics; and Zymeworks Inc. (all paid to institution).Faculty/PlannerKomal Jhaveri, MD, FACP, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for AbbVie Inc.; AstraZeneca; Blueprint Medicines; Bristol Myers Squibb; Daiichi Sankyo, Inc.; Eisai Inc.; F. Hoffmann-La Roche Ltd/Genentech, Inc.; Jounce Therapeutics, Inc.; Lilly/Loxo Oncology; Menarini Group/Stemline Therapeutics; Novartis Pharmaceuticals Corporation; Pfizer; Scorpion Therapeutics; Seattle Genetics, Inc. (Seagen Inc.); Sun Pharma Advanced Research Company; and Taiho Oncology, Inc.Grant/Research Support from ADC Therapeutics SA; AstraZeneca; Blueprint Medicines; Debiopharm; Genentech, Inc.; Gilead Sciences, Inc.; Lilly; Merck & Co., Inc.; Novartis Pharmaceuticals Corporation; Novita Pharmaceuticals, Inc.; Pfizer; Puma Biotechnology, Inc.; Scorpion Therapeutics; and Zymeworks Inc.Faculty/PlannerHope S. Rugo, MD, FASCO, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for Daiichi Sankyo, Inc.; Mylan/Viatris Inc.; Napo Pharmaceuticals, Inc.; and Puma Biotechnology, Inc.Grant/Research Support from AstraZeneca; Daiichi Sankyo, Inc.; F. Hoffmann-La Roche Ltd/Genentech, Inc.; Gilead Sciences, Inc.; Lilly; Merck & Co., Inc.; Novartis Pharmaceuticals Corporation; OBI Pharma, Inc.; Pfizer; Pionyr Immunotherapeutics; Sermonix Pharmaceuticals; and Stemline Therapeutics.Faculty/PlannerPaolo Tarantino, MD, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for AstraZeneca; Daiichi Sankyo, Inc.; Gilead Sciences, Inc.; and Lilly.Grant/Research Support from AstraZeneca.Planning Committee and Reviewer DisclosuresPlanners, independent reviewers, and staff of PVI, PeerView Institute for Medical Education, do not have any relevant financial relationships related to this CE activity unless listed below.
This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, downloadable Practice Aids, slides, and complete CME/MOC/AAPA information, and to apply for credit, please visit us at PeerView.com/CHJ865. CME/MOC/AAPA credit will be available until January 5, 2025.Modern Practice Principles: A Practical “How-To” Guide for Selection, Sequencing, and Optimal Use of HER2-Targeted Therapies in HER2-Positive Breast Cancer In support of improving patient care, this activity has been planned and implemented by PVI, PeerView Institute for Medical Education, GRASP, and Living Beyond Breast Cancer. PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported by independent educational grants from AstraZeneca, Daiichi Sankyo, Inc., and Seagen Inc.Disclosure PolicyAll relevant conflicts of interest have been mitigated prior to the commencement of the activity.Faculty/Planner DisclosuresChair/PlannerSara A. Hurvitz, MD, FACP, has a financial interest/relationship or affiliation in the form of:Grant/Research Support from Ambrx; Arvinas, Inc.; AstraZeneca; Bayer Corporation; Celcuity, Inc.; Cytomx Therapeutics, Inc.; Daiichi-Sankyo Inc.; Dantari; Dignitana AB; G1 Therapeutics, Inc.; Genentech, Inc./F. Hoffmann-La Roche Ltd.; Gilead Sciences, Inc.; GlaxoSmithKline; Greenwich Life Sciences Inc; Immunomedics, Inc; Lilly; Loxo Oncology; Macrogenics, Inc.; Novartis Pharmaceuticals Corporation; OBI Pharma, Inc.; Orinove Inc.; Orum; Pfizer; Phoenix Molecular Designs; Pieris Pharmaceuticals, Inc.; Puma Biotechnology, Inc.; Radius Health, Inc.; Sanofi; Seattle Genetics, Inc./Seagen Inc.; and Zymeworks Inc.Speaker for Curio and OncLive.Stock Shareholder in RomTech, spouse.Faculty/PlannerJavier Cortes, MD, PhD, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for AbbVie Inc.; AstraZeneca; Bioasis Technologies, Inc.; BioInvent International AB; Boehringer Ingelheim Pharmaceuticals, Inc.; Clovis Oncology; Daiichi Sankyo Co., Ltd; Ellipses Pharma; ExpreS2ion Biotechnologies ApS; F. Hoffmann-La Roche Ltd; GEMoaB GmbH; Gilead Sciences, Inc.; HiberCell; Jazz Pharmaceuticals, Inc.; Leuko Labs Inc.; Lilly; The Menarini Group; Merck Sharp & Dohme LLC; REVEAL GENOMICS, S.L.; Scorpion Therapeutics, Inc.; Seattle Genetics; and Zymeworks BC Inc.Grant/Research Support from ARIAD Pharmaceuticals, Inc.; AstraZeneca; Baxalta GmbH/LES LABORATOIRES SERVIER; Bayer Corporation; Eisai Inc.; F. Hoffmann-La Roche Ltd; Guardant Health; IQVIA Inc.; Merck Sharp & Dohme LLC; Pfizer; PIQUR Therapeutics; and Queen Mary University of London.Honoraria from AstraZeneca; Daiichi Sankyo Co., Ltd; Eisai Inc.; F. Hoffmann-La Roche Ltd; Gilead Sciences, Inc.; Lilly; Merck Sharp & Dohme LLC; Novartis AG; Pfizer; and Stemline Therapeutics.Faculty/PlannerPaolo Tarantino, MD, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for AstraZeneca; Daiichi Sankyo, Inc.; Gilead, and Lilly.Grant/Research Support from AstraZeneca.Planning Committee and Reviewer DisclosuresPlanners, independent reviewers, and staff of PVI, PeerView Institute for Medical Education, do not have any relevant financial relationships related to this CE activity unless listed below.
This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, downloadable Practice Aids, slides, and complete CME/MOC/AAPA information, and to apply for credit, please visit us at PeerView.com/CHJ865. CME/MOC/AAPA credit will be available until January 5, 2025.Modern Practice Principles: A Practical “How-To” Guide for Selection, Sequencing, and Optimal Use of HER2-Targeted Therapies in HER2-Positive Breast Cancer In support of improving patient care, this activity has been planned and implemented by PVI, PeerView Institute for Medical Education, GRASP, and Living Beyond Breast Cancer. PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported by independent educational grants from AstraZeneca, Daiichi Sankyo, Inc., and Seagen Inc.Disclosure PolicyAll relevant conflicts of interest have been mitigated prior to the commencement of the activity.Faculty/Planner DisclosuresChair/PlannerSara A. Hurvitz, MD, FACP, has a financial interest/relationship or affiliation in the form of:Grant/Research Support from Ambrx; Arvinas, Inc.; AstraZeneca; Bayer Corporation; Celcuity, Inc.; Cytomx Therapeutics, Inc.; Daiichi-Sankyo Inc.; Dantari; Dignitana AB; G1 Therapeutics, Inc.; Genentech, Inc./F. Hoffmann-La Roche Ltd.; Gilead Sciences, Inc.; GlaxoSmithKline; Greenwich Life Sciences Inc; Immunomedics, Inc; Lilly; Loxo Oncology; Macrogenics, Inc.; Novartis Pharmaceuticals Corporation; OBI Pharma, Inc.; Orinove Inc.; Orum; Pfizer; Phoenix Molecular Designs; Pieris Pharmaceuticals, Inc.; Puma Biotechnology, Inc.; Radius Health, Inc.; Sanofi; Seattle Genetics, Inc./Seagen Inc.; and Zymeworks Inc.Speaker for Curio and OncLive.Stock Shareholder in RomTech, spouse.Faculty/PlannerJavier Cortes, MD, PhD, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for AbbVie Inc.; AstraZeneca; Bioasis Technologies, Inc.; BioInvent International AB; Boehringer Ingelheim Pharmaceuticals, Inc.; Clovis Oncology; Daiichi Sankyo Co., Ltd; Ellipses Pharma; ExpreS2ion Biotechnologies ApS; F. Hoffmann-La Roche Ltd; GEMoaB GmbH; Gilead Sciences, Inc.; HiberCell; Jazz Pharmaceuticals, Inc.; Leuko Labs Inc.; Lilly; The Menarini Group; Merck Sharp & Dohme LLC; REVEAL GENOMICS, S.L.; Scorpion Therapeutics, Inc.; Seattle Genetics; and Zymeworks BC Inc.Grant/Research Support from ARIAD Pharmaceuticals, Inc.; AstraZeneca; Baxalta GmbH/LES LABORATOIRES SERVIER; Bayer Corporation; Eisai Inc.; F. Hoffmann-La Roche Ltd; Guardant Health; IQVIA Inc.; Merck Sharp & Dohme LLC; Pfizer; PIQUR Therapeutics; and Queen Mary University of London.Honoraria from AstraZeneca; Daiichi Sankyo Co., Ltd; Eisai Inc.; F. Hoffmann-La Roche Ltd; Gilead Sciences, Inc.; Lilly; Merck Sharp & Dohme LLC; Novartis AG; Pfizer; and Stemline Therapeutics.Faculty/PlannerPaolo Tarantino, MD, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for AstraZeneca; Daiichi Sankyo, Inc.; Gilead, and Lilly.Grant/Research Support from AstraZeneca.Planning Committee and Reviewer DisclosuresPlanners, independent reviewers, and staff of PVI, PeerView Institute for Medical Education, do not have any relevant financial relationships related to this CE activity unless listed below.
This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, downloadable Practice Aids, slides, and complete CME/MOC/AAPA information, and to apply for credit, please visit us at PeerView.com/CHJ865. CME/MOC/AAPA credit will be available until January 5, 2025.Modern Practice Principles: A Practical “How-To” Guide for Selection, Sequencing, and Optimal Use of HER2-Targeted Therapies in HER2-Positive Breast Cancer In support of improving patient care, this activity has been planned and implemented by PVI, PeerView Institute for Medical Education, GRASP, and Living Beyond Breast Cancer. PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported by independent educational grants from AstraZeneca, Daiichi Sankyo, Inc., and Seagen Inc.Disclosure PolicyAll relevant conflicts of interest have been mitigated prior to the commencement of the activity.Faculty/Planner DisclosuresChair/PlannerSara A. Hurvitz, MD, FACP, has a financial interest/relationship or affiliation in the form of:Grant/Research Support from Ambrx; Arvinas, Inc.; AstraZeneca; Bayer Corporation; Celcuity, Inc.; Cytomx Therapeutics, Inc.; Daiichi-Sankyo Inc.; Dantari; Dignitana AB; G1 Therapeutics, Inc.; Genentech, Inc./F. Hoffmann-La Roche Ltd.; Gilead Sciences, Inc.; GlaxoSmithKline; Greenwich Life Sciences Inc; Immunomedics, Inc; Lilly; Loxo Oncology; Macrogenics, Inc.; Novartis Pharmaceuticals Corporation; OBI Pharma, Inc.; Orinove Inc.; Orum; Pfizer; Phoenix Molecular Designs; Pieris Pharmaceuticals, Inc.; Puma Biotechnology, Inc.; Radius Health, Inc.; Sanofi; Seattle Genetics, Inc./Seagen Inc.; and Zymeworks Inc.Speaker for Curio and OncLive.Stock Shareholder in RomTech, spouse.Faculty/PlannerJavier Cortes, MD, PhD, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for AbbVie Inc.; AstraZeneca; Bioasis Technologies, Inc.; BioInvent International AB; Boehringer Ingelheim Pharmaceuticals, Inc.; Clovis Oncology; Daiichi Sankyo Co., Ltd; Ellipses Pharma; ExpreS2ion Biotechnologies ApS; F. Hoffmann-La Roche Ltd; GEMoaB GmbH; Gilead Sciences, Inc.; HiberCell; Jazz Pharmaceuticals, Inc.; Leuko Labs Inc.; Lilly; The Menarini Group; Merck Sharp & Dohme LLC; REVEAL GENOMICS, S.L.; Scorpion Therapeutics, Inc.; Seattle Genetics; and Zymeworks BC Inc.Grant/Research Support from ARIAD Pharmaceuticals, Inc.; AstraZeneca; Baxalta GmbH/LES LABORATOIRES SERVIER; Bayer Corporation; Eisai Inc.; F. Hoffmann-La Roche Ltd; Guardant Health; IQVIA Inc.; Merck Sharp & Dohme LLC; Pfizer; PIQUR Therapeutics; and Queen Mary University of London.Honoraria from AstraZeneca; Daiichi Sankyo Co., Ltd; Eisai Inc.; F. Hoffmann-La Roche Ltd; Gilead Sciences, Inc.; Lilly; Merck Sharp & Dohme LLC; Novartis AG; Pfizer; and Stemline Therapeutics.Faculty/PlannerPaolo Tarantino, MD, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for AstraZeneca; Daiichi Sankyo, Inc.; Gilead, and Lilly.Grant/Research Support from AstraZeneca.Planning Committee and Reviewer DisclosuresPlanners, independent reviewers, and staff of PVI, PeerView Institute for Medical Education, do not have any relevant financial relationships related to this CE activity unless listed below.
This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, downloadable Practice Aids, slides, and complete CME/MOC/AAPA information, and to apply for credit, please visit us at PeerView.com/CHJ865. CME/MOC/AAPA credit will be available until January 5, 2025.Modern Practice Principles: A Practical “How-To” Guide for Selection, Sequencing, and Optimal Use of HER2-Targeted Therapies in HER2-Positive Breast Cancer In support of improving patient care, this activity has been planned and implemented by PVI, PeerView Institute for Medical Education, GRASP, and Living Beyond Breast Cancer. PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported by independent educational grants from AstraZeneca, Daiichi Sankyo, Inc., and Seagen Inc.Disclosure PolicyAll relevant conflicts of interest have been mitigated prior to the commencement of the activity.Faculty/Planner DisclosuresChair/PlannerSara A. Hurvitz, MD, FACP, has a financial interest/relationship or affiliation in the form of:Grant/Research Support from Ambrx; Arvinas, Inc.; AstraZeneca; Bayer Corporation; Celcuity, Inc.; Cytomx Therapeutics, Inc.; Daiichi-Sankyo Inc.; Dantari; Dignitana AB; G1 Therapeutics, Inc.; Genentech, Inc./F. Hoffmann-La Roche Ltd.; Gilead Sciences, Inc.; GlaxoSmithKline; Greenwich Life Sciences Inc; Immunomedics, Inc; Lilly; Loxo Oncology; Macrogenics, Inc.; Novartis Pharmaceuticals Corporation; OBI Pharma, Inc.; Orinove Inc.; Orum; Pfizer; Phoenix Molecular Designs; Pieris Pharmaceuticals, Inc.; Puma Biotechnology, Inc.; Radius Health, Inc.; Sanofi; Seattle Genetics, Inc./Seagen Inc.; and Zymeworks Inc.Speaker for Curio and OncLive.Stock Shareholder in RomTech, spouse.Faculty/PlannerJavier Cortes, MD, PhD, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for AbbVie Inc.; AstraZeneca; Bioasis Technologies, Inc.; BioInvent International AB; Boehringer Ingelheim Pharmaceuticals, Inc.; Clovis Oncology; Daiichi Sankyo Co., Ltd; Ellipses Pharma; ExpreS2ion Biotechnologies ApS; F. Hoffmann-La Roche Ltd; GEMoaB GmbH; Gilead Sciences, Inc.; HiberCell; Jazz Pharmaceuticals, Inc.; Leuko Labs Inc.; Lilly; The Menarini Group; Merck Sharp & Dohme LLC; REVEAL GENOMICS, S.L.; Scorpion Therapeutics, Inc.; Seattle Genetics; and Zymeworks BC Inc.Grant/Research Support from ARIAD Pharmaceuticals, Inc.; AstraZeneca; Baxalta GmbH/LES LABORATOIRES SERVIER; Bayer Corporation; Eisai Inc.; F. Hoffmann-La Roche Ltd; Guardant Health; IQVIA Inc.; Merck Sharp & Dohme LLC; Pfizer; PIQUR Therapeutics; and Queen Mary University of London.Honoraria from AstraZeneca; Daiichi Sankyo Co., Ltd; Eisai Inc.; F. Hoffmann-La Roche Ltd; Gilead Sciences, Inc.; Lilly; Merck Sharp & Dohme LLC; Novartis AG; Pfizer; and Stemline Therapeutics.Faculty/PlannerPaolo Tarantino, MD, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for AstraZeneca; Daiichi Sankyo, Inc.; Gilead, and Lilly.Grant/Research Support from AstraZeneca.Planning Committee and Reviewer DisclosuresPlanners, independent reviewers, and staff of PVI, PeerView Institute for Medical Education, do not have any relevant financial relationships related to this CE activity unless listed below.
This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, downloadable Practice Aids, slides, and complete CME/MOC/AAPA information, and to apply for credit, please visit us at PeerView.com/CHJ865. CME/MOC/AAPA credit will be available until January 5, 2025.Modern Practice Principles: A Practical “How-To” Guide for Selection, Sequencing, and Optimal Use of HER2-Targeted Therapies in HER2-Positive Breast Cancer In support of improving patient care, this activity has been planned and implemented by PVI, PeerView Institute for Medical Education, GRASP, and Living Beyond Breast Cancer. PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported by independent educational grants from AstraZeneca, Daiichi Sankyo, Inc., and Seagen Inc.Disclosure PolicyAll relevant conflicts of interest have been mitigated prior to the commencement of the activity.Faculty/Planner DisclosuresChair/PlannerSara A. Hurvitz, MD, FACP, has a financial interest/relationship or affiliation in the form of:Grant/Research Support from Ambrx; Arvinas, Inc.; AstraZeneca; Bayer Corporation; Celcuity, Inc.; Cytomx Therapeutics, Inc.; Daiichi-Sankyo Inc.; Dantari; Dignitana AB; G1 Therapeutics, Inc.; Genentech, Inc./F. Hoffmann-La Roche Ltd.; Gilead Sciences, Inc.; GlaxoSmithKline; Greenwich Life Sciences Inc; Immunomedics, Inc; Lilly; Loxo Oncology; Macrogenics, Inc.; Novartis Pharmaceuticals Corporation; OBI Pharma, Inc.; Orinove Inc.; Orum; Pfizer; Phoenix Molecular Designs; Pieris Pharmaceuticals, Inc.; Puma Biotechnology, Inc.; Radius Health, Inc.; Sanofi; Seattle Genetics, Inc./Seagen Inc.; and Zymeworks Inc.Speaker for Curio and OncLive.Stock Shareholder in RomTech, spouse.Faculty/PlannerJavier Cortes, MD, PhD, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for AbbVie Inc.; AstraZeneca; Bioasis Technologies, Inc.; BioInvent International AB; Boehringer Ingelheim Pharmaceuticals, Inc.; Clovis Oncology; Daiichi Sankyo Co., Ltd; Ellipses Pharma; ExpreS2ion Biotechnologies ApS; F. Hoffmann-La Roche Ltd; GEMoaB GmbH; Gilead Sciences, Inc.; HiberCell; Jazz Pharmaceuticals, Inc.; Leuko Labs Inc.; Lilly; The Menarini Group; Merck Sharp & Dohme LLC; REVEAL GENOMICS, S.L.; Scorpion Therapeutics, Inc.; Seattle Genetics; and Zymeworks BC Inc.Grant/Research Support from ARIAD Pharmaceuticals, Inc.; AstraZeneca; Baxalta GmbH/LES LABORATOIRES SERVIER; Bayer Corporation; Eisai Inc.; F. Hoffmann-La Roche Ltd; Guardant Health; IQVIA Inc.; Merck Sharp & Dohme LLC; Pfizer; PIQUR Therapeutics; and Queen Mary University of London.Honoraria from AstraZeneca; Daiichi Sankyo Co., Ltd; Eisai Inc.; F. Hoffmann-La Roche Ltd; Gilead Sciences, Inc.; Lilly; Merck Sharp & Dohme LLC; Novartis AG; Pfizer; and Stemline Therapeutics.Faculty/PlannerPaolo Tarantino, MD, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for AstraZeneca; Daiichi Sankyo, Inc.; Gilead, and Lilly.Grant/Research Support from AstraZeneca.Planning Committee and Reviewer DisclosuresPlanners, independent reviewers, and staff of PVI, PeerView Institute for Medical Education, do not have any relevant financial relationships related to this CE activity unless listed below.
This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, downloadable Practice Aids, slides, and complete CME/MOC/AAPA information, and to apply for credit, please visit us at PeerView.com/CHJ865. CME/MOC/AAPA credit will be available until January 5, 2025.Modern Practice Principles: A Practical “How-To” Guide for Selection, Sequencing, and Optimal Use of HER2-Targeted Therapies in HER2-Positive Breast Cancer In support of improving patient care, this activity has been planned and implemented by PVI, PeerView Institute for Medical Education, GRASP, and Living Beyond Breast Cancer. PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported by independent educational grants from AstraZeneca, Daiichi Sankyo, Inc., and Seagen Inc.Disclosure PolicyAll relevant conflicts of interest have been mitigated prior to the commencement of the activity.Faculty/Planner DisclosuresChair/PlannerSara A. Hurvitz, MD, FACP, has a financial interest/relationship or affiliation in the form of:Grant/Research Support from Ambrx; Arvinas, Inc.; AstraZeneca; Bayer Corporation; Celcuity, Inc.; Cytomx Therapeutics, Inc.; Daiichi-Sankyo Inc.; Dantari; Dignitana AB; G1 Therapeutics, Inc.; Genentech, Inc./F. Hoffmann-La Roche Ltd.; Gilead Sciences, Inc.; GlaxoSmithKline; Greenwich Life Sciences Inc; Immunomedics, Inc; Lilly; Loxo Oncology; Macrogenics, Inc.; Novartis Pharmaceuticals Corporation; OBI Pharma, Inc.; Orinove Inc.; Orum; Pfizer; Phoenix Molecular Designs; Pieris Pharmaceuticals, Inc.; Puma Biotechnology, Inc.; Radius Health, Inc.; Sanofi; Seattle Genetics, Inc./Seagen Inc.; and Zymeworks Inc.Speaker for Curio and OncLive.Stock Shareholder in RomTech, spouse.Faculty/PlannerJavier Cortes, MD, PhD, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for AbbVie Inc.; AstraZeneca; Bioasis Technologies, Inc.; BioInvent International AB; Boehringer Ingelheim Pharmaceuticals, Inc.; Clovis Oncology; Daiichi Sankyo Co., Ltd; Ellipses Pharma; ExpreS2ion Biotechnologies ApS; F. Hoffmann-La Roche Ltd; GEMoaB GmbH; Gilead Sciences, Inc.; HiberCell; Jazz Pharmaceuticals, Inc.; Leuko Labs Inc.; Lilly; The Menarini Group; Merck Sharp & Dohme LLC; REVEAL GENOMICS, S.L.; Scorpion Therapeutics, Inc.; Seattle Genetics; and Zymeworks BC Inc.Grant/Research Support from ARIAD Pharmaceuticals, Inc.; AstraZeneca; Baxalta GmbH/LES LABORATOIRES SERVIER; Bayer Corporation; Eisai Inc.; F. Hoffmann-La Roche Ltd; Guardant Health; IQVIA Inc.; Merck Sharp & Dohme LLC; Pfizer; PIQUR Therapeutics; and Queen Mary University of London.Honoraria from AstraZeneca; Daiichi Sankyo Co., Ltd; Eisai Inc.; F. Hoffmann-La Roche Ltd; Gilead Sciences, Inc.; Lilly; Merck Sharp & Dohme LLC; Novartis AG; Pfizer; and Stemline Therapeutics.Faculty/PlannerPaolo Tarantino, MD, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for AstraZeneca; Daiichi Sankyo, Inc.; Gilead, and Lilly.Grant/Research Support from AstraZeneca.Planning Committee and Reviewer DisclosuresPlanners, independent reviewers, and staff of PVI, PeerView Institute for Medical Education, do not have any relevant financial relationships related to this CE activity unless listed below.
This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, slides, and complete CME/MOC/AAPA information, and to apply for credit, please visit us at PeerView.com/JTS865. CME/MOC/AAPA credit will be available until November 13, 2024.Revolutionizing Solid Tumor Treatment, Unleashing the Potential of Antibody–Drug Conjugates: How to Make the Most of the Latest Clinical Evidence to Enhance Patient Care In support of improving patient care, PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported by independent educational grants from AstraZeneca, Daiichi Sankyo, Inc., and Gilead Sciences, Inc.Disclosure PolicyAll relevant conflicts of interest have been mitigated prior to the commencement of the activity.Faculty/Planner DisclosuresChair/PlannerPaolo Tarantino, MD, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for AstraZeneca; Daiichi Sankyo, Inc.; F. Hoffmann-La Roche Ltd/Genentech, Inc.; Gilead Sciences, Inc.; and Lilly.Grant/Research Support from AstraZeneca.Speaker for AstraZeneca; Daiichi Sankyo, Inc.; and F. Hoffmann-La Roche Ltd/Genentech, Inc.Faculty/PlannerErika Hamilton, MD, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for Arcus Biosciences, Inc.; Arvinas, Inc.; AstraZeneca; Daiichi Sankyo, Inc.; Deciphera Pharmaceuticals, lnc.; Ellipses Pharma; F. Hoffmann-La Roche Ltd/Genentech, Inc.; Greenwich LifeSciences, Inc.; iTeos Therapeutics; Janssen Pharmaceuticals, Inc.; Lilly; Loxo Oncology; Mersana Therapeutics; Novartis Pharmaceuticals Corporation; Orum Therapeutics; Pfizer; Relay Therapeutics; Seagen Inc.; and Verascity Science (all paid to institution).Grant/Research Support from AbbVie Inc.; Accutar Biotechnology Inc; Acerta Pharma; ADC Therapeutics SA; Akeso Biophanna Co., Ltd.; Amgen Inc.; Aravive; Artios Pharma; Arvinas, Inc.; AstraZeneca; AtlasMedx, Inc.; BeiGene, lnc.; Black Diamond Therapeutics, Inc.; Bliss Biopharmaceutical (Hangzhou) Co., Ltd.; Boehringer lngelheim Pharmaceuticals, lnc.; Cascadian Therapeutics; Clovis Oncology; Compugen; Cullinan Oncology, Inc.; Curis, Inc.; CytomX Therapeutics, Inc.; Daiichi Sankyo, Inc.; Dana-Farber Cancer Institute; Dantari; Deciphera Pharmaceuticals, Inc.; Duality Biologics; eFFECTOR Therapeutics, Inc.; Ellipses Pharma; Elucida Oncology, Inc.; EMD Serano, Inc.; F. Hoffmann-La Roche Ltd/Genentech, Inc.; FUJIFILM Pharmaceuticals U.S.A., Inc.; G1 Therapeutics, Inc.; H3 Biomedicine Inc.; Harpoon Therapeutics; HUTCHMED (China) Limited; lmmunoGen, Inc.; lmmunomedics, Inc.; lncyte; Infinity Pharmaceuticals, Inc.; lnvestisBio; Jacobio Pharmaceuticals Group Co., Ltd.; K-Group Beta, lnc.; Karyopharm; Lilly; Loxo Oncology; Lycera; MabSpace Biosciences Co., Ltd.; MacroGenics, Inc.; Medlmmune, LLC; Mersana Therapeutics; Merus; Millennium Pharmaceuticals, Inc.; Molecular Templates, Inc.; Novartis Pharmaceuticals Corporation; Nucana; Olema Oncology; OncoMed Pharmaceuticals, Inc.; Onconova Therapeutics; Oncothyreon; ORIC Pharmaceuticals, Inc.; Orinove lnc.; Pfizer; PharmaMar; Pieris Pharmaceuticals, Inc.; Pionyr lmmunotherapeutics; Plexxikon; Radius Health, lnc.; Regeneron Pharmaceuticals Inc.; Relay Therapeutics; Repertoire Immune Medicines; Rgenix Inc.; Seagen lnc.; Sermonix Pharmaceuticals; Shattuck Labs Inc.; Stemcentrx, Inc.; Sutro Biopharma, lnc.; Syndax; Syros Pharmaceuticals, Inc.; Taiho Oncology, Inc.; Taplmmune lnc; TESARO, Inc.; Tolmar Pharmaceuticals, Inc.; Torque Therapeutics, Inc.; Treadwell Therapeutics; Verastem, Inc.; Vincerx Pharma; zenithepigenetics; and Zymeworks (all paid to institution).Faculty/PlannerYelena Y. Janjigian*, MD, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for AbbVie, Inc.; AmerisourceBergen; Arcus Biosciences; AskGene Pharma, Inc.; Astellas Pharma Inc.; AstraZeneca; Basilea Pharmaceutica Ltd.; Bayer Corporation; Bristol Myers Squibb; Daiichi Sankyo Inc.; GlaxoSmithKline; Guardant Health; Imugene Limited; Inspirna, Inc.; Lilly; Merck and Co., Inc.; Merck Serono; Mersana Therapeutics Inc.; Pfizer; Rgenix Inc.; Seagen Inc.; Silverback Therapeutics (ARS Pharmaceuticals) and Zymeworks Inc.Grant/Research Support from Arcus Biosciences; AstraZeneca; Bayer HealthCare Pharmaceuticals, Inc.; Bristol Myers Squibb; Cycle for Survival; Fred's Team; Genentech, Inc./F. Hoffmann-La Roche Ltd.; Inspirna, Inc.; Lilly; Merck and Co., Inc.; National Cancer Institute; Transcenta Holding; and U.S. Department of Defense.Stock Shareholder in Inspirna, Inc.Faculty/PlannerAntonio Passaro, MD, PhD, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for AstraZeneca; Boehringer Ingelheim International GmbH; Bristol Myers Squibb; Daiichi Sankyo, Inc.; GSK; Genentech, Inc./F. Hoffmann-La Roche Ltd.; Janssen Global Services, LLC.; Lilly; Merck Sharp and Dohme; Mundipharma International; Novartis AG; Pfizer; and Takeda Pharmaceutical Company Limited.Grant/Research Support from ArriVent Biopharma; AstraZeneca; Boehringer Ingelheim International GmbH; Bristol Myers Squibb; Daiichi Sankyo, Inc.; Genentech, Inc./F. Hoffmann-La Roche Ltd.; Janssen Global Services, LLC.; Lilly; Merck Serono; Merck Sharp and Dohme; Mirati Therapeutics, Inc.; Pfizer; and RMC Pharmaceutical Solutions Inc.Planning Committee and Reviewer DisclosuresPlanners, independent reviewers, and staff of PVI, PeerView Institute for Medical Education, do not have any relevant financial relationships related to this CE activity unless listed below.
This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, slides, and complete CME/MOC/AAPA information, and to apply for credit, please visit us at PeerView.com/JTS865. CME/MOC/AAPA credit will be available until November 13, 2024.Revolutionizing Solid Tumor Treatment, Unleashing the Potential of Antibody–Drug Conjugates: How to Make the Most of the Latest Clinical Evidence to Enhance Patient Care In support of improving patient care, PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported by independent educational grants from AstraZeneca, Daiichi Sankyo, Inc., and Gilead Sciences, Inc.Disclosure PolicyAll relevant conflicts of interest have been mitigated prior to the commencement of the activity.Faculty/Planner DisclosuresChair/PlannerPaolo Tarantino, MD, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for AstraZeneca; Daiichi Sankyo, Inc.; F. Hoffmann-La Roche Ltd/Genentech, Inc.; Gilead Sciences, Inc.; and Lilly.Grant/Research Support from AstraZeneca.Speaker for AstraZeneca; Daiichi Sankyo, Inc.; and F. Hoffmann-La Roche Ltd/Genentech, Inc.Faculty/PlannerErika Hamilton, MD, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for Arcus Biosciences, Inc.; Arvinas, Inc.; AstraZeneca; Daiichi Sankyo, Inc.; Deciphera Pharmaceuticals, lnc.; Ellipses Pharma; F. Hoffmann-La Roche Ltd/Genentech, Inc.; Greenwich LifeSciences, Inc.; iTeos Therapeutics; Janssen Pharmaceuticals, Inc.; Lilly; Loxo Oncology; Mersana Therapeutics; Novartis Pharmaceuticals Corporation; Orum Therapeutics; Pfizer; Relay Therapeutics; Seagen Inc.; and Verascity Science (all paid to institution).Grant/Research Support from AbbVie Inc.; Accutar Biotechnology Inc; Acerta Pharma; ADC Therapeutics SA; Akeso Biophanna Co., Ltd.; Amgen Inc.; Aravive; Artios Pharma; Arvinas, Inc.; AstraZeneca; AtlasMedx, Inc.; BeiGene, lnc.; Black Diamond Therapeutics, Inc.; Bliss Biopharmaceutical (Hangzhou) Co., Ltd.; Boehringer lngelheim Pharmaceuticals, lnc.; Cascadian Therapeutics; Clovis Oncology; Compugen; Cullinan Oncology, Inc.; Curis, Inc.; CytomX Therapeutics, Inc.; Daiichi Sankyo, Inc.; Dana-Farber Cancer Institute; Dantari; Deciphera Pharmaceuticals, Inc.; Duality Biologics; eFFECTOR Therapeutics, Inc.; Ellipses Pharma; Elucida Oncology, Inc.; EMD Serano, Inc.; F. Hoffmann-La Roche Ltd/Genentech, Inc.; FUJIFILM Pharmaceuticals U.S.A., Inc.; G1 Therapeutics, Inc.; H3 Biomedicine Inc.; Harpoon Therapeutics; HUTCHMED (China) Limited; lmmunoGen, Inc.; lmmunomedics, Inc.; lncyte; Infinity Pharmaceuticals, Inc.; lnvestisBio; Jacobio Pharmaceuticals Group Co., Ltd.; K-Group Beta, lnc.; Karyopharm; Lilly; Loxo Oncology; Lycera; MabSpace Biosciences Co., Ltd.; MacroGenics, Inc.; Medlmmune, LLC; Mersana Therapeutics; Merus; Millennium Pharmaceuticals, Inc.; Molecular Templates, Inc.; Novartis Pharmaceuticals Corporation; Nucana; Olema Oncology; OncoMed Pharmaceuticals, Inc.; Onconova Therapeutics; Oncothyreon; ORIC Pharmaceuticals, Inc.; Orinove lnc.; Pfizer; PharmaMar; Pieris Pharmaceuticals, Inc.; Pionyr lmmunotherapeutics; Plexxikon; Radius Health, lnc.; Regeneron Pharmaceuticals Inc.; Relay Therapeutics; Repertoire Immune Medicines; Rgenix Inc.; Seagen lnc.; Sermonix Pharmaceuticals; Shattuck Labs Inc.; Stemcentrx, Inc.; Sutro Biopharma, lnc.; Syndax; Syros Pharmaceuticals, Inc.; Taiho Oncology, Inc.; Taplmmune lnc; TESARO, Inc.; Tolmar Pharmaceuticals, Inc.; Torque Therapeutics, Inc.; Treadwell Therapeutics; Verastem, Inc.; Vincerx Pharma; zenithepigenetics; and Zymeworks (all paid to institution).Faculty/PlannerYelena Y. Janjigian*, MD, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for AbbVie, Inc.; AmerisourceBergen; Arcus Biosciences; AskGene Pharma, Inc.; Astellas Pharma Inc.; AstraZeneca; Basilea Pharmaceutica Ltd.; Bayer Corporation; Bristol Myers Squibb; Daiichi Sankyo Inc.; GlaxoSmithKline; Guardant Health; Imugene Limited; Inspirna, Inc.; Lilly; Merck and Co., Inc.; Merck Serono; Mersana Therapeutics Inc.; Pfizer; Rgenix Inc.; Seagen Inc.; Silverback Therapeutics (ARS Pharmaceuticals) and Zymeworks Inc.Grant/Research Support from Arcus Biosciences; AstraZeneca; Bayer HealthCare Pharmaceuticals, Inc.; Bristol Myers Squibb; Cycle for Survival; Fred's Team; Genentech, Inc./F. Hoffmann-La Roche Ltd.; Inspirna, Inc.; Lilly; Merck and Co., Inc.; National Cancer Institute; Transcenta Holding; and U.S. Department of Defense.Stock Shareholder in Inspirna, Inc.Faculty/PlannerAntonio Passaro, MD, PhD, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for AstraZeneca; Boehringer Ingelheim International GmbH; Bristol Myers Squibb; Daiichi Sankyo, Inc.; GSK; Genentech, Inc./F. Hoffmann-La Roche Ltd.; Janssen Global Services, LLC.; Lilly; Merck Sharp and Dohme; Mundipharma International; Novartis AG; Pfizer; and Takeda Pharmaceutical Company Limited.Grant/Research Support from ArriVent Biopharma; AstraZeneca; Boehringer Ingelheim International GmbH; Bristol Myers Squibb; Daiichi Sankyo, Inc.; Genentech, Inc./F. Hoffmann-La Roche Ltd.; Janssen Global Services, LLC.; Lilly; Merck Serono; Merck Sharp and Dohme; Mirati Therapeutics, Inc.; Pfizer; and RMC Pharmaceutical Solutions Inc.Planning Committee and Reviewer DisclosuresPlanners, independent reviewers, and staff of PVI, PeerView Institute for Medical Education, do not have any relevant financial relationships related to this CE activity unless listed below.
This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, slides, and complete CME/MOC/AAPA information, and to apply for credit, please visit us at PeerView.com/JTS865. CME/MOC/AAPA credit will be available until November 13, 2024.Revolutionizing Solid Tumor Treatment, Unleashing the Potential of Antibody–Drug Conjugates: How to Make the Most of the Latest Clinical Evidence to Enhance Patient Care In support of improving patient care, PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported by independent educational grants from AstraZeneca, Daiichi Sankyo, Inc., and Gilead Sciences, Inc.Disclosure PolicyAll relevant conflicts of interest have been mitigated prior to the commencement of the activity.Faculty/Planner DisclosuresChair/PlannerPaolo Tarantino, MD, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for AstraZeneca; Daiichi Sankyo, Inc.; F. Hoffmann-La Roche Ltd/Genentech, Inc.; Gilead Sciences, Inc.; and Lilly.Grant/Research Support from AstraZeneca.Speaker for AstraZeneca; Daiichi Sankyo, Inc.; and F. Hoffmann-La Roche Ltd/Genentech, Inc.Faculty/PlannerErika Hamilton, MD, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for Arcus Biosciences, Inc.; Arvinas, Inc.; AstraZeneca; Daiichi Sankyo, Inc.; Deciphera Pharmaceuticals, lnc.; Ellipses Pharma; F. Hoffmann-La Roche Ltd/Genentech, Inc.; Greenwich LifeSciences, Inc.; iTeos Therapeutics; Janssen Pharmaceuticals, Inc.; Lilly; Loxo Oncology; Mersana Therapeutics; Novartis Pharmaceuticals Corporation; Orum Therapeutics; Pfizer; Relay Therapeutics; Seagen Inc.; and Verascity Science (all paid to institution).Grant/Research Support from AbbVie Inc.; Accutar Biotechnology Inc; Acerta Pharma; ADC Therapeutics SA; Akeso Biophanna Co., Ltd.; Amgen Inc.; Aravive; Artios Pharma; Arvinas, Inc.; AstraZeneca; AtlasMedx, Inc.; BeiGene, lnc.; Black Diamond Therapeutics, Inc.; Bliss Biopharmaceutical (Hangzhou) Co., Ltd.; Boehringer lngelheim Pharmaceuticals, lnc.; Cascadian Therapeutics; Clovis Oncology; Compugen; Cullinan Oncology, Inc.; Curis, Inc.; CytomX Therapeutics, Inc.; Daiichi Sankyo, Inc.; Dana-Farber Cancer Institute; Dantari; Deciphera Pharmaceuticals, Inc.; Duality Biologics; eFFECTOR Therapeutics, Inc.; Ellipses Pharma; Elucida Oncology, Inc.; EMD Serano, Inc.; F. Hoffmann-La Roche Ltd/Genentech, Inc.; FUJIFILM Pharmaceuticals U.S.A., Inc.; G1 Therapeutics, Inc.; H3 Biomedicine Inc.; Harpoon Therapeutics; HUTCHMED (China) Limited; lmmunoGen, Inc.; lmmunomedics, Inc.; lncyte; Infinity Pharmaceuticals, Inc.; lnvestisBio; Jacobio Pharmaceuticals Group Co., Ltd.; K-Group Beta, lnc.; Karyopharm; Lilly; Loxo Oncology; Lycera; MabSpace Biosciences Co., Ltd.; MacroGenics, Inc.; Medlmmune, LLC; Mersana Therapeutics; Merus; Millennium Pharmaceuticals, Inc.; Molecular Templates, Inc.; Novartis Pharmaceuticals Corporation; Nucana; Olema Oncology; OncoMed Pharmaceuticals, Inc.; Onconova Therapeutics; Oncothyreon; ORIC Pharmaceuticals, Inc.; Orinove lnc.; Pfizer; PharmaMar; Pieris Pharmaceuticals, Inc.; Pionyr lmmunotherapeutics; Plexxikon; Radius Health, lnc.; Regeneron Pharmaceuticals Inc.; Relay Therapeutics; Repertoire Immune Medicines; Rgenix Inc.; Seagen lnc.; Sermonix Pharmaceuticals; Shattuck Labs Inc.; Stemcentrx, Inc.; Sutro Biopharma, lnc.; Syndax; Syros Pharmaceuticals, Inc.; Taiho Oncology, Inc.; Taplmmune lnc; TESARO, Inc.; Tolmar Pharmaceuticals, Inc.; Torque Therapeutics, Inc.; Treadwell Therapeutics; Verastem, Inc.; Vincerx Pharma; zenithepigenetics; and Zymeworks (all paid to institution).Faculty/PlannerYelena Y. Janjigian*, MD, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for AbbVie, Inc.; AmerisourceBergen; Arcus Biosciences; AskGene Pharma, Inc.; Astellas Pharma Inc.; AstraZeneca; Basilea Pharmaceutica Ltd.; Bayer Corporation; Bristol Myers Squibb; Daiichi Sankyo Inc.; GlaxoSmithKline; Guardant Health; Imugene Limited; Inspirna, Inc.; Lilly; Merck and Co., Inc.; Merck Serono; Mersana Therapeutics Inc.; Pfizer; Rgenix Inc.; Seagen Inc.; Silverback Therapeutics (ARS Pharmaceuticals) and Zymeworks Inc.Grant/Research Support from Arcus Biosciences; AstraZeneca; Bayer HealthCare Pharmaceuticals, Inc.; Bristol Myers Squibb; Cycle for Survival; Fred's Team; Genentech, Inc./F. Hoffmann-La Roche Ltd.; Inspirna, Inc.; Lilly; Merck and Co., Inc.; National Cancer Institute; Transcenta Holding; and U.S. Department of Defense.Stock Shareholder in Inspirna, Inc.Faculty/PlannerAntonio Passaro, MD, PhD, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for AstraZeneca; Boehringer Ingelheim International GmbH; Bristol Myers Squibb; Daiichi Sankyo, Inc.; GSK; Genentech, Inc./F. Hoffmann-La Roche Ltd.; Janssen Global Services, LLC.; Lilly; Merck Sharp and Dohme; Mundipharma International; Novartis AG; Pfizer; and Takeda Pharmaceutical Company Limited.Grant/Research Support from ArriVent Biopharma; AstraZeneca; Boehringer Ingelheim International GmbH; Bristol Myers Squibb; Daiichi Sankyo, Inc.; Genentech, Inc./F. Hoffmann-La Roche Ltd.; Janssen Global Services, LLC.; Lilly; Merck Serono; Merck Sharp and Dohme; Mirati Therapeutics, Inc.; Pfizer; and RMC Pharmaceutical Solutions Inc.Planning Committee and Reviewer DisclosuresPlanners, independent reviewers, and staff of PVI, PeerView Institute for Medical Education, do not have any relevant financial relationships related to this CE activity unless listed below.
This content has been developed for healthcare professionals only. Patients who seek health information should consult with their physician or relevant patient advocacy groups.For the full presentation, slides, and complete CME/MOC/AAPA information, and to apply for credit, please visit us at PeerView.com/JTS865. CME/MOC/AAPA credit will be available until November 13, 2024.Revolutionizing Solid Tumor Treatment, Unleashing the Potential of Antibody–Drug Conjugates: How to Make the Most of the Latest Clinical Evidence to Enhance Patient Care In support of improving patient care, PVI, PeerView Institute for Medical Education, is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.SupportThis activity is supported by independent educational grants from AstraZeneca, Daiichi Sankyo, Inc., and Gilead Sciences, Inc.Disclosure PolicyAll relevant conflicts of interest have been mitigated prior to the commencement of the activity.Faculty/Planner DisclosuresChair/PlannerPaolo Tarantino, MD, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for AstraZeneca; Daiichi Sankyo, Inc.; F. Hoffmann-La Roche Ltd/Genentech, Inc.; Gilead Sciences, Inc.; and Lilly.Grant/Research Support from AstraZeneca.Speaker for AstraZeneca; Daiichi Sankyo, Inc.; and F. Hoffmann-La Roche Ltd/Genentech, Inc.Faculty/PlannerErika Hamilton, MD, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for Arcus Biosciences, Inc.; Arvinas, Inc.; AstraZeneca; Daiichi Sankyo, Inc.; Deciphera Pharmaceuticals, lnc.; Ellipses Pharma; F. Hoffmann-La Roche Ltd/Genentech, Inc.; Greenwich LifeSciences, Inc.; iTeos Therapeutics; Janssen Pharmaceuticals, Inc.; Lilly; Loxo Oncology; Mersana Therapeutics; Novartis Pharmaceuticals Corporation; Orum Therapeutics; Pfizer; Relay Therapeutics; Seagen Inc.; and Verascity Science (all paid to institution).Grant/Research Support from AbbVie Inc.; Accutar Biotechnology Inc; Acerta Pharma; ADC Therapeutics SA; Akeso Biophanna Co., Ltd.; Amgen Inc.; Aravive; Artios Pharma; Arvinas, Inc.; AstraZeneca; AtlasMedx, Inc.; BeiGene, lnc.; Black Diamond Therapeutics, Inc.; Bliss Biopharmaceutical (Hangzhou) Co., Ltd.; Boehringer lngelheim Pharmaceuticals, lnc.; Cascadian Therapeutics; Clovis Oncology; Compugen; Cullinan Oncology, Inc.; Curis, Inc.; CytomX Therapeutics, Inc.; Daiichi Sankyo, Inc.; Dana-Farber Cancer Institute; Dantari; Deciphera Pharmaceuticals, Inc.; Duality Biologics; eFFECTOR Therapeutics, Inc.; Ellipses Pharma; Elucida Oncology, Inc.; EMD Serano, Inc.; F. Hoffmann-La Roche Ltd/Genentech, Inc.; FUJIFILM Pharmaceuticals U.S.A., Inc.; G1 Therapeutics, Inc.; H3 Biomedicine Inc.; Harpoon Therapeutics; HUTCHMED (China) Limited; lmmunoGen, Inc.; lmmunomedics, Inc.; lncyte; Infinity Pharmaceuticals, Inc.; lnvestisBio; Jacobio Pharmaceuticals Group Co., Ltd.; K-Group Beta, lnc.; Karyopharm; Lilly; Loxo Oncology; Lycera; MabSpace Biosciences Co., Ltd.; MacroGenics, Inc.; Medlmmune, LLC; Mersana Therapeutics; Merus; Millennium Pharmaceuticals, Inc.; Molecular Templates, Inc.; Novartis Pharmaceuticals Corporation; Nucana; Olema Oncology; OncoMed Pharmaceuticals, Inc.; Onconova Therapeutics; Oncothyreon; ORIC Pharmaceuticals, Inc.; Orinove lnc.; Pfizer; PharmaMar; Pieris Pharmaceuticals, Inc.; Pionyr lmmunotherapeutics; Plexxikon; Radius Health, lnc.; Regeneron Pharmaceuticals Inc.; Relay Therapeutics; Repertoire Immune Medicines; Rgenix Inc.; Seagen lnc.; Sermonix Pharmaceuticals; Shattuck Labs Inc.; Stemcentrx, Inc.; Sutro Biopharma, lnc.; Syndax; Syros Pharmaceuticals, Inc.; Taiho Oncology, Inc.; Taplmmune lnc; TESARO, Inc.; Tolmar Pharmaceuticals, Inc.; Torque Therapeutics, Inc.; Treadwell Therapeutics; Verastem, Inc.; Vincerx Pharma; zenithepigenetics; and Zymeworks (all paid to institution).Faculty/PlannerYelena Y. Janjigian*, MD, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for AbbVie, Inc.; AmerisourceBergen; Arcus Biosciences; AskGene Pharma, Inc.; Astellas Pharma Inc.; AstraZeneca; Basilea Pharmaceutica Ltd.; Bayer Corporation; Bristol Myers Squibb; Daiichi Sankyo Inc.; GlaxoSmithKline; Guardant Health; Imugene Limited; Inspirna, Inc.; Lilly; Merck and Co., Inc.; Merck Serono; Mersana Therapeutics Inc.; Pfizer; Rgenix Inc.; Seagen Inc.; Silverback Therapeutics (ARS Pharmaceuticals) and Zymeworks Inc.Grant/Research Support from Arcus Biosciences; AstraZeneca; Bayer HealthCare Pharmaceuticals, Inc.; Bristol Myers Squibb; Cycle for Survival; Fred's Team; Genentech, Inc./F. Hoffmann-La Roche Ltd.; Inspirna, Inc.; Lilly; Merck and Co., Inc.; National Cancer Institute; Transcenta Holding; and U.S. Department of Defense.Stock Shareholder in Inspirna, Inc.Faculty/PlannerAntonio Passaro, MD, PhD, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for AstraZeneca; Boehringer Ingelheim International GmbH; Bristol Myers Squibb; Daiichi Sankyo, Inc.; GSK; Genentech, Inc./F. Hoffmann-La Roche Ltd.; Janssen Global Services, LLC.; Lilly; Merck Sharp and Dohme; Mundipharma International; Novartis AG; Pfizer; and Takeda Pharmaceutical Company Limited.Grant/Research Support from ArriVent Biopharma; AstraZeneca; Boehringer Ingelheim International GmbH; Bristol Myers Squibb; Daiichi Sankyo, Inc.; Genentech, Inc./F. Hoffmann-La Roche Ltd.; Janssen Global Services, LLC.; Lilly; Merck Serono; Merck Sharp and Dohme; Mirati Therapeutics, Inc.; Pfizer; and RMC Pharmaceutical Solutions Inc.Planning Committee and Reviewer DisclosuresPlanners, independent reviewers, and staff of PVI, PeerView Institute for Medical Education, do not have any relevant financial relationships related to this CE activity unless listed below.
Drs. Lillian Siu and Melvin Chua discuss scientific innovations, disruptive technologies, and novel ways to practice oncology that were featured at the 2023 ASCO Breakthrough meeting in Yokohama, Japan, including CRISPR and gene editing, CAR T-cell and adoptive cell therapies, as well as emerging AI applications that are poised to revolutionize cancer care. TRANSCRIPT Dr. Melvin Chua: Hello, I'm Dr. Melvin Chua, your guest host of the ASCO Daily News Podcast today. I'm a radiation oncologist and I currently practice in the Division of Radiation Oncology at the National Cancer Center in Singapore. I also served as the chair-elect of the ASCO Breakthrough Program Committee, and, on today's episode, we'll be discussing key takeaways from this year's Breakthrough meeting. The global meeting in Yokohama, Japan, brought together world-renowned experts, clinicians, med-tech, pioneers, and novel drug developers to discuss scientific innovations and disruptive technologies that are transforming cancer care today. I'm joined by Dr. Lillian Siu, the chair of the Breakthrough Program Committee. Dr. Siu is a senior medical oncologist at the Princess Margaret Cancer Centre and a professor of medicine at the University of Toronto. You'll find our full disclosures in the transcript of this episode, and disclosures of all guests on the podcast are available at asco.org/DNpod. Lillian, it's great to be speaking with you today. Dr. Lillian Siu: Thanks, Dr. Chua. I'm happy to be here. Dr. Melvin Chua: We were just at ASCO Breakthrough, and it showcased some incredible scientific innovations, and really showed us how technology innovations in precision oncology, biotech, and artificial intelligence are transforming cancer care. What are your thoughts? Dr. Lillian Siu: Yeah, it was a really exciting meeting, Melvin. The theme of this year's Breakthrough meeting was “Shining a Light on Advances in Cancer Care.” And our Opening Session featured an illuminating keynote address by the renowned thought leader and tech trailblazer, Dr. Hiroshi or “Mickey” Mikitani, the founder and CEO of Rakuten and Rakuten Medical. In his address that was titled, “Innovative Technology and Oncology,” he spoke so passionately about innovation and really seeing around the corner to predict what is coming and taking risks. And I think that's what medicine is about, not just what we have in front of us, but to predict and forecast what's coming. I totally was inspired by his address, and I think a lot of the audience felt the same way. He also spoke to us a bit about his company's development in photoimmunotherapy using novel technology and light therapy in head and neck cancer. And I think that's also an area of new technology that we should watch in the next few years. Dr. Melvin Chua: I totally agree with you, Lillian. And one of the quotes that he spoke about really spoke to my heart. He spoke about the 2 choices: whether to do or not to do and not to do is not an option. So, I think that was a very compelling message to a lot of our audience at the meeting. So, on this same note, innovation is a driving force in oncology, and we saw countless examples of this throughout the Breakthrough meeting. Were there any sessions that really stood out for you? Dr. Lillian Siu: There were so many exciting sessions. First of all, there is the “Drugging the Undruggable” session. This is a really important session because in the past we felt that certain cancer targets such as KRAS, MYC, etc., are not druggable. KRAS G12C is the poster child in this area. So, during this session we heard about many ways that we are now looking to target these so-called undruggable molecules in the cancer cell. And we talked about molecular glues, we talked about degraders, and really novel ways that are not yet reaching the clinic, called “cyclic peptides” were discussed by one of the speakers. The other session that is very interesting also is CRISPR and gene editing. Obviously, we all know a little bit about gene editing, really trying to change or knock in some genes that are important perhaps to change the function. And one of the sessions talked about trail targeted induced mesenchymal stem cells, and perhaps this is a way to, again, deliver novel therapies and novel treatments to our patients. There were many examples of how CRISPR and gene editing can be ultimately going to the clinic to benefit our patients in terms of therapeutics. I want to highlight another session, which is the CAR T-cell and Adoptive Cell Therapies. I think everybody knows about CAR T-cells, but in this session we talk about non CAR T-cells or newer things such as off the shelf NK cells, Natural Killer cells from cord blood. So, this way it is allogeneics, in other words, we don't have to rely on only a patient's donation of their samples, but actually get it from off the shelf from other donors. There are other ways to really use human induced pluripotent stem cells that we can armor them by transgenes and also CRISPR out any unwanted genes, for example, to enhance an effective function of T-cells. So many, many exciting ways to bring these cell therapies to the patients. And last but not least, I want to highlight Dr. Chris Abbosh, who is one of our keynote speakers, talking about molecular and minimal residual disease and early cancer detection using circulating tumor DNA or liquid biopsy. He talked passionately about the TRACERx study, which he is instrumental in terms of leading together with Charlie Swanson in the UK. This is a study that really has uncovered a lot of science about cancer heterogeneity. And in that study, he also studied circulating tumor DNA and really shed a lot of light about clonal and subclonal dynamics over time that changes. Dr. Melvin Chua: And just to touch on that point about innovation and how that translates to cancer care, I think it was great that we had those case-based applications in lung cancer, in breast cancer, and the virus-associated cancers. And I like how the speakers were able to bring in the Ying and the Yang, bring the West and the Eastern perspectives in these interactive sessions. I particularly enjoyed all of them. But the session on the lung case discussion where we know that there were this EGFR mutant lung cancers that are prevalent in this part of the world in Asia. I thought the interaction between the speakers was fantastic. On the same note about therapies and we heard about novel therapeutics at this meeting as well. I wonder what your thoughts are about some of the sessions, and do you think some of these technologies were able to be brought into practice? And your thoughts on the novel therapeutic session that happened at Breakthrough, do you think this will actually impact clinical care? Dr. Lillian Siu: Oh, for sure, Melvin. The 5 areas that were covered during the Novel Therapeutics session are really drugs already in the clinic. And for example, the first one was about antibody drug conjugates. We know there are now at least 12 antibody drug conjugates already approved by the FDA and many more likely to be approved in the near future. And the session really talked about what's next, how to improve upon ADC, for example, using better drug antibody ratio, talking about new payloads and really new formats that make perhaps ADCs even more potent in the future. There was a session on oral immunotherapeutics. It was really how to target the innate immunity. And I think novel oral immunotherapeutics is very important because we all know PD-1, PD-L1 inhibitors have been the backbone, but we need another Breakthrough. And having oral immunotherapeutics will make it very attractive for patients because they don't have to come to the cancer center to receive the drugs. Another part of that session was about T-cell engagers and bispecifics, really how to bring molecules to the T-cell, to the effective cells so that they are able to be phytotoxic to the tumor. We talked about also oncolytic viruses, how are the new ways to utilize this kind of natural agent to target the cancer cells. And lastly, we also talked about personalized cancer vaccine, which is obviously very timely. We all know a lot about vaccine now after the COVID pandemic and how do we use cancer vaccines to be a good therapeutic drug? I think especially important in the earlier disease stages as adjuvant therapy. Some exciting data, for example, in pancreatic cancer, as adjuvant really is groundbreaking for this whole topic of cancer vaccination. Dr. Melvin Chua: That's great. And for me as a radiation oncologist who's not so deep in drug development, hearing all the talks at ASCO Breakthrough was really informative for me and I learned a lot. In particular, you spoke about the whole session there was oncolytic therapy and the results in glioblastoma multiforme, we know it's a deadly disease, was certainly very impressive. And so, it speaks to the whole notion that in fact, some of this stuff is in fact reaching the clinic and making a difference in deadly diseases. I think there's a lot to take in from there. Dr. Lillian Siu: Melvin, you're so humble. I know you're a big expert in artificial intelligence and I think the whole session about AI applications in precision medicine really was not just in that session, but a whole theme that went throughout the entire meeting. So, I'm very interested to know what you think about some of the presentations around AI and disruptive technologies in precision medicine, such as next-generation multiomics, etc. What are your thoughts? Dr. Melvin Chua: Absolutely, I agree with you. And there was so much material within the AI session, the multiomic session, as well as the keynote [address] by Dr. Maryellen Giger, which basically speaks about some of the pre-existing or historical work on artificial intelligence in radiology. And I'd like to first talk about the keynote by Dr. Maryellen Giger. It was very nice that she elegantly showed how AI was in fact already in practice in radiology, where it helped to fulfill or address a need for radiologists. Almost 20 years ago, they were able to show that using computer vision, you were able to basically facilitate the calling of abnormal mammograms. And it was inspiring to see how these early thoughts have now basically accelerated a lot of the advances that we see that are in practice today. The other thing that was also was to see this global collaboration, the need for global collaboration in the artificial intelligence space and the radiologists are clearly leading the way. And I think part of the impetus for this effort came from an opportunity that arose during the COVID pandemic that clearly affected all facets of healthcare. That was a nice segue to the very sort of dense 1 hour session we had on precision oncology care with artificial intelligence. I think when we designed this session, we were very deliberate that we wanted to address all aspects of how AI could be applied. From real-world clinical data, we saw examples of how having good, well-annotated data sets could actually help to accelerate and facilitate liver cancer screening in Hong Kong. Then we also saw a very simple, practical application of AI in pathology, where apart from just having this tool to be able to extract features that could potentially predict outcomes of patients and predict drug responses, we saw a very practical example that applying AI in digital pathology could actually homogenize or harmonize the ways the pathologists review their cases. And so, I thought that was very neat and could speak to all our clinicians across both developed and developing countries. We also saw very exciting stuff on the use of AI in terms of calling out mutations because we know that next-generation sequencing is pretty much a cornerstone of how we practice in oncology today. And yet we know that there are prohibitive costs that preclude this technology in certain parts of the world. And it was nice to see how AI could actually lower the cost of some of these sequencing technologies like being used in liquid biopsy. And then finally, there was some fancy science as well that was showcased in the spectrum when we saw how industry as well as academics are thinking about integrating multiomic data sets to then be able to accelerate drug discovery, help define patients better, and so that we can think about how to look at precision oncology using targeted treatments for specific patient phenotypes. So I think this was a very nice transition to the Next-Generation Multiomic Technology session, where, again, some of these topics were touched on, ranging from liquid biopsies, and this was already covered in Dr. Abbosh's talk, which you spoke about, and as well as the preceding day session where we heard snippets of it. And it was again reinforced by the speakers when it showcased liquid biopsies. We have heard so much about it in the last decade and we see it made approved now for use in the clinic, but yet so much remains unknown, like the discrepancies between assays, addressing the cost of assays and, importantly, how we deal with the information. So, I think we are just at the tip of the iceberg here. A lot of the clinical evidence needs to be generated in due course to address some of these questions. At the same time, it was also nice to see some of the new technologies being applied in discovery science. So, we know that immunotherapy is a major player in oncology today, and the Breakthrough represents a forum whereby we're able to bring translational scientists to showcase their work. And we saw examples of that at this meeting where single cell technology, digital spatial technology, being able to apply that in pathology specimens and how the two are integrated to be able to review more novel science to us, to show us how immunotherapy works or doesn't work in some patients. Both of us have touched on so much content that was showcased at the Breakthrough, and I think this speaks to the impact, the learning experience we've had from Breakthrough and I think that's the intended purpose of this meeting. Dr. Lillian Siu: Yeah, I agree. It truly was a very exciting 3 days. And I particularly like the multiomics session where we see that the technology is so advanced just in a really short period of time. Over the last few years, we've been now able to go into single cell resolution where in the past I don't think we would ever dream of being able to do that. In fact, I recall in the single cell session, we can even see messenger RNA on the slide, which I thought was fascinating, something that I cannot imagine we can see by the naked eye. It really is an exciting time in oncology, Melvin, and the field is advancing with these new innovations and therapies, but at the same time, I think it's important that we do live globally and we need to work really also to help improve access to quality-assured cancer medicines and diagnostics in the low and middle income countries. What do you think about that part? Did we do a good job in addressing that in the meeting? Dr. Melvin Chua: Absolutely, Lillian. We had a special session that was chaired by Dr. Peter Yu and the lecture was delivered by Dr. Gilberto Lopes from the University of Miami. And we know that he's a strong advocate for this. And the session title spoke to this topic very pointedly, “How Science, Technology, and Practice Can Be Enabled in Lower- and Middle-Resource Settings.” And I thought that the work that he highlighted, the whole ATOM coalition, was important. ATOM basically stands for Access to Oncology Medicines, and it was established last year by the UICC, the Union for International Cancer Control, along with global partners to improve access to anti-cancer drugs and to develop processes for ensuring quality delivery, as well as the optimal utilization of medicines in middle- and low-resource settings. And I think there's a lot more work to be done. Some of the information they showed was very compelling to me from this part of the world. But we know that Asia isn't very heterogeneous in terms of the resources, in terms of the culture. And I thought that the drug pricing, for example, how that should be addressed across the different countries is an important topic to pick up. And I hope his lecture only invigorates this conversation going forward. Dr. Lillian Siu: Yeah. Thanks, Melvin. I totally agree. That was very inspiring. Breakthrough is such a one of a kind, international gathering that we are not only able to network while we're there; we also have a session to really allow attendees to leverage international cancer networks, to learn a bit about them, all the way from, for example, some of the North American groups to Asia Pacific groups to even global groups, and how we interact between pharma and academia, really transcending boundaries. And I think it is really, really important for us to now have these networks address issues such as equity and cancer care innovation, novel approaches and so much more. And I think, I am sure you're going to do a good job in making sure that gets into the agenda in our next year's meeting in 2024. Ultimately, we hope that these collaborations in cancer research will help to improve the outcomes for our patients with cancer. Dr. Melvin Chua: Thank you again for sharing the great highlights of ASCO Breakthrough, and I'm really appreciative of your work, and your commitment to build a really robust program for this year. So, thank you. Dr. Lillian Siu: And thank you, Dr. Chua. And you can bet that I will not miss Breakthrough 2024 in Yokohama in August next year. I will be there. Dr. Melvin Chua: Okay, I'll hold you to that. And thank you to our listeners for your time today. You'll find links to all of the sessions discussed today in the transcript of this episode. And finally, if you value the insights that you hear on the podcast, please take a moment to rate, review and subscribe wherever you get your podcasts. Thank you again. Disclaimer: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience and conclusions. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement. Find out more about today's speakers: Dr. Lilian Siu @lillian_siu Dr. Melvin Chua @DrMLChua Follow ASCO on social media: @ASCO on Twitter ASCO on Facebook ASCO on LinkedIn Disclosures: Dr. Lillian Siu: Leadership (Immediate family member): Treadwell Therapeutics Stock and Other Ownership Interests (Immediate family member): Agios Consulting or Advisory Role: Merck, AstraZeneca/MedImmune, Roche, Voronoi Inc., Oncorus, GSK, Seattle Genetics, Arvinas, Navire, Janpix, Relay Therapeutics, Daiichi Sankyo/UCB Japan, Janssen, Research Funding (Institution): Bristol-Myers Squibb, Genentech/Roche, GlaxoSmithKline, Merck, Novartis, Pfizer, AstraZeneca, Boehringer Ingelheim, Bayer, Amgen, Astellas Pharma, Shattuck Labs, Symphogen, Avid, Mirati Therapeutics, Karyopharm Therapeutics, Amgen Dr. Melvin Chua: Leadership, Stock and Other Ownership Interests: Digital Life Line Honoraria: Janssen Oncology, Varian Consulting or Advisory Role: Janssen Oncology, Merck Sharp & Dohme, ImmunoSCAPE, Telix Pharmaceuticals, IQVIA, BeiGene Speakers' Bureau: AstraZeneca, Bayer, Pfizer, Janssen Research Funding: PVmed, Decipher Biosciences, EVYD Technology, MVision, BeiGene, EVYD Technology, MVision, BeiGene Patents, Royalties, Other Intellectual Property: High Sensitivity Lateral Flow Immunoassay for Detection of Analyte in Samples (10202107837T), Singapore. (Danny Jian Hang Tng, Chua Lee Kiang Melvin, Zhang Yong, Jenny Low, Ooi Eng Eong, Soo Khee Chee)
Dateline New Haven: Arvinas & BioPharma by WNHH Community Radio
Dr. John Sweetenham and Dr. Neeraj Agarwal discuss advances across the spectrum of malignancies, including key studies in precision oncology and disparities in cancer care in advance of the 2023 ASCO Annual Meeting. TRANSCRIPT Dr. John Sweetenham: Hello, I'm Dr. John Sweetenham, now the associate director for cancer network clinical affairs at UT Southwestern's Harold C. Simmons Comprehensive Cancer Center, and host of the ASCO Daily News Podcast. I'm delighted to welcome Dr. Neeraj Agarwal, director of the Genitourinary Oncology Program and a professor of medicine at the University of Utah Huntsman Cancer Institute, who is editor-in-chief of the ASCO Daily News. Today we'll be discussing some key advances across the spectrum of malignancies, as well as novel approaches in precision medicine and cancer disparities that will be featured at the 2023 ASCO Annual Meeting. Our full disclosures are available in the transcript of this episode, and disclosures of all guests on the podcast can be found on our transcripts at asco.org/DNpod. Neeraj, it's great to have you back on the podcast today. Dr. Neeraj Agarwal: Thank you so much, John, for having me. Dr. John Sweetenham: Neeraj, let's begin by discussing some practice-changing phase 3 trials, starting with Abstract 5500, the KEYNOTE-826 study. This study reports the final overall survival results from a randomized, double-blind, phase 3 study of pembrolizumab plus chemotherapy versus placebo plus chemotherapy for first-line treatment of persistent, recurrent, or metastatic cervical cancer, which will be presented by Dr. Bradley Monk. Dr. Neeraj Agarwal: I'd be happy to. The initial analysis of the KEYNOTE-826 study revealed that first-line pembrolizumab plus chemotherapy provided significant improvements in the overall survival and progression-free survival compared to placebo plus chemotherapy in patients with metastatic, persistent, or recurrent cervical cancer who had not previously received systemic chemotherapy and were not candidates for curative treatments such as surgery or radiation. In this study, patients were randomly assigned in a 1:1 ratio to receive pembrolizumab or placebo at 200 milligrams every three weeks for up to 35 cycles, along with chemotherapy with paclitaxel, plus a platinum therapy with or without bevacizumab. From November 2018 to January 2020, 617 patients were enrolled with 308 receiving pembrolizumab plus chemotherapy and 309 patients receiving placebo plus chemotherapy. At the data cutoff of October 3, 2022, the median follow-up was 39 months. At this protocol-specified final overall survival analysis, pembrolizumab plus chemotherapy treatment continues to show a significant improvement in overall survival and progression-free survival, regardless of whether patients receive bevacizumab or not. The incidence of grade 3 or more adverse events was higher in the pembrolizumab plus chemotherapy arm than the placebo plus chemotherapy arm, with the most common adverse event being anemia, neutropenia, and hypertension. Dr. John Sweetenham: These are exciting data, Neeraj. So the main message from this trial is that pembrolizumab plus chemotherapy, with or without bevacizumab, can now be considered as standard of care for first-line treatment of persistent, recurrent, or metastatic cervical cancer. Dr. Neeraj Agarwal: Yes, I agree, John. Now, moving on to a different common type of cancer, let's discuss Abstract 1001, titled “Second-Line Endocrine Therapy with or without Palbociclib Maintenance in Patients with Hormone Receptor-Positive/HER2-Negative Advanced Breast Cancer: Results from the PALMIRA Trial,” which will be discussed by Dr. Antonio Llombart-Cussac. So, John, based on this abstract, can you please tell us about the role of palbociclib after prior progression on this drug? Dr. John Sweetenham: Yes. In this study, the authors aimed to determine if palbociclib maintenance with an alternative endocrine therapy improves the anti-tumor activity of second-line treatment in patients with endocrine-sensitive hormone receptor-positive and HER2-negative advanced breast cancer who had disease progression to first-line treatment with palbociclib in combination with endocrine therapy. After including 198 patients in the trial with a 2:1 randomization, 136 patients received palbociclib with endocrine therapy and 62 patients received endocrine therapy alone. And at a median follow-up of 8.7 months, the primary endpoint of progression-free survival was not met with a median progression-free survival of 4.2 months in the palbociclib-containing combination versus 3.6 months in the control arm. Also, higher grade 3 to 4 adverse events were reported in patients treated in the palbociclib arm. Dr. Neeraj Agarwal: Thanks, John. So you are saying that continuing the CDK4/6 inhibitor palbociclib after prior disease progression on palbociclib, even when the primary endocrine therapy has been changed, doesn't seem to be beneficial, therefore, this practice may be discouraged in the clinical setting? Dr. John Sweetenham: Yes, that's correct. Neeraj, I think that's the conclusion from this study. Dr. Neeraj Agarwal: So, John, now let's switch gears and highlight some precision oncology studies. Dr. John Sweetenham: Well, Abstract 3602, titled “Real World Rates of FDA-Approved Targeted Therapy and Immunotherapy Prescriptions for Metastatic Colorectal Cancer Patients in the VA's National Precision Oncology Program” will be presented by Dr. Alice Nono Djosta. Can you tell us more about this abstract, Neeraj? Dr. Neeraj Agarwal: Well, comprehensive genomic profiling has the potential to guide the administration of FDA-approved biomarker-directed therapies and improve outcomes among patients with metastatic colorectal cancer. So, in this study, Abstract 3602, investigators sought to determine the rates of actionable biomarkers and prescription of associated FDA-approved therapies among veterans in the National Precision Oncology Program. Patients with metastatic colorectal cancer who had undergone comprehensive genomic profiling via tissue or liquid biopsy were included between 2019 and 2022 and had 1 of the following 5 actionable biomarker profiles including: NRAS, KRAS, BRAF wild-type, BRAF V600E mutation, MSI-high, TMB-high, NTRK fusion or rearrangements. Prescription data for seven FDA-approved biomarker-directed therapies were extracted and rates of comprehensive genomic profiling (CGP)-directed therapy prescriptions were assessed by the investigators. A total of 908 patients with metastatic colorectal cancer underwent comprehensive genomic profiling, with 80% patients having colon adenocarcinoma and 20% with rectal adenocarcinoma. The combined rates of any actionable variants were 47% in patients with colon adenocarcinoma and 45% in patients with rectal adenocarcinoma. After including 424 eligible patients for FDA-approved biomarker therapy, only 70% patients with MSI-high, 48% patients with TMB-high, 38% patients with NRAS, KRAS, and BRAF wild-type, and only 17% of patients with BRAF V600E mutation received FDA-approved CGP-directed therapies. Dr. John Sweetenham: Very important data, Neeraj. What's the main conclusion of this study? Dr. Neeraj Agarwal: So, in conclusion, this study found that almost 30% of patients with MSI-high metastatic colorectal cancer did not receive effective immune checkpoint inhibitors. And overall, a significant number of eligible patients did not receive FDA-approved biomarker-directed therapies. So, it is crucial that we evaluate the barriers to prescribing comprehensive genomic profiling-directed therapies in our patients with metastatic colorectal cancers. So, John, let's move on to lung cancer, where the use of single-gene testing is still common in the community practice. Can you please tell us about Abstract 6506, titled “The Impact of Single-Gene Testing on Subsequent Comprehensive Genomic Profiling Success in Community Oncology Practice for Advanced Non–small Cell Lung Cancer”? These are results from a prospective observational reference laboratory testing program and these results will be presented by Dr. Mary Nesline. Dr. John Sweetenham: Yes, definitely. In this study, researchers aim to investigate the impact of prior single-gene testing on comprehensive genomic profiling success and therapeutic opportunities for patients with non–small cell lung cancer in community settings. They included patients who underwent at least 1 single gene testing for guideline recommending genomic variants in non–small cell lung cancer such as BRAF, EGFR, KRAS, MET exon 14 skipping mutations, ALK, RET, and ROS1 rearrangements as well as PD-L1 immunohistochemistry. And they offered comprehensive genomic profiling either before or after receipt of a negative single gene test. Of 580 patients with non–small cell lung cancer with the comprehensive genomic profiling ordered between 2021 and 2022, around 30% of the patients had at least 1 single-gene testing ordered prior to the comprehensive testing, with a median of 5 prior single-gene tests. Compared to CGP-only cases. CGP per cases with prior negative single gene testing was canceled twice as often at tissue review, had a higher DNA extraction failure, and a lower DNA sequencing success. CGP also identified guideline-recommended variants in genes with no single-gene testing offered during the study period, such as ERBB2 mutations, or NTRK2/3 fusions, as well as variants targeted in ongoing clinical trials in 28% of patients. Dr. Neeraj Agarwal: Very interesting. So John, what is your key takeaway message from this? Dr. John Sweetenham: The main message is that in a community oncology setting, the practice of ordering single gene testing prior to comprehensive genomic profiling for patients with non–small cell lung cancer is common. Prior negative single-gene testing led to a higher rate of CGP test cancellation due to tissue insufficiency and increased CGP DNA extraction failures. The practice of single-gene testing does not align with practice guideline recommendations and may negatively impact the potential benefits of CGP testing for patients with non–small cell lung cancer. Now, let's move on to another important abstract that our fellow clinicians should hear about. This is Abstract 1534 titled “Real-World Experience of an In-House Dihydropyrimidine Dehydrogenase Genotype Test to Guide Fluoropyrimidine Dosing at a Multi-Site Cancer Hospital” that will be presented by Dr. Jai Patel. Can you tell us more about this abstract, Neeraj? Dr. Neeraj Agarwal: Sure. Fluoropyrimidines, such as 5-fluorouracil and capecitabine, are commonly used to treat solid tumor cancers such as gastrointestinal and breast cancers. We know that severe toxicity occurs in one-third of patients, which delays the timely completion of treatments and result in prolonged hospitalization of these patients. These toxicities may be due in part to genetic variation in the DPYD gene. Five variants are known to have moderate to strong evidence according to the Clinical Pharmacogenetics Implementation Consortium. So, in this observational study, the authors describe the implementation of an in-house DPYD test and its impact on the dosing of these fluoropyrimidines, which include capecitabine and 5-fluorouracil. From March 2020 to December 2022, 491 patients received DPYD genotyping testing, and 90% of them had gastrointestinal cancers. The median lab turnaround time was only 3 days. Pre-treatment testing was ordered in 80% of patients, and 93% of patients had results before starting cycle 1. Overall, 6% of patients were heterozygous carriers. Fluoropyrimidine dose was reduced, avoided, or discontinued in 90% of these patients. Moreover, in pre-treatment carriers, 90% of patients received an upfront dose reduction, avoidance, or they even declined chemotherapy. Dr. John Sweetenham: Thanks, Neeraj. So what do you think is the key takeaway message here? Dr. Neeraj Agarwal: So, DPYD genotype-guided dosing of fluoropyrimidine, including 5-fluorouracil and capecitabine, is logistically feasible with a rapid turnaround time and can result in treatment dose modifications for most carriers, potentially avoiding or mitigating severe toxicities, especially in those patients who received pre-treatment testing. Dr. John Sweetenham: Thanks again. Now let's transition to studies that focus on disparities in cancer care. Dr. Neeraj Agarwal: Definitely. Let's discuss Abstract 6530, titled “Impact of Free Hospital-Provided Rideshare Service on Radiation Therapy Completion Rates: A Matched Cohort Analysis.” In this study, Dr. Eric Chen and colleagues assess the potential of rideshare services in facilitating timely radiation therapy for patients facing barriers, such as limited transportation, financial constraints, and lack of adequate social support. So the authors analyzed data from about 2,900 patients who underwent radiation therapy and found that 58 of them utilized a free hospital-provided rideshare service. These free hospital-provided rideshare service utilizers had a lower median age and were more likely to identify as Black or African American compared to those who did not utilize these services. They also had higher socioeconomic disadvantages and traveled shorter distances for treatment. Interestingly, more rideshare utilizers underwent radiation therapy with curative intent, had longer treatment course duration, and a higher number of fractions prescribed. In the matched-cohort analysis, the study found that radiation therapy completion rates were significantly higher for rideshare utilizers compared to non-rideshare utilizers, especially for patients who were undergoing radiation therapy with curative intent. Dr. John Sweetenham: So what's the key take-home message from this abstract? Dr. Neeraj Agarwal: This study highlights the potential benefit of utilizing hospital-provided free ride-share services, particularly for patients facing barriers to timely treatment. So, using these services were associated with higher radiation therapy completion rates, especially in the curative setting. So, John, there is another study, Abstract 1606, titled “Trends and Disparities in Oncology Telehealth after the Initial Pandemic Era” that will be presented by Dr. Michael Lee and colleagues. They evaluated whether telehealth utilization continued after the pandemic and if demographic differences in its users persist. So John, please tell us more about this abstract. Dr. John Sweetenham: Yes, the authors conducted a retrospective cohort study in 22 Kaiser Permanente Northern California hematology and oncology clinics between October 1, 2020, and June 1, 2022. The study investigated the use of office, video, and telephone visits, analyzing more than 340,000 hematology oncology visits with MD or DO providers. Of these visits, 25% were in-office, 37% were video visits, and 39% were telephone visits. Monthly telehealth visits peaked in January 2021, representing around 86% of total visits, and decreased to 69% of the total visits by June 2022. Video visits were more common for new appointments, whereas telephone visits were more common for return appointments. Moving to the post-pandemic period, telehealth visits remained popular, with video visits being the most commonly utilized. However, telehealth use varied among demographic populations. Video visits were a significantly higher proportion of all visits among individuals less than 45 years old, primary English speakers, patients with commercial insurance, non-Hispanic Whites and Asians, compared with Hispanic, Whites, and Blacks, and patients living in the deprived neighborhoods. Dr. Neeraj Agarwal: Interesting data, John. So what is the key takeaway message from this abstract? Dr. John Sweetenham: Well, overall, it's encouraging to see that even after the pandemic, telehealth continued to be widely used. However, the concerning issue is that telehealth is less utilized in patients who may need it most. The next step, in my view, will be to work on barriers to access telehealth by underprivileged populations. And that brings our discussion to a close today. Before we wrap up the podcast, Neeraj, do you have any final thoughts to share? Dr. Neeraj Agarwal: Yes, thanks, John. I would urge our listeners to come and join us at the ASCO Annual Meeting, not only to celebrate these successes but also to help disseminate these cutting-edge data to practitioners and patients across the world. Dr. John Sweetenham: Absolutely. I'd like to thank our listeners for joining us today, and thank you, Neeraj, for sharing your insights with us as well. You will find links to the abstracts discussed today on the transcripts of this episode. Finally, if you value the insights that you hear on ASCO Daily News Podcast, please take a moment to rate, review, and subscribe wherever you get your podcasts. Disclaimer: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement. Find out more about today's speakers: Dr. John Sweetenham Dr. Neeraj Agarwal @neerajaiims Follow ASCO on social media: @ASCO on Twitter ASCO on Facebook ASCO on LinkedIn Disclosures: Dr. John Sweetenham: Consulting or Advisory Role: EMA Wellness Dr. Neeraj Agarwal: Consulting or Advisory Role: Pfizer, Bristol-Myers Squibb, AstraZeneca, Nektar, Lilly, Bayer, Pharmacyclics, Foundation Medicine, Astellas Pharma, Lilly, Exelixis, AstraZeneca, Pfizer, Merck, Novartis, Eisai, Seattle Genetics, EMD Serono, Janssen Oncology, AVEO, Calithera Biosciences, MEI Pharma, Genentech, Astellas Pharma, Foundation Medicine, and Gilead Sciences Research Funding (Institution): Bayer, Bristol-Myers Squibb, Takeda, Pfizer, Exelixis, Amgen, AstraZeneca, Calithera Biosciences, Celldex, Eisai, Genentech, Immunomedics, Janssen, Merck, Lilly, Nektar, ORIC Pharmaceuticals, Crispr Therapeutics, Arvinas
Dr. Neeraj Agarwal and Dr. Jeanny Aragon-Ching discuss the CLEAR study in renal cell carcinoma, a new exploratory analysis combining the TheraP and VISION trials in metastatic urothelial cancer, and compelling advances in prostate cancer and across GU oncology in advance of the 2023 ASCO Annual Meeting. TRANSCRIPT Dr. Neeraj Agarwal: Hello and welcome to the ASCO Daily News Podcast. I'm Dr. Neeraj Agarwal, your guest host for the ASCO Daily News Podcast today. I'm the director of the Genitourinary Oncology Program and a professor of medicine at the University of Utah Huntsman Cancer Institute, and editor-in-chief of the ASCO Daily News. I'm delighted to welcome Dr. Jeanny Aragon-Ching, a GU medical oncologist and the clinical director of the Genitourinary Cancers Program at the Inova Schar Cancer Institute in Virginia. Today, we'll be discussing some key abstracts in GU oncology that will be featured at the 2023 ASCO Annual Meeting. Our full disclosures are available in the show notes and disclosures of all guests on the podcast can be found on our transcript at asco.orgDNpod. Jeanny, it's great to have you on the podcast today. Dr. Jeanny Aragon-Ching: Thank you so much, Dr. Agarwal, for having me. Dr. Neeraj Agarwal: Jeanny, let's begin with Abstract 4502 regarding long-term updated results on the CLEAR study. The abstract reports the final, prespecified overall survival analysis of the CLEAR trial, a four-year follow-up of lenvatinib plus pembrolizumab versus sunitinib in patients with advanced renal cell carcinoma. Dr. Jeanny Aragon-Ching: Yes, I would be happy to. So, just as a reminder, the combination of lenvatinib and pembrolizumab was initially approved by the FDA in August 2021 for first-line treatment of adult patients with advanced renal cell carcinoma. So, this was based on significant benefits that were seen in progression-free survival, which was a primary endpoint, but also showed improvement in the overall response rates compared with sunitinib in first-line advanced renal cell carcinoma. So this abstract reports on longer-term follow-up now at a median of 49.8 months, and PFS favored the combination lenvatinib and pembrolizumab compared to sunitinib across all MSKCC risk groups, and PFS benefit versus lenvatinib and pembro compared to sunitinib was maintained with a hazard ratio of 0.47. And even overall survival was also maintained with the combination with a hazard ratio of 0.79, and the overall survival favored the combination across all risk groups. If we look at the CR rate, it was 18.3% for the combination compared to 4.8% with sunitinib, unless patients in the combination arm received subsequent anticancer therapies, and that's intuitive. And the PFS2 was also longer with the combination at 43 months compared to 26 months. Now, it is important to note that grade III or more treatment-related adverse events did occur in about 74% of the patients in the combination of lenvatinib and pembro, compared to 60.3% in patients with sunitinib. Dr. Neeraj Agarwal: Jeanny, this is good news. So the main message from the abstract is that sustained results from this combination of lenvatinib plus pembrolizumab are being seen even after a longer follow-up of more than four years. Dr. Jeanny Aragon-Ching: Yes, I agree. So now, moving on, Neeraj, to a different setting in the RCC space, let's look at Abstract 4519, which is titled “Efficacy of First-line Immunotherapy-based Regimens in Patients with Sarcomatoid and/or Rhabdoid Metastatic Non-Clear Cell RCC: Results from the IMDC,” which will be discussed by Dr. Chris Labaki. So, Neeraj, based on this abstract, can you tell us a little bit more about the impact of these adverse pathologic risk features in non-clear cell RCC? Dr. Neeraj Agarwal: Of course. So, using real-world patient data, the IMDC investigators compared the outcomes of patients with metastatic non-clear cell RCC who were treated with immunotherapy-based combination regimens versus those who were treated with VEGF-TKIs alone. They also assessed the impact of sarcomatoid and rhabdoid features on response to IO-based combinations versus VEGF-TKIs. Of 103 patients with metastatic non-clear cell RCC who had rhabdoid or sarcomatoid features, 32% of patients were treated with immunotherapy-based combinations. After adjusting for confounding factors, the authors show that those treated with a combination of two immune checkpoint inhibitors or an immune checkpoint inhibitor with a VEGF-TKI combination had significantly improved overall survival, which was not reached in the immunotherapy combination group versus seven months within the VEGF-TKI group. Time to treatment failure and objective responses were also prolonged, significantly higher, and better in the immunotherapy groups compared with patients who were treated with VEGF-TKIs alone. Interestingly, if you look at those 430 patients with metastatic non-clear cell RCC who did not have sarcomatoid or rhabdoid features, they didn't seem to benefit with immunotherapy-based combinations. Dr. Jeanny Aragon-Ching: This is an exciting update, Neeraj. What are the key takeaways from this abstract? Dr. Neeraj Agarwal: So the main takeaway is if you see a patient with advanced non-clear cell RCC who has sarcomatoid and rhabdoid features, there appears to be a rather substantial and selective benefit with IO-based combinations. And in this context, I would like to highlight the ongoing SWOG 2200 trial also known as PAPMET2 trial, which is comparing the combination of cabozantinib plus atezolizumab. So immuno-therapy-based combinations versus cabozantinib alone in advanced papillary renal cell carcinoma setting. So this trial is being led by Dr. Benjamin Maughan and Dr. Monty Pal. And I like to encourage our listeners to consider referring their patients for involvement in this federally funded trial so that we can validate the data from this retrospective study in a prospective way. So, Jeanny, let's now move on to another important disease type which is urothelial carcinoma. There is a very recent accelerated FDA approval of the drug combination of enfortumab vedotin and pembrolizumab for cisplatin-ineligible metastatic urothelial carcinoma patients. This is Abstract 4505, which is being presented by Dr. Shilpa Gupta and colleagues. Can you please tell us more about this update? Dr. Jeanny Aragon-Ching: Yeah, absolutely. So, as you mentioned, Neeraj, the FDA just granted accelerated approval in April 2023 for this combination of enfortumab vedotin or EV, which is and ADC, antibody drug conjugate against nectin-4 and the PD-1 inhibitor pembroluzimab. So it's a combination for patients with locally advanced or metastatic urothelial carcinoma who are considered cisplatin ineligible. So this is nearly a four-year follow-up. So as a reminder, this was a phase 1b/2 trial that included 45 patients and it had a primary endpoint of safety and tolerability although the key secondary endpoints included confirmed overall responses, duration of response, progression-free survival, and the resist criteria was investigated via investigator and BICRs which is in a blinded independent central review. Even overall survival was a key secondary endpoint. So, the bottom line was the confirmed overall response by BICR was 73.3%, the disease control rate was about 84%, and the CR rate was 15.6% with a PFS of close to 13 months, and a 12-month overall survival rate of 83%. However, it is important to cite that there were treatment-related adverse events including skin reactions in 66%, neuropathy occurred in 62%, and ocular disorders in 40%. And there was a little bit of pneumonitis in close to 9%, colitis, and hypothyroidism, so there are side effects to watch out for. Dr. Neeraj Agarwal: So, Jeanny this is great. What is the key takeaway from this trial? Dr. Jeanny Aragon-Ching: So I think the most important thing is we now have a new combination of EV and pembro which shows very promising responses and survival in part which led to the FDA accelerated approval in the cisplatin-ineligible population of patients. However, we must note that the phase 3 trial of EV302 will ultimately establish which approach is really beneficial for all of our cisplatin-ineligible patients, either a carboplatin-based chemotherapy regimen or a non-platinum-based regimen such as EV and pembro. Dr. Neeraj Agarwal: Thanks Jeanny, would you like to discuss any other study in the bladder cancer space? Dr. Jeanny Aragon-Ching: Absolutely. I think Abstract 4508 from Dr. Seth Lerner and colleagues will be very relevant to our colleagues. This abstract is SWOG S1011, which is a phase 3 surgical trial to evaluate the benefit of a standard versus an extended lymphadenectomy performed at the time of radical cystectomy for muscle-invasive bladder cancer. Dr. Neeraj Agarwal: Yes. So this trial, as you said, is an important trial which randomized in a one-on-one fashion 618 patients with muscle-invasive bladder cancer undergoing radical cystectomy, and these patients were randomized to either standard lymph node dissection or an extended lymph node dissection. And standard lymph node dissection included, as we know, external and internal iliac and operative lymph node. The extended lymph node dissection included lymph nodes up to aortic bifurcation which included common iliac, presciatic, and presacral lymph nodes. At a median follow-up of approximately 6 years, there was no disease-free survival or overall survival benefit in patients undergoing an extended lymph node dissection compared to standard lymph node dissection. And extended lymph node dissection was also associated with greater morbidity and preoperative mortality. Dr. Jeanny Aragon-Ching: Very interesting data, Neeraj. So these results, I think, will be very useful for a lot of our surgical colleagues in both academia and the community who may still be inclined to perform extended lymphadenectomy during cystectomy. This study shows that it's actually not necessary. Dr. Neeraj Agarwal: Absolutely. So now let's move on to another disease type, which is very important - prostate cancer. There are several practice-informing abstracts that are worthwhile discussing. The first of these involves Abstract 5002, which looks at the impact of the PSA nadir as a prognostic factor after radiation therapy for localized prostate cancer, which will be presented by Dr. Praful Ravi and colleagues. Jeannie, can you please tell us more about this abstract? Dr. Jeanny Aragon-Ching: Yeah, definitely. So this abstract, as you mentioned, Neeraj, is a prognostic impact of PSA nadir of more than or equal to 0.1 nanogram per ml within six months after completion of radiotherapy for localized prostate cancer - an individual patient data analysis of randomized trials from the ICECaP Collaborative. Basically, it refers to an attempt to evaluate early surrogate measures to predict for long term outcomes such as prostate cancer-specific survival, metastases-free survival, and overall survival. So they looked at a big registry from the ICECaP collaboration that included 10,415 patients across 16 randomized controlled trials. And those men underwent treatment for intermediate risk and high risk prostate cancer treated with either radiation therapy alone in about a quarter of patients, or they got RT with short-term ADT in about 58% of patients, and 17% of them got RT with long-term ADT. So, after a median follow-up of ten years, what they found was, if you had a PSA nadir that is over or equal to 0.1 nanogram per ml within six months after completion of radiation therapy, it was associated with worse prostate cancer-specific survival, metastases-free survival, and overall survival. For instance, the five-year metastases-free survival for those who achieved a PSA nadir of less than 0.1 was 91% compared to those who did not, which was 79%. Therefore, they concluded that if you achieve a bad PSA of 0.1 or above within six months after you completed radiation, you had worse outcomes. Dr. Neeraj Agarwal: Jeanny, what is the key takeaway message from this study? Dr. Jeanny Aragon-Ching: The key takeaway from this ICECaP analysis is that this information would be very important to augment a signal-seeking endpoint, especially for clinical trial development, so that we can develop further strategies to de-escalate for those who don't need systemic intensification or therapy intensification versus escalation for those who really do. Dr. Neeraj Agarwal: So, my radiation oncology colleagues need to watch out for those patients who do not achieve a PSA of less than 0.1 nanogram per ml within the first six months of finishing radiation therapy. Very interesting data. Dr. Jeanny Aragon-Ching: Yes, absolutely. So. Neeraj another important abstract for our fellow clinicians, switching gears a little bit now, is Abstract 5011, which is titled “Do Bone Scans Overstage Disease Compared to PSMA PET?” This was an international, multicenter retrospective study with blinded, independent readers. Can you tell us more about this abstract? Dr. Neeraj Agarwal: Yes, a relatively small retrospective study, but still pertinent to our practice. So I'll summarize it. This study by Dr. Wolfgang Fendler and colleagues evaluated the ability of bone scans to detect osseous metastasis using PSMA PET scan as a reference standard. So in this multicenter retrospective study, 167 patients were included, of which 77 patients were at the initial staging of prostate cancer, 60 had biochemical recurrence after definitive therapy, and 30 patients had CRPC or castor-resistant disease. These patients had been imaged with a bone scan and a PSMA PET scan within 100 days. And in all patients, the positive predictive value, negative predictive value and specificity for bone scan were evaluated at different time points. They had bone scan and PSMA PET scan and both were compared. And what they found was interesting. All these three values - positive predictive value, negative predictive value, and specificity for bone scan were 0.73, 0.82 and 0.82 in all patients, and in initial staging, it was even lower at 0.43 and 0.94 and 0.80. So, without getting into too much detail regarding these numbers, I want to highlight the most important part of the study, that at the initial staging, 57% patients who had a positive bone scan had false positive bone scans. The interreader agreement for bone disease was actually moderate for bone scans and quite substantial for the PSMA PET scan. Dr. Jeanny Aragon-Ching: So, Neeraj, what do you think is the key takeaway message here for our audience? Dr. Neeraj Agarwal: The key takeaway message is that positive predictive value of bone scan was low in prostate cancer patients at initial staging, with the majority of positive bone scans being false positive. This suggests that a large proportion of patients which we consider to have low-volume metastatic disease by bone scan actually have localized disease. So in the newly diagnosed patients with prostate cancer, patients should ideally have a PSMA PET scan to rule out metastatic disease. So, let's move on to another abstract I would like to discuss, which has important implications in treatment, especially now that lutetium 177 is approved, but frankly not available widely. Dr. Jeanny Aragon-Ching: Yeah, that's actually very timely. So the abstract you're referring to is 5045, which is being presented by Dr. Yu Yang Sun and colleagues entitled “Effects of Lutetium PSMA 617 on Overall Survival in TheraP Versus VISION Randomized Trials: An Exploratory Analysis.” So, Neeraj, can you tell us more about the relevance of this exploratory analysis? Dr. Neeraj Agarwal: Definitely. In this abstract, Dr. Yang Sun and colleagues assess the effect of lutetium PSMA on overall survival in two different trials, TheraP and VISION trials. So, just for our listeners' recollection, the phase 2 TheraP trial compared lutetium PSMA and cabazitaxel in patients with mCRPC who had progression on docetaxel and had significant PSMA avidity on gallium PSMA pet scan, which was defined as a minimum uptake of SUV max of 20 at least one site of disease and SUV max of more than 10 at all sites of measurable disease. In this trial, 20 of 101 patients in the cabazitaxel arm crossed over to lutetium PSMA, and 32 of 99 patients in the lutetium PSMA arm crossed over to cabazitaxel. In the VISION trial, patients with mCRPC who previously progressed on at least one ARPI and one taxane-based therapy and had a positive gallium PSMA scan, and here, positivity was not stringently pre-specified as it was done in the context of TheraP trial. So, positive gallium pet scans were randomly assigned in two to one fashion to receive either lutetium PSMA plus best supportive care or standard of care versus standard of care. And I'd like to highlight that the standard of care comprised ARPIs and bone protecting agents and these patients were not allowed to have cytotoxic chemotherapy such as cabazitaxel in the standard of care arm. Now, overall survival was similar in the lutetium PSMA group regardless of whether they got lutetium PSMA in the VISION trial or TheraP trial. There was no difference in overall survival with lutetium in the lutetium arms of VISION and TheraP trial with a hazard ratio of 0.92. And there was no difference in the overall survival between the lutetium PSMA and the cabazitaxel group in the TheraP trial if you use counterfactual analysis, assuming crossover had not occurred. So, quite interesting in my view. Dr. Jeanny Aragon-Ching: Yeah, thanks Neeraj for that wonderful synopsis and discussion. So, what is the key take home message then? Dr. Neeraj Agarwal: The main message in this new exploratory analysis, which combined both the TheraP and VISION trials, is that lutetium PSMA and cabazitaxel seem to be associated with similar overall survival benefit in these highly selected patients with PSMA positivity. Additionally, the difference in the observed effect of lutetium PSMA and overall survival in the TheraP and VISION trials may be actually better explained by the use of different treatments in the respective control arms of these trials. And these results, in my view, are quite pertinent for those patients and providers who do not have access to lutetium-177 therapy. Let's go to another abstract that is currently relevant to our practice, given many patients with advanced prostate cancer who have concurrent diabetes; I'm talking about Abstract 5066. Jeanny, can you please tell us more about this abstract? Dr. Jeanny Aragon-Ching: Certainly, Neeraj. So this abstract will be presented by Dr. Amy Shaver and colleagues. So it's also very relevant, since many men who are diagnosed with prostate cancer frequently also have a concomitant diagnosis of type 2 diabetes mellitus. So, this was a SEER-Medicare population database analysis that looked at men who were treated with either abiraterone or enzalutamide and also had concomitant diagnosis of type 2 diabetes mellitus (DM). And they were identified using ICD-9 and ICD-10 codes and they were all tied in to acute care utilization. So they looked at CMS research data codes and ER hospitalization visits six months after treatment initiation was recorded. So all in all, they took a sample of 11,163 men, of whom close to 62% were treated with abiraterone and about 38% were treated with enzalutamide. So, of these, about 27% of them had type 2 DM, of whom 59% received abiraterone and about 41% had enzalutamide. So, the bottom line is, compared to those without diabetes mellitus, those who had type 2 diabetes had worse acute care utilization, which was 43% higher than those who got abiraterone compared to enzalutamide, and also had higher overall mortality. Therefore, the bottom line is, having type 2 diabetes mellitus, unfortunately, portends worse outcomes in men with prostate cancer, so careful attention needs to be paid to those who are starting out already with such comorbidities. So Neeraj, any final thoughts you have regarding this abstract and overall before we wrap up on the podcast today? Dr. Neeraj Agarwal: Absolutely. So it looks like, based on this very important pertinent Abstract 5066, which talks about the impact of diabetes on our patients, I think we need to be very watchful regarding the impact of diabetes on our patients who are being treated with abiraterone or enzalutamide, especially drugs which are known to make the metabolic syndrome and diabetes worse. I think close monitoring and close attention to control of diabetes is very important. So with that, I would urge the listeners to come and join us at the Annual Meeting, not only to celebrate these successes but also to help disseminate this cutting-edge data to practitioners and maximize the benefit to our patients across the globe. And thank you to our listeners for joining us today. You will find links to the abstracts we discussed today on the transcript of this episode. Finally, if you value the insights that you hear on our ASCO Daily News Podcast, please take a moment to rate, review and subscribe wherever you get your podcast. Disclaimer: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement. Find out more about today's speakers: Dr. Neeraj Agarwal @neerajaiims Dr. Jeanny Aragon-Ching Follow ASCO on social media: @ASCO on Twitter ASCO on Facebook ASCO on LinkedIn Disclosures: Dr. Neeraj Agarwal: Consulting or Advisory Role: Pfizer, Bristol-Myers Squibb, AstraZeneca, Nektar, Lilly, Bayer, Pharmacyclics, Foundation Medicine, Astellas Pharma, Lilly, Exelixis, AstraZeneca, Pfizer, Merck, Novartis, Eisai, Seattle Genetics, EMD Serono, Janssen Oncology, AVEO, Calithera Biosciences, MEI Pharma, Genentech, Astellas Pharma, Foundation Medicine, and Gilead Sciences Research Funding (Institution): Bayer, Bristol-Myers Squibb, Takeda, Pfizer, Exelixis, Amgen, AstraZeneca, Calithera Biosciences, Celldex, Eisai, Genentech, Immunomedics, Janssen, Merck, Lilly, Nektar, ORIC Pharmaceuticals, Crispr Therapeutics, Arvinas Dr. Jeanny Aragon-Ching: Honoraria: Bristol-Myers Squibb, EMD Serono, Astellas Scientific and Medical Affairs Inc., Pfizer/EMD Serono Consulting or Advisory Role: Algeta/Bayer, Dendreon, AstraZeneca, Janssen Biotech, Sanofi, EMD Serono, MedImmune, Bayer, Merck, Seattle Genetics, Pfizer, Immunomedics, Amgen, AVEO, Pfizer/Myovant, Exelixis, Speakers' Bureau: Astellas Pharma, Janssen-Ortho, Bristol-Myers Squibb, Astellas/Seattle Genetics.
In this episode of Meeting Mic, we bring you the highlights and insights from the ACR Convergence 2022, as well as Healio's top headlines from the meeting. Virginia G. Kaklamani, MD, DSc, professor of medicine in the division of hematology/oncology at UT Health San Antonio and leader of the breast cancer program at UT Health San Antonio MD Anderson Cancer Center, reviews an abstract presentation on the impact of cyclin-dependent kinase 4/6 inhibitor therapy in patients with advanced breast cancer :00 Aditya Bardia, MD, MPH, director of the breast cancer research program at Massachusetts General Hospital and associate professor of medicine at Harvard Medical School, discusses a study on trastuzumab-deruxtecan and its response rate in patients with early breast cancer 5:00 Sara A. Hurvitz, MD, FACP, medical oncologist at UCLA Health, Santa Monica Medical Center, associate professor at David Geffen School of Medicine at UCLA, medical director of the Jonsson Comprehensive Cancer Center Clinical Research Unit, and director of the breast cancer clinical trials program at UCLA, examines trastuzumab-deruxtecan's effect on patients with breast cancer who were previously treated with trastuzumab and a taxane. 10:00 Read the full coverage here: Longer CDK 4/6 inhibitor therapy enhances elacestrant benefit in metastatic breast cancer Elacestrant extends PFS among certain women with metastatic breast cancer Trastuzumab deruxtecan ‘new gold standard' in second line for breast cancer subset Ribociclib regimen may be superior to chemotherapy in advanced breast cancer Breast cancer specialist receives lecture award Genomic assay may predict ovarian function suppression benefit in breast cancer subset Disclosures: Bardia reports research funding from or consultant/advisory roles with AstraZeneca, Daiichi Sankyo, Eli Lilly, Genentech, Immunomedics/Gilead Sciences, Merck, Novartis, Pfizer, Radius Health and Sanofi. Hurvitz reports honoraria from Daichi Sankyo and research funding to her institution from Ambrx, Amgen, Arvinas, AstraZeneca, Bayer, CytomX Therapeutics, Daiichi Sankyo, Dantari, Dignitana, Eli Lilly, G1 Therapeutics, Genentech/Roche, Gilead Sciences, GlaxoSmithKline, Immunomedics, MacroGenics, Novartis, OBI Pharma, Orinoco Pharmaceuticals, Pfizer, Phoenix Molecular Designs, Pieris Pharmaceuticals, Puma Biotechnology, Radius Health, Samumed, Sanofi, Seagen and Zymeworks. She also reports her spouse is a shareholder/stockholder in Ideal Implant. Kaklamani reports honoraria from, consultant/advisory roles with, speakers bureau roles with or other relationships with AstraZeneca, Daiichi Sankyo, Genentech, Genomic Health, Gilead Sciences, Novartis, Pfizer and Puma Biotechnology. Please see the abstract for all other researchers' relevant financial disclosures.
Her Story - Envisioning the Leadership Possibilities in Healthcare
Meet Leslie Norwalk:Leslie Norwalk serves as Strategic Counsel for Epstein Becker & Green. She sits on the boards of directors of Arvinas, ModivCare, Neurocrine Biosciences, NuVasive, and several privately held health care corporations. Leslie is also a member of APCO Worldwide's International Advisory Council. Previously, Leslie served the Bush Administration as the Acting Administrator for the Centers for Medicare & Medicaid Services (CMS). She received a bachelor's degree in economics and international relations from Wellesley College and a J.D. from George Mason University. Key Insights:Leslie Norwalk provides career insights, as well as a perspective on the implementation of Medicare Part D. Testifying for CMS. Leslie had to testify before Congress on multiple occasions. She recommends answering questions as straightforward, truthfully, and informationally as possible. Remember that your audience is broader than the person asking the question.Ignore the Bias. As a rule, Leslie tries to ignore the fact that there is gender bias. However, she still knows it exists, and always tries to be the most prepared person in the room.Sponsorship. Leslie thinks sponsorship may be as important if not more important than mentorship. To get on her first board of directors, someone sponsored Leslie and introduced her to the right people. This episode is hosted by Julie Gerberding, M.D. She is a member of the Advisory Council for Her Story and is the Chief Executive Officer for the Foundation for the National Institutes of Health. Relevant Links:Read more about Leslie NorwalkRead “Epstein Becker Green Attorneys Recognized by 2023 Best Lawyers for Excellence in the Legal Profession”
Guest host Dr. Neeraj Agarwal, of the University of Utah Huntsman Cancer Institute and the ASCO Daily News editor-in-chief, discusses key therapeutic advances in mRCC and mUC, as well as new research that proposes periodic scans to monitor patients with mCSPC for disease progression, with Dr. Jeanny-Aragon-Ching of the Inova Schar Cancer Institute. Transcript: Dr. Neeraj Agarwal: Hello and welcome to the ASCO Daily News podcast. I'm Dr. Neeraj Agarwal, the director of the Genitourinary Oncology Program, a professor of medicine at the University of Utah Huntsman Cancer Institute, and editor-in-chief of the ASCO Daily News. My guest today is Dr. Jeanny Aragon-Ching, who is a medical oncologist and the Clinical Program Director of Genitourinary Cancers at the Inova Schar Cancer Institute in Virginia. Today, we will be discussing key posters in genitourinary (GU) oncology that will be featured at the 2022 ASCO Annual Meeting. Our full disclosures are available in the show notes and disclosures of all guests on the podcast can be found on our transcripts at asco.org/podcast. Jeanny, it is great to have you on the podcast today. Dr. Jeanny Aragon-Ching: Thanks, Neeraj. It's a pleasure for me to be here as well. Dr. Neeraj Agarwal: Jeanny, let's begin with Abstract 4510. This is a trial that represents a growing interest among researchers worldwide in the microbiome and how it is impacted by antibiotics and how it modulates immune checkpoint inhibitor response. Can you tell us about this study? Dr. Jeanny Aragon-Ching: Thanks, Neeraj, I would be happy to. So, the title of the abstract is, “Characterization of the Microbial Resistome in a Prospective Trial of CBM 588 in Metastatic Renal Cell Carcinoma Offers Mechanism for Interplay Between Antibiotic Use and Immune Checkpoint Inhibitor Activity.” So, this is an interesting abstract that originated likely from the observation that getting antibiotics while on checkpoint inhibitors typically results in worse outcomes, perhaps because antibiotics can clear the normal gut flora and thereby increase these pathogenic antibiotic-resistant bacteria. Now, on the other hand, there were some retrospective studies using a live microbial product called CBM 588, which seems to improve outcomes in patients on checkpoint inhibitors and getting antibiotics. So, the idea, therefore, is that shifting the genes encoding antimicrobial resistance could result in a better checkpoint inhibitor response. So, this Abstract 4510 is a small study conducted by Dr. Nazli Dizman and Dr. Sumanta (Monty) Kumar Pal, and colleagues, and enrolled 29 metastatic clear cell RCC patients with intermediate or poorest disease. And they were stratified into receiving either nivolumab or ipilimumab compared to nivo/IPI with CBM 588. Now stool samples were collected at baseline in week 12. And they did this whole metagenome sequencing to analyze a stool microbiome composition, and they also looked at the antibiotic resistance genes for the most common classes of antibiotics. The results showed an astounding improvement in objective responses. So, 58%, for instance, in nivo/IPI and the CBM 588 arm compared to only 20% in the nivo/IPI arm. And it seems like also the antibiotics resistance genes were also decreased in those getting the CBM 588 alongside nivo/IPI. Therefore, responses were improved by shifting the gut microbiome alone. So, these findings were published actually recently by these authors in Nature Medicine. So, in case anyone wants to take a deep dive, it would be a good interesting read for this dataset. Dr. Neeraj Agarwal: Very interesting, indeed. Jeanny, what is the main message here for our colleagues? Dr. Jeanny Aragon-Ching: I think, Neeraj, the key takeaway message is that this is a very provocative proof of concept trial that suggests shifting the gut microbiome has the potential to improve responses to checkpoint inhibitors and outcomes. So, this is a very up-and-coming trial and is seen also across the board in other cancers. Dr. Neeraj Agarwal: Thanks, Jeanny. Moving on to urothelial cancer, there is a poster that I think is a must-see for our colleagues. This is Abstract 4577 titled, “Defining Platinum Ineligible Patients with Metastatic Urothelial Carcinoma.” Dr. Jeanny Aragon-Ching: So, Neeraj, what can you tell us about this abstract? Dr. Neeraj Agarwal: So, over the past few years, there has been a tremendous evolution in the treatment landscape for patients with metastatic urothelial carcinoma. For over 40 years the standard of care for these patients has been cisplatin-based chemotherapy. However, approximately 50% of patients are cisplatin-ineligible, due to underlying comorbidities, and are offered carboplatin as an alternative. So, although the checkpoint inhibitors pembrolizumab and atezolizumab were approved as first-line therapy for these patients in 2017, the U.S. Food and Drug Administration (FDA) has now restricted the use of first-line pembrolizumab to platinum ineligible patients with metastatic urothelial carcinoma. The challenge we face as oncologists since the FDA restriction is the absence of a formal definition of platinum ineligibility and the inclusion of this definition in the guidelines. So, in Abstract 4577, Drs. Shilpa Gupta and Jonathan Rosenberg, along with the team present an updated consensus definition for platinum ineligibility based on an online survey of 60 genitourinary oncologists in the United States. Based on the results from this survey, any patient with metastatic urothelial carcinoma, meeting 1 of the following 5 clinical and or laboratory parameters should be considered platinum ineligible, and these are 1 of the following: an ECOG performance status of 3 or more, creatinine clearance of fewer than 30 mils per minute, or peripheral neuropathy of grade 2 or more, or heart failure class of 3 or more—so, this is NYHA heart failure class of 3 or more—and lastly, the combination of performance status of 2 or more, plus a creatinine clearance of less than 30 mils per minute. Dr. Jeanny Aragon-Ching: Well, this is a timely update, Neeraj. So, what do you think is a key takeaway from this abstract? Dr. Neeraj Agarwal: These criteria based on simple and easily available clinical and or laboratory parameters will now allow us to readily define platinum ineligibility in our patients with metastatic urothelial carcinoma, which is a need in busy clinics, both in academic and community settings. So, I think once published and obviously once endorsed by guidelines, we really would like to be able to use this criterion to quickly define platinum ineligibility in our clinics. Dr. Jeanny Aragon-Ching: Agree. Yeah. Dr. Neeraj Agarwal: So, Jeanny, let me switch the gears. PSMA testing is a hot topic this year. And there is an abstract that could potentially have an impact on future guidelines, and how we will practice further down the road. So, I'm referring to the Abstract 5088 titled, “Predictive Value of Extra Prostatic Disease Detection by Preoperative PSMAPET for Biochemical Recurrence-free Survival in Patients with Otherwise Localized Prostate Cancer and Who are Treated with Radical Prostatectomy.” So, this is a follow-up analysis of a multicenter prospective phase 3 imaging trial. So, could you please tell us more about this abstract where they are using PSMA PET scan in the preoperative localized prostate cancer setting? Dr. Jeanny Aragon-Ching: Absolutely, Neeraj. So, you may recall that the multicenter prospective phase 3 imaging trial that garnered gallium PSMA approval by the FDA was actually based on this study that looked at the intermediate and high-risk patients with prostate cancer undergoing radical prostatectomy and lymph node dissection, and they underwent prior gallium PSMA PET scanning for pelvic nodal metastases prior to surgery. So, this was actually previously reported by Dr. Calais and group. Now they are reporting on Abstract 5088 as a post hoc analysis of the same population and group of patients looking for extraprostatic disease. And the final pathology was also correlated to look at nodal disease in these patients in order to predict biochemical recurrence, so they follow these patients for biochemical recurrence occurrence. So, of the 36% of patients who did undergo radical prostatectomy after they underwent PSMA PET scan, about 41% of them recurred with biochemical recurrence, and 40% of them underwent some kind of salvage therapy or some treatment. What was very interesting was when they looked at the biochemical recurrence-free survival. It was better in those who were PSMA negative, and that recurrence-free survival was easily about 33 months, compared to only about 7.3 months in those who were PSMA-positive scans. Furthermore, the ones who had the longest and the highest biochemical recurrence-free survival, intuitively, were those who were node-negative and PSMA PET-negative, so probably not surprisingly. And that rate was about 46 months—close to 4 years. Whereas those who are node-positive on final pathology and their PSMA PET was also positive, they only had about 3 months of biochemical recurrence-free survival. Dr. Neeraj Agarwal: Very interesting. So, it looks like the PSMA PET scan is predicting biochemical recurrence-free survival in localized prostate cancer settings. So, Jeanny, what is the key takeaway from this trial? Dr. Jeanny Aragon-Ching: I think, Neeraj, the bottom line is that patients with extraprostatic disease that is detected by their preoperative PSMA PET scan does predict strongly a high risk of biochemical relapse, and this can really be an additional tool that clinicians can use to help inform and guide future therapy. Dr. Neeraj Agarwal: Thanks, Jeanny. The research on preoperative PSMA testing and its implications on future treatment strategies in the setting is going to be really interesting to watch in the very near future. Dr. Jeanny Aragon-Ching: Yes, absolutely. I really think we should also discuss Abstract 5072, along those lines, the importance really of radiographic monitoring for disease progression in patients with metastatic hormone-sensitive prostate cancer. Dr. Neeraj Agarwal: Yes, thanks for reminding and this is Abstract 5072. This is a post hoc analysis of the ARCHES trial, titled, “Radiographic Progression in the Absence of PSA Progression in Patients with Metastatic Hormone-sensitive Prostate Cancer.” During the last several years, we have seen many of these agents typically given for gastric resistant prostate cancer moving upfront to the castration-sensitive prostate cancer setting. This is especially true for androgen receptor access targeting agents such as abiraterone, enzalutamide, and apalutamide, all being now approved for patients with metastatic castration-sensitive prostate cancer. What is noteworthy from all these trials, and is reported in Abstract 5072, is the use of imaging studies to evaluate disease progression. So, in Abstract 5072, Dr. Andrew Armstrong and Dr. Arun Azad performed a post hoc analysis of the ARCHES trial to investigate the concordance between radiographic progression and the PSA Progression as defined by PCWG2 criteria, or between radiographic progression and any rise in the PSA above nadir, in patients who were being treated with this novel hormonal therapies, in this case, enzalutamide for metastatic castration sensitive prostate cancer. And as a quick reminder, ARCHES was a phase 3 trial that showed a significant reduction and radiographic progression-free survival and improved overall survival for patients with metastatic castration sensitive prostate cancer treated with enzalutamide plus androgen deprivation therapy (ADT) versus those treated with placebo plus androgen deprivation therapy. So, very interestingly, the findings from this study indicate that 67% of patients on the enzalutamide plus ADT arm did not have [Prostate Cancer Clinical Trials Working Group 2 criteria] PCWG2-defined prostate-specific antigen (PSA) progression at the time of radiographic progression. And discordance was present in the ADT-only arm as well, where they found 42% of patients on the ADT-only arm had radiographic progression but did not have PCWG2-defined PSA progression. Interestingly, this discordance of radiographic disease progression was also seen with any rise in the PSA above nadir. And I personally found this information to be very clinically relevant when we are seeing the majority of patients actually experiencing radiographic disease progression, not experiencing PSA progression at the same time. Dr. Jeanny Aragon-Ching: Yeah, absolutely. I agree with that, Neeraj. So, very interesting data. So, what do you think is the key takeaway message for the clinicians listening to us? Dr. Neeraj Agarwal: I'll make the message very simple. I think the message is that patients with metastatic castration-sensitive prostate cancer need to be monitored for disease progression with periodic scans, and PSA monitoring alone is not sufficient in the majority of these patients. Again, we cannot undervalue the role of periodic imaging studies in these patients so that we can timely diagnose them to have disease progression. Dr. Jeanny Aragon-Ching: I agree with that. Dr. Neeraj Agarwal: Jeanny, the last abstract I would like to mention before we wrap up the podcast is Abstract 4509, the results from the phase1 live SPARC 001 study. So, can you please tell us more about this study titled, “Phase-1 Live SPARC 001: The Study of Belzutifan in Advanced Solid Tumors,” which is an update of the renal cell carcinoma cohort with more than 3 years of total follow up? Dr. Jeanny Aragon-Ching: Thanks, Neeraj. So, while the current therapeutic landscape for patients with metastatic clear cell renal cell carcinoma (RCC) has changed dramatically over the past several years, with significant improvement in patient outcomes. Most patients unfortunately still experience disease progression on current treatments. So, in-depth molecular profiling of clear cell RCC has revealed recurrent loss of function mutations in VHL in actually greater than 90% of patients. So, the VHL protein, as you will recall, is part of the oxygen-sensing pathway, regulating levels of HIF which is hypoxia-inducible factor protein, it's a transcriptional activator that mediates the response to hypoxic conditions. So, HIF-2α is a key oncogenic driver in RCC. So, previous data you may recall from the phase-1 Live SPARC 001 trial was designed to evaluate belzutifan so, this was a novel HIF-2α inhibitor which showed durable anti-tumor activity and acceptable safety profile in patients with metastatic clear cell RCC. So, in Abstract 4509, Drs. Jonasch and Toni Choueiri presented updated results from this trial after more than 3 years of follow-up. Of the 55 patients enrolled 16% of patients remained in treatment. And 62% of patients had discontinued treatment because of, unfortunately, disease progression. The median progression-free survival (PFS) for the total cohort was 14.5 months. And the overall disease control rate was 80%. Forty percent of patients experienced grade 3 treatment-related adverse events with the most frequent ones being anemia and hypoxia. There were no great 4 or 5 treatment-related adverse events. And these results, therefore, show that belzutifan monotherapy continues to show a high rate of disease control and a safety profile in a heavily treated population of patients with metastatic RCC. So, it is great to see that there were no new safety signals. Dr. Neeraj Agarwal: Very nice data indeed. So, Jeanny, what is the key takeaway message here for our listeners? Dr. Jeanny Aragon-Ching: Yeah, I think the message here is that the use of belzutifan monotherapy continues to show efficacy and safety in patients with metastatic clear cell RCC, which have progressed on multiple prior contemporary therapies, and there are phase 3 trials currently underway. Dr. Neeraj Agarwal: Jeanny, any final thoughts before we wrap up the podcast today? Dr. Jeanny Aragon-Ching: Thanks, Neeraj. I think it's a really exciting time to be in genitourinary (GU) oncology, and I'm truly looking forward to seeing some great sessions at the 2022 ASCO Annual Meeting. Dr. Neeraj Agarwal: Thank you, Jeanny, for sharing your insight with us today. It was a great conversation. And thank you to our listeners for joining us today. You will find links to the abstracts discussed today on the transcript of this episode. Finally, if you value the insights that you hear on the ASCO Daily News podcast, please take a moment to rate, review, and subscribe wherever you get your podcast. Disclosures: Dr. Neeraj Agarwal: Consulting or Advisory Role: Pfizer, Bristol-Myers Squibb, AstraZeneca, Nektar, Lilly, Bayer, Pharmacyclics, Foundation Medicine, Astellas Pharma, Lilly, Exelixis, AstraZeneca, Pfizer, Merck, Novartis, Eisai, Seattle Genetics, EMD Serono, Janssen Oncology, AVEO, Calithera Biosciences, MEI Pharma, Genentech, Astellas Pharma, Foundation Medicine, and Gilead Sciences Research Funding (Institution): Bayer, Bristol-Myers Squibb, Takeda, Pfizer, Exelixis, Amgen, AstraZeneca, Calithera Biosciences, Celldex, Eisai, Genentech, Immunomedics, Janssen, Merck, Lilly, Nektar, ORIC Pharmaceuticals, crispr therapeutics, Arvinas Dr. Jeanny Aragon-Ching: Honoraria: Bristol-Myers Squibb, EMD Serono, Astellas Scientific and Medical Affairs Inc Consulting or Advisory Role: Algeta/Bayer, Dendreon, AstraZeneca, Janssen Biotech, Sanofi, EMD Serono, AstraZeneca/MedImmune, Bayer, Merck, Seattle Genetics, Pfizer, Immunomedics, Amgen, AVEO, Pfizer/Myovant, Exelixis Speakers' Bureau: Astellas Pharma, Janssen-Ortho, Bristol-Myers Squibb , Astellas/Seattle Genetics Travel, Accommodations, Expenses: Dendreon, Algeta/Bayer, Bristol Myers Squibb, EMD Serono, Astellas Pharma Disclaimer: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast expressed their own opinions, experience, and conclusions. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement.
Dr. Neeraj Agarwal, of the University of Utah Huntsman Cancer Institute, tells host Dr. John Sweetenham, of the UT Southwestern Harold C. Simmons Comprehensive Cancer Center, about the first study to examine the quality of diagnosis and treatment of breast cancer in sex and gender minority patients and other key studies on disparities associated with access to clinical trials and rising drug costs. Transcript Dr. John Sweetenham: Hello, I'm John Sweetenham, the associate director for Clinical Affairs at UT Southwestern Harold C. Simmons Comprehensive Cancer Center and host of the ASCO Daily News podcast. I'm delighted to welcome my friend and colleague Dr. Neeraj Agarwal, the director of the Genitourinary Cancers Program and a professor of medicine at the University of Utah's Huntsman Cancer Institute. Dr. Agarwal also serves as editor-in-chief of the ASCO Daily News. Today, he'll be sharing his insights on compelling studies that will be featured at the 2022 ASCO Annual Meeting, addressing access to clinical trials, disparities associated with high deductible health plans, rising drug costs, and more. Our full disclosures are available in the show notes and disclosures of all guests on the podcast can be found on our transcripts at asco.org/podcasts. Neeraj, it's great to have you back on the podcast. Dr. Neeraj Agarwal: Thanks, John. Dr. John Sweetenham: Neeraj, let's begin with Abstract 6503. This study looks at the impacts of high deductible health plans on delays in metastatic cancer diagnosis. What do you think about this study and why should it be on our radar? Dr. Neeraj Agarwal: Well, John, in high deductible health plans, patients are liable for the cost of all cancer-related care, with the exception of screening tests, until their annual deductible is met. Due to increased out-of-pocket costs, patients may postpone seeing a physician for concerning symptoms or diagnostic testing, leading to delayed diagnosis. So, in this study, Mr. Nicholas Trad and J. Frank Wharam assessed the impact of high deductible health plans on the timing of metastatic cancer detection. The authors leveraged a nationally representative cohort of more than 340,000 privately insured members whose employers mandated a switch from a low deductible of less than $500 plan to a high deductible plan of more than $1,000. So, the group consisted of more than 1 million individuals in a contemporary time frame, whose employers offered only low deductible plans. Participants were matched based on multiple baseline characteristics, time to metastatic cancer diagnosis, and the before and after switching to high deductible health plans was investigated using a weighted Cox proportional-hazards model. After matching, there were no systematic differences between the 2 groups with regards to baseline characteristics, and there were no differences in time to metastatic cancer diagnosis prior to the switch to high deductible health plans. However, after the employer-mandated switch to the high deductible health plans, these participants had lower odds of metastatic cancer diagnosis, which was significant, statistically speaking, and indicates delayed detection of metastatic cancer diagnosis relative to the control group. Dr. John Sweetenham: This is certainly concerning data, Neeraj. What's your key takeaway from this study? Dr. Neeraj Agarwal: So, the key takeaway from the study is that compared with conventional health plans, high deductible health plans are associated with delayed detection of metastatic cancer, implying that patients postpone seeking care for concerning symptoms or even defer diagnostic testing when they're exposed to high-cost sharing. Dr. John Sweetenham: Thanks, Neeraj. So, let's continue with this theme of the financial burden of cancer care for our patients. Of course, we're all aware of the rising costs of targeted oral therapies, and this was addressed in Abstract 6504, where the study looks at the rising costs of targeted oral treatments among Medicare beneficiaries. And the study reported a substantial increase in the total cost and out-of-pocket costs of these medicines. Can you tell us more about this abstract? Dr. Neeraj Agarwal: Yes! So, due to the rapidly rising cost of targeted oral anticancer medicines, Drs. Meng Li and Ya-Chen T. Shih examined recent trends and the financial burden of these oral medicines among patients with cancer with Medicare Part D insurance. So, eligible patients in the SEER-Medicare database had to be 65 years and older and had to have one primary cancer diagnosis. The investigators estimated the trends in the share of patients who used targeted oral anticancer medicines, the percentage of users reaching catastrophic coverage, and the total and patient out-of-pocket spending on these medicines in the catastrophic phase in a year. So, from 2011 to 2016, the uptake of these oral anti-cancer medicines increased from approximately 4% to 9%. The percentage of those who reached catastrophic coverage increased from 55% to 60%. Among those who reached the catastrophic phase, the mean total annual gross spending on oral anti-cancer medicine increased 4-fold from approximately $16,000 to $64,000. And the mean out-of-pocket spending for the patients rose from approximately $600 to $2600. Dr. John Sweetenham: Yes, this is more evidence that the financial toxicity generated from an increase in spending and out-of-pocket costs is going to have serious impacts on our patients. Would you agree with that, Neeraj? Dr. Neeraj Agarwal: Yes, John. The key takeaway from this study is that the financial burden of these oral anti-cancer medicines continues to increase. In the relatively short period of time, we see here, 5 years from 2011 to 2016, there was a 4-fold increase in the total cost and out-of-pocket cost of these medicines. And in my view, these findings warrant immediate actions to rein in drug prices and cap out-of-pocket spending for our patients. Dr. John Sweetenham: Absolutely. It's very difficult to know where this will end unless we see some kind of slowdown in these rising costs. I'm going to change gears just a little bit now to address the access to clinical trials, which is the subject of Abstract 6505. This study looks at the implementation of the Affordable Care Act Medicaid expansion, which was associated with an almost threefold increase in the proportion of patients using Medicaid in cancer clinical trials by early 2020. What are your thoughts on this study? Dr. Neeraj Agarwal: As you said, the Affordable Care Act Medicaid expansion resulted in increased use of this platform across the nation. However, its impact on access to clinical trials has not been examined. So, in this study, Dr. Joseph Unger and Dr. Dawn Hershman examined the number and proportion of patients insured by Medicaid at enrollment over time using data from the SWOG Cancer Research Network. In addition, they also examined all patients, 18 to 64 years old, enrolled in treatment trials between 1992 to 2020 using Medicaid versus private insurance. So, the implementation of the Affordable Care Act Medicaid expansion was associated with a nearly threefold increase from 7% to 21% in the proportion of patients using Medicaid in cancer clinical trials by early 2020. The increase per year of Medicaid uses for patients in these treatment trials from states that implemented the Affordable Care Act Medicaid expansion was 27% compared to 7% for patients from other states who did not implement this platform of Affordable Care Act Medicaid expansion. So, the key takeaway from the study is that better access to clinical trials for more vulnerable patients is critical to improving confidence in how generalizable these trial findings are. In addition, these results suggest that the recently enacted Cancer Treatment Act may continue to improve access to clinical trials for those with Medicaid insurance or those who are vulnerable patients. Dr. John Sweetenham: Yes, I think this is a really important study which adds to the growing literature on the benefits of the Affordable Care Act and Medicaid expansion on cancer care in general, in this case, specifically related to clinical trials. So, so important, I think. On that theme of equity, I think the next 2 abstracts we're going to discuss address specific aspects of equity, which I think are both interesting and really important. So, Abstract 6510 has interesting research which conveys an urgent need to ensure equitable patient-reported access and implementation and to address the greater reported symptom burden among minority patients. Why do you think this study is important? Dr. Neeraj Agarwal: The routine collection of patient-reported outcomes for patients with cancer is an evidence-based practice and a critical component of high-quality cancer care, but the real-world adherence and reporting patterns are poorly understood. In this study, Dr. Samuel Takvorian and Dr. Ravi Parikh examined differences in adherence to the collection of patient-reported outcomes and reported symptoms by race and ethnicity. This was a retrospective cross-sectional study using de-identified electronic health record data from an National Cancer Institute (NCI)-designated Comprehensive Cancer Center. The participants included adults seen in follow-up at 1 of the 2 medical oncology practices—one was in academics and one was in the community—from June 2019 to February 2020. Using ordinary least-squares regression, the authors modeled patient adherence as a function of race or ethnicity, and this was adjusted for age, sex, insurance, median area income, ECOG, performance status, and many other patient-related characteristics. The results show that adjusted mean PRO adherence and reported symptoms varied by race and ethnicity, with Black and Hispanic patients being less likely to complete PRO questionnaires, but reporting significantly higher symptom burden compared to the White patients. Dr. John Sweetenham: Right. So, it seems that more work is needed to ensure equitable access and adherence to PRO questionnaires so we can better address the symptom burden of our minority patients. Dr. Neeraj Agarwal: Correct, John. In this large cohort reflecting real-world PRO collection patterns, Black and Hispanic patients were less likely than White patients to complete these PRO questionnaires, but more likely to report more severe symptoms. And I think there is an urgent need to ensure equitable PRO access and implementation and to address the greater reported symptom burden among minority patients. Dr. John Sweetenham: Let's continue the theme of health equity and cancer care equity into the use of telemedicine. Of course, we saw a massive expansion of telemedicine for patients with cancer during the COVID-19 pandemic. But studies are emerging now to show that there have been substantial disparities among the Black, uninsured, non-urban, and less affluent patients who are less likely to use telemedicine services. Abstract 6511 reminds us that telemedicine may expand access to specialty care, but the proliferation of these services may widen cancer care disparities if vulnerable populations don't have equitable access. Can you tell us more about this abstract? Dr. Neeraj Agarwal: These are indeed very interesting findings, John. The COVID-19 pandemic was associated with declines in in-person clinical visits, with a concurrent increase in the use of telemedicine. In this study, Dr. Gregory S. Calip assessed demographic and socioeconomic factors associated with telemedicine use among patients initiating treatment for 21 common cancers at community oncology clinics. This was a retrospective study and made use of the nationwide Flatiron electronic health record derived de-identified database of patients with cancer. The authors focused on differences in telemedicine use across race and ethnicity, insurance coverage, rural versus urban areas, and socioeconomic status. They used logistic regression models for this analysis, which was adjusted for clinical characteristics to examine differences in telemedicine use among these different cohorts. Results indicate Black patients were significantly less likely to use telemedicine services compared to White patients. Telemedicine use was also significantly lower among patients without documented insurance than well-insured patients. It was also lower in patients from rural and suburban areas versus patients who were living in urban areas. Lastly, telemedicine use was significantly lower in patients in the least affluent areas than those in the most affluent areas. So, during the COVID-19 pandemic, nearly one-fifth of patients initiating cancer treatment using telemedicine services—among these patients, we see substantial disparities. So, Black, uninsured, non-urban, and less affluent patients were less likely to use telemedicine services. So, the take home message from this study is that while telemedicine may expand access to care, the proliferation of these services may actually widen cancer care disparities if vulnerable populations do not have equitable access to these services. Dr. John Sweetenham: Thanks, Neeraj. So, the final study that we'll discuss today also looks at another aspect of disparities, and that's Abstract 6517. It's a case-controlled study of health care disparities in sex and gender minority patients with breast cancer. What are the key takeaways from this study? Dr. Neeraj Agarwal: Disparities and the quality of diagnosis and treatment of breast cancer in sex and gender minority populations are largely undefined. Only 24% of studies funded by the National Cancer Institute capture data on sexual orientation and only 10% capture data on gender identity. In this case-control study, Drs. Eric Eckhert and Allison W. Kurian matched sex and gender minority patients with breast cancer to cisgender heterosexual controls in the Stanford University health care database. Ninety-two sex and gender minority patients were identified who were then matched by year of diagnosis, age, stage of cancer, presence of estrogen receptor (ER), and HER-2/neu receptor status to cisgender heterosexual controls within this database. Additional data on demographics, diagnosis, treatment, and relapse were then manually abstracted from the electronic health care records. The sex and gender minority cohort were comprised of 80% lesbians, 13% bisexuals, and 6% transgender men. One of the most pertinent findings was a significant, almost twice as much delay in time to diagnosis from the onset of symptoms in these minority patients versus control. Although there was no difference in the receipt of surgery or surgical radiation or new adjuvant therapy, sex, and gender minority patients were significantly less likely to undergo chest reconstruction surgery, and if they were estrogen receptor-positive, they were significantly less likely to complete at least 5 years of ER directed therapy. Please also note that sex and gender minority patients used more alternative medicine, had a higher rate of documented refusal of recommended oncology treatments, and they experienced a higher recurrence rate. So, the key takeaway from this study is that—this is the first study, I really want to congratulate the investigators who examined the quality of diagnosis and treatment of breast cancer in sex and gender minority patients. Several novel potential health care disparities are identified in these patients, which should be further evaluated in population-based studies to inform further interventions. Dr. John Sweetenham: Neeraj, it's always a pleasure to talk with you and have an opportunity to spend some time with you. Thanks very much for sharing your insights on these compelling studies today. Our listeners will find the links to these abstracts in the transcripts of this episode. Dr. Neeraj Agarwal: Thanks, John. Dr. John Sweetenham: And thanks to our listeners for your time today. If you're enjoying the content on the ASCO Daily News podcast, please take a moment to rate, review and subscribe wherever you get your podcasts. Disclosures: Dr. John Sweetenham Consulting or Advisory Role: EMA Wellness Dr. Neeraj Agarwal: Consulting or Advisory Role: Pfizer, Medivation/Astellas, Bristol-Myers Squibb, AstraZeneca, Nektar, Lilly, Bayer, Pharmacyclics, Foundation Medicine, Astellas Pharma, Lilly, Exelixis, AstraZeneca, Merck, Novartis, lily, Eisai, Seattle Genetics, EMD Serono, Janssen Oncology, AVEO, Calithera Biosciences, MEI Pharma, Genentech, Astellas Pharma, Foundation Medicine, and Gilead Sciences Research Funding (Institution): Bayer, Bristol-Myers Squibb, Takeda, Pfizer, Exelixis, Amgen, AstraZeneca, Calithera Biosciences, Celldex, Eisai, Genentech, Immunomedics, Janssen, Merck, Lilly, Nektar, ORIC Pharmaceuticals, ORIC Pharmaceuticals, CRISPR therapeutics, and Arvinas Disclaimer: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement.
Dr. Neeraj Agarwal, ASCO Daily News editor-in-chief, and director of the Genitourinary Cancers Program at the University of Utah's Huntsman Cancer Institute, highlights key studies on disparities in GU cancers featured at the 2022 ASCO Genitourinary Cancers Symposium. Transcript: ASCO Daily News: Hello and welcome to the ASCO Daily News Podcast. I'm Geraldine Carroll, a reporter for the ASCO Daily News. In today's episode, Dr. Neeraj Agarwal, the ASCO Daily News editor in chief, will highlight compelling studies on disparities in GU cancers featured at the 2022 ASCO Genitourinary (GU) Cancers Symposium. Dr. Agarwal has no conflicts relating to the topic of this episode and his full disclosures are available in the show notes. Disclosures of all guests on the podcast can be found in our transcripts at asco.org/podcasts. Dr. Neeraj Agarwal: Hello and welcome to the ASCO Daily News Podcast. I'm Dr. Neeraj Agarwal, the director of the Genitourinary Cancers Program and professor of medicine at the University of Utah Huntsman Cancer Institute. So, I'd like to start with Abstract 20 presented by Dr. Alicia Morgans from the Dana-Farber Cancer Institute. Multiple population-based studies have reported a higher incidence of prostate cancer in Black men. [This disease] usually presents with aggressive features, at an earlier age, and is associated with higher mortality rates compared to White men. In contrast, multiple reports suggest that Black men with advanced prostate cancer also have better survival outcomes to novel hormonal therapies compared to White men. Using electronic medical records retrieved from a urology specialty database, Dr. Alicia Morgans investigated whether improved survival outcomes in Black men treated with enzalutamide are due to better responses compared to White men. So eligible patients, who are chemotherapy and abiraterone naive and included 214 Black men and 1,332 White men with advanced prostate cancer. Reserves from a multivariate analysis were adjusted for baseline characteristics and indicated a statistically significant delay in clinical progression-free survival for Black men treated with enzalutamide compared to White men. This supports the argument that given equal access to care, Black men may respond similarly or better than White men to treatment for advanced prostate cancer. The next abstract addressing disparities in GU cancers was Abstract 444 presented by Dr. Samuel Washington from UCSF School of Medicine. Radical cystectomy remains the gold standard for muscle-invasive bladder cancer, yet confers significant health care costs. Prior work on the impact of cost commonly relied on comparisons by insurance status and income. Few studies have examined the relationship between the net worth of the household and the encounter type, such as outpatient versus inpatient encounters. As we also know, outpatient encounters are usually cheaper or less expensive than more expensive inpatient encounters. So, in this intriguing and novel study, Dr. Samuel Washington presented a real-world analysis of demographics, household net worth, health plan cost, out-of-pocket cost, and total health care cost accrued from the day of admission to 90 days after radical cystectomy for muscle-invasive bladder cancer. This was the largest study of its kind and included more than 140,000 commercially insured patients to examine variations in health care utilization by net worth in 90 days after radical cystectomy. Results are very interesting and indicate that patients with lower household net worth were at a greater risk for an acute inpatient encounter and thus higher medical cost, while patients with greater household net worth had greater odds of office visits or outpatient encounters, which are associated with lower cost. So, these findings indicate that a lower household network continues to be a significant factor in health care utilization and higher health care costs, even within a commercially insured patient population. So very interesting findings indeed and these findings definitely should pay for further future studies involving or looking at this aspect of disparities. Thank you very much for your kind attention. ASCO Daily News: That was Dr. Neeraj Agarwal of the University of Utah's Huntsman Cancer Institute. If you've enjoyed this series, please take a moment to rate and review us wherever you get your podcasts. Disclosures: Dr. Neeraj Agarwal: Consulting or Advisory Role: Pfizer, Medivation/Astellas, Bristol-Myers Squibb, AstraZeneca, Nektar, Lilly, Bayer, Pharmacyclics, Foundation Medicine, Astellas Pharma, Lilly, Exelixis, AstraZeneca, Merck, Novartis, lily, Eisai, Seattle Genetics, EMD Serono, Janssen Oncology, AVEO, Calithera Biosciences, MEI Pharma, Genentech, Astellas Pharma, Foundation Medicine, and Gilead Sciences Research Funding (Institution): Bayer, Bristol-Myers Squibb, Takeda, Pfizer, Exelixis, Amgen, AstraZeneca, Calithera Biosciences, Celldex, Eisai, Genentech, Immunomedics, Janssen, Merck, Lilly, Nektar, ORIC Pharmaceuticals, ORIC Pharmaceuticals, CRISPR therapeutics, and Arvinas Disclaimer: The purpose of this podcast is to educate and to inform this is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement.
Guest host, Dr. Neeraj Agarwal, editor-in-chief of ASCO Daily News and director of the Genitourinary Cancers Program at the University of Utah's Huntsman Cancer Institute, and Dr. Jason Efstathiou, chair of the 2022 ASCO Genitourinary Cancers Symposium, discuss key abstracts and innovations in GU oncology featured at #GU22. Dr. Efstathiou is professor at Harvard Medical School and director of the Genitourinary Division in Radiation Oncology at Massachusetts General Hospital. Transcript Dr. Neeraj Agarwal: Hello, and welcome to the ASCO Daily News Podcast. I am Dr. Neeraj Agarwal, the director of the Genitourinary Program and professor of medicine at the University of Utah Huntsman Cancer Institute and editor in chief of the ASCO Daily News. Today we'll be discussing key advances in GU oncology featured at the 2022 ASCO Genitourinary (GU) Cancers Symposium. I'm delighted to welcome Dr. Jason Efstathiou, who was the chair of this year's GU ASCO meeting. Dr. Efstathiou is the professor at Harvard Medical School and the director of Genitourinary Division in Radiation Oncology and clinical co-director of The Claire and John Bertucci Center for GU Cancers at the Massachusetts General Hospital. Our full disclosures are available in the show notes and the disclosure of all guests on the podcast can be found on our transcript at asco.org/podcast. Jason, thank you for coming on the podcast today. Dr. Jason Efstathiou: Thank you very much, Neeraj. It's a real pleasure to be with you. Dr. Neeraj Agarwal: So, Jason, the GU meeting showcased some fantastic advances across the spectrum of GU malignancies, can you please tell us about some of the hot topics that made the headlines this year? Dr. Jason Efstathiou: Absolutely. This certainly was a dynamic and interactive hybrid ASCO GU meeting for all those attending in person, live streaming, or accessing the content on demand. With over 5,200 registrants this year, that's an actual record for this meeting and over 70 countries represented. This meeting truly serves as the premier global event for all those who diagnose, treat and study GU cancers. The meeting highlighted novel scientific and clinical findings that were high impacted. [And] in many cases will lead to practice changing care. The meeting had a real focus on diversity, global perspectives, enhanced interactivity, networking, multidisciplinary, collaborative, and evidence-based care. As you know, this year's theme was “World Class Science, Patient-Centered Care,” and this theme was highlighted throughout the program. The meeting kicked off with a rich day focusing on prostate cancer, lots on PSMA imaging, such as Abstract 9 and a very, very excellent session on PSMA targeting and beyond which explored opportunities and challenges with PSMA novel therapeutics, including biomarkers of response and mechanisms of resistance. Then Abstract 10 looked at PSMA PET and FDG PET as predictors of response and prognosis in a randomized phase 2 trial of Lutetium PSMA (177Lu-PSMA-617) vs cabazitaxel and metastatic castration-resistant prostate cancer (CRPC) progressing after docetaxel. And it suggested that Lutetium PSMA be prioritized in men with high PSMA expression. And this could actually be predictive. We had some awesome abstracts. Abstracts 222 and 223 suggested that a nozzle digital pathology-based biomarker developed using artificial intelligence is more effective than clinical prognostic markers for predicting long term outcomes in patients with prostate cancer. And that this AI tool can actually successfully guide the use of androgen deprivation therapy in men with intermediate risk localized prostate cancer. And then of course, there were some very exciting results in discussion with the primary results of 3 potentially practice-changing phase 3 trials in the setting of metastatic prostate cancer that were presented in the oral prostate session. These were: PROpel (Abstract 11), MAGNITUDE (Abstract 12), and the ARASENS trials (Abstract 13). Neeraj, as a practicing medical oncologist, what did you think of these 3 abstracts? Dr. Neeraj Agarwal: I agree with you, Jason. These are indeed practice-impacting, practice-changing abstracts, which was a record for a prostate oral session, all 3 abstracts. In fact, the results of the phase 3 trials are [likely] going to influence or impact our practice in coming months. I would like to start with Abstract 11 on the results of the PROpel trial. So, PROpel is a randomized phase 3 trial evaluating the efficacy and safety of olaparib plus abiraterone vs placebo plus abiraterone. In the first-line metastatic cast of resistant cluster cancer, docetaxel therapy was allowed for these patients if given in the metastatic castration sensitive prostate cancer setting. Enrollment in the study was independent of the defects in the homologous recombination repair gene pathway. The primary endpoint was investigator assessed radiographic progression-free survival with multiple secondary endpoints, including overall survival and safety. A total of 796 patients were randomly assigned to olaparib plus abiraterone or placebo plus abiraterone at the pre-plant interim analysis. Results show that with a significant improvement in the radiographic progression-fee survival for all patients receiving the combination therapy, regardless of the presence of homologous recombination repair gene mutations. Overall survival analysis is still immature with only 29% event having occurred thus far. It is interesting that even patients deemed a negative for homologous recombination repair gene mutations showed significant improvement in video graphic progression-free survival when treated with the combination of olaparib plus abiraterone versus placebo plus abiraterone. I would like to mention the MAGNITUDE trial, which is Abstract 12, in the same context, as these have very similar populations and combination regimens. So, MAGNITUDE is a randomized phase 3 trial evaluating the efficacy and safety of niraparib plus abiraterone vs placebo plus abiraterone in the first-line metastatic castrate resistant prostate cancer setting. The eligible patient population was slightly different from that in the PROpel trial—prior attacks in therapy or novel hormonal therapy in the metastatic castration sensitive prostate cancer or non-metastatic castrate resistant prostate cancer were allowed. Also, patients were eligible if they had received up to 4 months of abiraterone in the first-line metastatic CRPC setting. Prospective selection of the patients with, and without homologous recombination repair gene mutations was required. So, the primary endpoint was radiographic progression-free survival by central with multiple secondary endpoints, including overall survival and safety. A pre-specified early fragility analysis was planned after enrolling 200 patients who are [homologous recombination repair] (HRR) negative and who were randomly assigned to receive either niraparib plus abiraterone or placebo plus abiraterone. The pre-planned fertility analysis showed no benefit in the biomarker negative cohort. Four hundred and twenty-three patients who were HRR positive were randomly assigned to receive either the combination of niraparib plus abiraterone or placebo plus niraparib at the pre-planned interim analysis. The results show that trial method—primary endpoint with a significant improvement in the radiographic progression-free survival for BRCA1 and 2 patients—and all patients who are homologous recombination repair mutation positive [were] receiving the combination of niraparib plus abiraterone versus placebo plus niraparib. Overall survival reserve is still immature. My combined take on the PROpel and the MAGNITUDE trial, based on the data presented so far or available in the public domain so far, is that both trials establish that combination of a PARP inhibitor plus abiraterone on in the first-line settings for me, for [patients with] HRR mutation positive metastatic castration resistant prostate cancer [will] improve radiographic progression-free survival. Even though overall survival data immature for both trials, I expect both combinations will be approved by the U.S. Food and Drug Administration in the near future and will be available to our patients. The HRR negative in the PROpel trial also seemed to benefit with the combination of abiraterone plus olaparib. I'm looking forward to data on confirmation of HRR negative status by tissue-based genomic profiling results in the full-length publication, which we expect to be published soon. If indeed confirmed, I see the combination of abiraterone plus olaparib to be reasonable option for patients who are HRR negative in the first metastatic castration prostate cancer set. The last practice changing abstract in the oral prostate session was Abstract 13 on the results of the ARASENS trial. ARASENS is a randomized phase 3 trial evaluating the efficacy and safety of darolutamide plus ADT or androgen deprivation therapy plus docetaxel versus placebo plus ADT plus docetaxel in patients with metastatic castration sensitive prostate cancer or mCSPC. It is important to note that this study only included patients that were eligible for ADT plus docetaxel chemotherapy. The primary endpoint was overall survival with multiple secondary endpoints, including time to casted resistance, time to pain progression, time to first symptomatic skeletal event, and time to start of next antineoplastic therapy and of course, safety. A total of 1,300 patients were randomly assigned to the darolutamide plus ADT plus docetaxel vs placebo plus ADT plus docetaxel. Results show the primary endpoint of the study was met with a significant improvement in overall survival and a 32% reduction in risk of death for patients on the triplet therapy with thalidomide plus ADT plus docetaxel. While this study offers an additional excellent option for our patients with metastatic castration sensitive prostate cancer, in an older patient population [the] use of docetaxel may be a significant limitation to this combination. In addition, this study did not answer the question [of] if adding docetaxel to ADT plus a novel hormonal therapy backbone will also improve survival with the advent of multiple doublets and triplet combinations. In the recent years, it is very important to find biomarkers which may predict response to these treatments and personalized therapy. Dr. Jason Efstathiou: Well, Neeraj, it certainly is a mic drop moment. Isn't it? When you can announce that the New England Journal of Medicine has just released the publication of your ARASENS trial, as you're presenting it at ASCO GU don't you think (DOI: 10.1056/NEJMoa2119115)? Dr. Neeraj Agarwal: Indeed, I think this is one of the most exciting ASCO GU meetings I've seen ever from GU ASCO. This is not an exaggeration. Dr. Jason Efstathiou: I totally agree. It was a phenomenal meeting and a very dynamic rich prostate day. Dr. Neeraj Agarwal: So, let's move on to the bladder cancer. Jason, what are your key takeaways from the studies of bladder cancer presented in this meet? Dr. Jason Efstathiou: Thanks, Neeraj. Yeah, the sessions on urothelial cancer were phenomenal and there were great sessions on novel therapies, such as antibody drug conjugates in advanced urothelial cancer and management of toxicities. There were abstracts such as [Abstract] 440 suggesting that neoadjuvant gemcitabine and cisplatin produced a favorable pathologic response rate and was well tolerated in patients with high grade upper tract urothelial carcinoma, and thus should be potentially deemed a new standard. Abstract 442 was a phase 2 trial that suggested that maintenance treatment with niraparib plus best supportive care did not improve outcomes compared to best supportive care alone, in patients with advanced urothelial carcinoma that did not progress after first-line chemotherapy. There was Abstract 435, which was an earlier face study suggesting that neoadjuvant treatment with enfortumab demonstrated promising activity among patients who are cisplatin ineligible with muscle invasive bladder cancer. And then there was a lot of focus in the meeting on trimodality therapy and optimizing bladder preservation. Dr. Alexandre R. Zlotta presented Abstract 433, which was a large multi-institutional match comparison of radical cystectomy to trimodality therapy for patients with muscle-invasive bladder cancer. And it suggested equivalent oncologic outcomes for select patients, and that trimodality therapy should be offered as an effective alternative for these patients. So Neeraj, moving on to kidney cancer, what were your key takeaways from these studies on kidney cancer presented in this meeting? Dr. Neeraj Agarwal: Yes, Jason, thank you. There were exciting results presented from multiple studies in kidney cancer as well. For example, Abstract 290 presented by Dr. Toni K. Choueiri from the Dana-Farber Cancer Institute on the 30-month follow-up of the KEYNOTE-564, which showed continued and strong disease-free survival benefit with adjuvant pembrolizumab in the context of localized or completely dissected renal cell carcinoma. I would like to highlight that highest benefit was seen in those patients who had oligometastatic disease, who on different surgery to remove those metastatic foresight and then were randomly assigned to receive pembrolizumab vs placebo in this trial. Abstract 291, presented by Dr. Matthew Zibelman from Fox Chase Cancer Center, showed the combination of axitinib with nivolumab was associated with close to 70% objective responses. Abstract 300 on kidney cancer on more than 1,000 patients—and on the International Metastatic Renal Cell Carcinoma Consortium, or IMDC Consortium—show that in the context of first-line immunotherapy regimens, presence of lung metastasis, CT nephrectomy and better MDC risk scores correlated with improved objective responses on this novel immunotherapy regimens. Abstract 350 on the update of the cabozantinib nivolumab was a sunitinib trial in metastatic renal cell carcinoma in the first-line setting. And it showed that the combination of cabozantinib nivolumab continues to be associated with an improved survival with the 30% reduction risk of death, even after this longer follow up—approximately 3 years. So, indeed, multiple abstracts on kidney cancer with real impact on how we practice medicine. So, Jason, let me switch gears here and talk about the education session. For example, there was a compelling keynote addressed by Dr. Karen Knudsen, the CEO of the American Cancer Society, about disparities in GU cancers in the United States. Are there any key messages that you would like to highlight briefly before we wrap up the podcast today? Dr. Jason Efstathiou: Thanks, Neeraj. Absolutely. The educational sessions were phenomenal. There was a must-see session, by the way, on management of rare variants in GU cancers. They made management of nuanced, rare variants and rare situations, very practical. And then there was an exciting prostate focus session called “Regulating the Wild West: PET-Based Imaging in Trials and the Clinic.” This session was planned with representatives from the U.S. Food and Drug Administration as we have done for the past 3 years. But this year it looked at how often PET based imaging affects clinical decision making and prostate cancer and how the integration of novel molecular based imaging like PET informs clinical trial design and endpoints, including regulatory considerations. And yes, of course, as you noted this year's program also focused on identifying and addressing disparities in cancer care and research with sessions each day, focused on this topic (Abstract 225, 446, 472, and 26). There were great oral presentations and there was a phenomenal Virtual Poster Walk with Dr. Ahmedin Jemal from the American Cancer Society. He, by the way, is an author that we have all quoted. So, please check that out. But we were thrilled, absolutely thrilled to have Dr. Karen Knudsen, the CEO of the American Cancer Society (ACS) as our keynote speaker to address this important topic in her phenomenal and frankly, inspiring talk called “A Path Forward: Addressing Disparities in Genitourinary Cancers.” This talk was especially poignant because as you know, there is a new and robust collaboration between ASCO and the ACS that was announced earlier this month on February 1, regarding equity, diversity, and inclusion in cancer care. ASCO's work aims to address all of the important differences that can impact access to cancer care and outcomes, including age, gender, race, sexual orientation, and geography, both in the U.S. and internationally. ASCO has clearly aligned its equity, diversity, and inclusion (EDI) goals within the mission pillars of research, education, and quality. Dr. Neeraj Agarwal: Thank you, Jason, for sharing your insights with us today. It is really an exciting time in GU oncology. Thank you. Dr. Jason Efstathiou: Thank You, Neeraj. I totally agree. Dr. Neeraj Agarwal: And thank you to our listeners for joining us today. You will find links to the abstracts discussed today on the transcript of this episode. Finally, if you like what you're hearing on the ASCO Daily News podcast, please take a moment to rate, review and subscribe wherever you get your podcast. Thank you so much. Disclosures: Dr. Neeraj Agarwal: Consulting or Advisory Role: Pfizer, Medivation/Astellas, Bristol-Myers Squibb, AstraZeneca, Nektar, Lilly, Bayer, Pharmacyclics, Foundation Medicine, Astellas Pharma, Lilly, Exelixis, AstraZeneca, Merck, Novartis, lily, Eisai, Seattle Genetics, EMD Serono, Janssen Oncology, AVEO, Calithera Biosciences, MEI Pharma, Genentech, Astellas Pharma, Foundation Medicine, and Gilead Sciences Research Funding (Institution): Bayer, Bristol-Myers Squibb, Takeda, Pfizer, Exelixis, Amgen, AstraZeneca, Calithera Biosciences, Celldex, Eisai, Genentech, Immunomedics, Janssen, Merck, Lilly, Nektar, ORIC Pharmaceuticals, ORIC Pharmaceuticals, crispr therapeutics, and Arvinas Dr. Jason Efstathiou: Consulting or Advisory Role: Blue Earth Diagnostics, AstraZeneca, Boston Scientific, Roivant Pharma, Merck, and Myovant Sciences Disclaimer: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. Guests' statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement.
CBIA BizCast host Ali Warshavsky speaks with Steve Weis, vice president of human resources at New Haven-based biopharma company Arvinas. Arvinas is one of a number of bioscience companies participating in the Sprint Initiative—Student Program to Ready Interns for Next-Generation Talent. Launched by the New Haven Regional Bioscience Collaborative, the program is designed to provide real-world job experience for students attending Colleges and universities in Connecticut. Weiss said students will intern at a bioscience company, with an option to focus on areas like IT or accounting if they aren't studying the life sciences. “We definitely see New Haven specifically as a biotech hub and we want to be a part of that growth and attract that talent and retain that talent to the area,” he said. The program coincides with the Life-Science Sprints in Connecticut campaign, designed to increase visibility and boost the growth of the state's bioscience industry. The collaborative was launched last May by the Governor's Workforce Council, with industry leadership and support provided by the Greater New Haven Chamber of Commerce. Please rate, review, and subscribe to the BizCast wherever you get your podcasts—we appreciate your support! If you have a story to tell, contact Ali Warshavsky.
Dr. Karim Fizazi, medical oncologist at Gustave Roussy and professor in Oncology at the University of Paris-Saclay in France, tells guest host, Neeraj Agarwal, editor-in-chief of ASCO Daily News and director of the Genitourinary Cancers Programs at the University of Utah's Huntsman Cancer Institute, about the practice-changing PEACE-1 trial, an ongoing phase 3 trial among men diagnosed with de novo metastatic castration-sensitive prostate cancer. Transcript: Dr. Neeraj Agarwal: Hello and welcome to the ASCO Daily News Podcast. I'm Dr. Neeraj Agarwal, the director of Genitourinary Oncology Program and professor of medicine at the University of Utah Huntsman Cancer Institute and editor-in-chief of the ASCO Daily News. Our topic today is the practice-changing PEACE-1 trial, an ongoing phase 3 trial among men with de novo metastatic castration-sensitive prostate cancer. Joining me today to discuss the results of this trial is Dr. Karim Fizazi, who is a world-renowned medical oncologist practicing at Gustave Roussy and a full professor in Oncology at the University of Paris-Saclay in Villejuif, France. Dr. Fizazi has led multiple practice-changing trials in advanced prostate cancer and is also the founder of the Prostate Cancer Consortium in Europe known as PEACE Consortium. Our full disclosures are available in the show notes, and disclosures related to all episodes of the podcast can be found on our transcripts at the asco.org podcasts. Welcome, Karim. It is so great to have you on the podcast today, and thank you so much for taking time to be with us. Dr. Karim Fizazi: Thank you very much, Neeraj. It's a pleasure and an honor. Dr. Neeraj Agarwal: You recently presented the primary results of the phase 3 PEACE-1 trial in men with de novo metastatic castration-sensitive prostate cancer in the ESMO 2021 meeting. Could you please tell us more about the design of this study and why you did this study? Dr. Karim Fizazi: Sure, yes, happy to do so. So, PEACE-1 is a large academic European phase 3 trial, which is enrolling patients with de novo metastatic prostate cancer. And it is basically asking 2 questions. Number 1, should we add abiraterone acetate on top of standard of care for these men? And in most of them, standard of care consisted in androgen prevention therapy plus chemotherapy with docetaxel. So, this is the number 1 question—in other words, 3 drugs instead of just 2. And the second question is whether we should use radiation therapy directed to the primary cancer in these men who are treated with intensive systemic treatments? And we're doing that because we already know the answer regarding the radiation question, and it's a yes answer for men who received androgen deprivation therapy (ADT) alone, but we don't really know whether this applies when intensified treatment is being used. So, it's a 2x2 design, and we were able to enroll almost 1,200 men in the trial. We completed the inclusion in the trial back in 2018, so the patients or at least those who are alive are on follow-up. And this year, 2021, we have analyzed the co-primary endpoints of radiographic progression-free survival and overall survival for the abiraterone equation. In probably 1 or 2 years from now, we will be able to do the same thing regarding the radiation therapy equations when we have sufficient number of events for these patients. Dr. Neeraj Agarwal: Very interesting trial design and massive effort at the multinational level in Europe. So please tell us about the results of the study and how it will affect the current treatment paradigm of our patients with de novo metastatic castration-sensitive prostate cancer. Dr. Karim Fizazi: Sure. So, as I said, right now, we have data regarding the abiraterone question. And again, the question is whether we should use ADT plus docetaxel with or without abiraterone acetate and prednisone. At ASCO [Annual Meeting] this year, we reported the radiographic progression-free survival data, which is a co-primary endpoint of the trial, and this is clearly positive (Abstract 5000). If patients received 3 agents—ADT, docetaxel, and abiraterone—they will enjoy 4.5 years without radiographic progression or death in the experimental arm versus only 2 years in the control arm. So, in other words, this mean 2 and a half year of additional life without problems, if you will, without a significant progression or death for this patient, which is big. I think many people were already convinced with this data and thought this could be practice changing. I remember our discussion, you and me, Neeraj, at this time. But some others were not necessarily convinced and request the overall survival data before making their decision. Or if it's possible to collect the events, and of course, in the COVID-19 times, this has been challenging. But I think we made it, and we were able to show the data for overall survival at ESMO this year in September. And of course, this was planned—pre-planned and dependent on a pre-planned number of events, which was reached. The news here is good again. And actually, patients receiving ADT plus docetaxel plus abiraterone clearly have an improvement significantly by overall survival as compared to those who received just 2 treatments. The reduction in the risk of death was approximately 25% for these patients receiving the triplet treatment, and it's even greater for men with what we call high-volume disease, so those with multiple bone metastases, at least 4, or visceral metastases, of course, men with a poor outcome. For these men, the reduction in the risk of death achieved by the triplet treatment was 28% in reduction of risk of death and was translated in a marked difference in medians, 3.5 years in the control arm with ADT plus docetaxel, and this was actually what we were expecting for this population of men, as compared to 5.1 years for patients receiving the triplet treatment. So, in other words, it's more than 1 and a half additional year of life for these men receiving 3 treatments up front. I think what is very unique also in this trial is that men in the control arm were treated very aggressively when they progressed. And actually, more than 80% of them received at least one next-generation hormonal agents, and basically, 85% of them received at least 1 drug associated with proven life prolongation. Again, this is in marked contrast to what we saw in previous pharma industry-sponsored trial conducted in the past, where patients in the control arm were not necessarily very aggressively treated. This is clearly showing us that— Dr. Neeraj Agarwal: Yeah. This is very interesting. I was really impressed by the fact that patients in control arm and as well as experimental arm—so basically patient on ADT plus docetaxel versus ADT plus docetaxel plus abiraterone—more than 80% patients were receiving subsequent life prolonging therapies, which is in marked contrast to other trials we have seen in the recent past. And despite that, you were able to show a remarkable, clinically meaningful improvement in overall survival with the triplet therapy. I think that is the most important message I got from the updated presentation in ESMO 2021. Would you agree? Dr. Karim Fizazi: Absolutely. I think it's truly a demonstration that early intensification is better than use—a subsequent use of these agents when the cancer is already more heterogeneous, more aggressive, and harder to treat. We should intensify treatment up front. I think this is very important, especially those with predicted poor outcome. Dr. Neeraj Agarwal: So, Karim, these data are obviously very impressive, in my view, practice changing. Many of my community oncology colleagues have asked me about the potential side effects of this combination versus chemotherapy with docetaxel or abiraterone therapy alone in addition to ADT. Any tips for our colleagues and friends out there in the community on how to manage side effects or what should we be looking for as a community? What should we be telling the patients and any tips on managing the side effects? Dr. Karim Fizazi: Absolutely. I think this is a key question, and also, this was great news from the trial. We couldn't find basically synergistic toxicity between docetaxel and abiraterone in the trial. So, in other words, what we saw was the expected toxicity from docetaxel, and we expected toxicity from abiraterone, but nothing additional or nothing worse, if you will. For example, the neutropenic fever incidence was exactly the same in the two arms. The GI toxicity from docetaxel was not increased, and actually, it was even a bit less, numerically speaking at least. And regarding the abiraterone toxicity, what we saw mainly was an excess in hypertension, usually of lower grade, and an excess in transaminase increase, which was actually rare, approximately 6% if I recall well, which is really in line with what you would expect with the general use of this agent. And of course, this is something you can monitor, and you should monitor. We know how to handle toxicity with abiraterone, and the same also applies to the hypertension management with this agent. Dr. Neeraj Agarwal: Got it. So, say a patient is hesitant, and of course, this was not addressed by the clinical trial. But given compelling survival benefit, if I'm talking to a patient in the clinic tomorrow morning and the patient is hesitant to start all 3 drugs at the same time, do you think it would be reasonable to start chemotherapy with docetaxel, finish 4 to 6 cycles, and then start abiraterone? With the caveat that this was not addressed by the trial, but I'm just asking a very practical question. Dr. Karim Fizazi: Again, this is a difficult question you're asking. And I'm saying that because, as you rightly said, in PEACE-1 we combined abiraterone with docetaxel. So, in other words, abiraterone was given concomitantly with docetaxel and then was continued when docetaxel was stopped. So, we don't really know whether giving abiraterone as a maintenance strategy, if you will, in your example, post docetaxel would be associated with the same benefit. It's probably reasonable to think it does, but it's not a given. So, my preference would be actually to combine up front, if possible, of course. Dr. Neeraj Agarwal: Absolutely. And as I said, this was not tested or addressed by the trial. So final message is, as far as combination therapy is concerned, there is no synergy—there is synergy with the efficacy, but we are not seeing synergy, if you will, from the side effect perspective. And if we are deciding to start triplet therapy, we should be starting all drugs at the same time. At least docetaxel and abiraterone should be started together and not sequenced. Any final message for our friends and colleagues in the community by you, Karim? Dr. Karim Fizazi: Well, maybe just 1 or 2 final messages. The 1 is a hurrah message because I'm happy, of course, with the data. And just to put this into perspective, back in 2015, before we had all of the recent trials in M1 castration-sensitive disease, men with high-volume disease had approximately 3 years of life expectancy. And now just 5 or 6 years afterwards, thanks to all clinical research we conducted during this time frame, in PEACE-1, these patients can live more than 5 years, which I think is remarkable. I think the second and last message is that we should soon have more data for these men regarding the triplet combination with ADT, docetaxel, and a next-generation hormonal agent. Specifically, the ARASENS trial (NCT02799602), which is testing darolutamide randomly in this setting, is to release its data probably very soon. And the same applies to the enzalutamide trial with ENZAMET, which should be updated specifically for these men receiving the triplet treatment. So, we should see even more data than what I was fortunate enough to report this year with PEACE-1. Dr. Neeraj Agarwal: Thank you. So, thank you, Karim, again, for sharing these exciting data from the PEACE-1 trial. Congratulations for conducting this massive trial and coming out with such great news for our patients. I wish you all the best. Dr. Karim Fizazi: Thank you very much, Neeraj. It was a pleasure. Thank you so much. Dr. Neeraj Agarwal: And thank you to our listeners for your time today. If you enjoyed this podcast, please take a moment to rate, review, and subscribe wherever you get your podcasts. Thank you very much. Disclosures: Dr. Neeraj Agarwal: Consulting or Advisory Role: Pfizer, Medivation/Astellas, Bristol-Myers Squibb, AstraZeneca, Nektar, Lilly, Bayer, Pharmacyclics, Foundation Medicine, Astellas Pharma, Exelixis, Pfizer, Merck, Novartis, Eisai, Seattle Genetics, EMD Serono, Janssen Oncology, AVEO, Calithera Biosciences, MEI Pharma, Genentech, Foundation Medicine, Gilead Sciences Research Funding (inst.): Bayer, Bristol-Myers Squibb, Takeda, Pfizer, Exelixis, Amgen, AstraZeneca, Calithera Biosciences, Celldex, Eisai, Genentech, Immunomedics, Janssen, Merck, Lilly, Nektar, ORIC Pharmaceuticals, ORIC Pharmaceuticals, crispr therapeutics, and Arvinas Dr. Karim Fizazi: Honoraria (inst.): Janssen, Sanofi, Astellas Pharma, Bayer Consulting or Advisory Role (inst.): Janssen Oncology, Astellas Pharma, Sanofi, AstraZeneca, ESSA, Amgen, Bristol-Myers Squibb, Clovis Oncology Consulting or Advisory Role: Curevac, Orion Pharma GmbH, Bayer Travel, Accommodations, Expenses: Janssen, MSD Disclaimer: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. Guests' statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement.
Guest host, Dr. Neeraj Agarwal, ASCO Daily News editor-in-chief and director of the Genitourinary Cancers Program at the University of Utah's Huntsman Cancer Institute, discusses the practice-changing KEYNOTE-564 and SWOG 1500 trials with Drs. Toni Choueiri and Sumanta "Monty" Pal. Dr. Choueiri is director of the Lank Center for Genitourinary Oncology at the Dana-Farber Cancer Institute and Dr. Pal is co-director of City of Hope's Kidney Cancer Program and associate editor of Cancer.Net. (This episode was recorded on 11/18/2021) Transcript Dr. Neeraj Agarwal: Hello, and welcome to the ASCO Daily News podcast. I am Dr. Neeraj Agarwal, the director of the Genitourinary Oncology Program, and the professor of Medicine at the University of Utah Huntsman Cancer Institute, and editor-in-chief of the ASCO Daily News. I'm delighted to welcome two internationally recognized leaders in the field, Dr. Toni Choueiri and Dr. Sumanta (Monty) Pal, for a discussion about two practice-changing studies in kidney cancer published this year-- KEYNOTE-564 and SWOG 1500. As a quick introduction, Dr. Choueiri is the director of Lank Center of Genitourinary Oncology at the Dana-Farber Cancer Institute. He's also the Jerome and Nancy Kohlberg Chair, and professor of medicine at the Harvard Medical School. Dr. Sumanta "Monty" Pal is a professor in oncology, and co-director of City of Hope's Kidney Cancer Program, and he is an associate editor of cancer.net of ASCO. Our full disclosures are available in the show notes. And disclosures relating to all episodes of podcasts can be found on our transcripts at ASCO.org/podcast. Toni and Monty, what a day it has been for our patients with kidney cancer. I woke up with the news of the U.S. Food and Drug Administration (FDA) approval of the first ever adjuvant immunotherapy for patients with renal cell carcinoma. It is so great to have you both on the podcast today. Dr. Monty Pal: Glad to be here. Thanks, Neeraj. Dr. Toni Choueiri: Thank you, Neeraj. So glad to be here. Dr. Neeraj Agarwal: So, let me start by asking questions to you first, Toni. So, you recently published the primary results of the phase 3 KEYNOTE-564 study, showing the efficacy of adjuvant therapy with pembrolizumab and immune checkpoint inhibitor in patients with renal cell carcinoma. And this study led to the approval of pembrolizumab this morning. So, please tell us more about the study design and why did you do this study. Dr. Toni Choueiri: Thank you, Neeraj. And thank you, really, ASCO for this wonderful podcast series. And a big hit, I always listen to them when I'm driving or jogging. And really, thanks for this opportunity because kidney cancer adjuvant therapy has been something like a holy grail we're trying to find for a long, long time. The first adjuvant trial, a randomized trial, in renal cell cancer was in 1973 with radiation therapy. And since that time, all the trials except for one have been a complete failure in a way. And the first adjuvant immunotherapy trial was with old immunotherapy cytokine that we don't use much anymore and was in 1992. I was not done with medical school. I was not actually done with high school at that time, let alone medical school. And now that we have, as we all know, a revolution in the oncology field through these immune checkpoint inhibitors that reinvented immunotherapy in cancer, and now that pembrolizumab has shown activity in patients with more advanced disease, we thought about taking this into the adjuvant setting, a setting of patients where they were subjected to surgery. But on the pathology report, we knew that their risk of this cancer coming back, of recurrence, is somewhat intermediate high or high. These are patients that have stage 2 but grade 4, stage 3, D3, D4. These are patients that had node-positive resected. And we took even patients where the kidney is out, but, also, they had a removal of a metastatic site--let's say a lung metastasis--within a year of removing the kidney. And we know these patients we refer to as M1NED are at quite high risk of recurrence. And we randomly assigned 994 patients to receive pembrolizumab for a year versus placebo. And after a median follow-up of only 2 years--so I want to insist here that this is short for any trial in general--we saw a decrease in the risk of recurrence or death. The hazard ratio for disease-free survival was 0.68. So, a 32% decrease in the risk of recurrence or death. We looked at safety, and we already are familiar in the field of GU oncology with pembrolizumab. And we didn't see when we looked at the safety profile any surprises, any enhanced toxicity. Of course, immune-related adverse events are the number one concern with pembrolizumab. There were no deaths on trial related to pembrolizumab. We saw around 7% of patients needing high dose steroid to medicate these immune-related adverse event, and some patients had to come off therapy for that. We also took a look, Neeraj, an early look, at overall survival. We only had 25% of events, 51 deaths. And we did not meet the very rigorous statistical significance that is needed to say that study is positive for overall survival. But the hazard ratio was 0.54, a 46% decrease in the risk of death, which is kind of encouraging. And after a year, the curve starts to separate. Before a year, they're not separating. And that is consistent with prior studies in general. Dr. Neeraj Agarwal: This is a very interesting point you just raised, that DFS, disease-free survival, is strongly positive. And even overall survival is trending in the right direction, right? Dr. Toni Choueiri: Correct. Dr. Neeraj Agarwal: That's great. So obviously, I would like to raise another point here. When we talk about adjuvant study, we usually think about a localized kidney cancer, which is removed by the surgeon, and then [the] patient is coming to see us for treatment in adjuvant setting. But this study, I would like to highlight, as you said, also included patients who had oligometastatic disease, had successful surgical removal of the oligometastatic disease, and they were also eligible for this trial. Dr. Toni Choueiri: Yes, absolutely. And I think this is somewhat on the recent side in clinical trials in kidney cancer. The reason for that is that, in practice, we see those patients. And we even had two small trials in the TKI era with sorafenib and pazopanib, small studies, were also completely negative. So, we thought here that we should not exclude these patients. They end up being 6%, 7% of all participants, but this remains an area of unmet medical need. Dr. Neeraj Agarwal: So, how is the hazard ratio in those patients who had metastatic disease removed and then treated with pembrolizumab? Dr. Toni Choueiri: Yeah, it was very low. It was 0.2, so 0.29. And this was great to see. I don't want to go into really over-interpreting these results. All the hazard ratio--when you look at subgroup analysis or in the forest plot, all the hazard ratio are less than 1. We didn't see something--let's say 1.5--in favor of pembrolizumab. Now you go into a smaller subgroup, then your confidence intervals are very large and hard to interpret, except that to say, look, on average there could be a significant benefit here, but we can't tell. Dr. Neeraj Agarwal: Sure, absolutely. I agree with you. So, how this is going to affect the current treatment paradigm, which is for patients with newly diagnosed metastatic RCC, where combination of VEGF-TKI plus immunotherapies (IOs) or IO/IO combinations have become standard of care or treatment paradigm? Dr. Toni Choueiri: I do believe it will be a standard of care currently in the right population. There are a lot of unanswered questions, but that will be answered hopefully with more follow up. We have already, beside these results, reported--so these results were reported in the plenary session at the 2021 ASCO [Annual Meeting]. But later on, another analysis dealing with patient-reported outcome and quality of life was reported at ESMO and also showed no detriment in quality of life--that's the voice of the patient--no detriment with pembrolizumab (pembro). There is a lot still to do and a lot of unanswered questions, such as the non-clear cell histology, those patients who had surgery of their metastatic disease more than a year. But most important, I think, two questions. One, how can you know from the get-go who are the patients that need adjuvant pembrolizumab? We do not have any valid ctDNA. And I know Dr. Pal was involved with a lot of these type of research. We don't have any ctDNA test that is really that faithful and sensitive in the MRD space in renal cell. Many of us are working, so we don't know. We may end up over-treating patients that need surgery only. And actually, we may end up under-treating patients that need, perhaps, pembro, and another drug. And the second thing in those patients--and I hope it does not happen, but unfortunately, it will to some extent--whose tumor progress on adjuvant pembrolizumab, what do you do? What's the treatment paradigm? And actually, there is no data. This is a data-free zone. And I would think somebody whose tumor progressed, tumor continued to grow or grows, while they're actively on pembrolizumab, on IO, is way different than someone whose tumor comes back after 2 or 3 years from stopping the drug. Should we treat them with the same drug? Should we treat them with the TKI plus IO? Luckily, there are trials that are ongoing in patients whose tumor progressed after PD-1/PD-L1 inhibitor to give them a TKI as a control arm, or a TKI plus an immune checkpoint inhibitor. And I know Dr. Pal is very heavily involved with such trials. So, hopefully, we will answer this question, but not anytime soon. Dr. Neeraj Agarwal: Very interesting, and definitely new results are posing new challenges in how we practice medicine here in the coming future. So, Monty, you are leading a trial with a very similar trial with atezolizumab. And I'm really hoping, we are all really hoping, that we see the other trial being positive, so we have more treatment options for our patients. Dr. Monty Pal: I couldn't agree with you more. I mean, I definitely think that Toni's study really adds a lot of fuel to the fire suggesting that this strategy of adjuvant immunotherapy may be successful in localized renal cell. Dr. Neeraj Agarwal: And I'm not going to really delve into the side effects of pembrolizumab and atezolizumab because these drugs are used quite often. They are in widespread use for different types of cancer. But just a quick question, any safety signal, Toni? Did you see any safety signal with pembrolizumab in this patient population? Dr. Toni Choueiri: Yeah, this is an excellent question. So, nothing that would be different than using pembrolizumab overall knowing in other diseases as a single agent. So, this drug not first in human, as you know, and it's been approved in combination or as a single agent in many diseases. A tumor that the three of us treat is bladder cancer, and we know from another study how to use pembrolizumab. I think that the use of corticosteroid is somewhat of an objective way, at least to me, in looking at immune-related adverse event. And it has been between 5% to 10%, so we're not way off here. But there is no doubt that there are patients that we had no death on trial attributed to drug that may have, with pembrolizumab, some serious toxicities. We had patients that had autoimmune diabetes, hypophysitis, pneumonitis--quite uncommon, but not impossible. Dr. Neeraj Agarwal: We'll still need to keep an eye for that, basically. Dr. Toni Choueiri: No doubt. Dr. Neeraj Agarwal: Yes. So, changing gears, let's talk to you, Monty. You recently presented the primary results of the SWOG 1500 trial in patients with metastatic non-clear cell renal cell carcinoma. Could you please tell us why you did this study and how this study's design was unique compared to similar studies in this setting? Dr. Monty Pal: Yeah. No, absolutely. Toni did a great job of outlining areas that are sort of free of data in the adjuvant space, particularly with immunotherapy. I think that data-free area for us in kidney cancer for a long time has been non-clear cell histology. We just don't really know how to treat them. And I actually got advice from Toni when I was devising SWOG 1500. We planned it out as a very simple study comparing sunitinib and cabozantinib. And Toni will remember this history well. It sort of went through several iterations. The study blossomed into a six-arm trial. Ultimately, it turned into a four-arm study, looking at sunitinib versus cabozantinib versus two other MET inhibitors--savolitinib and crizotinib. And ultimately, the study was boiled down to essentially what we'd originally proposed. Two of the MET inhibitors--savolitinib and crizotinib--failed to surpass that initial analysis for PFS. So, ultimately, we demonstrated a superiority with cabozantinib over sunitinib for progression-free survival. Dr. Neeraj Agarwal: So, what is the current treatment paradigm for patients who have newly diagnosed metastatic papillary RCC now? Dr. Monty Pal: I think for patients who don't have genomic selection, I think that cabozantinib remains the standard. I really want to champion- and maybe Toni can talk a little bit more about this--a study that Toni is leading called the SAMETA trial, which I think has a really innovative design. And it's going to be genomically characterizing patients and randomizing to savolitinib with durvalumab or sunitinib. Tell me, Toni, if I have the design right there. Dr. Toni Choueiri: Yes. Actually, this is a specific study in a specific population. It's not in papillary RCC as much as in those 30%, 40% of papillary RCC that have MET-driven tumors, so MET alteration, whether through chromosome 7 duplication, through chromosome 7 trisomy, through mutation or amplification. These patients will get either control arm or they will get savolitinib, which is a pure MET inhibitor that is devoid of VEGF-related toxicities, savolitinib plus durvalumab, or durvalumab alone. So, two experimental arms and one control. And the reason for this is we saw activity and quite a good toxicity profile with savolitinib, a pure MET inhibitor, over sunitinib in an earlier trial that was sunitinib against savolitinib in selected patient populations. The study had to close early. So, despite the numerical difference, this was not statistically significant. And then in another study led by Dr. Powles and colleagues, there was also some interesting activity how durvalumab could augment that activity. So, we're launching a phase 3 trial with three arms that you described very well. Dr. Neeraj Agarwal: That's wonderful. So, what are the next steps, Monty? I mean, this is amazing to see you designing an investigator-initiated trial. This was your concept. You designed it. You built this to be a huge multicenter trial, which was open across the country, funded by the National Cancer Institute. And congratulations for making that happen. It's rare for us to see these trials going from a concept stage to a national trial, and then changing the standard of care. So, what are the next steps now for you and your team in SWOG for papillary RCC or metastatic papillary RCC? How do you build out further with the backbone of cabozantinib? Dr. Monty Pal: I really appreciate the question, Neeraj. It's so critical to understand that we're just not quite done yet. Toni's study, as I've mentioned, is incredibly innovative. I'm also really thrilled to be working with someone who you've mentored so well, Ben Maughan, at the Huntsman Cancer Institute in Utah. And he's actually designed a brilliant study, which we're going to be leading together, which looks at cabozantinib with or without atezolizumab. Recently, in a study that you and I and Toni were a part of that we just published in JCO, we actually saw quite impressive response rates with the combination of cabozantinib and atezolizumab in patients with papillary RCC, around 47%. Those response rates were actually replicated in a separate study run by Joe Lee at Memorial Sloan Kettering. In the context of papillary disease response rates were again above a threshold of around 40%. So, I think there's something to it. But until we really subject this to randomization, I think we're not going to know whether or not cabo plus IO is standard. So, I encourage everyone to consider Toni's study. I encourage everyone to look out for our trial of cabo plus or minus atezo, which should be rolling out next year. Dr. Neeraj Agarwal: What is the name of the trial, or the number, for our audience? Dr. Monty Pal: Yeah, we lucked out with another great number. We got 1500 for the first trial. This is going to be SWOG 2200. So SWOG 2200, and I think it's due to open maybe in the first quarter of 2022. Dr. Neeraj Agarwal: That's fantastic news. Any new signal? We know cabozantinib is already approved for our patients with metastatic RCC, courtesy METEOR trial led by Dr. Choueiri. Toni, it's amazing to see how many times you have changed standard of care for our patients with metastatic RCC. So, any new safety signal of cabozantinib in this patient population with metastatic papillary RCC? Dr. Monty Pal: Nothing that appreciated. The toxicity profile was pretty much on par with what you'd anticipate for cabozantinib in the setting. Major side effects were hypertension, hand-foot syndrome, [and] diarrhea. Nothing that really sort of stood out relative to what we would expect in a clear cell population of patients. Dr. Neeraj Agarwal: That's great. Any final messages for our patients, for our audience, for our listeners? Dr. Toni Choueiri: Well, let me start, and maybe Monty can add. It's been, and it hopefully will continue to be, this humbling experience, where median survival from metastatic RCC in mid-2000--not long time ago during our training--has been 1 year. And now in metastatic disease, it's 4 to 5 years. And that is only going to get better. And then it's even more humbling to be in a time where you can talk about adjuvant treatment in this disease, renal cell cancer, that continues every year to kill, unfortunately, 14,000 Americans. That's just in the U.S. alone. So, we have to continue in getting more targets, more drugs, more reasonable combination, and the right patient, whether through specific biomarker that are tissue or blood-based or specific liquid biopsies that can tell you who has and who doesn't have cancer at the microscopic levels. Dr. Neeraj Agarwal: Thank you. How about you, Monty? Any final message for our audience? Dr. Monty Pal: I couldn't have summarized it better than Toni, just such a wonderful statement around optimism for what we've achieved so far and what's yet to come. And if I could emphasize to anyone in the audience today the need to keep progressing the field further with clinical trials, I think that would be my underlying message. Dr. Neeraj Agarwal: Thank you again, Toni, Monty, for your valuable insights and thoughts. Thank you for all the inspiration. This is indeed so inspiring to see your work, which is changing the lives of our patients on a daily basis. Our listeners will find links to your studies in the transcript of this episode. I wish you all the best. Dr. Toni Choueiri: Thank you. Dr. Neeraj Agarwal: And thank you to our listeners for your time today. If you enjoyed this episode, please take a moment to rate, review, and subscribe wherever you get your podcasts. Thank you so much. Disclosures: Dr. Neeraj Agarwal: Consulting or Advisory Role: Pfizer, Medivation/Astellas, Bristol-Myers Squibb, AstraZeneca, Nektar, Lilly, Bayer, Pharmacyclics, Foundation Medicine, Astellas Pharma, Exelixis, Pfizer, Merck , Novartis, Eisai, Seattle Genetics, EMD Serono, Janssen Oncology, AVEO, Calithera Biosciences, MEI Pharma, Genentech, Foundation Medicine, Gilead Sciences Research Funding (inst.): Bayer, Bristol-Myers Squibb, Takeda, Pfizer, Exelixis, Amgen, AstraZeneca, Calithera Biosciences, Celldex, Eisai, Genentech, Immunomedics, Janssen, Merck, Lilly, Nektar, ORIC Pharmaceuticals, ORIC Pharmaceuticals, crispr therapeutics, and Arvinas Dr. Sumanta (Monty) Pal: Consulting or Advisory Role: F. Hoffmann LaRoche, F. Hoffman Research Funding (inst.): Eisai, Genentech, Roche, Exelixis, Pfizer Travel, Accommodations, Expenses: Genentech, Seattle Genetics Dr. Toni Choueiri: Employment: Dana Farber Cancer Hospital Leadership: Dana Farber Cancer Hospital, NCCN, KidneyCan, ASCO, ESMO Stock and Other Ownership Interests: Pionyr, TEMPEST Honoraria: NCCN, UpToDate, Michael J. Hennessy Associates, ASCO, Harborside Press, Analysis Group, AstraZeneca, Alexion Pharmaceuticals, Sanofi/Aventis, Bayer, Bristol-Myers Squibb, Genentech/Roche, GlaxoSmithKline, Merck , Novartis, Peloton Therapeutics , Pfizer, Corvus Pharmaceuticals, Ipsen, Foundation Medicine, Eisai, PlatformQ Health, Clinical Care Options, Navinata Healthcare, Kidney Cancer Journal, Exelixis, Prometheus, Lpath, NEJM, Lancet Oncology, Cerulean Pharma, alligent, EMD Serono, HERON, Lilly, Janssen Oncology, IQvia, Aveo, and NCI. Consulting or Advisory Role: Pfizer, Bayer, Novartis, GlaxoSmithKline, Merck, Bristol-Myers Squibb, Roche/Genentech, Eisai, Foundation Medicine, Cerulean Pharma, AstraZeneca, Exelixis, Prometheus Laboratories, alligent, Ipsen, Corvus Pharmaceuticals, Lpath, Alexion Pharmaceuticals, Sanofi/Aventis, Peloton Therapeutics, UpToDate, NCCN, Michael J. Hennessy Associates, Analysis Group, Kidney Cancer Journal, Clinical Care Options, Paltform Q, Navinata Healthcare, Harborside Press, ASCO, NEJM, Lancet Oncology, EMD Serono, HERON, Lilly, ESMO, NiKang Therapeutics, Kanaph Therapeutics, Infinity Pharmaceuticals, and Aravive Research Funding (inst.): Pfizer, Novartis, Merck, Exelixis , TRACON Pharma, GlaxoSmithKline, Bristol-Myers Squibb, AstraZeneca, Peloton Therapeutics, Roche/Genentech, Celldex, Agensys, Eisai, Takeda, Prometheus, Ipsen, Corvus Pharmaceuticals, Cerulean Pharma, Seattle Genetics/Astellas, Bayer, Foundation Medicine, Roche, Calithera Biosciences, Analysis Group, NCI, GATEWAY for Cancer Research, and Congressionally Directed Medical Research Programs (DOD) Patents, Royalties, Other Intellectual Property (inst.): International Patent Application No. PCT/US2018/058430, entitled “Biomarkers of Clinical Response and Benefit to Immune Checkpoint Inhibitor Therapy, International Patent Application No. PCT/US2018/12209, entitled “PBRM1 Biomarkers Predictive of Anti-Immune Checkpoint Response Patents, Royalties, Other Intellectual Property: ctDNA technologies Travel, Accommodations, Expenses: Pfizer, Bayer, Novartis, GlaxoSmithKline, Merck, Bristol-Myers Squibb, Roche/Genentech, Eisai, Foundation Medicine, Cerulean Pharma, AstraZeneca, Exelixis, Prometheus, alligent, Ipsen, Corvus Pharmaceuticals, Lpath, Alexion Pharmaceuticals, Sanofi/Aventis, UpToDate, Peloton Therapeutics, NCCN, Michael J. Hennessy Associates, Analysis Group, Kidney Cancer Journal, Clinical Care Options, PlatformQ Health, Harborside Press, Navinata Healthcare, NEJM, Lancet Oncology, EMD Serono, HERON, Lilly, and ESMO Other Relationship: Medical writing and editorial assistance support may have been funded by Communications companies funded by pharmaceutical companies such as ClinicalThinking, Health Interactions, Envision Pharma Group, Fishawack Group of Companies, Parexel Disclaimer: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement.
Guest host Dr. Neeraj Agarwal, editor-in-chief of ASCO Daily News and director of the Genitourinary Cancers Program at the University of Utah Huntsman Cancer Institute, interviews Dr. Oliver Sartor, medical director of the Tulane Cancer Center in New Orleans, on the practice-changing VISION trial and its impact on the current treatment paradigm for mCRPC. Transcript ASCO Daily News: Welcome to the ASCO Daily News Podcast. Our topic today is the practice-changing VISION trial, a phase III trial of radioligand therapy in patients with metastatic castration-resistant prostate cancer. Our guest host, Dr. Neeraj Agarwal, the editor-in-chief of the ASCO Daily News and director of the Genitourinary Cancers Program at the University of Utah's Huntsman Cancer Institute, will speak with one of the trial's investigators, Dr. Oliver Sartor, the medical director of the Tulane Cancer Center and Laborde Professor for Cancer Research. Their full disclosures are available on the transcript of this episode, and disclosures relating to all episodes of the Daily News Podcast are available on our transcripts at asco.org/podcasts. Dr. Neeraj Agarwal: Hi, my name is Dr. Neeraj Agarwal. I am with Dr. Oliver Sartor. Today, we are going to discuss one of the practice-changing trials in the context of metastatic castration-resistant prostate cancer. Welcome to the ASCO Daily News Podcast, Dr. Sartor. Thanks for taking the time to be with us today. Dr. Oliver Sartor: Thank you, Neeraj. A pleasure to be here. Dr. Neeraj Agarwal: You recently published the primary results of the phase III VISION trial, which tested the efficacy of a novel radioligand therapy, Lutetium-177-PSMA-617, in men with metastatic castrate-resistant prostate cancer. Could you please tell us more about this compound and why you did this study? Dr. Oliver Sartor: So I'll start off with the compound itself. Radioligand therapy is a therapy that has a little warhead, and that warhead in this case is Lutetium-177. But it's guided by binding to PSMA. Now, PSMA is prostate-specific membrane antigen, and many of us are familiar with it, but some may not be. So PSMA is a protein expressed on the surface of most prostate cancer cells. Not all patients have it, but most do. And the ability of the PSMA Lutetium-177 to target the cancer was indicated in some preliminary studies, but they have not been to phase III. So the purpose of the phase III VISION trial was really to design a definitive study to look at overall survival, in particular, to determine whether or not this agent was truly active. And the good news is, it is truly active. And in the VISION trial, we were able to not only extend life with an overall survival benefit, haz ratio 0.62, but there was also a time-to-progression image-based radiographic progression-free survival. It was also much in favor of the PSMA Lutetium with a haz ratio of 0.4. So whether or not you look at time to cancer progression or whether or not you look at overall survival, this is an effective therapy. It, of course, does have some adverse side effects. We can talk more about that, but it's reasonably well tolerated. And I do anticipate that there'll be an FDA approval as a consequence of these pivotal findings. Dr. Neeraj Agarwal: These are wonderful results and news for our patients. Please tell me how it will affect the current treatment paradigm of our patients with mCRPC. As we know, you selected patients who had disease progression on chemotherapy with taxanes and novel hormonal therapy. But real-world studies, many of which were published by you, have shown that docetaxel is received by a minority of patients with metastatic prostate cancer. So how do you envision treating your patients who do not want to be treated with chemotherapy as many of my patients do? How will you apply Lutetium-177 in their treatment? Dr. Oliver Sartor: Well, Neeraj, I think that we're going to be restricted in accordance with the label that the FDA provides. And I fully expect that the label will include a progression after treatment with docetaxel or at least one taxane-based therapy because that's the way the VISION trial was constructed. Now, you're raising a very critical point, and that is, what about the individuals that do not want to receive or are ineligible to receive a chemotherapy such as docetaxel? And for those individuals, we now have a new trial called PSMA4, and that trial is going to be testing the Lutetium-177-PSMA-617 in the context of chemotherapy-naive patients. So I think we're going to have to wait until we have more results, more clinical trials completed, prior to the application of PSMA-617 into the more general population of chemotherapy-naive patients. But those clinical trials are now underway. Dr. Neeraj Agarwal: That's great. So, Oliver, in the VISION trial, you did mandate a diagnostic PSMA PET scan, and patients who were positive on the diagnostic PSMA PET scan were deemed to be eligible for enrollment on the VISION trial. Do you expect FDA to include diagnostic PSMA scan for eligibility for treatment with the Lutetium-177 in the real-world setting? If it doesn't or if it does, how it is going to affect the treatment of our patients, that availability of treatment for our patients? Dr. Oliver Sartor: That's really a great question. And I do expect that PSMA PET imaging will be a criteria given that it was used for patient selection. Now, as it turned out, about 87% of the patients actually did qualify after getting a PSMA PET scan. And given that that was part of the inclusion criteria, I anticipate that the FDA will also incorporate such imaging. Now, it does get to be a bit of an issue because it turns out that PSMA PET is just now coming into more widespread use. We did have, in May of this year, the approval by the FDA for the PSMA PET imaging agent and-- I shouldn't say "the"-- a PSMA PET imaging agent. Prior to that, in December of last year, there was both UCLA and UCSF approval by the FDA for yet another PSMA PET imaging agent. As we move forward, I anticipate that PET imaging is going to be more widely available. And of course, we don't have the approval as of yet today for the PSMA-617-Lutetium-177. And when we do get the anticipated approval, which likely will be in 2022, then I also anticipate that PSMA PET will be more widely available. Now, there are still issues with reimbursement for PSMA PET, and we've encountered those in our own practice. But that's a rapidly changing area, and we're working with the insurance companies in an effort to ensure that patients will get the imaging that they need. Dr. Neeraj Agarwal: Got it. And obviously, I asked this question because many of my community friends and colleagues have asked me this question. Before we talk about the side effects of Lutetium-177, would you have any message for our friends and colleagues in the community who are bracing themselves for treating their patients with the Lutetium-177, whether they should be proactive in establishing contacts and relationships with the nuclear medicine facilities and so on? Dr. Oliver Sartor: That's a great question, Neeraj, because I think you're raising a very important point. This is going to be the type of therapy that involves multidisciplinary care. We can see that there'll be diagnostic PET imaging as being a component of the study. There'll be the necessity of licensed physicians, typically either nuclear medicine or radiation oncology, to actually administer the drug. And then, quite frankly, the medical oncologists or those urologists who are trained in advanced prostate cancer are going to need to manage the patient. This is a lot more than just getting an injection. Many of these patients are ill. They need to have symptom management. They need to manage their bone health. They need to manage their hormonal manipulations. They need management with regard to pain. So this is not just about giving an injection. And I encourage those people who are interested to involve multidisciplinary teams starting now. And I realize that the therapy is not available now, but you have to anticipate that it will be. And I think it will be a game changer of a therapy, and many patients are going to want it. So that means it's incumbent upon the physicians to be prepared, and that means multidisciplinary care. Dr. Neearj Agarwal: Excellent point. So basically, we should be ready. We should start establishing relationships with nuclear medicine facilities or radiation oncologists who are going to deliver Lutetium-177. Overall, when I was reading the New England Journal paper, the side effect profile seemed very reasonable. I did not see any red flags. To me, it sounded like a pretty well-tolerated drug. So what is your take on the side effects of Lutetium-177? Dr. Oliver Sartor: I think the side effects are quite manageable. One of the unique side effects is that of dry mouth and that's because the PSMA can actually be expressed in the salivary glands and that there is some potential for salivary gland binding in the PSMA-617-Lutetium. And that means that you can have damage to the salivary glands, and that means dry mouth. It turns out that a little over 40% of the patients actually did complain of a dry mouth, and that needs to be managed typically with fluid intake or various ways of mouth moisturizers. Fatigue is a potential issue. It was raised, as well as some bone marrow suppression. And if you look at the grade 3/4 toxicities, anemia was present a little more than 10% of the time. And that, of course, needs to be monitored. There is some potential collateral damage to the bone marrow. So these patients need to have their counts monitored. They need to have their symptoms assessed. And they need to be managed as they go through the process. It's not just about giving an injection, but clearly, the licensed individuals, including nuclear medicine and radiation oncology, need to be engaged, because without them, there is no injection. So this is a complex multidisciplinary care paradigm. And emphasizing the point, symptom management, yes; adverse event management, yes. But you have to deliver the drug, and that means multidisciplinary care. Dr. Neeraj Agarwal: Those are fantastic points. Thank you very much, Dr. Sartor, for taking time to be with us. And I'm really hoping that this podcast will be very enriching to our listeners. Thank you very much. Dr. Oliver Sartor: Thank you, Neeraj. Glad to be here. ASCO Daily News: You've been listening to Dr. Neeraj Agarwal of the Huntsman Cancer Institute and Dr. Oliver Sartor of the Tulane Cancer Center. Our listeners will find a link to the VISION study in the transcript of this episode. Thank you to our listeners for joining us today. If you enjoyed this episode, please take a moment to rate, review, and subscribe wherever you get your podcasts. Disclosures: Dr. Neeraj Agarwal Consulting or Advisory Role: Pfizer, Medivation/Astellas, Bristol-Myers Squibb, AstraZeneca, Nektar, Lilly, Bayer, Pharmacyclics, Foundation Medicine, Astellas Pharma, Exelixis, Merck, Novartis, Eisai, Seattle Genetics, EMD Serono, Janssen Oncology, AVEO, Calithera Biosciences, MEI Pharma, Genentech, Astellas Pharma, Foundation Medicine, and Gilead Sciences Research Funding (Inst.): Bayer Your Institution, Bristol-Myers Squibb, Takeda, Pfizer, Exelixis, Amgen, AstraZeneca, Calithera Biosciences, Celldex, Eisai, Genentech, Immunomedics, Janssen, Merck, Lilly, Nektar, ORIC Pharmaceuticals, crispr therapeutics, and Arvinas Disclosures: Dr. Oliver Sartor Stocks & Other Ownership Interests: Lilly, GlaxoSmithKline, Abbvie, Cardinal Health, United Health Group, PSMA Therapeutics, Clarity Pharmaceuticals, Noria Therapeutics, Inc., Clovis Consulting or Advisory Role: Bayer, Sanofi, AstraZeneca, Dendreon, Constellation Pharmaceuticals, Advanced Accelerator Applications, Pfizer, Bristol-Myers Squibb, Bavarian Nordic, EMD Serono, Astellas Pharma, Progenics, Blue Earth Diagnostics, Myovant, Myriad Genetics, Novartis, Clarify Pharmaceuticals, Fusion, Istopen Technologien Meunchen, Janssen, Noxopharm, Clovis, Noria Therapeutics, Point Biopharma, TeneoBio, Telix, Theragnostics Research Funding (Inst): Sotio, Janssen, Progenics, Bayer, Sanofi, Endocyte, Merck, Invitae, Constellation Pharmaceuticals, Advanced Accelerator Applications, Dendreon, AstraZeneca Expert Testimony: Sanofi Travel, Accommodations, Expenses: Bayer, Johnson & Johnson, Sanofi, AstraZeneca, Progenics Disclaimer: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement. Dr. Oliver Sartor on the VISION Trial and Improving Care for Patients With mCRPC ASCO Daily News: Welcome to the ASCO Daily News Podcast. Our topic today is the practice-changing VISION trial, a phase III trial of radioligand therapy in patients with metastatic castration-resistant prostate cancer. Our guest host, Dr. Neeraj Agarwal, the editor-in-chief of the ASCO Daily News and director of the Genitourinary Cancers Program at the University of Utah's Huntsman Cancer Institute, will speak with one of the trial's investigators, Dr. Oliver Sartor, the medical director of the Tulane Cancer Center and Laborde Professor for Cancer Research. Their full disclosures are available on the transcript of this episode, and disclosures relating to all episodes of the Daily News Podcast are available on our transcripts at asco.org/podcasts. Dr. Neeraj Agarwal: Hi, my name is Dr. Neeraj Agarwal. I am with Dr. Oliver Sartor. Today, we are going to discuss one of the practice-changing trials in the context of metastatic castration-resistant prostate cancer. Welcome to the ASCO Daily News Podcast, Dr. Sartor. Thanks for taking the time to be with us today. Dr. Oliver Sartor: Thank you, Neeraj. A pleasure to be here. Dr. Neeraj Agarwal: You recently published the primary results of the phase III VISION trial, which tested the efficacy of a novel radioligand therapy, Lutetium-177-PSMA-617, in men with metastatic castrate-resistant prostate cancer. Could you please tell us more about this compound and why you did this study? Dr. Oliver Sartor: So I'll start off with the compound itself. Radioligand therapy is a therapy that has a little warhead, and that warhead in this case is Lutetium-177. But it's guided by binding to PSMA. Now, PSMA is prostate-specific membrane antigen, and many of us are familiar with it, but some may not be. So PSMA is a protein expressed on the surface of most prostate cancer cells. Not all patients have it, but most do. And the ability of the PSMA Lutetium-177 to target the cancer was indicated in some preliminary studies, but they have not been to phase III. So the purpose of the phase III VISION trial was really to design a definitive study to look at overall survival, in particular, to determine whether or not this agent was truly active. And the good news is, it is truly active. And in the VISION trial, we were able to not only extend life with an overall survival benefit, haz ratio 0.62, but there was also a time-to-progression image-based radiographic progression-free survival. It was also much in favor of the PSMA Lutetium with a haz ratio of 0.4. So whether or not you look at time to cancer progression or whether or not you look at overall survival, this is an effective therapy. It, of course, does have some adverse side effects. We can talk more about that, but it's reasonably well tolerated. And I do anticipate that there'll be an FDA approval as a consequence of these pivotal findings. Dr. Neeraj Agarwal: These are wonderful results and news for our patients. Please tell me how it will affect the current treatment paradigm of our patients with mCRPC. As we know, you selected patients who had disease progression on chemotherapy with taxanes and novel hormonal therapy. But real-world studies, many of which were published by you, have shown that docetaxel is received by a minority of patients with metastatic prostate cancer. So how do you envision treating your patients who do not want to be treated with chemotherapy as many of my patients do? How will you apply Lutetium-177 in their treatment? Dr. Oliver Sartor: Well, Neeraj, I think that we're going to be restricted in accordance with the label that the FDA provides. And I fully expect that the label will include a progression after treatment with docetaxel or at least one taxane-based therapy because that's the way the VISION trial was constructed. Now, you're raising a very critical point, and that is, what about the individuals that do not want to receive or are ineligible to receive a chemotherapy such as docetaxel? And for those individuals, we now have a new trial called PSMA4, and that trial is going to be testing the Lutetium-177-PSMA-617 in the context of chemotherapy-naive patients. So I think we're going to have to wait until we have more results, more clinical trials completed, prior to the application of PSMA-617 into the more general population of chemotherapy-naive patients. But those clinical trials are now underway. Dr. Neeraj Agarwal: That's great. So, Oliver, in the VISION trial, you did mandate a diagnostic PSMA PET scan, and patients who were positive on the diagnostic PSMA PET scan were deemed to be eligible for enrollment on the VISION trial. Do you expect FDA to include diagnostic PSMA scan for eligibility for treatment with the Lutetium-177 in the real-world setting? If it doesn't or if it does, how it is going to affect the treatment of our patients, that availability of treatment for our patients? Dr. Oliver Sartor: That's really a great question. And I do expect that PSMA PET imaging will be a criteria given that it was used for patient selection. Now, as it turned out, about 87% of the patients actually did qualify after getting a PSMA PET scan. And given that that was part of the inclusion criteria, I anticipate that the FDA will also incorporate such imaging. Now, it does get to be a bit of an issue because it turns out that PSMA PET is just now coming into more widespread use. We did have, in May of this year, the approval by the FDA for the PSMA PET imaging agent and-- I shouldn't say "the"-- a PSMA PET imaging agent. Prior to that, in December of last year, there was both UCLA and UCSF approval by the FDA for yet another PSMA PET imaging agent. As we move forward, I anticipate that PET imaging is going to be more widely available. And of course, we don't have the approval as of yet today for the PSMA-617-Lutetium-177. And when we do get the anticipated approval, which likely will be in 2022, then I also anticipate that PSMA PET will be more widely available. Now, there are still issues with reimbursement for PSMA PET, and we've encountered those in our own practice. But that's a rapidly changing area, and we're working with the insurance companies in an effort to ensure that patients will get the imaging that they need. Dr. Neeraj Agarwal: Got it. And obviously, I asked this question because many of my community friends and colleagues have asked me this question. Before we talk about the side effects of Lutetium-177, would you have any message for our friends and colleagues in the community who are bracing themselves for treating their patients with the Lutetium-177, whether they should be proactive in establishing contacts and relationships with the nuclear medicine facilities and so on? Dr. Oliver Sartor: That's a great question, Neeraj, because I think you're raising a very important point. This is going to be the type of therapy that involves multidisciplinary care. We can see that there'll be diagnostic PET imaging as being a component of the study. There'll be the necessity of licensed physicians, typically either nuclear medicine or radiation oncology, to actually administer the drug. And then, quite frankly, the medical oncologists or those urologists who are trained in advanced prostate cancer are going to need to manage the patient. This is a lot more than just getting an injection. Many of these patients are ill. They need to have symptom management. They need to manage their bone health. They need to manage their hormonal manipulations. They need management with regard to pain. So this is not just about giving an injection. And I encourage those people who are interested to involve multidisciplinary teams starting now. And I realize that the therapy is not available now, but you have to anticipate that it will be. And I think it will be a game changer of a therapy, and many patients are going to want it. So that means it's incumbent upon the physicians to be prepared, and that means multidisciplinary care. Dr. Neearj Agarwal: Excellent point. So basically, we should be ready. We should start establishing relationships with nuclear medicine facilities or radiation oncologists who are going to deliver Lutetium-177. Overall, when I was reading the New England Journal paper, the side effect profile seemed very reasonable. I did not see any red flags. To me, it sounded like a pretty well-tolerated drug. So what is your take on the side effects of Lutetium-177? Dr. Oliver Sartor: I think the side effects are quite manageable. One of the unique side effects is that of dry mouth and that's because the PSMA can actually be expressed in the salivary glands and that there is some potential for salivary gland binding in the PSMA-617-Lutetium. And that means that you can have damage to the salivary glands, and that means dry mouth. It turns out that a little over 40% of the patients actually did complain of a dry mouth, and that needs to be managed typically with fluid intake or various ways of mouth moisturizers. Fatigue is a potential issue. It was raised, as well as some bone marrow suppression. And if you look at the grade 3/4 toxicities, anemia was present a little more than 10% of the time. And that, of course, needs to be monitored. There is some potential collateral damage to the bone marrow. So these patients need to have their counts monitored. They need to have their symptoms assessed. And they need to be managed as they go through the process. It's not just about giving an injection, but clearly, the licensed individuals, including nuclear medicine and radiation oncology, need to be engaged, because without them, there is no injection. So this is a complex multidisciplinary care paradigm. And emphasizing the point, symptom management, yes; adverse event management, yes. But you have to deliver the drug, and that means multidisciplinary care. Dr. Neeraj Agarwal: Those are fantastic points. Thank you very much, Dr. Sartor, for taking time to be with us. And I'm really hoping that this podcast will be very enriching to our listeners. Thank you very much. Dr. Oliver Sartor: Thank you, Neeraj. Glad to be here. ASCO Daily News: You've been listening to Dr. Neeraj Agarwal of the Huntsman Cancer Institute and Dr. Oliver Sartor of the Tulane Cancer Center. Our listeners will find a link to the VISION study in the transcript of this episode. Thank you to our listeners for joining us today. If you enjoyed this episode, please take a moment to rate, review, and subscribe wherever you get your podcasts. Disclosures: Dr. Neeraj Agarwal Consulting or Advisory Role: Pfizer, Medivation/Astellas, Bristol-Myers Squibb, AstraZeneca, Nektar, Lilly, Bayer, Pharmacyclics, Foundation Medicine, Astellas Pharma, Exelixis, Merck, Novartis, Eisai, Seattle Genetics, EMD Serono, Janssen Oncology, AVEO, Calithera Biosciences, MEI Pharma, Genentech, Astellas Pharma, Foundation Medicine, and Gilead Sciences Research Funding (Inst.): Bayer Your Institution, Bristol-Myers Squibb, Takeda, Pfizer, Exelixis, Amgen, AstraZeneca, Calithera Biosciences, Celldex, Eisai, Genentech, Immunomedics, Janssen, Merck, Lilly, Nektar, ORIC Pharmaceuticals, crispr therapeutics, and Arvinas Disclosures: Dr. Oliver Sartor Stocks & Other Ownership Interests: Lilly, GlaxoSmithKline, Abbvie, Cardinal Health, United Health Group, PSMA Therapeutics, Clarity Pharmaceuticals, Noria Therapeutics, Inc., Clovis Consulting or Advisory Role: Bayer, Sanofi, AstraZeneca, Dendreon, Constellation Pharmaceuticals, Advanced Accelerator Applications, Pfizer, Bristol-Myers Squibb, Bavarian Nordic, EMD Serono, Astellas Pharma, Progenics, Blue Earth Diagnostics, Myovant, Myriad Genetics, Novartis, Clarify Pharmaceuticals, Fusion, Istopen Technologien Meunchen, Janssen, Noxopharm, Clovis, Noria Therapeutics, Point Biopharma, TeneoBio, Telix, Theragnostics Research Funding (Inst): Sotio, Janssen, Progenics, Bayer, Sanofi, Endocyte, Merck, Invitae, Constellation Pharmaceuticals, Advanced Accelerator Applications, Dendreon, AstraZeneca Expert Testimony: Sanofi Travel, Accommodations, Expenses: Bayer, Johnson & Johnson, Sanofi, AstraZeneca, Progenics Disclaimer: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement. Dr. Oliver Sartor on the VISION Trial and Improving Care for Patients With mCRPC ASCO Daily News: Welcome to the ASCO Daily News Podcast. Our topic today is the practice-changing VISION trial, a phase III trial of radioligand therapy in patients with metastatic castration-resistant prostate cancer. Our guest host, Dr. Neeraj Agarwal, the editor-in-chief of the ASCO Daily News and director of the Genitourinary Cancers Program at the University of Utah's Huntsman Cancer Institute, will speak with one of the trial's investigators, Dr. Oliver Sartor, the medical director of the Tulane Cancer Center and Laborde Professor for Cancer Research. Their full disclosures are available on the transcript of this episode, and disclosures relating to all episodes of the Daily News Podcast are available on our transcripts at asco.org/podcasts. Dr. Neeraj Agarwal: Hi, my name is Dr. Neeraj Agarwal. I am with Dr. Oliver Sartor. Today, we are going to discuss one of the practice-changing trials in the context of metastatic castration-resistant prostate cancer. Welcome to the ASCO Daily News Podcast, Dr. Sartor. Thanks for taking the time to be with us today. Dr. Oliver Sartor: Thank you, Neeraj. A pleasure to be here. Dr. Neeraj Agarwal: You recently published the primary results of the phase III VISION trial, which tested the efficacy of a novel radioligand therapy, Lutetium-177-PSMA-617, in men with metastatic castrate-resistant prostate cancer. Could you please tell us more about this compound and why you did this study? Dr. Oliver Sartor: So I'll start off with the compound itself. Radioligand therapy is a therapy that has a little warhead, and that warhead in this case is Lutetium-177. But it's guided by binding to PSMA. Now, PSMA is prostate-specific membrane antigen, and many of us are familiar with it, but some may not be. So PSMA is a protein expressed on the surface of most prostate cancer cells. Not all patients have it, but most do. And the ability of the PSMA Lutetium-177 to target the cancer was indicated in some preliminary studies, but they have not been to phase III. So the purpose of the phase III VISION trial was really to design a definitive study to look at overall survival, in particular, to determine whether or not this agent was truly active. And the good news is, it is truly active. And in the VISION trial, we were able to not only extend life with an overall survival benefit, haz ratio 0.62, but there was also a time-to-progression image-based radiographic progression-free survival. It was also much in favor of the PSMA Lutetium with a haz ratio of 0.4. So whether or not you look at time to cancer progression or whether or not you look at overall survival, this is an effective therapy. It, of course, does have some adverse side effects. We can talk more about that, but it's reasonably well tolerated. And I do anticipate that there'll be an FDA approval as a consequence of these pivotal findings. Dr. Neeraj Agarwal: These are wonderful results and news for our patients. Please tell me how it will affect the current treatment paradigm of our patients with mCRPC. As we know, you selected patients who had disease progression on chemotherapy with taxanes and novel hormonal therapy. But real-world studies, many of which were published by you, have shown that docetaxel is received by a minority of patients with metastatic prostate cancer. So how do you envision treating your patients who do not want to be treated with chemotherapy as many of my patients do? How will you apply Lutetium-177 in their treatment? Dr. Oliver Sartor: Well, Neeraj, I think that we're going to be restricted in accordance with the label that the FDA provides. And I fully expect that the label will include a progression after treatment with docetaxel or at least one taxane-based therapy because that's the way the VISION trial was constructed. Now, you're raising a very critical point, and that is, what about the individuals that do not want to receive or are ineligible to receive a chemotherapy such as docetaxel? And for those individuals, we now have a new trial called PSMA4, and that trial is going to be testing the Lutetium-177-PSMA-617 in the context of chemotherapy-naive patients. So I think we're going to have to wait until we have more results, more clinical trials completed, prior to the application of PSMA-617 into the more general population of chemotherapy-naive patients. But those clinical trials are now underway. Dr. Neeraj Agarwal: That's great. So, Oliver, in the VISION trial, you did mandate a diagnostic PSMA PET scan, and patients who were positive on the diagnostic PSMA PET scan were deemed to be eligible for enrollment on the VISION trial. Do you expect FDA to include diagnostic PSMA scan for eligibility for treatment with the Lutetium-177 in the real-world setting? If it doesn't or if it does, how it is going to affect the treatment of our patients, that availability of treatment for our patients? Dr. Oliver Sartor: That's really a great question. And I do expect that PSMA PET imaging will be a criteria given that it was used for patient selection. Now, as it turned out, about 87% of the patients actually did qualify after getting a PSMA PET scan. And given that that was part of the inclusion criteria, I anticipate that the FDA will also incorporate such imaging. Now, it does get to be a bit of an issue because it turns out that PSMA PET is just now coming into more widespread use. We did have, in May of this year, the approval by the FDA for the PSMA PET imaging agent and-- I shouldn't say "the"-- a PSMA PET imaging agent. Prior to that, in December of last year, there was both UCLA and UCSF approval by the FDA for yet another PSMA PET imaging agent. As we move forward, I anticipate that PET imaging is going to be more widely available. And of course, we don't have the approval as of yet today for the PSMA-617-Lutetium-177. And when we do get the anticipated approval, which likely will be in 2022, then I also anticipate that PSMA PET will be more widely available. Now, there are still issues with reimbursement for PSMA PET, and we've encountered those in our own practice. But that's a rapidly changing area, and we're working with the insurance companies in an effort to ensure that patients will get the imaging that they need. Dr. Neeraj Agarwal: Got it. And obviously, I asked this question because many of my community friends and colleagues have asked me this question. Before we talk about the side effects of Lutetium-177, would you have any message for our friends and colleagues in the community who are bracing themselves for treating their patients with the Lutetium-177, whether they should be proactive in establishing contacts and relationships with the nuclear medicine facilities and so on? Dr. Oliver Sartor: That's a great question, Neeraj, because I think you're raising a very important point. This is going to be the type of therapy that involves multidisciplinary care. We can see that there'll be diagnostic PET imaging as being a component of the study. There'll be the necessity of licensed physicians, typically either nuclear medicine or radiation oncology, to actually administer the drug. And then, quite frankly, the medical oncologists or those urologists who are trained in advanced prostate cancer are going to need to manage the patient. This is a lot more than just getting an injection. Many of these patients are ill. They need to have symptom management. They need to manage their bone health. They need to manage their hormonal manipulations. They need management with regard to pain. So this is not just about giving an injection. And I encourage those people who are interested to involve multidisciplinary teams starting now. And I realize that the therapy is not available now, but you have to anticipate that it will be. And I think it will be a game changer of a therapy, and many patients are going to want it. So that means it's incumbent upon the physicians to be prepared, and that means multidisciplinary care. Dr. Neearj Agarwal: Excellent point. So basically, we should be ready. We should start establishing relationships with nuclear medicine facilities or radiation oncologists who are going to deliver Lutetium-177. Overall, when I was reading the New England Journal paper, the side effect profile seemed very reasonable. I did not see any red flags. To me, it sounded like a pretty well-tolerated drug. So what is your take on the side effects of Lutetium-177? Dr. Oliver Sartor: I think the side effects are quite manageable. One of the unique side effects is that of dry mouth and that's because the PSMA can actually be expressed in the salivary glands and that there is some potential for salivary gland binding in the PSMA-617-Lutetium. And that means that you can have damage to the salivary glands, and that means dry mouth. It turns out that a little over 40% of the patients actually did complain of a dry mouth, and that needs to be managed typically with fluid intake or various ways of mouth moisturizers. Fatigue is a potential issue. It was raised, as well as some bone marrow suppression. And if you look at the grade 3/4 toxicities, anemia was present a little more than 10% of the time. And that, of course, needs to be monitored. There is some potential collateral damage to the bone marrow. So these patients need to have their counts monitored. They need to have their symptoms assessed. And they need to be managed as they go through the process. It's not just about giving an injection, but clearly, the licensed individuals, including nuclear medicine and radiation oncology, need to be engaged, because without them, there is no injection. So this is a complex multidisciplinary care paradigm. And emphasizing the point, symptom management, yes; adverse event management, yes. But you have to deliver the drug, and that means multidisciplinary care. Dr. Neeraj Agarwal: Those are fantastic points. Thank you very much, Dr. Sartor, for taking time to be with us. And I'm really hoping that this podcast will be very enriching to our listeners. Thank you very much. Dr. Oliver Sartor: Thank you, Neeraj. Glad to be here. ASCO Daily News: You've been listening to Dr. Neeraj Agarwal of the Huntsman Cancer Institute and Dr. Oliver Sartor of the Tulane Cancer Center. Our listeners will find a link to the VISION study in the transcript of this episode. Thank you to our listeners for joining us today. If you enjoyed this episode, please take a moment to rate, review, and subscribe wherever you get your podcasts. Disclosures: Dr. Neeraj Agarwal Consulting or Advisory Role: Pfizer, Medivation/Astellas, Bristol-Myers Squibb, AstraZeneca, Nektar, Lilly, Bayer, Pharmacyclics, Foundation Medicine, Astellas Pharma, Exelixis, Merck, Novartis, Eisai, Seattle Genetics, EMD Serono, Janssen Oncology, AVEO, Calithera Biosciences, MEI Pharma, Genentech, Astellas Pharma, Foundation Medicine, and Gilead Sciences Research Funding (Inst.): Bayer Your Institution, Bristol-Myers Squibb, Takeda, Pfizer, Exelixis, Amgen, AstraZeneca, Calithera Biosciences, Celldex, Eisai, Genentech, Immunomedics, Janssen, Merck, Lilly, Nektar, ORIC Pharmaceuticals, crispr therapeutics, and Arvinas Disclosures: Dr. Oliver Sartor Stocks & Other Ownership Interests: Lilly, GlaxoSmithKline, Abbvie, Cardinal Health, United Health Group, PSMA Therapeutics, Clarity Pharmaceuticals, Noria Therapeutics, Inc., Clovis Consulting or Advisory Role: Bayer, Sanofi, AstraZeneca, Dendreon, Constellation Pharmaceuticals, Advanced Accelerator Applications, Pfizer, Bristol-Myers Squibb, Bavarian Nordic, EMD Serono, Astellas Pharma, Progenics, Blue Earth Diagnostics, Myovant, Myriad Genetics, Novartis, Clarify Pharmaceuticals, Fusion, Istopen Technologien Meunchen, Janssen, Noxopharm, Clovis, Noria Therapeutics, Point Biopharma, TeneoBio, Telix, Theragnostics Research Funding (Inst): Sotio, Janssen, Progenics, Bayer, Sanofi, Endocyte, Merck, Invitae, Constellation Pharmaceuticals, Advanced Accelerator Applications, Dendreon, AstraZeneca Expert Testimony: Sanofi Travel, Accommodations, Expenses: Bayer, Johnson & Johnson, Sanofi, AstraZeneca, Progenics Disclaimer: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement.
Arvinas' PROTAC technology has led to two exciting molecules that are in the clinic for the treatment of breast cancer and prostate cancer. The company has spent years optimizing their protein degraders to achieve specific and effective protein degradation. ARV-471 targets the Estrogen Receptor for degradation and is in clinical trials for patients with HR+/HER2- breast cancer. The early efficacy and safety data bode very well for the company and an upcoming update will be provided in December 2021. The company's Androgen Receptor targeting asset (ARV-110) has also shown exciting early data and they plan to nominate a number of additional assets for IND submission. In this video, I discuss the excitement around Arvinas and their technology with the CEO of the company, John Houston. Help out the show (or join the discord) by becoming a patron at: https://www.patreon.com/breakingbiotech Follow me on twitter @matthewlepoire Send me an email matthewlepoire@gmail.com www.breakingbiotech.com #breakingbiotech Disclaimer: All opinions expressed by Matt (or his guests) in this podcast are solely his (their) opinions. You should not treat any opinion expressed by Matt in this podcast as a specific inducement to make a particular investment or follow a particular strategy, but only as an expression of his opinion. Matt's opinions are based upon information he considers reliable, but Matt cannot warrant its completeness or accuracy, and it should not be relied upon as such. Matt is not under any obligation to update or correct any information provided in this podcast. Past performance is not indicative of future results. Matt does not guarantee any specific outcome or profit. You should be aware of the real risk of loss in following any strategy or investment discussed in this podcast. #biotech
Most likely everyone reading this has been affected by cancer or knows someone who has had cancer. Using natural cell degradation, today's guest and the team at Arvinas are treating previously undruggable diseases like cancer and Parkinson's. Their goal is to cure cancer or at a minimum, reduce it to a disease where you take your medication and continue living a full life without the terrible side effects of today's treatments. Dr. Ian Taylor, Chief Science Officer at Arvinas, explains how his team is accomplishing this with PROTAC. Arvinas is a clinical-stage biopharmaceutical company focused on developing new therapeutics for cancers and other difficult-to-treat diseases. If you are hoping for another treatment for cancer besides historical approaches (like chemotherapy), you need to listen to what Dr. Taylor has to say. It's innovating and extremely exciting. More about Dr. Ian Taylor:Dr. Taylor came to the company after nearly 10 years at Pfizer Oncology, most recently as an Early Development Team Leader. In this role, Dr. Taylor was responsible for leading a cross-functional drug development team that conducted Phase 1 and Phase 2 clinical trials for multiple assets in several cancer indications. His initial role at Pfizer Oncology was as Senior Director of Translational Oncology. In this role, he was responsible for directing translational science activities, which included designing and executing translational research plans and leading companion diagnostic partnerships for programs in both preclinical and clinical (Phase 1 -3) stages. Prior to Pfizer, Dr. Taylor worked at Bayer Healthcare, Pharmaceuticals, holding positions of increasing responsibility, including Vice President of Cancer Biology. In this position, he led the department responsible for all biology aspects of small molecule drug discovery of cancer therapeutics in the mechanistic areas of signal transduction, cell cycle regulation, angiogenesis and apoptosis. During his tenure, the Cancer Biology group delivered numerous molecules to the Development organization. He also started and led the Biomarker group, which contributed to the development of sorafenib. Dr. Taylor earned his B.A. from Bowdoin College and his Ph.D. in Molecular Biology and Genetics from Harvard University. He also completed his postdoctoral training in the laboratory of Dr. Harold Varmus at the University of California, San Francisco and the National Institutes of Health (NIH).Show noteshttps://www.arvinas.comArvinas treatment pipeline: https://www.arvinas.com/pipeline-programs/pipelineBe a guest on the show: https://docs.google.com/forms/d/e/1FAIpQLSeEU7Owi8VDv30hzmWbj4JsXPKyfsWvKXHMeghEAyirAbR18A/viewformMusic by keldez
Originally Published as The Niche PodcastSequencing technology, decentralized Alzheimer's trials, busts in gene therapy and microbiomes, and a $2.4B oncology collaboration Find out more athttps://thenichepod.comStory Referenceshttps://tinyurl.com/Niche-060-1https://tinyurl.com/Niche-060-2https://tinyurl.com/Niche-060-3https://tinyurl.com/Niche-060-4https://tinyurl.com/Niche-060-5Music by Luke Goodsonhttps://www.soundcloud.com/lukegoodsonLife Science Today is your source for stories, insights, and trends across the life science industry. Expect weekly highlights about new technologies, pharmaceutical mergers and acquisitions, news about the moves of venture capital and private equity, and how the stock market responds to biotech IPOs. Life Science Today also explores trends around clinical research, including the evolving patterns that determine how drugs and therapies are developed and approved. It's news, with a dash of perspective, focused on the life science industry.
BizCast host Shannon King talks to Arvinas CEO John Houston about their leadership in targeted protein degradation, a new way to treat diseases and cancers. Houston also discusses why the quality of workforce talent and quality of life in Connecticut have boosted the growth of the bioscience and pharmaceutical industry in the state. For additional information about the pandemic, including guidance for protecting workplace health and safety, business continuity and planning, risk mitigation, labor and employment law compliance, and more, visit CBIA's coronavirus resource center: www.cbia.com/resource/category/coronavirus/. Have a story to tell? Email shannon.king@cbia.com.
Arvinas CFO Sean Cassidy caught the high-growth bug early in his career. Shortly into his stint with Deloitte, Cassidy transitioned from a massive global financial services company to work with middle-market clients. He felt he could make a more tangible difference for those companies by supporting them as they raised capital and made acquisitions. His passion led him to the life sciences industry where Cassidy has served as the finance chief of a number of high-growth biotech and biopharma companies. In a previous stint, Cassidy helped CuraGen subsidiary 454 Life Sciences get its back office in order for a potential IPO. During his two years guiding that effort, the business grew from 20 people to 150 employees and from zero to $70 million in revenue. “It was a very exciting time,” Cassidy asserts. “The company almost went public, but in the end it made more sense to do a strategic transaction.” The experience helped elevate him to CuraGen’s CFO office and, more recently, to Arvinas, a biopharmaceutical company focused on developing therapeutics for cancers and other difficult-to-treat diseases. Cassidy discusses how his approach to corporate finance leadership pivots on flexibility. “You can’t be too rigid in your planning,” he adds. “Science changes on a dime.”
“I really wanted to be in a place where I could see if I could build something" —John Houston, President and Chief Executive Officer of Arvinas. John is the 2018 BioCT Entrepreneur of the Year. Welcome to BioBoss.
CHI interviews Dr. Craig Crews, Professor of Molecular, Cellular and Developmental Biology, Chemistry and Pharmacology at Yale University. Dr. Crews tells the story of the birth and evolution of PROTACs, provides commentary on preclinical challenges, and provides his outlook for continued development. Discussion and Questions Include: • The ability to target components of the Ubiquitin Proteasome System with bifunctional PROTACs molecules has recently generated significant interest within the drug discovery community. Can you share with us a bit about the history and progression of this new mode of drug action? • There are several commercial entities currently working on a new generation of bifunctional molecules, including Arvinas, a biotech you’ve founded. Can you discuss some of the current challenges surrounding this approach during pre-clinical development? • You are chairing a session and giving a keynote address during the upcoming Targeting the Ubiquitin Proteasome System conference, September 26-27 in Boston. Can you share with us a bit on what you hope to convey during the session and keynote lecture? • We would like your opinion on the future of PROTACs – which appears to be very promising. We’ve talked about some of the current challenges, but can you share with us how you are working to address and overcome these challenges for continued development? For more information, please visit http://www.DiscoveryOnTarget.com/Ubiquitin-Proteasome/
Today in FirstWord: