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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

In this episode of SHE MD, Dr. Thaïs Aliabadi and Mary Alice Haney welcome melanoma specialist Dr. Omid Hamid. They explore the rising incidence of melanoma in young people, debunk common misconceptions, and discuss groundbreaking treatments. Dr. Hamid explains the different stages of melanoma and the revolutionary immunotherapy treatments that are changing patient outcomes. The hosts and guest discuss real-life cases, including those of celebrities Khloe Kardashian and Teddy Mellencamp, to illustrate the importance of awareness and regular skin checks. The conversation also touches on melanoma during pregnancy and genetic predisposition to the disease - learn why genetic testing is crucial, even without family history.Access more information about the podcast and additional expert health tips by visiting SHE MD Podcast and Ovii. Sponsors: Myriad: Knowing your family's history of cancer is the first step to understanding your own cancer risk and may qualify you for the MyRisk Hereditary Cancer Test with RiskScore hereditary cancer test. It's easy, accurate and covered by most insurers. Learn more at GetMyRisk.comCymbiotika: Go to Cymbiotikia.com/SHEMD for 20% off your order + free shipping today.Purely Elizabeth: Visit purelyelizabeth.com and use code SHEMD at checkout for 20% off. Purely Elizabeth. Taste the ObsessionEquip: To learn more about Equip treatment, visit equip.health/sobermomlife.Strivektin: Discover the Science Behind Great SkinDavid's Protein: David is giving my listeners an exclusive offer – buy four cartons and get the fifth free at davidprotein.com/shemdCure Hydration: Cure is offering 20% off your first order! Stay hydrated and feel your best by visiting curehydration.com/SHEMD and using promo code SHEMD at checkout. Dr. Omid Hamid's Key Takeaways:1. Reduce Sun Exposure: Limit time spent in direct sunlight, especially during peak hours. Use protective clothing, hats, and sunglasses to shield your skin from harmful UV rays.2. Schedule Regular Skin Checks: Schedule routine visits with a dermatologist for comprehensive skin examinations. Self-examine your skin monthly for any new or changing moles or lesions.3. Use Effective Sunscreen: Apply broad-spectrum sunscreen with at least SPF 30 daily, even on cloudy days. Reapply every two hours when outdoors, and after swimming or sweating.4. Get Genetic Testing Done: If you have a family history of melanoma or other cancers, consider genetic testing to assess your risk. Tests like the MYRIS can identify melanoma-related gene mutations.5. Avoid Tanning Beds: Steer clear of tanning beds, as they significantly increase the risk of developing melanoma and other skin cancers.6. Be Your Own Health Advocate: Stay informed about your health, ask questions, and seek second opinions if necessary. Advocate for yourself and your loved ones by being proactive about potential health concerns.In This Episode: (00:00) Intro: Melanoma Awareness Month(02:40) Dr. Omid Hamid: Melanoma specialist introduction(6:58) Surgery for melanoma explained(10:49) Immunotherapy revolutionizes melanoma treatment(14:57) Genetic testing for melanoma risk(23:25) Importance of advocating for yourself(32:22) Teddy Mellencamp's stage 4 melanoma journey(50:51) Hormonal changes and melanoma risk(57:00) Two key melanoma prevention tipsRESOURCES:Melanoma Research Alliance: https://www.curemelanoma.org/blog/omid-hamid-mdMelanoma Research Foundation https://melanoma.org/Myriad Genetics: https://myriad.com/ GUEST BIOGRAPHY:Omid Hamid, MD, is the Chief of the Translational Research and Immuno-Oncology Department at The Angeles Clinic and Research Institute and serves as the Co-Director of the Melanoma and Phase I Programs. Academic Title as Professor, Department of Medicine at Cedars-Sinai Medical Center. His areas of expertise include immunotherapy and Phase I drug development.Dr. Hamid has published extensively and has been at the forefront of the development of paradigm-shifting breakthroughs including BRAF/MEK targeted agents, AntiCTL4A, antiPD1, and PDL1 therapies. His current interests include new immunotherapeutic options for patients including bi-specific antibodies, Adoptive T-cell Therapy, and oncolytic therapies with a focus on combinatorial approaches resulting in potentially great patient benefit.See Privacy Policy at https://art19.com/privacy and California Privacy Notice at https://art19.com/privacy#do-not-sell-my-info.

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

936: Medtronic CIO Rashmi Kumar discusses her leadership in advancing digital transformation for one of the world's largest healthcare technology companies. Rashmi shares how hyperautomation, artificial intelligence, and robotic-assisted surgery are reshaping patient care and operational efficiency. She also highlights Medtronic's recent establishment of a global IT center in Hyderabad and her journey to joining the board of Myriad Genetics. In this episode of Technovation, host Peter High explores Rashmi's unconventional path from metallurgical engineering to technology leadership, the cultural changes needed to foster innovation, and the role of AI in the future of healthcare. Rashmi also delves into Medtronic's use of generative AI for internal operations and product innovation, including its transformative impact on patient care and global healthcare access.

This is Derek Miller, Speaking on Business. Kinect Capital's mission is to empower emerging and diverse entrepreneurs in creating sustainable companies that bring high-quality jobs and new economic opportunities in under-served regions of the United States. Here with more is Board Member Matt Warnock. Matt Warnock: Utah's tech scene is red hot — but starting a company is hard. Most startups fail, often because they lack experience, capital, or both. At Kinect Capital, we help founders put both experience and capital in their corner. Founded in 1983, Kinect Capital is the world's oldest and most successful nonprofit venture accelerator. Our alumni include Ancestry dot com, Myriad Genetics, and over a thousand others. We pair promising startups with a multidisciplinary team of experienced volunteers, helping them attract capital from smart investors. Over 60 percent of our alumni raise capital, and 80 percent are still in business 10 years later. Unlike many accelerators, we don't move our startups to Silicon Valley or other places — we've been bringing capital to local communities right here in Utah for over 40 years! At Kinect Capital, we help founders start right, raise capital, and change the world. We're building the future, one startup at a time. Derek Miller: Kinect Capital believes that diversity brings better connections and better returns. This thriving community of entrepreneurs, mentors, and capital sources extends beyond tech, adding value and creating unexpected connections across many industries. Find out more at kinectcapital.org. I'm Derek Miller, with the Salt Lake Chamber, Speaking on Business. Originally aired: 11/13/24

Jessica Ordonez, certified genetic counselor and Medical Science Liaison at Myriad Genetics explains genetics' role in breast cancer and how the MyRisk® with RiskScore® tests can help you better understand your 5-year and lifetime risk. You'll learn what you need to know about different kinds of genetic factors, including the impact of changes in genes like BRCA1, BRCA2, CHEK2, and others. Uncover the fallacy that you aren't at risk if you don't have “the BRCA gene.” We'll also discuss how a genetic counselor can guide you if your results show a high lifetime risk. If you have a family history of cancer or are simply curious about your genetic health, this episode offers insights into genetic testing, risk factors, and empowering yourself with knowledge.For more resources, visit our website: SheMDpodcast.comFollow us across social media: @SheMDpodcastSponsor:Knowing your family's history of cancer is the first step to understanding your own cancer risk and may qualify you for the MyRisk Hereditary Cancer Test with RiskScore hereditary cancer test. It's easy, accurate and covered by most insurers. Learn more at GetMyRisk.com, https://myriad.ws/getmyriskIN THIS EPISODE: [1:06] Jessica describes the role of a genetic counselor and a medical science liaison[2:51] Discussion of genetic markers and BRCA1 and BRCA2 genes[13:41] The difference between gene mutations and variants of uncertain significance[23:16] Explanation of the CHEK2 gene[27:11] How would a genetic counselor counsel a woman whose genetic test comes back with a high lifetime riskRESOURCES:Myriad Genetics InstagramGet MyRisk WebsiteGUEST BIOGRAPHY: Jessica Ordonez is a certified genetic counselor and Medical Science Liaison at Myriad Genetics. She holds diplomate status with the American Board of Genetic Counseling and is an active member of the National Society of Genetic Counselors and the Florida Association of Genetic Counselors.Jessica completed her undergraduate and graduate studies at the University of Michigan, earning a Bachelor's in Cell & Molecular Biology and Spanish Literature and a Master's in Genetic Counseling. With over a decade of experience as a clinical genetic counselor, she has provided care in pediatric, adult, and cancer genetics clinics within academic and private hospital settings, focusing on Spanish-speaking patients.As a Medical Science Liaison, Jessica educates clinicians across Florida on hereditary cancer and reproductive genetics. She is involved in several company projects at Myriad, specifically leading a needs assessment for patient-facing Spanish resources to enhance inclusiveness and equity in care.See Privacy Policy at https://art19.com/privacy and California Privacy Notice at https://art19.com/privacy#do-not-sell-my-info.

In this jam-packed episode, Mitch Robbins sits down with Dr. Greg Critchfield, a titan in molecular diagnostics and biotech. This is a leader who's done it all—from spearheading Myriad Genetics into global prominence to raising over $300 million for groundbreaking women's health innovations. But that's just scratching the surface!

JCO PO author Dr. Jonathan D. Tward, M.D., Ph.D., FASTRO, at the HCI Genitourinary Cancers Center and the Huntsman Cancer Institute at the University of Utah, shares insights into his JCO PO article, “Using the Cell-Cycle Risk Score to Predict the Benefit of Androgen-Deprivation Therapy Added to Radiation Therapy in Patients With Newly Diagnosed Prostate Cancer.” Host Dr. Rafeh Naqash and Dr. Tward discuss how the cell-cycle risk score predicts the benefit of androgen-deprivation therapy in prostate cancer treatment. TRANSCRIPT Dr. Abdul Rafeh Naqash: Hello and welcome to JCO Precision Oncology Conversations, where we bring you engaging conversations with authors of clinically relevant and highly significant JCO PO articles. I'm your host, Dr. Rafeh Naqash, Assistant Professor at the OU Health Stephenson Cancer center. Today, we are excited to be joined by Dr. Jonathan Tward, Leader at the HCI Genitourinary Cancer Center, and Vincent P. and Janet Mancini Presidential Endowed Chair in Genitourinary malignancies at the Huntsman Cancer Institute at the University of Utah. Dr. Tward is also the lead author of the JCO Precision Oncology article titled “Using the Cell-Cycle Risk Score to Predict the Benefit of Androgen-Deprivation Therapy Added to Radiation Therapy in Patients With Newly Diagnosed Prostate Cancer.”  At the time of this recording, our guest's disclosures will be linked in the transcript.  Doctor Tward, welcome to the podcast and thank you for joining us today. Dr. Jonathan Tward: Thank you so much, Dr. Naqash. I'm excited to share this important research with your audience.  Dr. Abdul Rafeh Naqash: Awesome. For the sake of simplicity, we'll refer to each other using our first names, if that's okay with you.  Dr. Jonathan Tward: That's great.  Dr. Abdul Rafeh Naqash: Okay. So, Jonathan, this complex but very interesting topic revolves around a lot of different subtopics as I understand it. There is genomics, there are implications for treatment, there is machine learning and computational data science research. So, to start off why you started this project or why you did this research, could you, for the sake of our audience, try to help us understand what androgen deprivation therapy is? When is it used in prostate cancer? When is it used in combination with radiation therapy? And that would probably give us a decent background of why you were trying to do what you actually did in this research. Dr. Jonathan Tward: Yes, thank you very much. So, men who are diagnosed with localized prostate cancer, which is the majority of prostate cancer diagnosis, are faced with a lot of treatment decisions. And those decisions range all the way from, “Should I just go on active surveillance with the idea that it might be safe to treat later?” to “Should I consider surgery or radiation?” And then there's various forms of radiation. Now, as a radiation oncologist, one of the things that I have to consider when I meet a patient with localized prostate cancer who is pondering receiving radiation therapy, is whether or not we want to intensify treatment by doing more than just radiation alone. And androgen deprivation therapy, very specifically also thought of as chemical castration, what that really is is some kind of therapy where you are trying to reduce a man's testosterone levels to nearly zero. And the rationale for using androgen deprivation therapy in prostate cancer and in this case, specifically localized prostate cancer, is that one can think of testosterone almost as the food and growth signal for prostate cancer. There have been numerous prospective randomized trials that have been performed in the past that have clearly demonstrated that adding androgen deprivation therapy to certain contexts of patients with localized prostate cancer receiving radiation improves the outcome, including risk of metastasis and overall survival.  The problem is, we don't want to just intensify therapy for everybody who walks through our doors with localized prostate cancer. Some men have lower risk disease, and some men have higher risk disease. And conventionally, the way we make this decision is by looking at things like NCCN risk groups, which kind of lump patients into a few different boxes, generally speaking, called low risk, intermediate risk, and high risk. And if you think of those risk groups, the patients with the contemporary standard of who to add ADT to are men who are considered high risk localized, or men who are considered unfavorable intermediate risk localized. That being said, I think there's a recognition that we're overtreating some unfavorable intermediate risk men and undertreating them, and the same could be said of high-risk disease. So, I think we're always looking for better tools that make it a little bit more personalized, rather than lumping men into just one of several boxes. Dr. Abdul Rafeh Naqash: Sure. And this sort of reminds me of the oncotype DX, in a way, trying to connect people with ER/PR, breast cancer, and where chemotherapy, plus anti-estrogen and progesterone therapy may be applicable. So, I think you were trying to do something similar in this research, and as far as I remember, please correct me if I'm wrong, this is knowledge that I remember from my board exams, we classify this high risk, intermediate risk, and low risk based on the Gleason score. Is that correct? Is that still true, or has this changed? Dr. Jonathan Tward: It's still true. Conventional risk stratification, which is still used, literally only looks at a few parameters. You mentioned one, which is the Gleason score, which is really a human subjective judgment by a pathologist about how deranged cells look under a microscope. That's one parameter. The second parameter is the PSA value at the time of diagnosis. And the third parameter is the cT stage, which is really based on the digital rectal exam. Now, when you ponder that the entirety of our risk classification system is based on two subjective and one objective pieces of information, meaning what a Gleason score looks like, what the T stage is based on human interpretation, and then the only objective piece of data, PSA, it's rather rudimentary way of classifying men. I mean, it's done us well since the late ‘90s, when that particular classification system was derived. But it strikes me as odd that we should take all newly diagnosed localized prostate cancer patients and say you fit into one of three boxes, when we know there's so much more complexity to people and so many different treatment options and choices out there, which we're trying to match to the patient to ensure that we right size the treatment for them. Dr. Abdul Rafeh Naqash: Understood. Now, as we go into the precision medicine component of this research, there's genomics research in metastatic cancers. But is there any genomics research in early-stage prostate cancer where there have been differences that have been identified between the intermediate low risk, high risk? Is that something that has been explored to date? Dr. Jonathan Tward: Well, there are certainly somatic mutations that track with certain aggressive features. But I think when I think about the spirit of your question, within the localized prostate cancer space, there's been several molecular signatures that have been developed and, in fact, been commercialized that have been shown quite clearly that if you have a certain array of gene expressions, let's say, that that can correlate with metastasis or risk of recurrence or death. And the work that we're talking about today is one that actually uses one of the commercially available biomarkers, commercially it's known as Prolaris. But very specifically, in the work that I think we're discussing today, what we're looking at is cell cycle progression genes. And these are genes that maybe, to simplify it, are sort of hallmarks of how quickly cells are turning over. And what's interesting about looking at cell cycle progression is it's not certainly particular to prostate cancer. I mean, you could make an argument that cell cycle progression genes are probably relevant measures in any cancers, but there's been much work done over the past 15 to 20 years that have clearly validated that this particular cell cycle progression gene signature, which is now commercially available, clearly correlates with risk of progression, risk of metastasis in localized prostate cancer patients, whether they're receiving surgery or radiation. But what we've done is we've built upon this molecular work and added clinical risk features and added results of prospective randomized trials to use this test to personalize the precise risk reduction of what would happen to a man who is pondering adding ADT to radiation therapy. So, it's a very powerful precision tool.  Dr. Abdul Rafeh Naqash: Sounds very interesting. When you go deeper into this platform, is this genomic testing platform, does it incorporate RNA transcriptome or is it DNA, or is it a composite of both? Dr. Jonathan Tward: There are various molecular tests that are out there. In this particular case, these are mRNA expression levels of cell cycle progression genes, and they are kind of calibrated against some normal housekeeping genes, which is how the test is run. Dr. Abdul Rafeh Naqash: Understood. So, from what I understand in the discussion, you very appropriately said, in fact in your first paragraph, the goal here is to match patient level precision medicine approaches and reconcile them with population level therapeutic options. It's a very catchy statement. Can you help explain for our audience how you tried to do that? And this goes back to the question that you were trying to understand, where to use combination therapy in a localized prostate cancer based on risk stratification and deriving that risk stratification from the cell cycle score and then arriving to certain thresholds. So could you go through that in simple terms to help us understand how you tried to do it and what was the outcome and what are the implications of that? Dr. Jonathan Tward: Sure, there's a lot to unpack there, but I'll do my best to simplify it. So, we'll start with the basic question that faces a patient and their radiation oncologist, which is, if they're going to receive radiation, should you add hormone therapy? And if hormone therapy was completely nontoxic, you'd say, “Sure, just add it to everybody if there's a benefit.” But the problem is, of course, hormone therapy is associated with all kinds of unpleasant side effects and additional risks, so we don't want to utilize it unless we're sure that the benefit is clear. When you think about the way most of oncology decides whether or not adding an intervention should be done in a particular patient context, it's actually been derived originally from prospectively randomized trials, which usually assigned a hazard ratio or some kind of known relative reduction to doing ‘thing B' versus ‘thing A' or ‘thing B' in addition to ‘thing A'. But what's curious about always looking at hazard ratios and saying that those are the reasons why you should do additional things, discounts a really important fact, which is the baseline risk of something bad happening has to be accounted for first before you decide whether or not it a relative risk reduction matters. So to state more clearly, if I knew a prostate cancer patient sitting in front of me only had a 2% risk of developing metastasis within 10 years, if I just did radiation alone, if I then say adding hormone therapy might cut that in half from 2% to 1%, a patient might say, “You know what? I'm not sure I want to accept the toxicity of many months of hormone therapy to cut my risk of metastasis from 2% to 1%.” But if you had a patient where that risk was 20% risk of metastasis with radiation alone, and you told them I can cut that risk down to 10% or 12%, then that's something they would seriously consider.   And so what this work really does is precisely that. It gives us a tool where, using the molecular signature of the cell cycle progression genes, which afford a patient a certain risk of metastasis, and also taking into account clinical risk factors that we know are prognostic, Gleason score, PSA, their age, how many cores of the biopsy were possible. We use all this information, and I'll use a strange term, multiplex it into a robust risk model that will prognosticate extremely clearly what that patient's precise risk of metastasis will be within the next 10 years, and this is the key point, if they receive radiation alone.   So, think of this work in two phases. Phase one is calibrate the risk in a patient if they get radiation alone, by using both molecular and clinical prognosticators. But then take the power of numerous randomized trials, which have clearly set the hazard ratio reduction for adding the hormone therapy, and then using mathematical principles, applying that hazard ratio risk reduction to the absolute risk. And then what you ultimately do is, at a very individual level, have a patient sitting in front of you where you can say, “Mr. Jones, I've run this test on you, and I can tell you definitively that if you receive radiation therapy for your localized prostate cancer, the risk of metastasis will be 12%. But if you add, let's say, six months of hormone therapy, that could be reduced to 7%, and the absolute risk reduction might only be 5%.” And if you think about that number in a number needed to treat mentality, then you could say, “Listen, I have to give 20 men identical to you, hormone therapy for one to benefit. Is that worth it to you?”   And what it really does is it empowers the patient. Rather than following a guideline that says, “Effectively, thou shalt do this for this risk group,” you really want to engage the patient in the conversation about the risk benefit of what you're going to do. And I think it's uncommon in oncology for physicians to be able to very precisely tell a patient sitting in front of them, if you do ‘thing A', this is the risk, something bad happen. If you do ‘thing B', this is how the risk reduces. And I think now we really get into shared decision making, rather than a, “Trust me, I'm a doctor,” paternalistic situation. Dr. Abdul Rafeh Naqash: That's a very interesting approach. Again, you're basically personalizing the personalized medicine approach, refining it further, and involving the patient in discussions, which helps them understand why something would make sense. And some of this, as you might already know, people have tried to do in some other tumor types, hasn't necessarily led to significant clinical decision-making changes. But I think the way the field is evolving, especially this research that you published on and others are working towards, will hopefully result in more personalized approaches for individual decision making for these patients.   Now, I do understand that simplicity sometimes results in more uptake of some information versus when sometimes things get more complex. So, in your assessment, when you came up with these results, you looked at the genomic score, you took the randomized clinical trial data, you did the absolute risk reduction. From what I understood in the manuscript, it does look like you did come up with a threshold of what would appropriately risk stratify individuals, meaning individuals that are at a higher risk if they cross that threshold, versus individuals that are at a lower risk if they cross that threshold. Is that a fair statement or is this a continuum? So there is no binary, but this is over a scale that this assessment can be made. Dr. Jonathan Tward: So, there are elements of your summary that are fair, but this is a continuum which allows any individual to accept whatever risk reduction they want. That being said, there is no standard in oncology for what percent risk should you intensify a treatment for? And when you poll physicians and doctors as to how much reduction in death or how much reduction in metastasis, doctors and patients are all over the map at what they consider to be a threshold. But we designed these thresholds actually from prior work, based on surveying both patients themselves, as well as experts who were on cooperative trial group steering committees, and ask them, essentially, “At what level of risk reduction would you want to intensify treatment?” And what's interesting is most people who are asked that question are willing to do more treatment intensity for an important outcome like metastasis if the absolute risk reduction of that event happening is 5%. So as a general principle, that's how it was set.  These thresholds in the current paper we're discussing actually weren't defined in this current work. They were defined in prior works, where we had clearly shown in retrospective data sets that they could discriminate very well who does or doesn't benefit from hormone therapy. What's, I think, novel about this paper, even though we had previously validated those thresholds, is that now that we're using the randomized trial data, it's extremely robust in our risk estimates, and we can say that it's truly a predictive biomarker. Because it's one thing to prognosticate an outcome, but predict a difference in treatment A versus treatment B usually requires randomized trial data so that you get the highest level of evidence and the confidence that it works. Dr. Abdul Rafeh Naqash: So the next steps for this very, very provocative research, is it something prospective validation or are you going to try to utilize maybe proper group trial data or other pharma trial data, individual patient data to risk stratify these individuals and validate?  Dr. Jonathan Tward: So these thresholds, for example, that you refer to are very well validated. There's multiple prior studies, well over at this point, 1500 patients where there's validation. And yes, we have reached out to cooperative groups to do some additional validation. That being said, this work is already ready for prime time and being used. In fact, this test is the commercially available Prolaris test. The results gleaned from this work are published on the score report that a patient and a physician receives. So the reality is that this is already existing as a clinical tool in the community. And the NCCN guidelines also support the use of this and other tests to move from a stratification to personalized medicine. So it's not like this is so much in the experimental realm as it is effectively a complete tool that is being used today. And effectively, it's available for any patient or physician diagnosed with localized prostate cancer to immediately order on biopsy tissue. Dr. Abdul Rafeh Naqash: One naive question, Jonathan, I wanted to ask is most prostate cancers tend to be prostatic adenocarcinoma. So if it's a neuroendocrine localized prostate cancer, does the same risk assessment apply? Because neuroendocrine tumors in general seem to be higher replication stress or higher tendency to metastasis. Does it change from your perspective, from the genomic assessment standpoint, the CCR score standpoint? Dr. Jonathan Tward: That's a very interesting question, because what I will tell you is that there are probably a lot of, well, I wouldn't say a lot, but there are some neuroendocrine cancers mixed in with the adenocarcinomas that no one identified as neuroendocrine, which in a way were baked into the cake of the risk signature. Even though that is so, I dont think we've independently looked very specifically at known neuroendocrine cancers and compared them to the adenocarcinomas. What I would actually argue though, is that if you have a neuroendocrine cancer sitting in front of you, the point about whether or not you're adding ADT is relatively moot because neuroendocrine cancers may or may not respond to ADT, and you have to start considering chemotherapeutic-like decisions.   So the question, which is very interesting and academic, is that I would presume the cell cycle progression score should be elevated, although I don't know that in a neuroendocrine cancer, this tool doesn't appear to be useful at this moment for neuroendocrine cancers because we're not making decisions about chemo. That's an interesting and provocative question, and now you make me want to study that. So potentially, the next paper would be neuroendocrine cancers, whether or not it might prognosticate using a topicide or something else like this. But we would have to rely on prospective trial data as well to see whether or not we could use it the same way.  Dr. Abdul Rafeh Naqash: Hopefully, if you do work on it, then you can submit the manuscript again to JCO PO for us to talk again. Dr. Jonathan Tward: Yeah, and you'll be on the author bar.  Dr. Abdul Rafeh Naqash: Appreciate the inclusion. So thank you so much, Jonathan, for talking to us about the science. And a few quick minutes about yourself. Can you tell us a little bit about your career trajectory, how you ended up doing what you're doing, and maybe some lessons learned and some advice for early career junior investigators that would be helpful for them?  Dr. Jonathan Tward: Yes, that's a happy memory. When I was a young undergrad, I was fortunate to do some volunteer work in a radiation oncology department and had mentors there who guided me into considering a career in medicine and specifically a career as a physician scientist. So I'll start with the best advice is to get mentors early on and throughout your career who are really interested in your career development and who are accomplished that can kind of help you along. But I went to medical school with an open mind and continued to love oncology. I think it has some of the most complex questions that are unanswered. It is very high stakes oncology. There's still a lot of death and disability and consequences of our therapies. And I just love the idea of working in an environment, both clinically and as a researcher, to try to solve some of those questions like, how do I improve outcomes? How do I make therapy less toxic?  And radiation oncology for me, was a nice fit in genitourinary cancer, I guess, specifically because mid GU cancer realm patients are presented with a menu of treatment options. It's kind of interesting. It's a little bit unlike other cancers. But I had fantastic mentors throughout both my medical school as well as residency program who really helped guide me and encourage me along the way. And so without spending too much time, I would say go out of your way to find people who are successful at what they do, are interested in making you better, and really sit at their knee and listen to them when they are trying to guide you because they really have your best interests in mind. And I think as a mentor and a mentee, what makes me most proud is watching people I've trained go out and succeed. I mean, the reward of being a mentor is watching your mentees succeed.  Dr. Abdul Rafeh Naqash: Thank you. Appreciate all those words of wisdom, Jonathan, and excited to see all the subsequent steps and results from the research that you're doing. Thank you again for joining us today and providing a very simple summary of a very complex topic which I think our audience and perhaps some of the trainees listening to this podcast will appreciate. We really appreciate your time.  Dr. Jonathan Tward: Thank you so much, Rafeh.  Dr. Abdul Rafeh Naqash: And thank you for listening to JCO Precision Oncology Conversations. Don't forget to give us a rating or review and be sure to subscribe so you never miss an episode. You can find all ASCO shows at asco.org/podcast.     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. Tward Diclosures:   HonorariaCompany name: Bayer Consulting or Advisory RoleCompany name: Myriad Genetics, Blue Earth Diagnostics, Janssen Scientific Affairs, Merck, Bayer, Boston Scientific, Myovant Sciences, Myriad Genetics, Lantheus Medical Imaging Research FundingCompany name: Bayer, Myriad Genetics Travel, Accommodations, ExpensesCompany name: Myriad Genetics, Bayer

Join Endgame's first and biggest conference ever! https://www.endgametownhall.com ---------------------- Join Gita Wirjawan for an in-depth conversation with Nobel Laureate Walter Gilbert as he shares his extraordinary journey from his early life in Cambridge to his groundbreaking contributions to science. Explore his shift from chemistry to theoretical physics, the pivotal role of technology in his lab experiments, and the critical discoveries that shaped modern genetics. Delve into his entrepreneurial ventures, the ethics of scientific advancements, and his thoughts on the current state of science and society. #Endgame #GitaWirjawan #WalterGilbert ---------------------- About Luminary: Walter Gilbert is a renowned American biochemist and 1980 Nobel Laureate in Chemistry, known for his pioneering work in DNA sequencing. He also co-founded biotech companies Biogen, Myriad Genetics, and Paratek Pharmaceuticals. Beyond science, Gilbert is also an accomplished artist, working primarily in photography and visual arts, with his works exhibited in galleries worldwide. About the Host: Gita Wirjawan is an Indonesian entrepreneur, educator, and Honorary Professor of Politics and International Relations at the School of Politics and International Relations, University of Nottingham. He is also a visiting scholar at The Shorenstein Asia-Pacific Research Center (APARC) at Stanford University (2022—2024) and a fellow at Harvard Kennedy School's Belfer Center for Science and International Affairs. ---------------------- Earn a Master of Public Policy degree and be Indonesia's future narrator. More info: admissions@sgpp.ac.id https://admissions.sgpp.ac.id https://wa.me/628111522504 Visit and subscribe: ‪@SGPPIndonesia‬ | @Endgame_Clips‬

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

https://www.paypal.me/Truelifepodcast?locale.x=en_USJordan Richardson is a cosmic navigator of the entertainment universe, fusing creativity and rebellion to transcend the ordinary. A USC Thornton School of Music alum, his journey has traversed music, television, tech-thought, and medicine, leaving an indelible mark on each.From Capitol Records' storied halls to SBV Talent Agency's dynamic campaigns, Jordan orchestrated voices for NBC and ABC's Soapnet. At VH1, he sculpted cultural narratives with “Behind The Music” and “I Love The 2000's,” shaping icons in real-time.Jordan's revolutionary spirit sparked the #LoveIsLove brand activation with Absolut Vodka, co-creating SayReal. This independent music group's meteoric rise and acclaim culminated in Hollywood Music in Media Awards recognition as “LA's Hottest New Band.”At Not Impossible Labs, Jordan's visionary talent management ignited projects like the Hunger: Not Impossible COVID-19 campaign, earning the 2020 Shorty Award and a place in the JFK Library Foundation's New Frontier Forum. His insights graced “After Shock,” the sequel to Alvin Toffler's “Future Shock.”Venturing into precision medical genetics with Myriad Genetics, Inc., Jordan shattered norms. Applying his “12 Tenets of Talent Management,” he achieved stellar success, securing consecutive President's Club honors and the title of 2023 Southwest MVP and Western U.S. Mentor of the Year.Through Cardboard Rockets LLC, Jordan champions the belief that every professional is a talent and every leader a talent manager. His voice echoes globally, featured in CNN, Swiss Public Television, FOX, and Reti Televisive Italiane. As a sought-after speaker, he shares psychedelic insights on human connection, talent development, and collaborative innovation.Jordan Richardson is not just a name but a movement—a testament to creativity, resilience, and the relentless quest for deeper connection.https://www.jordanrichardsonspeaking.com/ https://www.paypal.me/Truelifepodcast?locale.x=en_US

Black women have a higher risk of developing triple-negative breast cancer at a young age than white women. At the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, Dr. Holly Pederson, of the Cleveland Clinic, and Dr. Elisha Hughes, of Myriad Genetics, presented their research on how a polygenic risk score can help predict the risk of early-onset triple-negative breast cancer in Black women. Listen to the episode to hear Drs. Pederson and Hughes explain: what a polygenic risk score is the results of their research how the results are being used

IP in the Digital Environment Software and Digital Media Copyright Protection: Software and digital media are primarily protected under copyright law. Software Licensing: Various licensing models, such as open-source and proprietary licenses, dictate how software can be used, modified, and distributed. Digital Rights Management (DRM): Technologies designed to prevent unauthorized copying and use of digital media. Legal Considerations Infringement and Enforcement: Identifying and prosecuting copyright infringement in the digital realm is complex due to the global nature of the internet and the anonymity it can provide. Fair Use and Exceptions: Balancing the rights of IP holders with those of users, particularly in contexts like education and research, where fair use exceptions might apply. Case Law Oracle America, Inc. v. Google LLC: A landmark case addressing whether the use of Java APIs in Android constitutes fair use. Biotechnology and Genetic Engineering Key Issues Patenting Life Forms: The extent to which living organisms, genetic sequences, and biotechnological inventions can be patented. Ethical and Moral Considerations: Balancing IP protection with ethical concerns, such as the impact on biodiversity, human rights, and public health. Legal Considerations Patent Eligibility: Determining what constitutes patentable subject matter in biotechnology, including genetically modified organisms (GMOs), gene editing technologies like CRISPR, and synthetic biology. Regulatory Compliance: Navigating the complex regulatory frameworks that govern biotechnology, which can vary significantly between jurisdictions. Case Law Diamond v. Chakrabarty: A seminal Supreme Court case that allowed for the patenting of a genetically modified bacterium, establishing that living organisms could be patented if they are the product of human ingenuity. Association for Molecular Pathology v. Myriad Genetics, Inc.: Addressed whether human genes could be patented. Artificial Intelligence and IP Key Issues Authorship and Ownership: Determining who owns the IP rights to creations generated by AI, such as artwork, music, or inventions. Patentability of AI Innovations: Assessing whether AI-generated inventions meet the criteria for patent protection, including inventiveness and non-obviousness. Legal Considerations AI as an Inventor: Current IP laws generally require a human inventor. The question of whether AI can be recognized as an inventor is hotly debated. Data and Training Sets: Protecting the data used to train AI systems, which often involves large datasets that may include copyrighted material. Case Law Thaler v. Commissioner of Patents: A case in which the Federal Court of Australia ruled that AI could be listed as an inventor on a patent application. Future Trends and Legislative Changes Key Trends Harmonization of IP Laws: Efforts to harmonize IP laws across jurisdictions to facilitate global trade and reduce complexity for multinational companies. Digital Transformation: Adapting IP laws to better protect digital assets and address issues like cyber piracy and the protection of digital identities. Legislative Changes Copyright Modernization: Updating copyright laws to better reflect the realities of the digital age, such as shorter terms of protection for digital works or more flexible fair use provisions. Patent Law Reforms: Revisiting patent eligibility criteria, particularly in fields like biotechnology and AI, to encourage innovation while balancing public interest. Case Law and Policy Developments European Union's Digital Single Market Directive: Aims to modernize copyright rules to facilitate digital trade within the EU. US Patent and Trademark Office (USPTO) AI Initiative: Exploring how AI impacts patent law, including the potential need for legislative changes to accommodate AI-generated inventions --- Send in a voice message: https://podcasters.spotify.com/pod/show/law-school/message Support this podcast: https://podcasters.spotify.com/pod/show/law-school/support

In this episode, we talk with Dennis Watson and Cliff Reid, two entrepreneurs in the cancer space. They speak about the difference between genetics and genomics, and the role of genetic and genomic testing in clinical decision-making. They also touch on the history and impact of DNA sequencing and the challenges in applying genomics to cancer treatment. This conversation explores the development of Travera, a company advancing personalized cancer treatments. Dennis and Cliff share their hopes for the future of oncology, including the expansion of diagnostic tools and the increasing involvement of patients in their own care. Key Highlights: The field of DNA sequencing has evolved over the years, but the application of genomics in cancer treatment still faces challenges in achieving widespread success.  Sales and commercial teams play a crucial role in educating clinicians about new innovations in personalized oncology, and oftentimes scientific/product innovations take a while to actually become a part of a clinician's practice.  The future of personalized oncology involves the development of multiple techniques for selecting the right drug for the right patient at the right time, as well as increased patient involvement in their own care. About our guests: Dennis Watson joined Travera in July of 2022 as the Vice President of Business Development. He brings 15+ years of extensive sales and management experience in the oncology molecular diagnostic space. Dennis spent nearly 10 years with Agendia, beginning as a field-based sales professional, working his way up to gain experience in multiple facets of the business, receiving top-tier awards and recognition throughout his tenure. He served 4 years as a Regional Director in the Central US, before moving on to lead the US commercial sales organization in January of 2018. Prior to his work with Agendia, Dennis spent 5 years with the Oncology division of Myriad Genetics. Before Myriad Genetics, he also held positions in the pharmaceutical, industrial services, and web services industries. Clifford Reid was the founding CEO of Travera. Previously, Dr. Reid was the founding Chairman, President, and Chief Executive Officer of Complete Genomics (NASDAQ: GNOM), a leading developer of whole human genome DNA sequencing technologies and services. Prior to Complete Genomics, he founded two enterprise software companies: Eloquent (NASDAQ: ELOQ), an internet video company, and Verity (NASDAQ: VRTY), an enterprise search engine company. Dr. Reid is on the Visiting Committee of the Biological Engineering Department at the Massachusetts Institute of Technology (MIT), a member of the MIT Corporation Development Committee, and an advisor to Warburg Pincus.   Visit the Manta Cares website  Disclaimer: This podcast is for general informational purposes only and does not constitute the practice of medicine, nursing or other professional health care services, including the giving of medical advice, and no doctor/patient relationship is formed. The use of information on this podcast or materials linked from this podcast is at the user's own risk. The content of this podcast is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Users should not disregard, or delay in obtaining, medical advice for any medical condition they may have, and should seek the assistance of their health care professionals for any such conditions. --- Support this podcast: https://podcasters.spotify.com/pod/show/manta-cares/support

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/IPCE information, and to apply for credit, please visit us at PeerView.com/YRR865. CME/MOC/AAPA/IPCE credit will be available until February 25, 2025.Doing Better Under Pressure in Prostate Cancer: Key Evidence and Real-World Care Strategies In support of improving patient care, this activity has been planned and implemented by PVI, PeerView Institute for Medical Education, and ZERO Prostate 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 educational activity is supported by medical education grants from Astellas and Pfizer, Inc., Bayer HealthCare Pharmaceuticals Inc., Exelixis, Inc., Lantheus Medical Imaging, and Lilly.Disclosure PolicyAll relevant conflicts of interest have been mitigated prior to the commencement of the activity.Faculty/Planner DisclosuresChair/PlannerRobert Dreicer, MD, MS, MACP, FASCO, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for Astellas Pharma Inc.; Bayer Corporation; Exelixis, Inc.; Gilead Sciences, Inc.; Hinova; Janssen Pharmaceuticals, Inc.; Merck & Co., Inc.; Pfizer; Sanofi Genzyme; Seagen Inc.; and Tavanta Therapeutics.Faculty/PlannerAlicia K. Morgans, MD, MPH, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for Advanced Accelerator Applications (AAA); Antev Ltd.; Astellas Pharma Inc.; AstraZeneca; Bayer Corporation; Lantheus; Merck & Co., Inc.; Myovant Sciences Ltd.; Myriad Genetics, Inc.; Novartis Pharmaceuticals Corporation; Pfizer; Sanofi; and Telix Pharmaceuticals Limited.Grant/Research Support from Astellas Pharma Inc.; Bayer Corporation; Myovant Sciences Ltd.; Pfizer; and Sanofi.Faculty/PlannerNeal D. Shore, MD, FACS, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for AbbVie; Accord Healthcare; Alessa Therapeutics; Amgen Inc.; Antev Ltd.; Arquer Diagnostics; Asieris Pharmaceuticals; Astellas Pharma Inc.; AstraZeneca; Aura Biosciences, Inc.; Bayer Corporation; BioProtect Ltd.; Boston Scientific Corporation; Bristol Myers Squibb; CG Oncology; Clarity Pharmaceuticals Ltd; Cold Genesys Inc; Dendreon Pharmaceuticals LLC; Exact Imaging; F. Hoffmann-La Roche Ltd./Genentech, Inc.; Ferring Pharmaceuticals; FIZE Medical; Foundation Medicine, Inc.; GenesisCare; ImmunityBio, Inc.; Incyte Corporation; Invitae Corporation; Janssen Pharmaceuticals, Inc.; Lantheus; Lilly; MDX; Merck & Co., Inc.; Minomic International Ltd; Myovant Sciences Ltd.; Myriad Genetics, Inc.; Nonagen Bioscience; Novartis Pharmaceuticals Corporation; Nymox Pharmaceutical Corporation; Pacific Edge; Palette Life Sciences, Inc.; Pfizer; Photocure; PlatformQ; PreView Medical, Inc.; ProFound Medical; Promaxo; Propella Therapeutics, Inc.; Protara Therapeutics Inc.; Sanofi Genzyme; Specialty Networks; Telix Pharmaceuticals Limited; Tolmar Pharmaceuticals, Inc.; and UroGen Pharma, Inc.Faculty/PlannerMatthew R. Smith, MD, PhD, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for Ambrx; Astellas Pharma Inc.; Bayer Corporation; Janssen Pharmaceuticals, Inc.; Lilly; 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/IPCE information, and to apply for credit, please visit us at PeerView.com/YRR865. CME/MOC/AAPA/IPCE credit will be available until February 25, 2025.Doing Better Under Pressure in Prostate Cancer: Key Evidence and Real-World Care Strategies In support of improving patient care, this activity has been planned and implemented by PVI, PeerView Institute for Medical Education, and ZERO Prostate 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 educational activity is supported by medical education grants from Astellas and Pfizer, Inc., Bayer HealthCare Pharmaceuticals Inc., Exelixis, Inc., Lantheus Medical Imaging, and Lilly.Disclosure PolicyAll relevant conflicts of interest have been mitigated prior to the commencement of the activity.Faculty/Planner DisclosuresChair/PlannerRobert Dreicer, MD, MS, MACP, FASCO, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for Astellas Pharma Inc.; Bayer Corporation; Exelixis, Inc.; Gilead Sciences, Inc.; Hinova; Janssen Pharmaceuticals, Inc.; Merck & Co., Inc.; Pfizer; Sanofi Genzyme; Seagen Inc.; and Tavanta Therapeutics.Faculty/PlannerAlicia K. Morgans, MD, MPH, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for Advanced Accelerator Applications (AAA); Antev Ltd.; Astellas Pharma Inc.; AstraZeneca; Bayer Corporation; Lantheus; Merck & Co., Inc.; Myovant Sciences Ltd.; Myriad Genetics, Inc.; Novartis Pharmaceuticals Corporation; Pfizer; Sanofi; and Telix Pharmaceuticals Limited.Grant/Research Support from Astellas Pharma Inc.; Bayer Corporation; Myovant Sciences Ltd.; Pfizer; and Sanofi.Faculty/PlannerNeal D. Shore, MD, FACS, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for AbbVie; Accord Healthcare; Alessa Therapeutics; Amgen Inc.; Antev Ltd.; Arquer Diagnostics; Asieris Pharmaceuticals; Astellas Pharma Inc.; AstraZeneca; Aura Biosciences, Inc.; Bayer Corporation; BioProtect Ltd.; Boston Scientific Corporation; Bristol Myers Squibb; CG Oncology; Clarity Pharmaceuticals Ltd; Cold Genesys Inc; Dendreon Pharmaceuticals LLC; Exact Imaging; F. Hoffmann-La Roche Ltd./Genentech, Inc.; Ferring Pharmaceuticals; FIZE Medical; Foundation Medicine, Inc.; GenesisCare; ImmunityBio, Inc.; Incyte Corporation; Invitae Corporation; Janssen Pharmaceuticals, Inc.; Lantheus; Lilly; MDX; Merck & Co., Inc.; Minomic International Ltd; Myovant Sciences Ltd.; Myriad Genetics, Inc.; Nonagen Bioscience; Novartis Pharmaceuticals Corporation; Nymox Pharmaceutical Corporation; Pacific Edge; Palette Life Sciences, Inc.; Pfizer; Photocure; PlatformQ; PreView Medical, Inc.; ProFound Medical; Promaxo; Propella Therapeutics, Inc.; Protara Therapeutics Inc.; Sanofi Genzyme; Specialty Networks; Telix Pharmaceuticals Limited; Tolmar Pharmaceuticals, Inc.; and UroGen Pharma, Inc.Faculty/PlannerMatthew R. Smith, MD, PhD, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for Ambrx; Astellas Pharma Inc.; Bayer Corporation; Janssen Pharmaceuticals, Inc.; Lilly; 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/IPCE information, and to apply for credit, please visit us at PeerView.com/YRR865. CME/MOC/AAPA/IPCE credit will be available until February 25, 2025.Doing Better Under Pressure in Prostate Cancer: Key Evidence and Real-World Care Strategies In support of improving patient care, this activity has been planned and implemented by PVI, PeerView Institute for Medical Education, and ZERO Prostate 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 educational activity is supported by medical education grants from Astellas and Pfizer, Inc., Bayer HealthCare Pharmaceuticals Inc., Exelixis, Inc., Lantheus Medical Imaging, and Lilly.Disclosure PolicyAll relevant conflicts of interest have been mitigated prior to the commencement of the activity.Faculty/Planner DisclosuresChair/PlannerRobert Dreicer, MD, MS, MACP, FASCO, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for Astellas Pharma Inc.; Bayer Corporation; Exelixis, Inc.; Gilead Sciences, Inc.; Hinova; Janssen Pharmaceuticals, Inc.; Merck & Co., Inc.; Pfizer; Sanofi Genzyme; Seagen Inc.; and Tavanta Therapeutics.Faculty/PlannerAlicia K. Morgans, MD, MPH, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for Advanced Accelerator Applications (AAA); Antev Ltd.; Astellas Pharma Inc.; AstraZeneca; Bayer Corporation; Lantheus; Merck & Co., Inc.; Myovant Sciences Ltd.; Myriad Genetics, Inc.; Novartis Pharmaceuticals Corporation; Pfizer; Sanofi; and Telix Pharmaceuticals Limited.Grant/Research Support from Astellas Pharma Inc.; Bayer Corporation; Myovant Sciences Ltd.; Pfizer; and Sanofi.Faculty/PlannerNeal D. Shore, MD, FACS, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for AbbVie; Accord Healthcare; Alessa Therapeutics; Amgen Inc.; Antev Ltd.; Arquer Diagnostics; Asieris Pharmaceuticals; Astellas Pharma Inc.; AstraZeneca; Aura Biosciences, Inc.; Bayer Corporation; BioProtect Ltd.; Boston Scientific Corporation; Bristol Myers Squibb; CG Oncology; Clarity Pharmaceuticals Ltd; Cold Genesys Inc; Dendreon Pharmaceuticals LLC; Exact Imaging; F. Hoffmann-La Roche Ltd./Genentech, Inc.; Ferring Pharmaceuticals; FIZE Medical; Foundation Medicine, Inc.; GenesisCare; ImmunityBio, Inc.; Incyte Corporation; Invitae Corporation; Janssen Pharmaceuticals, Inc.; Lantheus; Lilly; MDX; Merck & Co., Inc.; Minomic International Ltd; Myovant Sciences Ltd.; Myriad Genetics, Inc.; Nonagen Bioscience; Novartis Pharmaceuticals Corporation; Nymox Pharmaceutical Corporation; Pacific Edge; Palette Life Sciences, Inc.; Pfizer; Photocure; PlatformQ; PreView Medical, Inc.; ProFound Medical; Promaxo; Propella Therapeutics, Inc.; Protara Therapeutics Inc.; Sanofi Genzyme; Specialty Networks; Telix Pharmaceuticals Limited; Tolmar Pharmaceuticals, Inc.; and UroGen Pharma, Inc.Faculty/PlannerMatthew R. Smith, MD, PhD, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for Ambrx; Astellas Pharma Inc.; Bayer Corporation; Janssen Pharmaceuticals, Inc.; Lilly; 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/IPCE information, and to apply for credit, please visit us at PeerView.com/YRR865. CME/MOC/AAPA/IPCE credit will be available until February 25, 2025.Doing Better Under Pressure in Prostate Cancer: Key Evidence and Real-World Care Strategies In support of improving patient care, this activity has been planned and implemented by PVI, PeerView Institute for Medical Education, and ZERO Prostate 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 educational activity is supported by medical education grants from Astellas and Pfizer, Inc., Bayer HealthCare Pharmaceuticals Inc., Exelixis, Inc., Lantheus Medical Imaging, and Lilly.Disclosure PolicyAll relevant conflicts of interest have been mitigated prior to the commencement of the activity.Faculty/Planner DisclosuresChair/PlannerRobert Dreicer, MD, MS, MACP, FASCO, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for Astellas Pharma Inc.; Bayer Corporation; Exelixis, Inc.; Gilead Sciences, Inc.; Hinova; Janssen Pharmaceuticals, Inc.; Merck & Co., Inc.; Pfizer; Sanofi Genzyme; Seagen Inc.; and Tavanta Therapeutics.Faculty/PlannerAlicia K. Morgans, MD, MPH, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for Advanced Accelerator Applications (AAA); Antev Ltd.; Astellas Pharma Inc.; AstraZeneca; Bayer Corporation; Lantheus; Merck & Co., Inc.; Myovant Sciences Ltd.; Myriad Genetics, Inc.; Novartis Pharmaceuticals Corporation; Pfizer; Sanofi; and Telix Pharmaceuticals Limited.Grant/Research Support from Astellas Pharma Inc.; Bayer Corporation; Myovant Sciences Ltd.; Pfizer; and Sanofi.Faculty/PlannerNeal D. Shore, MD, FACS, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for AbbVie; Accord Healthcare; Alessa Therapeutics; Amgen Inc.; Antev Ltd.; Arquer Diagnostics; Asieris Pharmaceuticals; Astellas Pharma Inc.; AstraZeneca; Aura Biosciences, Inc.; Bayer Corporation; BioProtect Ltd.; Boston Scientific Corporation; Bristol Myers Squibb; CG Oncology; Clarity Pharmaceuticals Ltd; Cold Genesys Inc; Dendreon Pharmaceuticals LLC; Exact Imaging; F. Hoffmann-La Roche Ltd./Genentech, Inc.; Ferring Pharmaceuticals; FIZE Medical; Foundation Medicine, Inc.; GenesisCare; ImmunityBio, Inc.; Incyte Corporation; Invitae Corporation; Janssen Pharmaceuticals, Inc.; Lantheus; Lilly; MDX; Merck & Co., Inc.; Minomic International Ltd; Myovant Sciences Ltd.; Myriad Genetics, Inc.; Nonagen Bioscience; Novartis Pharmaceuticals Corporation; Nymox Pharmaceutical Corporation; Pacific Edge; Palette Life Sciences, Inc.; Pfizer; Photocure; PlatformQ; PreView Medical, Inc.; ProFound Medical; Promaxo; Propella Therapeutics, Inc.; Protara Therapeutics Inc.; Sanofi Genzyme; Specialty Networks; Telix Pharmaceuticals Limited; Tolmar Pharmaceuticals, Inc.; and UroGen Pharma, Inc.Faculty/PlannerMatthew R. Smith, MD, PhD, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for Ambrx; Astellas Pharma Inc.; Bayer Corporation; Janssen Pharmaceuticals, Inc.; Lilly; 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/IPCE information, and to apply for credit, please visit us at PeerView.com/YRR865. CME/MOC/AAPA/IPCE credit will be available until February 25, 2025.Doing Better Under Pressure in Prostate Cancer: Key Evidence and Real-World Care Strategies In support of improving patient care, this activity has been planned and implemented by PVI, PeerView Institute for Medical Education, and ZERO Prostate 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 educational activity is supported by medical education grants from Astellas and Pfizer, Inc., Bayer HealthCare Pharmaceuticals Inc., Exelixis, Inc., Lantheus Medical Imaging, and Lilly.Disclosure PolicyAll relevant conflicts of interest have been mitigated prior to the commencement of the activity.Faculty/Planner DisclosuresChair/PlannerRobert Dreicer, MD, MS, MACP, FASCO, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for Astellas Pharma Inc.; Bayer Corporation; Exelixis, Inc.; Gilead Sciences, Inc.; Hinova; Janssen Pharmaceuticals, Inc.; Merck & Co., Inc.; Pfizer; Sanofi Genzyme; Seagen Inc.; and Tavanta Therapeutics.Faculty/PlannerAlicia K. Morgans, MD, MPH, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for Advanced Accelerator Applications (AAA); Antev Ltd.; Astellas Pharma Inc.; AstraZeneca; Bayer Corporation; Lantheus; Merck & Co., Inc.; Myovant Sciences Ltd.; Myriad Genetics, Inc.; Novartis Pharmaceuticals Corporation; Pfizer; Sanofi; and Telix Pharmaceuticals Limited.Grant/Research Support from Astellas Pharma Inc.; Bayer Corporation; Myovant Sciences Ltd.; Pfizer; and Sanofi.Faculty/PlannerNeal D. Shore, MD, FACS, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for AbbVie; Accord Healthcare; Alessa Therapeutics; Amgen Inc.; Antev Ltd.; Arquer Diagnostics; Asieris Pharmaceuticals; Astellas Pharma Inc.; AstraZeneca; Aura Biosciences, Inc.; Bayer Corporation; BioProtect Ltd.; Boston Scientific Corporation; Bristol Myers Squibb; CG Oncology; Clarity Pharmaceuticals Ltd; Cold Genesys Inc; Dendreon Pharmaceuticals LLC; Exact Imaging; F. Hoffmann-La Roche Ltd./Genentech, Inc.; Ferring Pharmaceuticals; FIZE Medical; Foundation Medicine, Inc.; GenesisCare; ImmunityBio, Inc.; Incyte Corporation; Invitae Corporation; Janssen Pharmaceuticals, Inc.; Lantheus; Lilly; MDX; Merck & Co., Inc.; Minomic International Ltd; Myovant Sciences Ltd.; Myriad Genetics, Inc.; Nonagen Bioscience; Novartis Pharmaceuticals Corporation; Nymox Pharmaceutical Corporation; Pacific Edge; Palette Life Sciences, Inc.; Pfizer; Photocure; PlatformQ; PreView Medical, Inc.; ProFound Medical; Promaxo; Propella Therapeutics, Inc.; Protara Therapeutics Inc.; Sanofi Genzyme; Specialty Networks; Telix Pharmaceuticals Limited; Tolmar Pharmaceuticals, Inc.; and UroGen Pharma, Inc.Faculty/PlannerMatthew R. Smith, MD, PhD, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for Ambrx; Astellas Pharma Inc.; Bayer Corporation; Janssen Pharmaceuticals, Inc.; Lilly; 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/IPCE information, and to apply for credit, please visit us at PeerView.com/YRR865. CME/MOC/AAPA/IPCE credit will be available until February 25, 2025.Doing Better Under Pressure in Prostate Cancer: Key Evidence and Real-World Care Strategies In support of improving patient care, this activity has been planned and implemented by PVI, PeerView Institute for Medical Education, and ZERO Prostate 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 educational activity is supported by medical education grants from Astellas and Pfizer, Inc., Bayer HealthCare Pharmaceuticals Inc., Exelixis, Inc., Lantheus Medical Imaging, and Lilly.Disclosure PolicyAll relevant conflicts of interest have been mitigated prior to the commencement of the activity.Faculty/Planner DisclosuresChair/PlannerRobert Dreicer, MD, MS, MACP, FASCO, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for Astellas Pharma Inc.; Bayer Corporation; Exelixis, Inc.; Gilead Sciences, Inc.; Hinova; Janssen Pharmaceuticals, Inc.; Merck & Co., Inc.; Pfizer; Sanofi Genzyme; Seagen Inc.; and Tavanta Therapeutics.Faculty/PlannerAlicia K. Morgans, MD, MPH, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for Advanced Accelerator Applications (AAA); Antev Ltd.; Astellas Pharma Inc.; AstraZeneca; Bayer Corporation; Lantheus; Merck & Co., Inc.; Myovant Sciences Ltd.; Myriad Genetics, Inc.; Novartis Pharmaceuticals Corporation; Pfizer; Sanofi; and Telix Pharmaceuticals Limited.Grant/Research Support from Astellas Pharma Inc.; Bayer Corporation; Myovant Sciences Ltd.; Pfizer; and Sanofi.Faculty/PlannerNeal D. Shore, MD, FACS, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for AbbVie; Accord Healthcare; Alessa Therapeutics; Amgen Inc.; Antev Ltd.; Arquer Diagnostics; Asieris Pharmaceuticals; Astellas Pharma Inc.; AstraZeneca; Aura Biosciences, Inc.; Bayer Corporation; BioProtect Ltd.; Boston Scientific Corporation; Bristol Myers Squibb; CG Oncology; Clarity Pharmaceuticals Ltd; Cold Genesys Inc; Dendreon Pharmaceuticals LLC; Exact Imaging; F. Hoffmann-La Roche Ltd./Genentech, Inc.; Ferring Pharmaceuticals; FIZE Medical; Foundation Medicine, Inc.; GenesisCare; ImmunityBio, Inc.; Incyte Corporation; Invitae Corporation; Janssen Pharmaceuticals, Inc.; Lantheus; Lilly; MDX; Merck & Co., Inc.; Minomic International Ltd; Myovant Sciences Ltd.; Myriad Genetics, Inc.; Nonagen Bioscience; Novartis Pharmaceuticals Corporation; Nymox Pharmaceutical Corporation; Pacific Edge; Palette Life Sciences, Inc.; Pfizer; Photocure; PlatformQ; PreView Medical, Inc.; ProFound Medical; Promaxo; Propella Therapeutics, Inc.; Protara Therapeutics Inc.; Sanofi Genzyme; Specialty Networks; Telix Pharmaceuticals Limited; Tolmar Pharmaceuticals, Inc.; and UroGen Pharma, Inc.Faculty/PlannerMatthew R. Smith, MD, PhD, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for Ambrx; Astellas Pharma Inc.; Bayer Corporation; Janssen Pharmaceuticals, Inc.; Lilly; 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/RRR865. CME/MOC/NCPD/CPE/AAPA/IPCE credit will be available until February 9, 2025.Custom Care Compass: Mastering Multifactorial Clinical Decision-Making in High-Risk HR+, HER2- 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/PlannerJoyce O'Shaughnessy, MD, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for AbbVie Inc.; Agendia; Amgen Inc.; Aptitude Health; AstraZeneca; Bayer HealthCare Pharmaceuticals, Inc.; Bristol Myers Squibb; Celgene Corporation; Daiichi Sankyo, Inc.; Duality Biologics; Eisai Inc.; F. Hoffmann-La Roche Ltd.; G1 Therapeutics, Inc.; Genentech, Inc.; Gilead Sciences, Inc.; GRAIL, Inc.; Halozyme, Inc.; Heron Therapeutics, Inc.; Immunomedics, Inc.; Ipsen Biopharmaceuticals, Inc.; Lilly; Merck & Co., Inc.; Myriad Genetics, Inc.; Nektar; Novartis Pharmaceuticals Corporation; Ontada LLC; Pfizer; Pharmacyclics LLC; Pierre Fabre group; prIME Oncology; Puma Biotechnology, Inc.; Samsung Bioepis; Sanofi; Scorpion Therapeutics, Inc.; Seagen Inc.; Stemline Therapeutics, Inc./The Menarini Group; Syndax Pharmaceuticals Inc.; Synthon; Taiho Oncology, Inc.; and Takeda Pharmaceutical Company Limited.Faculty/PlannerSara M. Tolaney, MD, MPH, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for 4D pharma plc; Aadi Bioscience, Inc.; ARC Therapeutics; Artios Pharma; AstraZeneca; Bayer HealthCare Pharmaceuticals, Inc.; BeyondSpring Pharmaceuticals Inc.; Blueprint Medicines; Bristol Myers Squibb; CytomX Therapeutics, Inc.; Daiichi Sankyo Inc.; eFFECTOR Therapeutics; Eisai Inc.; Exelixis, Inc.; Genentech, Inc./F. Hoffmann-La Roche Ltd.; Gilead Sciences, Inc.; Incyte; Jazz Pharmaceuticals; Lilly; Merck & Co., Inc.; Myovant Sciences Ltd.; Natera; Novartis Pharmaceuticals Corporation; Pfizer; Reveal Genomics; Sanofi; Seattle Genetics, Inc.; Stemline Therapeutics, Inc./The Menarini Group; Systimmune; Tango Therapeutics; Umoja Biopharma; Zentalis; Zetagen; and Zymeworks Inc.Grant/Research Support from AstraZeneca; Bristol Myers Squibb; Cyclacel Pharmaceuticals, Inc.; Eisai Inc.; Exelixis, Inc.; Genentech, Inc./F. Hoffmann-La Roche Ltd.; Gilead Sciences, Inc.; Lilly; Merck & Co., Inc.; NanoString Technologies Inc.; Nektar; Novartis Pharmaceuticals Corporation; Pfizer; Sanofi; and Seattle Genetics, Inc.Other Financial or Material Support from Steering committee for CytomX Therapeutics, Inc. and OncXerna Therapeutics, 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, downloadable Practice Aids, slides, and complete CME/MOC/NCPD/CPE/AAPA/IPCE information, and to apply for credit, please visit us at PeerView.com/RRR865. CME/MOC/NCPD/CPE/AAPA/IPCE credit will be available until February 9, 2025.Custom Care Compass: Mastering Multifactorial Clinical Decision-Making in High-Risk HR+, HER2- 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/PlannerJoyce O'Shaughnessy, MD, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for AbbVie Inc.; Agendia; Amgen Inc.; Aptitude Health; AstraZeneca; Bayer HealthCare Pharmaceuticals, Inc.; Bristol Myers Squibb; Celgene Corporation; Daiichi Sankyo, Inc.; Duality Biologics; Eisai Inc.; F. Hoffmann-La Roche Ltd.; G1 Therapeutics, Inc.; Genentech, Inc.; Gilead Sciences, Inc.; GRAIL, Inc.; Halozyme, Inc.; Heron Therapeutics, Inc.; Immunomedics, Inc.; Ipsen Biopharmaceuticals, Inc.; Lilly; Merck & Co., Inc.; Myriad Genetics, Inc.; Nektar; Novartis Pharmaceuticals Corporation; Ontada LLC; Pfizer; Pharmacyclics LLC; Pierre Fabre group; prIME Oncology; Puma Biotechnology, Inc.; Samsung Bioepis; Sanofi; Scorpion Therapeutics, Inc.; Seagen Inc.; Stemline Therapeutics, Inc./The Menarini Group; Syndax Pharmaceuticals Inc.; Synthon; Taiho Oncology, Inc.; and Takeda Pharmaceutical Company Limited.Faculty/PlannerSara M. Tolaney, MD, MPH, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for 4D pharma plc; Aadi Bioscience, Inc.; ARC Therapeutics; Artios Pharma; AstraZeneca; Bayer HealthCare Pharmaceuticals, Inc.; BeyondSpring Pharmaceuticals Inc.; Blueprint Medicines; Bristol Myers Squibb; CytomX Therapeutics, Inc.; Daiichi Sankyo Inc.; eFFECTOR Therapeutics; Eisai Inc.; Exelixis, Inc.; Genentech, Inc./F. Hoffmann-La Roche Ltd.; Gilead Sciences, Inc.; Incyte; Jazz Pharmaceuticals; Lilly; Merck & Co., Inc.; Myovant Sciences Ltd.; Natera; Novartis Pharmaceuticals Corporation; Pfizer; Reveal Genomics; Sanofi; Seattle Genetics, Inc.; Stemline Therapeutics, Inc./The Menarini Group; Systimmune; Tango Therapeutics; Umoja Biopharma; Zentalis; Zetagen; and Zymeworks Inc.Grant/Research Support from AstraZeneca; Bristol Myers Squibb; Cyclacel Pharmaceuticals, Inc.; Eisai Inc.; Exelixis, Inc.; Genentech, Inc./F. Hoffmann-La Roche Ltd.; Gilead Sciences, Inc.; Lilly; Merck & Co., Inc.; NanoString Technologies Inc.; Nektar; Novartis Pharmaceuticals Corporation; Pfizer; Sanofi; and Seattle Genetics, Inc.Other Financial or Material Support from Steering committee for CytomX Therapeutics, Inc. and OncXerna Therapeutics, 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, downloadable Practice Aids, slides, and complete CME/MOC/NCPD/CPE/AAPA/IPCE information, and to apply for credit, please visit us at PeerView.com/RRR865. CME/MOC/NCPD/CPE/AAPA/IPCE credit will be available until February 9, 2025.Custom Care Compass: Mastering Multifactorial Clinical Decision-Making in High-Risk HR+, HER2- 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/PlannerJoyce O'Shaughnessy, MD, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for AbbVie Inc.; Agendia; Amgen Inc.; Aptitude Health; AstraZeneca; Bayer HealthCare Pharmaceuticals, Inc.; Bristol Myers Squibb; Celgene Corporation; Daiichi Sankyo, Inc.; Duality Biologics; Eisai Inc.; F. Hoffmann-La Roche Ltd.; G1 Therapeutics, Inc.; Genentech, Inc.; Gilead Sciences, Inc.; GRAIL, Inc.; Halozyme, Inc.; Heron Therapeutics, Inc.; Immunomedics, Inc.; Ipsen Biopharmaceuticals, Inc.; Lilly; Merck & Co., Inc.; Myriad Genetics, Inc.; Nektar; Novartis Pharmaceuticals Corporation; Ontada LLC; Pfizer; Pharmacyclics LLC; Pierre Fabre group; prIME Oncology; Puma Biotechnology, Inc.; Samsung Bioepis; Sanofi; Scorpion Therapeutics, Inc.; Seagen Inc.; Stemline Therapeutics, Inc./The Menarini Group; Syndax Pharmaceuticals Inc.; Synthon; Taiho Oncology, Inc.; and Takeda Pharmaceutical Company Limited.Faculty/PlannerSara M. Tolaney, MD, MPH, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for 4D pharma plc; Aadi Bioscience, Inc.; ARC Therapeutics; Artios Pharma; AstraZeneca; Bayer HealthCare Pharmaceuticals, Inc.; BeyondSpring Pharmaceuticals Inc.; Blueprint Medicines; Bristol Myers Squibb; CytomX Therapeutics, Inc.; Daiichi Sankyo Inc.; eFFECTOR Therapeutics; Eisai Inc.; Exelixis, Inc.; Genentech, Inc./F. Hoffmann-La Roche Ltd.; Gilead Sciences, Inc.; Incyte; Jazz Pharmaceuticals; Lilly; Merck & Co., Inc.; Myovant Sciences Ltd.; Natera; Novartis Pharmaceuticals Corporation; Pfizer; Reveal Genomics; Sanofi; Seattle Genetics, Inc.; Stemline Therapeutics, Inc./The Menarini Group; Systimmune; Tango Therapeutics; Umoja Biopharma; Zentalis; Zetagen; and Zymeworks Inc.Grant/Research Support from AstraZeneca; Bristol Myers Squibb; Cyclacel Pharmaceuticals, Inc.; Eisai Inc.; Exelixis, Inc.; Genentech, Inc./F. Hoffmann-La Roche Ltd.; Gilead Sciences, Inc.; Lilly; Merck & Co., Inc.; NanoString Technologies Inc.; Nektar; Novartis Pharmaceuticals Corporation; Pfizer; Sanofi; and Seattle Genetics, Inc.Other Financial or Material Support from Steering committee for CytomX Therapeutics, Inc. and OncXerna Therapeutics, 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, downloadable Practice Aids, slides, and complete CME/MOC/NCPD/CPE/AAPA/IPCE information, and to apply for credit, please visit us at PeerView.com/RRR865. CME/MOC/NCPD/CPE/AAPA/IPCE credit will be available until February 9, 2025.Custom Care Compass: Mastering Multifactorial Clinical Decision-Making in High-Risk HR+, HER2- 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/PlannerJoyce O'Shaughnessy, MD, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for AbbVie Inc.; Agendia; Amgen Inc.; Aptitude Health; AstraZeneca; Bayer HealthCare Pharmaceuticals, Inc.; Bristol Myers Squibb; Celgene Corporation; Daiichi Sankyo, Inc.; Duality Biologics; Eisai Inc.; F. Hoffmann-La Roche Ltd.; G1 Therapeutics, Inc.; Genentech, Inc.; Gilead Sciences, Inc.; GRAIL, Inc.; Halozyme, Inc.; Heron Therapeutics, Inc.; Immunomedics, Inc.; Ipsen Biopharmaceuticals, Inc.; Lilly; Merck & Co., Inc.; Myriad Genetics, Inc.; Nektar; Novartis Pharmaceuticals Corporation; Ontada LLC; Pfizer; Pharmacyclics LLC; Pierre Fabre group; prIME Oncology; Puma Biotechnology, Inc.; Samsung Bioepis; Sanofi; Scorpion Therapeutics, Inc.; Seagen Inc.; Stemline Therapeutics, Inc./The Menarini Group; Syndax Pharmaceuticals Inc.; Synthon; Taiho Oncology, Inc.; and Takeda Pharmaceutical Company Limited.Faculty/PlannerSara M. Tolaney, MD, MPH, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for 4D pharma plc; Aadi Bioscience, Inc.; ARC Therapeutics; Artios Pharma; AstraZeneca; Bayer HealthCare Pharmaceuticals, Inc.; BeyondSpring Pharmaceuticals Inc.; Blueprint Medicines; Bristol Myers Squibb; CytomX Therapeutics, Inc.; Daiichi Sankyo Inc.; eFFECTOR Therapeutics; Eisai Inc.; Exelixis, Inc.; Genentech, Inc./F. Hoffmann-La Roche Ltd.; Gilead Sciences, Inc.; Incyte; Jazz Pharmaceuticals; Lilly; Merck & Co., Inc.; Myovant Sciences Ltd.; Natera; Novartis Pharmaceuticals Corporation; Pfizer; Reveal Genomics; Sanofi; Seattle Genetics, Inc.; Stemline Therapeutics, Inc./The Menarini Group; Systimmune; Tango Therapeutics; Umoja Biopharma; Zentalis; Zetagen; and Zymeworks Inc.Grant/Research Support from AstraZeneca; Bristol Myers Squibb; Cyclacel Pharmaceuticals, Inc.; Eisai Inc.; Exelixis, Inc.; Genentech, Inc./F. Hoffmann-La Roche Ltd.; Gilead Sciences, Inc.; Lilly; Merck & Co., Inc.; NanoString Technologies Inc.; Nektar; Novartis Pharmaceuticals Corporation; Pfizer; Sanofi; and Seattle Genetics, Inc.Other Financial or Material Support from Steering committee for CytomX Therapeutics, Inc. and OncXerna Therapeutics, 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. Neeraj Agarwal and Todd Morgan discuss CONTACT-02, KEYNOTE-564, CheckMate-67T, and other notable studies featured at the 2024 ASCO Genitourinary Cancers Symposium, as well as additional key abstracts in prostate, kidney, and bladder cancers that will significantly influence clinical practice. 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 and professor of medicine at the Huntsman Cancer Institute at the University of Utah, and editor-in-chief of ASCO Daily News. Today, we'll be discussing practice-changing abstracts and other key advances in GU oncology featured at the 2024 ASCO Genitourinary Cancers Symposium. Joining me for this discussion is Dr. Todd Morgan, the chair of this year's ASCO GU. Dr. Morgan is a urologic surgeon, chief of urologic oncology at Michigan Medicine, and a professor of urology at the University of Michigan. Our full disclosures are available in the transcript of this episode, and the disclosures of all guests on the podcast can be found at asco.org/DNpod. Todd, thank you for joining us today. Dr. Todd Morgan: Thanks so much, Neeraj. It's an honor to be here and I'm just thrilled to be able to do this with you. Dr. Neeraj Agarwal: Thank you. So, the GU meeting showcased significant advancements across the spectrum of GU malignancies. Can you tell us about the hot topics that captured the headlines this year? What did you find exciting this year at the ASCO GU Symposium? Dr. Todd Morgan: The theme of this year's meeting was "20 Years of Advancing Science and Transforming Patient Care," and this reflected ASCO GU's incredible milestone in GU cancer research over the last 2 decades. We were thrilled to welcome over 5,200 attendees from over 70 countries, and, believe it or not, there were more than 875 abstract submissions, compared to more than 300 in the meeting's first year. Most of the participants were present in person and that was fantastic. It enabled great networking opportunities and opportunities for experts, trainees, and mentees to exchange knowledge and ideas. Without a doubt, ASCO GU remains the annual meeting in our field, and it's amazing to hear the breadth and depth of the state-of-the-art science that's presented at this meeting, and so much of it impacts patient care the second that you return home. Additionally, the meeting's focus on diversity and interactivity, networking, multidisciplinary collaboration, and evidence-based care were absolutely phenomenal from my standpoint. We had a lunch session for women's networking that was a huge success—the first time we've done that. The keynote lecture by Dr. Cheryl Lee that talked about ensuring adequate representation in clinical trials was a huge hit, and we had tremendous positive feedback from that lecture. There were also multiple featured sessions on different diagnostic and therapeutic challenges in localized, recurrent, and advanced GU cancers. And, Neeraj, my personal favorite during the symposium is always the Trainee and Early-Career Networking Luncheon on the first day and then the additional networking luncheons on the 2 following days. I had great conversations with a ton of trainees and junior faculty, and I feel so fortunate for the opportunity to get to know the future superstars in our field. So I'd like to kick it back to you for a second because the first day started with a focus on prostate cancer and some of the key clinical trials. A great example is Abstract 17, which was the second oral presentation delivered, and really congratulations to you, Neeraj, on sharing the exciting data from the CONTACT-02 trial which we were eagerly awaiting. And I'd love to get your thoughts on the data that you presented. Could you tell us more about that trial? Dr. Neeraj Agarwal: Yes, Todd, I agree with you. It was such an exciting conference overall, and thank you for your leadership of this conference. So let's talk about the CONTACT-02 trial. It was a phase 3 randomized trial assessing the combination of cabozantinib and atezolizumab versus a second NHT in patients with metastatic castration-resistant prostate cancer after progression on one NHT. This patient population had to have extrapelvic soft tissue metastases, which could be liver metastases, lung metastases, or lymph nodal metastases, and about up to a quarter of patients had liver metastases. And overall, this was a high-risk patient population which was randomized to, as I said, cabozantinib plus atezolizumab versus a second line NHT. And these patients had received a prior NHT, mostly in the mCRPC setting.  The co- or dual primary endpoints were overall survival and progression-free survival (PFS). And a unique thing was that PFS was assessed only by RECIST 1.1 because, as per our discussions with regulatory authorities, the trial was focused on soft tissue metastases because of questions in the past that cabozantinib can affect bone lesions in an artifactual fashion, possibly concerns. That's why the PCWG 3 criteria were not used as the primary endpoint, but, of course, indeed used as another key endpoint, so we have information on both. Anyway, coming back to the endpoint 1:1 randomization. The randomization was stratified by presence or absence of liver metastases, prior docetaxel chemotherapy, and the setting in which NHT was given (mCSPC or CRPC). The PFS or primary endpoint was significantly improved with a 35% reduction in risk of progression or death with the cabozantinib-atezolizumab combination versus second NHT. And there was a trend for overall survival, with a hazard ratio of 0.79 favoring the cabozantinib-atezolizumab combination. Interestingly, all subgroups benefitted, regardless of age, region, site of metastases, but we decided to choose three clinical subgroups of interest such as patients with liver metastases, patients with prior docetaxel chemotherapy in the castration-sensitive setting, and bone metastases, and all these subgroups seemed to be benefitting with the strongest signal in the liver metastasis subgroup, with a 57% reduction in risk of progression or death, which I would argue we have never seen with any combination or any regimen in the metastatic prostate cancer setting yet, barring some targeted therapies in very selected patients. But overall, across the non-biomarker-selected patients, we have never seen this kind of signal. Toxicity — no discussion is complete without discussing toxicity, so I would like to highlight that. Safety signal — there were no new safety signals. The most common grade 3-4 adverse events were hypertension in 7%, anemia in 6%, which were similar in both arms, and, of course, diarrhea and fatigue in 4% each. And if we look at the secondary endpoints, such as time to chemotherapy and time to symptomatic skeletal events, they tended to favor the cabozantinib-atezolizumab. To sum it up, cabozantinib-atezolizumab showed a significant PFS benefit, with a 35% reduction in risk of progression or death, with a trend for overall survival in this patient population with an unmet need. So thank you so much, Todd, for allowing me to summarize the results of this trial. Dr. Todd Morgan: Yeah, wow. That's so impressive, and not surprising that you could so fluidly go right through all that data. Amazing. We heard some discussion of the NHT control arm in this trial. Could you discuss that for a bit? Because it obviously has implications on the similar control arm of other ongoing trials in this setting. Dr. Neeraj Agarwal: Absolutely. Pretty much all trials, every trial which has recently been reported or started in metastatic castrate-resistant prostate cancer have a similar second NHT arm. Whether there were multiple immunotherapy trials which we have just reported, or new trials which are starting or just started enrolling patients. And the reason for that is no randomized trial has ever shown superiority of docetaxel chemotherapy over a second NHT after failure of prior NHT in the mCRPC setting. That's number one. If you look at NHT as a control, it is accepted by health authorities globally with multiple recent trials which are just starting also having NHDR and it would not have been possible without the approval of global regulatory authorities across the world.  Then, if you look at the recently reported trial in the mCRPC setting with prior treatment with an NHT, there is an indication that chemotherapy may not be superior to NHT. For example, in the KEYNOTE-641 trial in patients with mCRPC with prior NHT, randomizing patients to enzalutamide plus pembrolizumab versus enzalutamide, the median PFS with enzalutamide was 9 months. This is very similar with docetaxel in patients randomized to docetaxel plus pembrolizumab versus docetaxel; the median PFS with docetaxel is 8 months or 8.3 months. And lastly, if you really want to have a comparison of chemotherapy with NHT which has been done after progression on NHT and docetaxel chemotherapy, so later line of mCRPC setting, that is the CARD trial, as you can imagine, cabazitaxel versus NHT, especially in patients with visceral metastasis, which was the point of discussion. For example, people may not feel comfortable randomizing patients to NHT compared to taxane. The hazard ratio for PFS supporting cabazitaxel was 0.79, so almost a 0.80 PFS hazard ratio, which we have never seen turning out to be a clinically significant benefit. So, if you combine all these data together, I think it was absolutely acceptable to us as investigators to have a second NHT as the control arm. And of course, when we are consenting the patient, we have to keep alternatives in mind, and we do talk about those alternatives with the patients. And if alternatives seem more applicable, we should not be talking to patients about those clinical trials or a given clinical trial in the clinic. I'm glad you brought this up, Todd, because this control NHT arm is not an issue with this trial, but all trials which should be presented in GU ASCO in the future meetings in the coming years. So, thank you. Dr. Todd Morgan: Yeah, thank you. It's such an important topic and controversy at some level, but it's a difficult problem to think about and obviously highly relevant to all the trials that we're looking at. Congrats again on that trial, that's tremendous. There was another important randomized phase 3 trial and it covers radiotherapy in patients with high-risk localized prostate cancer. Can you give us your insights on that one? Dr. Neeraj Agarwal: Yeah, Todd, I think you are referring to LBA259, titled "Long-term Results of Dose Escalation of Radiation Therapy from 70 Gy to 80 Gy Combined with Long-term Androgen Deprivation Therapy in High-risk Prostate Cancer: The GETUG-AFU 18 Randomized Trial." As you mentioned, in this randomized phase 3 trial, Dr. Christophe Hennequin and colleagues randomized patients with high-risk prostate cancer, which means they had to have either clinical stage T3 or T4 disease, or PSA ≥20 nanograms per milliliter, or a Gleason score between 8 and 10. These patients were randomized to receive ADT for 3 years combined with either dose-escalated intensity-modulated radiotherapy. So, I'd like to highlight, this was in the context of IMRT in the dose of 80 Gy or a conventional dose of 70 Gy. Now, you can argue that more people are using more than 70 Gy nowadays, but across the world, the conventional dose is still considered 70 Gy. So, 80 Gy versus 70 Gy were tested. Patients also had to have negative lymph node status on CT scans and MRI. The primary endpoint was biochemical progression-free survival or clinical progression-free survival at 5 years following the ASTRO Phoenix definition. Secondary endpoints – and these are quite important secondary endpoints – include overall survival, acute and late toxicity, and quality of life. The best part is that this trial met its primary endpoint with a 44% reduction in risk of biochemical or clinical progression or death in the dose-escalation radiotherapy arm compared with the conventional radiotherapy arm. Interestingly, a significant 52% improvement in prostate cancer-specific survival and a 39% improvement in overall survival was observed in the dose-escalated arm. So, 80 Gy continued to be superior to 70 Gy IMRT across the primary and secondary endpoints. Now, the best part is, regarding the toxicity profile, there was no significant difference between the 2 arms, with 78% of patients in the higher dose arm and 76% of patients in the conventional arm experiencing grade 2 or more toxicities. Dr. Todd Morgan: Great summary and really important, great news for our patients. Of course, it's a slightly different setting as it's high-risk localized prostate cancer. I checked in with our radiation oncologists at the University of Michigan after that [presentation] because I couldn't remember exactly where we are in terms of dose on these patients. And they were like, “Yeah, we've been doing 80 to 90 Gy for several years,” so it's great having this data to support that. And I think, as you said, the field at many centers has already moved that way. And again, the key takeaway from this abstract would be that IMRT, in combination with long-term androgen deprivation therapy, is effective and safe and increases not only the biochemical or clinical PFS rate, but also the cancer-specific survival and overall survival, again, in high-risk localized prostate cancer patients. And it does not appear to increase long-term toxicity. So really important. It'd be great to switch gears and discuss kidney cancer, if that's okay, and talk about some key abstracts in that field. What do you think? Dr. Neeraj Agarwal: There were so many exciting data in all cancers, which is amazing. So, Todd, could tell us about the LBA359, which I thought was one of the most impactful abstract presentations in the ASCO GU this year. It was titled, “Overall Survival Results from the Phase 3 KEYNOTE-564 Study of Adjuvant Pembrolizumab Versus Placebo for Treatment of Clear Cell Renal Cell Carcinoma (ccRCC)."   Dr. Todd Morgan: Yeah, this was a really big moment in our field, complete with a mid-presentation round of applause that was well deserved. And so this abstract was presented by Dr. Toni Choueiri from Dana-Farber Cancer Institute, and it included patients with clear cell renal cell carcinoma at intermediate high or high risk of recurrence, meaning that they had positive nodal disease or negative nodal disease with PT 2 and grade 4, or sarcomatoid features, or stage PT 3 or 4. These patients underwent nephrectomy with or without metastasectomy less than 12 weeks before randomization and had not received prior systemic therapy for clear cell RCC. Patients were randomized to receive either pembrolizumab 200 milligrams or placebo IV every three weeks for at least 17 cycles, or until disease recurrence, intolerable toxicity, or withdrawal of consent. Disease-free survival by investigator assessment was the primary endpoint, and overall survival was a key secondary endpoint. In this abstract, Dr. Choueiri and colleagues report results of the third prespecified interim analysis with a median follow-up of around 57 months in 496 patients receiving pembrolizumab and 498 patients receiving placebo. So, just as a reminder to the audience here, the first interim analysis reported at a median follow-up of 24 months and showed a significant reduction of 32% in the risk to recurrence or death in patients in the pembrolizumab arm. Then subsequently in November of 2021, the FDA approved pembrolizumab for the adjuvant treatment of patients with RCC who are at intermediate high or high risk of recurrence following nephrectomy or following nephrectomy and resection of metastatic lesions. At that time, though, overall survival data were still immature. So, at the third prespecified interim analysis with a median follow-up of around 57 months, pembrolizumab showed, for the first time in an adjuvant RCC setting, improved overall survival with a 38% reduction in the risk of death. The estimated OS rate at 48 months was 91.2% with pembrolizumab and 86% with placebo. Furthermore, the OS benefit was observed across key subgroups, including patients with non-metastatic disease, patients with metastatic but no evidence of disease, patients with PDL-1 combined positive score less than or greater than or equal to one, and patients with presence or absence of sarcomatoid features. In each of these subgroups, the forest plot looks really impressive. And the DFS benefit was similar to previously reported interim analyses with a hazard ratio of 0.72. Also, no new safety signals with pembrolizumab were observed so just tremendous data. Dr. Neeraj Agarwal: Thank you, Todd, for such a great summary of these very important results. So the key message from this abstract, as you said, is that after a median follow-up of around 57 months, which is a long follow-up, adjuvant pembrolizumab demonstrates a statistically significant and clinically meaningful improvement in overall survival versus placebo in patients with RCC at high risk of disease recurrence after surgery. And this is, by the way, the first phase 3 study to show improved overall survival with any adjuvant therapy in RCC. Basically, this means we should continue to use adjuvant pembrolizumab or at least bring it up in our discussion with our patients who are in a similar situation with high-risk RCC after surgery. So this is great news overall. Todd, there was another kidney cancer abstract, LBA360, which compared, interestingly, subcutaneous nivolumab with intravenous nivolumab in patients with metastatic renal cell carcinoma. Could you please give us your insight about this abstract?   Dr. Todd Morgan: Sure. Really interesting study. Really interesting data that were presented. So as you mentioned, CheckMate 67T was a multicenter, randomized, open-label phase three study led by Dr. Saby George and colleagues that evaluated pharmacokinetics and objective response rate non-inferiority of subcutaneous nivolumab versus IV nivolumab in patients with locally advanced or metastatic clear cell RCC. So patients with measurable disease that progressed during or after 1 to 2 prior systemic regimens and who did not receive a prior immuno-oncology treatment were randomized 1-1 to receive either subcutaneous nivolumab 1200 milligrams every 4 weeks or IV nivolumab 3 milligrams per kilogram every two weeks until disease progression, unacceptable toxicity, withdrawal of consent, completion of two years of treatment, or death. The coprimary pharmacokinetics endpoints for non-inferiority testing were time-average serum concentration over the first 28 days and minimum serum concentration at steady state determined by a population pharmacokinetics analysis. A key secondary endpoint was objective response rate by independent review. So in 248 patients receiving subcutaneous nivolumab and 247 patients receiving IV nivolumab, non-inferiority for the coprimary pharmacokinetics and key-powered secondary objective response rate endpoints were met. The relative risk ratio for objective response rate was 1.33. The median PFS by independent review was 7.23 months in the subcutaneous group and 5.65 months in the IV group. Treatment-related serious adverse events occurred in 6.5% of patients in each group, and study drug toxicity led to 3 deaths in the subcutaneous group and 1 death in the IV group. These results could support using subcutaneous nivolumab as a new option to improve healthcare efficiency, especially since the average injection time with subcutaneous nivolumab was less than 5 minutes. I think we all know what issues are going on in infusion beds across the country, including, I'm sure, your center and mine. Dr. Neeraj Agarwal: Yes, absolutely. I think this is great news for our patients, Todd. Thank you. This shows that we are not only improving therapeutic options and diagnostic tools, but maybe we're also on the right track towards more practical administration routes, assisting in addressing the treatment burden and improving the efficiencies of healthcare systems. We love to have this option available for our patients, especially those who are pressed for time. So, Todd, would you like to move on to bladder cancer now?  Dr. Todd Morgan: Yeah, Neeraj, that'll be fantastic. I'm sure listeners would love to hear more about LBA530. Could you tell us more about this one, Neeraj? Dr. Neeraj Agarwal: Of course. I think this abstract is titled "Enfortumab Vedotin in Combination with Pembrolizumab Versus Chemotherapy in Previously Untreated, Locally Advanced or Metastatic Urothelial Carcinoma: Subgroup Analysis Results from EV-302," which was a global phase three study and was presented by Dr. Michiel Van Der Heijden. As our audience may recall, the EV-302 trial was presented at the ESMO 2023 meeting by Dr Tom Powles and the results were very exciting where, for the first time, a combination outperformed traditional gemcitabine-cisplatin chemotherapy. In this trial, patients with previously untreated with metastatic advanced urothelial carcinoma were randomized 1-1 to receive a 3-week cycle of a combination of enfortumab vedotin, which, as we know, is an antibody-drug conjugate targeting nectin-4 expressed on the cancer cells and pembrolizumab, which is a PD-1 inhibitor, versus gemcitabine and cisplatin or carboplatin, which were, until recently, the standard of care in this setting, and continue to be so in many countries in the world. The combination of enfortumab and pembrolizumab reduced the risk of progression or death by 55% and reduced the risk of death by 53% in the overall population. So consistent decrease in the hazard ratios for PFS and OS, and consistent improvement in overall survival and PFS in that previously reported presentation in the ESMO 2023. Now, based on these results, this combination was recently approved by the FDA in December 2023 for patients with advanced or metastatic urothelial carcinoma. So now the abstract, which was presented at the ASCO GU 2024 meeting, reported the results of a prespecified subgroup analysis. Select secondary endpoints included objective responses, duration of response, and safety. In 442 patients receiving the combination of enfortumab vedotin plus pembrolizumab, and a similar number of patients receiving chemotherapy both PFS and OS were higher for the combination of EV and pembro among prespecified subgroups such as race, platinum eligibility, PDL-1 expression, metastatic site, involvement of the liver or kidney function. Interestingly, the combination of EV and pembro reduced the risk of death by 53% in patients with visceral metastasis and 54% in patients with node-only metastasis. The improvement in PFS seems to be consistent regardless of the site of metastasis. In patients with moderate to severe renal function, the risk of death was reduced by 50% in patients receiving combination therapy. This is one of the best findings of these results because we always face challenges in treating patients with suboptimal kidney function and we cannot use cisplatin. Overall, EV plus pembro continues to show superior efficacy compared to platinum-based regimens across subgroups across the subgroups across the site of metastasis regardless of kidney function and so on. Dr. Todd Morgan: Yeah, just amazing data. I love hearing you spell it out like that. So, thank you again for the opportunity for me to sit here with you and listen to you talk about these data. It's impressive that we have been able to expand our therapeutic arsenal for urothelial carcinoma with an immune-targeting regimen that can spare our patients potential side effects of chemotherapy. What would your final takeaway on this abstract be? Dr. Neeraj Agarwal: I agree with you, Todd. I would add that the OS benefit was consistently observed across these select prespecified subgroups, including those historically associated with poor prognosis. The results of this new analysis support the finding of primary results, which indicate that EV plus pembro is a potentially new standard of care for patients with newly diagnosed, locally advanced, or metastatic urothelial carcinoma. Before we wrap up the bladder cancer session and the podcast, Todd, could you please give us insights about LBA531? Dr. Todd Morgan: Yeah, absolutely. I loved getting to hear this abstract presented. This one is titled “Ambassador,” known as the AMBASSADOR trial aligns A031501, a phase 3 randomized adjuvant study of pembrolizumab in muscle-invasive and locally advanced urothelial carcinoma versus observation, that was presented by Dr. Andrea Apolo. It's an open-label, randomized, phase 3 trial that included patients with muscle-invasive urothelial carcinoma of the bladder, upper tract, or urethra. Eligible patients had pathologic tumor stage T2 or greater and/or positive pathologic nodal disease or positive margins at surgery following neoadjuvant chemotherapy, or patients with pathologic tumor stage T3 or greater and/or positive pathologic nodal disease or positive margins at surgery without prior neoadjuvant chemotherapy, and who were cisplatin ineligible or declined adjuvant cisplatin-based therapy. These patients were randomized one to one to either receive pembrolizumab 200 milligrams every 3 weeks for 1 year or observation. The dual primary endpoints were disease-free survival and overall survival. Secondary objectives included evaluation of DFS and OS in PDL-1 positive and negative patients and assessing safety. A total of 354 patients were enrolled to receive pembrolizumab and 348 to the observation arm, and 21% of the patients in the observation arm received a subsequent immune checkpoint inhibitor. At a median follow-up of 22.3 months for DFS, the median disease-free survival in the pembrolizumab arm was 29 months, while it was only 14 months in the observation arm with a hazard ratio of 0.69. At the interim analysis, OS data showed only a trend toward better outcomes in the pembrolizumab arm, which did not, however, reach statistical significance, with a median of 50.9 months in the pembrolizumab arm and 55.8 months in the observation arm with a hazard ratio of 0.98. These results could nevertheless have been impacted by the subsequent treatment of patients in the observation arm with an immune checkpoint inhibitor, especially after the FDA approval of nivolumab in 2021 for patients with muscle-invasive urothelial carcinoma, based on results of the CheckMate 274 trial. In terms of the safety profile, grade three or more adverse events occurred in 48.4% of patients in the pembrolizumab arm and 31.8% of patients in the observation arm. Dr. Neeraj Agarwal: That's great, Todd. This is such a great summary of this trial, and this is exciting news for our patients with muscle-invasive urothelial carcinoma. I'm hoping that pembrolizumab will be another option for our patients when we are discussing adjuvant immunotherapy in the clinic, moving forward very soon. With that, we have covered several abstracts addressing prostate, bladder, and kidney cancer, significantly influencing our medical practices, at least at the current moment or in the near future. Todd, thank you for sharing your insights today. These are undoubtedly exciting updates for all members of the GU oncology community, and we are grateful for your valuable contribution to the discussion. Many thanks. Dr. Todd Morgan: Thanks, for having me, Neeraj; this was really fun. I'm just really proud and excited to still be part of this field, to be part of the GU oncology field, and it continues to be exciting for all the folks who are coming up. Dr. Neeraj Agarwal: Indeed. 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 podcasts. Thank you very much.   Disclaimer: The purpose of this podcast is to educate and 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. Todd Morgan @wandering_gu   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. Todd Morgan: Consulting or Advisory Role: Myriad Genetics, MDxHealth, TerumoBCT Research Funding (Institution): Prostate Cancer Foundation, National Institutes of Health, Department of Defence, GenomeDX Biosciences, Myriad Genetics, MDxHealth  

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/XJV865. CME/MOC/AAPA credit will be available until December 28, 2024.Pioneering Precision Medicine in Bladder Cancer: Multidisciplinary Perspectives on Personalizing Patient Care In support of improving patient care, this activity has been planned and implemented by PVI, PeerView Institute for Medical Education, and Bladder Cancer Advocacy Network. 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, Bristol Myers Squibb, Janssen Biotech, Inc., administered by Janssen Scientific Affairs, LLC, and Merck & Co., Inc.Disclosure PolicyAll relevant conflicts of interest have been mitigated prior to the commencement of the activity.Faculty/Planner DisclosuresChair/PlannerNeal D. Shore, MD, FACS, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for AbbVie; Accord Healthcare; Alessa Therapeutics; Amgen Inc.; Arquer Diagnostics; Asieris Pharmaceuticals; Astellas Pharma Inc.; AstraZeneca; Aurora Biosciences; Bayer Corporation; BioProtect Ltd.; Boston Scientific Corporation; Bristol Myers Squibb; CG Oncology; Clarity Pharmaceuticals Ltd; Dendreon Pharmaceuticals LLC; Exact Images; Ferring Pharmaceuticals; FIZE Medical; Foundation Medicine, Inc.; F. Hoffmann-La Roche Ltd./Genentech Inc.; GenesisCare; ImmunityBio; Incyte Corporation; Invitae Corporation; Janssen Pharmaceuticals, Inc.; Lantheus; Lilly; MDX; Merck & Co., Inc.; Minomic International Ltd; Myovant Sciences Ltd; Myriad Genetics, Inc.; Nonagen Bioscience; Novartis Pharmaceuticals Corporation; Nymox Pharmaceutical Corporation; Pacific Edge; Palette Life Sciences, Inc.; Pfizer; Photocure; PlatformQ; ProFound Therapeutics; Promaxo; Propella Therapeutics, Inc.; Protara Therapeutics Inc.; Sanofi/Genzyme; Specialty Networks; Telix Pharmaceuticals; Tolmar Pharmaceuticals, Inc.; and UroGen Pharma, Inc.Faculty/PlannerSia Daneshmand, MD, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for Ferring Pharmaceuticals; Janssen Pharmaceuticals, Inc.; Pacific Edge; Pfizer; Photocure; Protara Therapeutics, Inc.; Sesen Bio (Carisma Therapeutics); TARIS Biomedical; and UroGen.Grant/Research Support from Janssen Pharmaceuticals, Inc.Faculty/PlannerGuru P. Sonpavde, MD, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for AstraZeneca; Bicycle Therapeutics; Bristol Myers Squibb; EMD Serono Inc.; Ellipses Pharma; Exelixis, Inc.; G1 Therapeutics, Inc.; Genentech, Inc.; Gilead Sciences, Inc.; Infinity Pharmaceuticals, Inc.; IMV Inc.; Janssen Pharmaceuticals, Inc.; Lilly/Loxo Oncology, Inc.; Lucence Health Inc.; Merck & Co., Inc.; Pfizer; PRECISCA; Sanofi; Scholar Rock; Seattle Genetics (Seagen Inc.)/Astellas Pharma Inc.; Servier Laboratories; SUBA THERAPEUTICS, INC.; Syapse; Syncorp Health; Tempus; and Vial.Grant/Research Support from AstraZeneca; Bristol Myers Squibb; EMD Serono Inc.; Gilead Sciences, Inc.; Helsinn Healthcare SA; Jazz Pharmaceuticals; Lucence; and Sanofi. Research support to institution.Speaker for AVEO Pharmaceuticals, Inc.; Bayer Corporation; BIO Brazilian Information Oncology; Exelixis, Inc.; Gilead Sciences, Inc.; Janssen Pharmaceuticals, Inc.; Natera, Inc.; OLE Forum (Mexico); and Seagen 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, downloadable Practice Aids, slides, and complete CME/MOC/AAPA information, and to apply for credit, please visit us at PeerView.com/XJV865. CME/MOC/AAPA credit will be available until December 28, 2024.Pioneering Precision Medicine in Bladder Cancer: Multidisciplinary Perspectives on Personalizing Patient Care In support of improving patient care, this activity has been planned and implemented by PVI, PeerView Institute for Medical Education, and Bladder Cancer Advocacy Network. 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, Bristol Myers Squibb, Janssen Biotech, Inc., administered by Janssen Scientific Affairs, LLC, and Merck & Co., Inc.Disclosure PolicyAll relevant conflicts of interest have been mitigated prior to the commencement of the activity.Faculty/Planner DisclosuresChair/PlannerNeal D. Shore, MD, FACS, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for AbbVie; Accord Healthcare; Alessa Therapeutics; Amgen Inc.; Arquer Diagnostics; Asieris Pharmaceuticals; Astellas Pharma Inc.; AstraZeneca; Aurora Biosciences; Bayer Corporation; BioProtect Ltd.; Boston Scientific Corporation; Bristol Myers Squibb; CG Oncology; Clarity Pharmaceuticals Ltd; Dendreon Pharmaceuticals LLC; Exact Images; Ferring Pharmaceuticals; FIZE Medical; Foundation Medicine, Inc.; F. Hoffmann-La Roche Ltd./Genentech Inc.; GenesisCare; ImmunityBio; Incyte Corporation; Invitae Corporation; Janssen Pharmaceuticals, Inc.; Lantheus; Lilly; MDX; Merck & Co., Inc.; Minomic International Ltd; Myovant Sciences Ltd; Myriad Genetics, Inc.; Nonagen Bioscience; Novartis Pharmaceuticals Corporation; Nymox Pharmaceutical Corporation; Pacific Edge; Palette Life Sciences, Inc.; Pfizer; Photocure; PlatformQ; ProFound Therapeutics; Promaxo; Propella Therapeutics, Inc.; Protara Therapeutics Inc.; Sanofi/Genzyme; Specialty Networks; Telix Pharmaceuticals; Tolmar Pharmaceuticals, Inc.; and UroGen Pharma, Inc.Faculty/PlannerSia Daneshmand, MD, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for Ferring Pharmaceuticals; Janssen Pharmaceuticals, Inc.; Pacific Edge; Pfizer; Photocure; Protara Therapeutics, Inc.; Sesen Bio (Carisma Therapeutics); TARIS Biomedical; and UroGen.Grant/Research Support from Janssen Pharmaceuticals, Inc.Faculty/PlannerGuru P. Sonpavde, MD, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for AstraZeneca; Bicycle Therapeutics; Bristol Myers Squibb; EMD Serono Inc.; Ellipses Pharma; Exelixis, Inc.; G1 Therapeutics, Inc.; Genentech, Inc.; Gilead Sciences, Inc.; Infinity Pharmaceuticals, Inc.; IMV Inc.; Janssen Pharmaceuticals, Inc.; Lilly/Loxo Oncology, Inc.; Lucence Health Inc.; Merck & Co., Inc.; Pfizer; PRECISCA; Sanofi; Scholar Rock; Seattle Genetics (Seagen Inc.)/Astellas Pharma Inc.; Servier Laboratories; SUBA THERAPEUTICS, INC.; Syapse; Syncorp Health; Tempus; and Vial.Grant/Research Support from AstraZeneca; Bristol Myers Squibb; EMD Serono Inc.; Gilead Sciences, Inc.; Helsinn Healthcare SA; Jazz Pharmaceuticals; Lucence; and Sanofi. Research support to institution.Speaker for AVEO Pharmaceuticals, Inc.; Bayer Corporation; BIO Brazilian Information Oncology; Exelixis, Inc.; Gilead Sciences, Inc.; Janssen Pharmaceuticals, Inc.; Natera, Inc.; OLE Forum (Mexico); and Seagen 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, downloadable Practice Aids, slides, and complete CME/MOC/AAPA information, and to apply for credit, please visit us at PeerView.com/XJV865. CME/MOC/AAPA credit will be available until December 28, 2024.Pioneering Precision Medicine in Bladder Cancer: Multidisciplinary Perspectives on Personalizing Patient Care In support of improving patient care, this activity has been planned and implemented by PVI, PeerView Institute for Medical Education, and Bladder Cancer Advocacy Network. 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, Bristol Myers Squibb, Janssen Biotech, Inc., administered by Janssen Scientific Affairs, LLC, and Merck & Co., Inc.Disclosure PolicyAll relevant conflicts of interest have been mitigated prior to the commencement of the activity.Faculty/Planner DisclosuresChair/PlannerNeal D. Shore, MD, FACS, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for AbbVie; Accord Healthcare; Alessa Therapeutics; Amgen Inc.; Arquer Diagnostics; Asieris Pharmaceuticals; Astellas Pharma Inc.; AstraZeneca; Aurora Biosciences; Bayer Corporation; BioProtect Ltd.; Boston Scientific Corporation; Bristol Myers Squibb; CG Oncology; Clarity Pharmaceuticals Ltd; Dendreon Pharmaceuticals LLC; Exact Images; Ferring Pharmaceuticals; FIZE Medical; Foundation Medicine, Inc.; F. Hoffmann-La Roche Ltd./Genentech Inc.; GenesisCare; ImmunityBio; Incyte Corporation; Invitae Corporation; Janssen Pharmaceuticals, Inc.; Lantheus; Lilly; MDX; Merck & Co., Inc.; Minomic International Ltd; Myovant Sciences Ltd; Myriad Genetics, Inc.; Nonagen Bioscience; Novartis Pharmaceuticals Corporation; Nymox Pharmaceutical Corporation; Pacific Edge; Palette Life Sciences, Inc.; Pfizer; Photocure; PlatformQ; ProFound Therapeutics; Promaxo; Propella Therapeutics, Inc.; Protara Therapeutics Inc.; Sanofi/Genzyme; Specialty Networks; Telix Pharmaceuticals; Tolmar Pharmaceuticals, Inc.; and UroGen Pharma, Inc.Faculty/PlannerSia Daneshmand, MD, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for Ferring Pharmaceuticals; Janssen Pharmaceuticals, Inc.; Pacific Edge; Pfizer; Photocure; Protara Therapeutics, Inc.; Sesen Bio (Carisma Therapeutics); TARIS Biomedical; and UroGen.Grant/Research Support from Janssen Pharmaceuticals, Inc.Faculty/PlannerGuru P. Sonpavde, MD, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for AstraZeneca; Bicycle Therapeutics; Bristol Myers Squibb; EMD Serono Inc.; Ellipses Pharma; Exelixis, Inc.; G1 Therapeutics, Inc.; Genentech, Inc.; Gilead Sciences, Inc.; Infinity Pharmaceuticals, Inc.; IMV Inc.; Janssen Pharmaceuticals, Inc.; Lilly/Loxo Oncology, Inc.; Lucence Health Inc.; Merck & Co., Inc.; Pfizer; PRECISCA; Sanofi; Scholar Rock; Seattle Genetics (Seagen Inc.)/Astellas Pharma Inc.; Servier Laboratories; SUBA THERAPEUTICS, INC.; Syapse; Syncorp Health; Tempus; and Vial.Grant/Research Support from AstraZeneca; Bristol Myers Squibb; EMD Serono Inc.; Gilead Sciences, Inc.; Helsinn Healthcare SA; Jazz Pharmaceuticals; Lucence; and Sanofi. Research support to institution.Speaker for AVEO Pharmaceuticals, Inc.; Bayer Corporation; BIO Brazilian Information Oncology; Exelixis, Inc.; Gilead Sciences, Inc.; Janssen Pharmaceuticals, Inc.; Natera, Inc.; OLE Forum (Mexico); and Seagen 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, downloadable Practice Aids, slides, and complete CME/MOC/AAPA information, and to apply for credit, please visit us at PeerView.com/XJV865. CME/MOC/AAPA credit will be available until December 28, 2024.Pioneering Precision Medicine in Bladder Cancer: Multidisciplinary Perspectives on Personalizing Patient Care In support of improving patient care, this activity has been planned and implemented by PVI, PeerView Institute for Medical Education, and Bladder Cancer Advocacy Network. 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, Bristol Myers Squibb, Janssen Biotech, Inc., administered by Janssen Scientific Affairs, LLC, and Merck & Co., Inc.Disclosure PolicyAll relevant conflicts of interest have been mitigated prior to the commencement of the activity.Faculty/Planner DisclosuresChair/PlannerNeal D. Shore, MD, FACS, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for AbbVie; Accord Healthcare; Alessa Therapeutics; Amgen Inc.; Arquer Diagnostics; Asieris Pharmaceuticals; Astellas Pharma Inc.; AstraZeneca; Aurora Biosciences; Bayer Corporation; BioProtect Ltd.; Boston Scientific Corporation; Bristol Myers Squibb; CG Oncology; Clarity Pharmaceuticals Ltd; Dendreon Pharmaceuticals LLC; Exact Images; Ferring Pharmaceuticals; FIZE Medical; Foundation Medicine, Inc.; F. Hoffmann-La Roche Ltd./Genentech Inc.; GenesisCare; ImmunityBio; Incyte Corporation; Invitae Corporation; Janssen Pharmaceuticals, Inc.; Lantheus; Lilly; MDX; Merck & Co., Inc.; Minomic International Ltd; Myovant Sciences Ltd; Myriad Genetics, Inc.; Nonagen Bioscience; Novartis Pharmaceuticals Corporation; Nymox Pharmaceutical Corporation; Pacific Edge; Palette Life Sciences, Inc.; Pfizer; Photocure; PlatformQ; ProFound Therapeutics; Promaxo; Propella Therapeutics, Inc.; Protara Therapeutics Inc.; Sanofi/Genzyme; Specialty Networks; Telix Pharmaceuticals; Tolmar Pharmaceuticals, Inc.; and UroGen Pharma, Inc.Faculty/PlannerSia Daneshmand, MD, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for Ferring Pharmaceuticals; Janssen Pharmaceuticals, Inc.; Pacific Edge; Pfizer; Photocure; Protara Therapeutics, Inc.; Sesen Bio (Carisma Therapeutics); TARIS Biomedical; and UroGen.Grant/Research Support from Janssen Pharmaceuticals, Inc.Faculty/PlannerGuru P. Sonpavde, MD, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for AstraZeneca; Bicycle Therapeutics; Bristol Myers Squibb; EMD Serono Inc.; Ellipses Pharma; Exelixis, Inc.; G1 Therapeutics, Inc.; Genentech, Inc.; Gilead Sciences, Inc.; Infinity Pharmaceuticals, Inc.; IMV Inc.; Janssen Pharmaceuticals, Inc.; Lilly/Loxo Oncology, Inc.; Lucence Health Inc.; Merck & Co., Inc.; Pfizer; PRECISCA; Sanofi; Scholar Rock; Seattle Genetics (Seagen Inc.)/Astellas Pharma Inc.; Servier Laboratories; SUBA THERAPEUTICS, INC.; Syapse; Syncorp Health; Tempus; and Vial.Grant/Research Support from AstraZeneca; Bristol Myers Squibb; EMD Serono Inc.; Gilead Sciences, Inc.; Helsinn Healthcare SA; Jazz Pharmaceuticals; Lucence; and Sanofi. Research support to institution.Speaker for AVEO Pharmaceuticals, Inc.; Bayer Corporation; BIO Brazilian Information Oncology; Exelixis, Inc.; Gilead Sciences, Inc.; Janssen Pharmaceuticals, Inc.; Natera, Inc.; OLE Forum (Mexico); and Seagen 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, downloadable Practice Aids, slides, and complete CME/MOC/AAPA information, and to apply for credit, please visit us at PeerView.com/XJV865. CME/MOC/AAPA credit will be available until December 28, 2024.Pioneering Precision Medicine in Bladder Cancer: Multidisciplinary Perspectives on Personalizing Patient Care In support of improving patient care, this activity has been planned and implemented by PVI, PeerView Institute for Medical Education, and Bladder Cancer Advocacy Network. 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, Bristol Myers Squibb, Janssen Biotech, Inc., administered by Janssen Scientific Affairs, LLC, and Merck & Co., Inc.Disclosure PolicyAll relevant conflicts of interest have been mitigated prior to the commencement of the activity.Faculty/Planner DisclosuresChair/PlannerNeal D. Shore, MD, FACS, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for AbbVie; Accord Healthcare; Alessa Therapeutics; Amgen Inc.; Arquer Diagnostics; Asieris Pharmaceuticals; Astellas Pharma Inc.; AstraZeneca; Aurora Biosciences; Bayer Corporation; BioProtect Ltd.; Boston Scientific Corporation; Bristol Myers Squibb; CG Oncology; Clarity Pharmaceuticals Ltd; Dendreon Pharmaceuticals LLC; Exact Images; Ferring Pharmaceuticals; FIZE Medical; Foundation Medicine, Inc.; F. Hoffmann-La Roche Ltd./Genentech Inc.; GenesisCare; ImmunityBio; Incyte Corporation; Invitae Corporation; Janssen Pharmaceuticals, Inc.; Lantheus; Lilly; MDX; Merck & Co., Inc.; Minomic International Ltd; Myovant Sciences Ltd; Myriad Genetics, Inc.; Nonagen Bioscience; Novartis Pharmaceuticals Corporation; Nymox Pharmaceutical Corporation; Pacific Edge; Palette Life Sciences, Inc.; Pfizer; Photocure; PlatformQ; ProFound Therapeutics; Promaxo; Propella Therapeutics, Inc.; Protara Therapeutics Inc.; Sanofi/Genzyme; Specialty Networks; Telix Pharmaceuticals; Tolmar Pharmaceuticals, Inc.; and UroGen Pharma, Inc.Faculty/PlannerSia Daneshmand, MD, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for Ferring Pharmaceuticals; Janssen Pharmaceuticals, Inc.; Pacific Edge; Pfizer; Photocure; Protara Therapeutics, Inc.; Sesen Bio (Carisma Therapeutics); TARIS Biomedical; and UroGen.Grant/Research Support from Janssen Pharmaceuticals, Inc.Faculty/PlannerGuru P. Sonpavde, MD, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for AstraZeneca; Bicycle Therapeutics; Bristol Myers Squibb; EMD Serono Inc.; Ellipses Pharma; Exelixis, Inc.; G1 Therapeutics, Inc.; Genentech, Inc.; Gilead Sciences, Inc.; Infinity Pharmaceuticals, Inc.; IMV Inc.; Janssen Pharmaceuticals, Inc.; Lilly/Loxo Oncology, Inc.; Lucence Health Inc.; Merck & Co., Inc.; Pfizer; PRECISCA; Sanofi; Scholar Rock; Seattle Genetics (Seagen Inc.)/Astellas Pharma Inc.; Servier Laboratories; SUBA THERAPEUTICS, INC.; Syapse; Syncorp Health; Tempus; and Vial.Grant/Research Support from AstraZeneca; Bristol Myers Squibb; EMD Serono Inc.; Gilead Sciences, Inc.; Helsinn Healthcare SA; Jazz Pharmaceuticals; Lucence; and Sanofi. Research support to institution.Speaker for AVEO Pharmaceuticals, Inc.; Bayer Corporation; BIO Brazilian Information Oncology; Exelixis, Inc.; Gilead Sciences, Inc.; Janssen Pharmaceuticals, Inc.; Natera, Inc.; OLE Forum (Mexico); and Seagen 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, downloadable Practice Aids, slides, and complete CME/MOC/AAPA information, and to apply for credit, please visit us at PeerView.com/XJV865. CME/MOC/AAPA credit will be available until December 28, 2024.Pioneering Precision Medicine in Bladder Cancer: Multidisciplinary Perspectives on Personalizing Patient Care In support of improving patient care, this activity has been planned and implemented by PVI, PeerView Institute for Medical Education, and Bladder Cancer Advocacy Network. 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, Bristol Myers Squibb, Janssen Biotech, Inc., administered by Janssen Scientific Affairs, LLC, and Merck & Co., Inc.Disclosure PolicyAll relevant conflicts of interest have been mitigated prior to the commencement of the activity.Faculty/Planner DisclosuresChair/PlannerNeal D. Shore, MD, FACS, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for AbbVie; Accord Healthcare; Alessa Therapeutics; Amgen Inc.; Arquer Diagnostics; Asieris Pharmaceuticals; Astellas Pharma Inc.; AstraZeneca; Aurora Biosciences; Bayer Corporation; BioProtect Ltd.; Boston Scientific Corporation; Bristol Myers Squibb; CG Oncology; Clarity Pharmaceuticals Ltd; Dendreon Pharmaceuticals LLC; Exact Images; Ferring Pharmaceuticals; FIZE Medical; Foundation Medicine, Inc.; F. Hoffmann-La Roche Ltd./Genentech Inc.; GenesisCare; ImmunityBio; Incyte Corporation; Invitae Corporation; Janssen Pharmaceuticals, Inc.; Lantheus; Lilly; MDX; Merck & Co., Inc.; Minomic International Ltd; Myovant Sciences Ltd; Myriad Genetics, Inc.; Nonagen Bioscience; Novartis Pharmaceuticals Corporation; Nymox Pharmaceutical Corporation; Pacific Edge; Palette Life Sciences, Inc.; Pfizer; Photocure; PlatformQ; ProFound Therapeutics; Promaxo; Propella Therapeutics, Inc.; Protara Therapeutics Inc.; Sanofi/Genzyme; Specialty Networks; Telix Pharmaceuticals; Tolmar Pharmaceuticals, Inc.; and UroGen Pharma, Inc.Faculty/PlannerSia Daneshmand, MD, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for Ferring Pharmaceuticals; Janssen Pharmaceuticals, Inc.; Pacific Edge; Pfizer; Photocure; Protara Therapeutics, Inc.; Sesen Bio (Carisma Therapeutics); TARIS Biomedical; and UroGen.Grant/Research Support from Janssen Pharmaceuticals, Inc.Faculty/PlannerGuru P. Sonpavde, MD, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for AstraZeneca; Bicycle Therapeutics; Bristol Myers Squibb; EMD Serono Inc.; Ellipses Pharma; Exelixis, Inc.; G1 Therapeutics, Inc.; Genentech, Inc.; Gilead Sciences, Inc.; Infinity Pharmaceuticals, Inc.; IMV Inc.; Janssen Pharmaceuticals, Inc.; Lilly/Loxo Oncology, Inc.; Lucence Health Inc.; Merck & Co., Inc.; Pfizer; PRECISCA; Sanofi; Scholar Rock; Seattle Genetics (Seagen Inc.)/Astellas Pharma Inc.; Servier Laboratories; SUBA THERAPEUTICS, INC.; Syapse; Syncorp Health; Tempus; and Vial.Grant/Research Support from AstraZeneca; Bristol Myers Squibb; EMD Serono Inc.; Gilead Sciences, Inc.; Helsinn Healthcare SA; Jazz Pharmaceuticals; Lucence; and Sanofi. Research support to institution.Speaker for AVEO Pharmaceuticals, Inc.; Bayer Corporation; BIO Brazilian Information Oncology; Exelixis, Inc.; Gilead Sciences, Inc.; Janssen Pharmaceuticals, Inc.; Natera, Inc.; OLE Forum (Mexico); and Seagen 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, downloadable Practice Aids, slides, and complete CME/MOC/AAPA information, and to apply for credit, please visit us at PeerView.com/UAR865. CME/MOC/AAPA credit will be available until December 31, 2024.Under Pressure to Improve Prostate Cancer Care: Unlocking the Power of Advanced Therapeutics to Enhance Outcomes Across the Disease Continuum 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 medical educational grants from Astellas and Pfizer, Inc., AstraZeneca, Exelixis, Inc., Janssen Biotech, Inc., administered by Janssen Scientific Affairs, LLC, Lilly, Merck & Co., Inc., and Novartis Pharmaceuticals Corporation.Disclosure PolicyAll relevant conflicts of interest have been mitigated prior to the commencement of the activity.Faculty/Planner DisclosuresChair/PlannerNeal D. Shore, MD, FACS, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for AbbVie; Accord Healthcare; Alessa Therapeutics; Amgen Inc.; Arquer Diagnostics; Asieris Pharmaceuticals; Astellas Pharma Inc.; AstraZeneca; Aurora Biosciences; Bayer Corporation; BioProtect Ltd.; Boston Scientific Corporation; Bristol Myers Squibb; CG Oncology; Clarity Pharmaceuticals Ltd; Dendreon Pharmaceuticals LLC; Exact Images; Ferring Pharmaceuticals; FIZE Medical; Foundation Medicine, Inc.; F. Hoffmann-La Roche Ltd./Genentech Inc.; GenesisCare; ImmunityBio; Incyte Corporation; Invitae Corporation; Janssen Pharmaceuticals, Inc.; Lantheus; Lilly; MDX; Merck & Co., Inc.; Minomic International Ltd; Myovant Sciences Ltd; Myriad Genetics, Inc.; Nonagen Bioscience; Novartis Pharmaceuticals Corporation; Nymox Pharmaceutical Corporation; Pacific Edge; Palette Life Sciences, Inc.; Pfizer; Photocure; PlatformQ; ProFound Therapeutics; Promaxo; Propella Therapeutics, Inc.; Protara Therapeutics Inc.; Sanofi/Genzyme; Specialty Networks; Telix Pharmaceuticals; Tolmar Pharmaceuticals, Inc.; and UroGen Pharma, Inc.Faculty/PlannerAlicia K. Morgans, MD, MPH, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for Advanced Accelerator Applications (AAA); Astellas Pharma Inc.; AstraZeneca; Bayer Corporation; Lantheus; Merck & Co., Inc.; Myovant Sciences Ltd.; Myriad Genetics, Inc.; Novartis Pharmaceuticals Corporation; Pfizer; Sanofi; and Telix Pharmaceuticals Limited.Grant/Research Support from Astellas Pharma Inc.; Bayer Corporation; Myovant Sciences Ltd.; Pfizer; and Sanofi.Faculty/PlannerAshley E. Ross, MD, PhD, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for Astellas/Pfizer/Sumitovant/Myovant; Bayer Corporation; BillionToOne Inc.; Blue Earth Therapeutics; and Janssen Pharmaceuticals, Inc.Grant/Research Support from Astellas/Pfizer/Sumitovant/Myovant; Bayer Corporation; Blue Earth Therapeutics; and Lantheus.Speakers Bureau participant with Bayer HealthCare Pharmaceuticals, Inc.; Janssen Pharmaceuticals, Inc.; Blue Earth Therapeutics; Lantheus; and Veracyte, Inc.Faculty/PlannerMatthew R. Smith, MD, PhD, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for Ambrx; Astellas Pharma US, Inc.; Bayer Corporation; Janssen Pharmaceuticals, Inc.; Lilly; 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/UAR865. CME/MOC/AAPA credit will be available until December 31, 2024.Under Pressure to Improve Prostate Cancer Care: Unlocking the Power of Advanced Therapeutics to Enhance Outcomes Across the Disease Continuum 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 medical educational grants from Astellas and Pfizer, Inc., AstraZeneca, Exelixis, Inc., Janssen Biotech, Inc., administered by Janssen Scientific Affairs, LLC, Lilly, Merck & Co., Inc., and Novartis Pharmaceuticals Corporation.Disclosure PolicyAll relevant conflicts of interest have been mitigated prior to the commencement of the activity.Faculty/Planner DisclosuresChair/PlannerNeal D. Shore, MD, FACS, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for AbbVie; Accord Healthcare; Alessa Therapeutics; Amgen Inc.; Arquer Diagnostics; Asieris Pharmaceuticals; Astellas Pharma Inc.; AstraZeneca; Aurora Biosciences; Bayer Corporation; BioProtect Ltd.; Boston Scientific Corporation; Bristol Myers Squibb; CG Oncology; Clarity Pharmaceuticals Ltd; Dendreon Pharmaceuticals LLC; Exact Images; Ferring Pharmaceuticals; FIZE Medical; Foundation Medicine, Inc.; F. Hoffmann-La Roche Ltd./Genentech Inc.; GenesisCare; ImmunityBio; Incyte Corporation; Invitae Corporation; Janssen Pharmaceuticals, Inc.; Lantheus; Lilly; MDX; Merck & Co., Inc.; Minomic International Ltd; Myovant Sciences Ltd; Myriad Genetics, Inc.; Nonagen Bioscience; Novartis Pharmaceuticals Corporation; Nymox Pharmaceutical Corporation; Pacific Edge; Palette Life Sciences, Inc.; Pfizer; Photocure; PlatformQ; ProFound Therapeutics; Promaxo; Propella Therapeutics, Inc.; Protara Therapeutics Inc.; Sanofi/Genzyme; Specialty Networks; Telix Pharmaceuticals; Tolmar Pharmaceuticals, Inc.; and UroGen Pharma, Inc.Faculty/PlannerAlicia K. Morgans, MD, MPH, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for Advanced Accelerator Applications (AAA); Astellas Pharma Inc.; AstraZeneca; Bayer Corporation; Lantheus; Merck & Co., Inc.; Myovant Sciences Ltd.; Myriad Genetics, Inc.; Novartis Pharmaceuticals Corporation; Pfizer; Sanofi; and Telix Pharmaceuticals Limited.Grant/Research Support from Astellas Pharma Inc.; Bayer Corporation; Myovant Sciences Ltd.; Pfizer; and Sanofi.Faculty/PlannerAshley E. Ross, MD, PhD, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for Astellas/Pfizer/Sumitovant/Myovant; Bayer Corporation; BillionToOne Inc.; Blue Earth Therapeutics; and Janssen Pharmaceuticals, Inc.Grant/Research Support from Astellas/Pfizer/Sumitovant/Myovant; Bayer Corporation; Blue Earth Therapeutics; and Lantheus.Speakers Bureau participant with Bayer HealthCare Pharmaceuticals, Inc.; Janssen Pharmaceuticals, Inc.; Blue Earth Therapeutics; Lantheus; and Veracyte, Inc.Faculty/PlannerMatthew R. Smith, MD, PhD, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for Ambrx; Astellas Pharma US, Inc.; Bayer Corporation; Janssen Pharmaceuticals, Inc.; Lilly; 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/UAR865. CME/MOC/AAPA credit will be available until December 31, 2024.Under Pressure to Improve Prostate Cancer Care: Unlocking the Power of Advanced Therapeutics to Enhance Outcomes Across the Disease Continuum 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 medical educational grants from Astellas and Pfizer, Inc., AstraZeneca, Exelixis, Inc., Janssen Biotech, Inc., administered by Janssen Scientific Affairs, LLC, Lilly, Merck & Co., Inc., and Novartis Pharmaceuticals Corporation.Disclosure PolicyAll relevant conflicts of interest have been mitigated prior to the commencement of the activity.Faculty/Planner DisclosuresChair/PlannerNeal D. Shore, MD, FACS, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for AbbVie; Accord Healthcare; Alessa Therapeutics; Amgen Inc.; Arquer Diagnostics; Asieris Pharmaceuticals; Astellas Pharma Inc.; AstraZeneca; Aurora Biosciences; Bayer Corporation; BioProtect Ltd.; Boston Scientific Corporation; Bristol Myers Squibb; CG Oncology; Clarity Pharmaceuticals Ltd; Dendreon Pharmaceuticals LLC; Exact Images; Ferring Pharmaceuticals; FIZE Medical; Foundation Medicine, Inc.; F. Hoffmann-La Roche Ltd./Genentech Inc.; GenesisCare; ImmunityBio; Incyte Corporation; Invitae Corporation; Janssen Pharmaceuticals, Inc.; Lantheus; Lilly; MDX; Merck & Co., Inc.; Minomic International Ltd; Myovant Sciences Ltd; Myriad Genetics, Inc.; Nonagen Bioscience; Novartis Pharmaceuticals Corporation; Nymox Pharmaceutical Corporation; Pacific Edge; Palette Life Sciences, Inc.; Pfizer; Photocure; PlatformQ; ProFound Therapeutics; Promaxo; Propella Therapeutics, Inc.; Protara Therapeutics Inc.; Sanofi/Genzyme; Specialty Networks; Telix Pharmaceuticals; Tolmar Pharmaceuticals, Inc.; and UroGen Pharma, Inc.Faculty/PlannerAlicia K. Morgans, MD, MPH, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for Advanced Accelerator Applications (AAA); Astellas Pharma Inc.; AstraZeneca; Bayer Corporation; Lantheus; Merck & Co., Inc.; Myovant Sciences Ltd.; Myriad Genetics, Inc.; Novartis Pharmaceuticals Corporation; Pfizer; Sanofi; and Telix Pharmaceuticals Limited.Grant/Research Support from Astellas Pharma Inc.; Bayer Corporation; Myovant Sciences Ltd.; Pfizer; and Sanofi.Faculty/PlannerAshley E. Ross, MD, PhD, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for Astellas/Pfizer/Sumitovant/Myovant; Bayer Corporation; BillionToOne Inc.; Blue Earth Therapeutics; and Janssen Pharmaceuticals, Inc.Grant/Research Support from Astellas/Pfizer/Sumitovant/Myovant; Bayer Corporation; Blue Earth Therapeutics; and Lantheus.Speakers Bureau participant with Bayer HealthCare Pharmaceuticals, Inc.; Janssen Pharmaceuticals, Inc.; Blue Earth Therapeutics; Lantheus; and Veracyte, Inc.Faculty/PlannerMatthew R. Smith, MD, PhD, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for Ambrx; Astellas Pharma US, Inc.; Bayer Corporation; Janssen Pharmaceuticals, Inc.; Lilly; 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/UAR865. CME/MOC/AAPA credit will be available until December 31, 2024.Under Pressure to Improve Prostate Cancer Care: Unlocking the Power of Advanced Therapeutics to Enhance Outcomes Across the Disease Continuum 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 medical educational grants from Astellas and Pfizer, Inc., AstraZeneca, Exelixis, Inc., Janssen Biotech, Inc., administered by Janssen Scientific Affairs, LLC, Lilly, Merck & Co., Inc., and Novartis Pharmaceuticals Corporation.Disclosure PolicyAll relevant conflicts of interest have been mitigated prior to the commencement of the activity.Faculty/Planner DisclosuresChair/PlannerNeal D. Shore, MD, FACS, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for AbbVie; Accord Healthcare; Alessa Therapeutics; Amgen Inc.; Arquer Diagnostics; Asieris Pharmaceuticals; Astellas Pharma Inc.; AstraZeneca; Aurora Biosciences; Bayer Corporation; BioProtect Ltd.; Boston Scientific Corporation; Bristol Myers Squibb; CG Oncology; Clarity Pharmaceuticals Ltd; Dendreon Pharmaceuticals LLC; Exact Images; Ferring Pharmaceuticals; FIZE Medical; Foundation Medicine, Inc.; F. Hoffmann-La Roche Ltd./Genentech Inc.; GenesisCare; ImmunityBio; Incyte Corporation; Invitae Corporation; Janssen Pharmaceuticals, Inc.; Lantheus; Lilly; MDX; Merck & Co., Inc.; Minomic International Ltd; Myovant Sciences Ltd; Myriad Genetics, Inc.; Nonagen Bioscience; Novartis Pharmaceuticals Corporation; Nymox Pharmaceutical Corporation; Pacific Edge; Palette Life Sciences, Inc.; Pfizer; Photocure; PlatformQ; ProFound Therapeutics; Promaxo; Propella Therapeutics, Inc.; Protara Therapeutics Inc.; Sanofi/Genzyme; Specialty Networks; Telix Pharmaceuticals; Tolmar Pharmaceuticals, Inc.; and UroGen Pharma, Inc.Faculty/PlannerAlicia K. Morgans, MD, MPH, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for Advanced Accelerator Applications (AAA); Astellas Pharma Inc.; AstraZeneca; Bayer Corporation; Lantheus; Merck & Co., Inc.; Myovant Sciences Ltd.; Myriad Genetics, Inc.; Novartis Pharmaceuticals Corporation; Pfizer; Sanofi; and Telix Pharmaceuticals Limited.Grant/Research Support from Astellas Pharma Inc.; Bayer Corporation; Myovant Sciences Ltd.; Pfizer; and Sanofi.Faculty/PlannerAshley E. Ross, MD, PhD, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for Astellas/Pfizer/Sumitovant/Myovant; Bayer Corporation; BillionToOne Inc.; Blue Earth Therapeutics; and Janssen Pharmaceuticals, Inc.Grant/Research Support from Astellas/Pfizer/Sumitovant/Myovant; Bayer Corporation; Blue Earth Therapeutics; and Lantheus.Speakers Bureau participant with Bayer HealthCare Pharmaceuticals, Inc.; Janssen Pharmaceuticals, Inc.; Blue Earth Therapeutics; Lantheus; and Veracyte, Inc.Faculty/PlannerMatthew R. Smith, MD, PhD, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for Ambrx; Astellas Pharma US, Inc.; Bayer Corporation; Janssen Pharmaceuticals, Inc.; Lilly; 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/UAR865. CME/MOC/AAPA credit will be available until December 31, 2024.Under Pressure to Improve Prostate Cancer Care: Unlocking the Power of Advanced Therapeutics to Enhance Outcomes Across the Disease Continuum 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 medical educational grants from Astellas and Pfizer, Inc., AstraZeneca, Exelixis, Inc., Janssen Biotech, Inc., administered by Janssen Scientific Affairs, LLC, Lilly, Merck & Co., Inc., and Novartis Pharmaceuticals Corporation.Disclosure PolicyAll relevant conflicts of interest have been mitigated prior to the commencement of the activity.Faculty/Planner DisclosuresChair/PlannerNeal D. Shore, MD, FACS, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for AbbVie; Accord Healthcare; Alessa Therapeutics; Amgen Inc.; Arquer Diagnostics; Asieris Pharmaceuticals; Astellas Pharma Inc.; AstraZeneca; Aurora Biosciences; Bayer Corporation; BioProtect Ltd.; Boston Scientific Corporation; Bristol Myers Squibb; CG Oncology; Clarity Pharmaceuticals Ltd; Dendreon Pharmaceuticals LLC; Exact Images; Ferring Pharmaceuticals; FIZE Medical; Foundation Medicine, Inc.; F. Hoffmann-La Roche Ltd./Genentech Inc.; GenesisCare; ImmunityBio; Incyte Corporation; Invitae Corporation; Janssen Pharmaceuticals, Inc.; Lantheus; Lilly; MDX; Merck & Co., Inc.; Minomic International Ltd; Myovant Sciences Ltd; Myriad Genetics, Inc.; Nonagen Bioscience; Novartis Pharmaceuticals Corporation; Nymox Pharmaceutical Corporation; Pacific Edge; Palette Life Sciences, Inc.; Pfizer; Photocure; PlatformQ; ProFound Therapeutics; Promaxo; Propella Therapeutics, Inc.; Protara Therapeutics Inc.; Sanofi/Genzyme; Specialty Networks; Telix Pharmaceuticals; Tolmar Pharmaceuticals, Inc.; and UroGen Pharma, Inc.Faculty/PlannerAlicia K. Morgans, MD, MPH, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for Advanced Accelerator Applications (AAA); Astellas Pharma Inc.; AstraZeneca; Bayer Corporation; Lantheus; Merck & Co., Inc.; Myovant Sciences Ltd.; Myriad Genetics, Inc.; Novartis Pharmaceuticals Corporation; Pfizer; Sanofi; and Telix Pharmaceuticals Limited.Grant/Research Support from Astellas Pharma Inc.; Bayer Corporation; Myovant Sciences Ltd.; Pfizer; and Sanofi.Faculty/PlannerAshley E. Ross, MD, PhD, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for Astellas/Pfizer/Sumitovant/Myovant; Bayer Corporation; BillionToOne Inc.; Blue Earth Therapeutics; and Janssen Pharmaceuticals, Inc.Grant/Research Support from Astellas/Pfizer/Sumitovant/Myovant; Bayer Corporation; Blue Earth Therapeutics; and Lantheus.Speakers Bureau participant with Bayer HealthCare Pharmaceuticals, Inc.; Janssen Pharmaceuticals, Inc.; Blue Earth Therapeutics; Lantheus; and Veracyte, Inc.Faculty/PlannerMatthew R. Smith, MD, PhD, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for Ambrx; Astellas Pharma US, Inc.; Bayer Corporation; Janssen Pharmaceuticals, Inc.; Lilly; 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/UAR865. CME/MOC/AAPA credit will be available until December 31, 2024.Under Pressure to Improve Prostate Cancer Care: Unlocking the Power of Advanced Therapeutics to Enhance Outcomes Across the Disease Continuum 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 medical educational grants from Astellas and Pfizer, Inc., AstraZeneca, Exelixis, Inc., Janssen Biotech, Inc., administered by Janssen Scientific Affairs, LLC, Lilly, Merck & Co., Inc., and Novartis Pharmaceuticals Corporation.Disclosure PolicyAll relevant conflicts of interest have been mitigated prior to the commencement of the activity.Faculty/Planner DisclosuresChair/PlannerNeal D. Shore, MD, FACS, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for AbbVie; Accord Healthcare; Alessa Therapeutics; Amgen Inc.; Arquer Diagnostics; Asieris Pharmaceuticals; Astellas Pharma Inc.; AstraZeneca; Aurora Biosciences; Bayer Corporation; BioProtect Ltd.; Boston Scientific Corporation; Bristol Myers Squibb; CG Oncology; Clarity Pharmaceuticals Ltd; Dendreon Pharmaceuticals LLC; Exact Images; Ferring Pharmaceuticals; FIZE Medical; Foundation Medicine, Inc.; F. Hoffmann-La Roche Ltd./Genentech Inc.; GenesisCare; ImmunityBio; Incyte Corporation; Invitae Corporation; Janssen Pharmaceuticals, Inc.; Lantheus; Lilly; MDX; Merck & Co., Inc.; Minomic International Ltd; Myovant Sciences Ltd; Myriad Genetics, Inc.; Nonagen Bioscience; Novartis Pharmaceuticals Corporation; Nymox Pharmaceutical Corporation; Pacific Edge; Palette Life Sciences, Inc.; Pfizer; Photocure; PlatformQ; ProFound Therapeutics; Promaxo; Propella Therapeutics, Inc.; Protara Therapeutics Inc.; Sanofi/Genzyme; Specialty Networks; Telix Pharmaceuticals; Tolmar Pharmaceuticals, Inc.; and UroGen Pharma, Inc.Faculty/PlannerAlicia K. Morgans, MD, MPH, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for Advanced Accelerator Applications (AAA); Astellas Pharma Inc.; AstraZeneca; Bayer Corporation; Lantheus; Merck & Co., Inc.; Myovant Sciences Ltd.; Myriad Genetics, Inc.; Novartis Pharmaceuticals Corporation; Pfizer; Sanofi; and Telix Pharmaceuticals Limited.Grant/Research Support from Astellas Pharma Inc.; Bayer Corporation; Myovant Sciences Ltd.; Pfizer; and Sanofi.Faculty/PlannerAshley E. Ross, MD, PhD, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for Astellas/Pfizer/Sumitovant/Myovant; Bayer Corporation; BillionToOne Inc.; Blue Earth Therapeutics; and Janssen Pharmaceuticals, Inc.Grant/Research Support from Astellas/Pfizer/Sumitovant/Myovant; Bayer Corporation; Blue Earth Therapeutics; and Lantheus.Speakers Bureau participant with Bayer HealthCare Pharmaceuticals, Inc.; Janssen Pharmaceuticals, Inc.; Blue Earth Therapeutics; Lantheus; and Veracyte, Inc.Faculty/PlannerMatthew R. Smith, MD, PhD, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for Ambrx; Astellas Pharma US, Inc.; Bayer Corporation; Janssen Pharmaceuticals, Inc.; Lilly; 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/UAR865. CME/MOC/AAPA credit will be available until December 31, 2024.Under Pressure to Improve Prostate Cancer Care: Unlocking the Power of Advanced Therapeutics to Enhance Outcomes Across the Disease Continuum 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 medical educational grants from Astellas and Pfizer, Inc., AstraZeneca, Exelixis, Inc., Janssen Biotech, Inc., administered by Janssen Scientific Affairs, LLC, Lilly, Merck & Co., Inc., and Novartis Pharmaceuticals Corporation.Disclosure PolicyAll relevant conflicts of interest have been mitigated prior to the commencement of the activity.Faculty/Planner DisclosuresChair/PlannerNeal D. Shore, MD, FACS, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for AbbVie; Accord Healthcare; Alessa Therapeutics; Amgen Inc.; Arquer Diagnostics; Asieris Pharmaceuticals; Astellas Pharma Inc.; AstraZeneca; Aurora Biosciences; Bayer Corporation; BioProtect Ltd.; Boston Scientific Corporation; Bristol Myers Squibb; CG Oncology; Clarity Pharmaceuticals Ltd; Dendreon Pharmaceuticals LLC; Exact Images; Ferring Pharmaceuticals; FIZE Medical; Foundation Medicine, Inc.; F. Hoffmann-La Roche Ltd./Genentech Inc.; GenesisCare; ImmunityBio; Incyte Corporation; Invitae Corporation; Janssen Pharmaceuticals, Inc.; Lantheus; Lilly; MDX; Merck & Co., Inc.; Minomic International Ltd; Myovant Sciences Ltd; Myriad Genetics, Inc.; Nonagen Bioscience; Novartis Pharmaceuticals Corporation; Nymox Pharmaceutical Corporation; Pacific Edge; Palette Life Sciences, Inc.; Pfizer; Photocure; PlatformQ; ProFound Therapeutics; Promaxo; Propella Therapeutics, Inc.; Protara Therapeutics Inc.; Sanofi/Genzyme; Specialty Networks; Telix Pharmaceuticals; Tolmar Pharmaceuticals, Inc.; and UroGen Pharma, Inc.Faculty/PlannerAlicia K. Morgans, MD, MPH, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for Advanced Accelerator Applications (AAA); Astellas Pharma Inc.; AstraZeneca; Bayer Corporation; Lantheus; Merck & Co., Inc.; Myovant Sciences Ltd.; Myriad Genetics, Inc.; Novartis Pharmaceuticals Corporation; Pfizer; Sanofi; and Telix Pharmaceuticals Limited.Grant/Research Support from Astellas Pharma Inc.; Bayer Corporation; Myovant Sciences Ltd.; Pfizer; and Sanofi.Faculty/PlannerAshley E. Ross, MD, PhD, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for Astellas/Pfizer/Sumitovant/Myovant; Bayer Corporation; BillionToOne Inc.; Blue Earth Therapeutics; and Janssen Pharmaceuticals, Inc.Grant/Research Support from Astellas/Pfizer/Sumitovant/Myovant; Bayer Corporation; Blue Earth Therapeutics; and Lantheus.Speakers Bureau participant with Bayer HealthCare Pharmaceuticals, Inc.; Janssen Pharmaceuticals, Inc.; Blue Earth Therapeutics; Lantheus; and Veracyte, Inc.Faculty/PlannerMatthew R. Smith, MD, PhD, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for Ambrx; Astellas Pharma US, Inc.; Bayer Corporation; Janssen Pharmaceuticals, Inc.; Lilly; 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.

In this CME episode, Dr. Andrew Cutler interviews Dr. Jeffrey Strawn about the role of pharmacogenomic testing in guiding treatment of major depressive disorder (MDD). They discuss how pharmacogenomic testing works, the impact of failed treatments and side effects on patients with MDD, and the clinical applications and future directions of pharmacogenomic testing. Optional CME/CE Credits and Certificate Instructions: After listening to the podcast, to take the optional posttest and receive CME/CE credit, click: https://nei.global/POD23-GEN Learning Objectives: After completing this educational activity, you should be better able to: Recognize the role of a patient's genetics in informing the efficacy and tolerability of antidepressants Consider opportunities to use pharmacogenomics as an evidence-based tool that can be employed to inform clinical decision making Implement pharmacogenomic testing to optimize patient outcomes, including symptom improvement, medication response, and remission rate Accreditation: In support of improving patient care, Neuroscience Education Institute (NEI) 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. NEI designates this enduring material for a maximum of 1.0 AMA PRA Category 1 Credit ™. Physicians should claim only the credit commensurate with the extent of their participation in the activity. A posttest score of 70% or higher is required to receive CME/CE credit. The content in this activity pertains to pharmacology and is worth 1.0 continuing education hour of pharmacotherapeutics. Credit Types: The following are being offered for this activity: Nurse Practitioner: ANCC contact hours Pharmacy: ACPE application-based contact hours Physician: ACCME AMA PRA Category 1 Credits ™ Physician Associate: AAPA Category 1 CME credits Psychology: APA CE credits Social Work: ASWB-ACE CE credits Non-Physician Member of the Healthcare Team: Certificate of Participation stating the program is designated for AMA PRA Category 1 Credits™ Peer Review: The content was peer-reviewed by an MD specializing in psychiatry to ensure the scientific accuracy and medical relevance of information presented and its independence from commercial bias. NEI takes responsibility for the content, quality, and scientific integrity of this CME/CE activity. Disclosures: All individuals in a position to influence or control content are required to disclose any relevant financial relationships. Potential conflicts of interest are identified and mitigated prior to the activity being planned, developed, or presented. Interviewer Andrew J. Cutler, MD Clinical Associate Professor, Department of Psychiatry, SUNY Upstate Medical University, Syracuse, NY Chief Medical Officer, Neuroscience Education Institute, Carlsbad, CA Consultant/Advisor: AbbVie, Acadia, Alfasigma, Alkermes, Axsome, Biogen, BioXcel, Boehringer Ingelheim, Cerevel, Corium, Intra-Cellular, Ironshore, Janssen, Jazz, Karuna, Neumora, Neurocrine, Noven, Otsuka, Relmada, Sage Therapeutics, Sunovion, Supernus, Teva, Tris Pharma, VistaGen Therapeutics Speakers Bureau: AbbVie, Acadia, Alkermes, Axsome, BioXcel, Corium, Intra-Cellular, Ironshore, Janssen, Jazz, Lundbeck, Neurocrine, Noven, Otsuka, Sunovion, Supernus, Takeda, Teva, Tris Pharma Interviewee Jeffrey R. Strawn, MD Professor, Department of Psychiatry and Behavioral Neuroscience and Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, OH Grant/Research: Allergan/AbbVie Consultant/Advisor: Cerevel, Intra-Cellular, Otsuka Pre-Interview Author Gabriela Alarcón, PhD Senior Medical Writer, Neuroscience Education Institute, Carlsbad, CA No financial relationships to disclose. The Planning Committee, Content Editor, and Peer Reviewer have no financial relationships to disclose. Disclosure of Off-Label Use: This educational activity may include discussion of unlabeled and/or investigational uses of agents that are not currently labeled for such use by the FDA. Please consult the product prescribing information for full disclosure of labeled uses. Cultural Linguistic Competencies and Implicit Bias: A variety of resources addressing cultural and linguistic competencies and strategies for understanding and reducing implicit bias can be found in this handout—download me. Support: This activity is supported by an unrestricted educational grant from Myriad Genetics. Released: December 13, 2023      CME/CE credit expires: December 13, 2026

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/IPCE information, and to apply for credit, please visit us at PeerView.com/BVX865. CME/MOC/AAPA/IPCE credit will be available until December 10, 2024.The ABCs of ADCs for Gynecologic Cancer: Expert Insights on Effective Implementation and Practical Tips for Use in Patients With Cervical, Ovarian, or Endometrial Cancer 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., Eisai Inc., and Seagen and Genmab.Disclosure PolicyAll relevant conflicts of interest have been mitigated prior to the commencement of the activity.Faculty/Planner DisclosuresChair/PlannerBradley J. Monk, MD, FACS, FACOG, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for Acrivon Therapeutics; Adaptimmune Therapeutics plc.; Agenus Inc.; Akeso Biopharma Co., Ltd.; Amgen Inc.; Aravive; AstraZeneca; Bayer Corporation; Clovis Oncology; Eisai Inc.; Elevar, LLC; EMD Serono, Inc.; F. Hoffmann-La Roche Ltd./Genentech, Inc.; Genmab A/S/Seagen Inc.; The GOG Foundation Inc; Gradalis, Inc.; ImmunoGen, Inc.; Iovance Biotherapeutics, Inc.; Jiangsu Hengrui Pharmaceuticals Co., Ltd.; Karyopharm; Laekna Therapeutics; Merck & Co., Inc.; Mersana Therapeutics; Myriad Genetics, Inc.; Novartis Pharmaceuticals Corporation; Novocure GmbH; OncoC4, Inc.; Panavance Therapeutics Inc.; Pfizer; Pieris Pharmaceuticals, Inc.; Puma Biotechnology, Inc.; Regeneron Pharmaceuticals Inc.; Sorrento Therapeutics, Inc.; TESARO, Inc./GlaxoSmithKline; US Oncology Research, LLC; VBL Therapeutics; Verastem, Inc.; and Zentalis Pharmaceuticals.Grant/Research Support from US Oncology Research, LLC.Speaker for AstraZeneca; Clovis Oncology; Eisai Inc.; F. Hoffmann-La Roche Ltd./Genentech, Inc.; Merck & Co., Inc.; and TESARO, Inc./GlaxoSmithKline.Faculty/PlannerAna Oaknin, MD, PhD, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for Agenus Inc.; AstraZeneca; Clovis Oncology; Corcept Therapeutics; Deciphera Pharmaceuticals; Eisai Co., Ltd.; EMD Serono; Exelisis, Inc.; F. Hoffmann-La Roche; Genmab A/S; GlaxoSmithKline; ImmunoGen, Inc.; iTeos Therapeutics; Merck Sharp & Dohme de Espana SA; Mersana Therapeutics; Novocure GmbH; OncXerna Therapeutics, Inc.; Pharma Mar SA; Regeneron Pharmaceuticals Inc.; Seagen, Inc.; Shattuck Labs, Inc.; and Sutro Biopharma, Inc.Grant/Research Support from AbbVie Deutschland; Advaxis Inc.; Aeterna Zentaris; Amgen Inc.; Aprea Therapeutics AB; Bristol Myers Squibb; Clovis Oncology; Eisai Co., Ltd.; F. Hoffmann-La Roche; ImmunoGen, Inc.; Merck Sharp & Dohme de Espana SA; Millennium Pharmaceuticals Inc.; Pharma Mar SA; Regeneron Pharmaceuticals Inc; and Tesaro.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/IPCE information, and to apply for credit, please visit us at PeerView.com/BVX865. CME/MOC/AAPA/IPCE credit will be available until December 10, 2024.The ABCs of ADCs for Gynecologic Cancer: Expert Insights on Effective Implementation and Practical Tips for Use in Patients With Cervical, Ovarian, or Endometrial Cancer 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., Eisai Inc., and Seagen and Genmab.Disclosure PolicyAll relevant conflicts of interest have been mitigated prior to the commencement of the activity.Faculty/Planner DisclosuresChair/PlannerBradley J. Monk, MD, FACS, FACOG, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for Acrivon Therapeutics; Adaptimmune Therapeutics plc.; Agenus Inc.; Akeso Biopharma Co., Ltd.; Amgen Inc.; Aravive; AstraZeneca; Bayer Corporation; Clovis Oncology; Eisai Inc.; Elevar, LLC; EMD Serono, Inc.; F. Hoffmann-La Roche Ltd./Genentech, Inc.; Genmab A/S/Seagen Inc.; The GOG Foundation Inc; Gradalis, Inc.; ImmunoGen, Inc.; Iovance Biotherapeutics, Inc.; Jiangsu Hengrui Pharmaceuticals Co., Ltd.; Karyopharm; Laekna Therapeutics; Merck & Co., Inc.; Mersana Therapeutics; Myriad Genetics, Inc.; Novartis Pharmaceuticals Corporation; Novocure GmbH; OncoC4, Inc.; Panavance Therapeutics Inc.; Pfizer; Pieris Pharmaceuticals, Inc.; Puma Biotechnology, Inc.; Regeneron Pharmaceuticals Inc.; Sorrento Therapeutics, Inc.; TESARO, Inc./GlaxoSmithKline; US Oncology Research, LLC; VBL Therapeutics; Verastem, Inc.; and Zentalis Pharmaceuticals.Grant/Research Support from US Oncology Research, LLC.Speaker for AstraZeneca; Clovis Oncology; Eisai Inc.; F. Hoffmann-La Roche Ltd./Genentech, Inc.; Merck & Co., Inc.; and TESARO, Inc./GlaxoSmithKline.Faculty/PlannerAna Oaknin, MD, PhD, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for Agenus Inc.; AstraZeneca; Clovis Oncology; Corcept Therapeutics; Deciphera Pharmaceuticals; Eisai Co., Ltd.; EMD Serono; Exelisis, Inc.; F. Hoffmann-La Roche; Genmab A/S; GlaxoSmithKline; ImmunoGen, Inc.; iTeos Therapeutics; Merck Sharp & Dohme de Espana SA; Mersana Therapeutics; Novocure GmbH; OncXerna Therapeutics, Inc.; Pharma Mar SA; Regeneron Pharmaceuticals Inc.; Seagen, Inc.; Shattuck Labs, Inc.; and Sutro Biopharma, Inc.Grant/Research Support from AbbVie Deutschland; Advaxis Inc.; Aeterna Zentaris; Amgen Inc.; Aprea Therapeutics AB; Bristol Myers Squibb; Clovis Oncology; Eisai Co., Ltd.; F. Hoffmann-La Roche; ImmunoGen, Inc.; Merck Sharp & Dohme de Espana SA; Millennium Pharmaceuticals Inc.; Pharma Mar SA; Regeneron Pharmaceuticals Inc; and Tesaro.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/IPCE information, and to apply for credit, please visit us at PeerView.com/BVX865. CME/MOC/AAPA/IPCE credit will be available until December 10, 2024.The ABCs of ADCs for Gynecologic Cancer: Expert Insights on Effective Implementation and Practical Tips for Use in Patients With Cervical, Ovarian, or Endometrial Cancer 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., Eisai Inc., and Seagen and Genmab.Disclosure PolicyAll relevant conflicts of interest have been mitigated prior to the commencement of the activity.Faculty/Planner DisclosuresChair/PlannerBradley J. Monk, MD, FACS, FACOG, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for Acrivon Therapeutics; Adaptimmune Therapeutics plc.; Agenus Inc.; Akeso Biopharma Co., Ltd.; Amgen Inc.; Aravive; AstraZeneca; Bayer Corporation; Clovis Oncology; Eisai Inc.; Elevar, LLC; EMD Serono, Inc.; F. Hoffmann-La Roche Ltd./Genentech, Inc.; Genmab A/S/Seagen Inc.; The GOG Foundation Inc; Gradalis, Inc.; ImmunoGen, Inc.; Iovance Biotherapeutics, Inc.; Jiangsu Hengrui Pharmaceuticals Co., Ltd.; Karyopharm; Laekna Therapeutics; Merck & Co., Inc.; Mersana Therapeutics; Myriad Genetics, Inc.; Novartis Pharmaceuticals Corporation; Novocure GmbH; OncoC4, Inc.; Panavance Therapeutics Inc.; Pfizer; Pieris Pharmaceuticals, Inc.; Puma Biotechnology, Inc.; Regeneron Pharmaceuticals Inc.; Sorrento Therapeutics, Inc.; TESARO, Inc./GlaxoSmithKline; US Oncology Research, LLC; VBL Therapeutics; Verastem, Inc.; and Zentalis Pharmaceuticals.Grant/Research Support from US Oncology Research, LLC.Speaker for AstraZeneca; Clovis Oncology; Eisai Inc.; F. Hoffmann-La Roche Ltd./Genentech, Inc.; Merck & Co., Inc.; and TESARO, Inc./GlaxoSmithKline.Faculty/PlannerAna Oaknin, MD, PhD, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for Agenus Inc.; AstraZeneca; Clovis Oncology; Corcept Therapeutics; Deciphera Pharmaceuticals; Eisai Co., Ltd.; EMD Serono; Exelisis, Inc.; F. Hoffmann-La Roche; Genmab A/S; GlaxoSmithKline; ImmunoGen, Inc.; iTeos Therapeutics; Merck Sharp & Dohme de Espana SA; Mersana Therapeutics; Novocure GmbH; OncXerna Therapeutics, Inc.; Pharma Mar SA; Regeneron Pharmaceuticals Inc.; Seagen, Inc.; Shattuck Labs, Inc.; and Sutro Biopharma, Inc.Grant/Research Support from AbbVie Deutschland; Advaxis Inc.; Aeterna Zentaris; Amgen Inc.; Aprea Therapeutics AB; Bristol Myers Squibb; Clovis Oncology; Eisai Co., Ltd.; F. Hoffmann-La Roche; ImmunoGen, Inc.; Merck Sharp & Dohme de Espana SA; Millennium Pharmaceuticals Inc.; Pharma Mar SA; Regeneron Pharmaceuticals Inc; and Tesaro.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/IPCE information, and to apply for credit, please visit us at PeerView.com/BVX865. CME/MOC/AAPA/IPCE credit will be available until December 10, 2024.The ABCs of ADCs for Gynecologic Cancer: Expert Insights on Effective Implementation and Practical Tips for Use in Patients With Cervical, Ovarian, or Endometrial Cancer 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., Eisai Inc., and Seagen and Genmab.Disclosure PolicyAll relevant conflicts of interest have been mitigated prior to the commencement of the activity.Faculty/Planner DisclosuresChair/PlannerBradley J. Monk, MD, FACS, FACOG, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for Acrivon Therapeutics; Adaptimmune Therapeutics plc.; Agenus Inc.; Akeso Biopharma Co., Ltd.; Amgen Inc.; Aravive; AstraZeneca; Bayer Corporation; Clovis Oncology; Eisai Inc.; Elevar, LLC; EMD Serono, Inc.; F. Hoffmann-La Roche Ltd./Genentech, Inc.; Genmab A/S/Seagen Inc.; The GOG Foundation Inc; Gradalis, Inc.; ImmunoGen, Inc.; Iovance Biotherapeutics, Inc.; Jiangsu Hengrui Pharmaceuticals Co., Ltd.; Karyopharm; Laekna Therapeutics; Merck & Co., Inc.; Mersana Therapeutics; Myriad Genetics, Inc.; Novartis Pharmaceuticals Corporation; Novocure GmbH; OncoC4, Inc.; Panavance Therapeutics Inc.; Pfizer; Pieris Pharmaceuticals, Inc.; Puma Biotechnology, Inc.; Regeneron Pharmaceuticals Inc.; Sorrento Therapeutics, Inc.; TESARO, Inc./GlaxoSmithKline; US Oncology Research, LLC; VBL Therapeutics; Verastem, Inc.; and Zentalis Pharmaceuticals.Grant/Research Support from US Oncology Research, LLC.Speaker for AstraZeneca; Clovis Oncology; Eisai Inc.; F. Hoffmann-La Roche Ltd./Genentech, Inc.; Merck & Co., Inc.; and TESARO, Inc./GlaxoSmithKline.Faculty/PlannerAna Oaknin, MD, PhD, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for Agenus Inc.; AstraZeneca; Clovis Oncology; Corcept Therapeutics; Deciphera Pharmaceuticals; Eisai Co., Ltd.; EMD Serono; Exelisis, Inc.; F. Hoffmann-La Roche; Genmab A/S; GlaxoSmithKline; ImmunoGen, Inc.; iTeos Therapeutics; Merck Sharp & Dohme de Espana SA; Mersana Therapeutics; Novocure GmbH; OncXerna Therapeutics, Inc.; Pharma Mar SA; Regeneron Pharmaceuticals Inc.; Seagen, Inc.; Shattuck Labs, Inc.; and Sutro Biopharma, Inc.Grant/Research Support from AbbVie Deutschland; Advaxis Inc.; Aeterna Zentaris; Amgen Inc.; Aprea Therapeutics AB; Bristol Myers Squibb; Clovis Oncology; Eisai Co., Ltd.; F. Hoffmann-La Roche; ImmunoGen, Inc.; Merck Sharp & Dohme de Espana SA; Millennium Pharmaceuticals Inc.; Pharma Mar SA; Regeneron Pharmaceuticals Inc; and Tesaro.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/IPCE information, and to apply for credit, please visit us at PeerView.com/BVX865. CME/MOC/AAPA/IPCE credit will be available until December 10, 2024.The ABCs of ADCs for Gynecologic Cancer: Expert Insights on Effective Implementation and Practical Tips for Use in Patients With Cervical, Ovarian, or Endometrial Cancer 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., Eisai Inc., and Seagen and Genmab.Disclosure PolicyAll relevant conflicts of interest have been mitigated prior to the commencement of the activity.Faculty/Planner DisclosuresChair/PlannerBradley J. Monk, MD, FACS, FACOG, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for Acrivon Therapeutics; Adaptimmune Therapeutics plc.; Agenus Inc.; Akeso Biopharma Co., Ltd.; Amgen Inc.; Aravive; AstraZeneca; Bayer Corporation; Clovis Oncology; Eisai Inc.; Elevar, LLC; EMD Serono, Inc.; F. Hoffmann-La Roche Ltd./Genentech, Inc.; Genmab A/S/Seagen Inc.; The GOG Foundation Inc; Gradalis, Inc.; ImmunoGen, Inc.; Iovance Biotherapeutics, Inc.; Jiangsu Hengrui Pharmaceuticals Co., Ltd.; Karyopharm; Laekna Therapeutics; Merck & Co., Inc.; Mersana Therapeutics; Myriad Genetics, Inc.; Novartis Pharmaceuticals Corporation; Novocure GmbH; OncoC4, Inc.; Panavance Therapeutics Inc.; Pfizer; Pieris Pharmaceuticals, Inc.; Puma Biotechnology, Inc.; Regeneron Pharmaceuticals Inc.; Sorrento Therapeutics, Inc.; TESARO, Inc./GlaxoSmithKline; US Oncology Research, LLC; VBL Therapeutics; Verastem, Inc.; and Zentalis Pharmaceuticals.Grant/Research Support from US Oncology Research, LLC.Speaker for AstraZeneca; Clovis Oncology; Eisai Inc.; F. Hoffmann-La Roche Ltd./Genentech, Inc.; Merck & Co., Inc.; and TESARO, Inc./GlaxoSmithKline.Faculty/PlannerAna Oaknin, MD, PhD, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for Agenus Inc.; AstraZeneca; Clovis Oncology; Corcept Therapeutics; Deciphera Pharmaceuticals; Eisai Co., Ltd.; EMD Serono; Exelisis, Inc.; F. Hoffmann-La Roche; Genmab A/S; GlaxoSmithKline; ImmunoGen, Inc.; iTeos Therapeutics; Merck Sharp & Dohme de Espana SA; Mersana Therapeutics; Novocure GmbH; OncXerna Therapeutics, Inc.; Pharma Mar SA; Regeneron Pharmaceuticals Inc.; Seagen, Inc.; Shattuck Labs, Inc.; and Sutro Biopharma, Inc.Grant/Research Support from AbbVie Deutschland; Advaxis Inc.; Aeterna Zentaris; Amgen Inc.; Aprea Therapeutics AB; Bristol Myers Squibb; Clovis Oncology; Eisai Co., Ltd.; F. Hoffmann-La Roche; ImmunoGen, Inc.; Merck Sharp & Dohme de Espana SA; Millennium Pharmaceuticals Inc.; Pharma Mar SA; Regeneron Pharmaceuticals Inc; and Tesaro.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.