Podcasts about neoadjuvant

Neoadjuvant chemotherapy translates to chemotherapy for cancer before surgery, with a recent study demonstrating its benefit for people with esophagus cancer. Kimmel Cancer Center director William Nelson at Johns Hopkins says this strategy is time tested. Nelson: Neoadjuvant therapy is … Are there advantages to receiving chemotherapy for cancer before surgery? Elizabeth Tracey reports Read More »

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In this episode of Oncology Unplugged, a podcast series from OncLive and MedNews Week, podcast host Chandler Park, MD, a medical oncologist at Norton Cancer Institute in Louisville, Kentucky, was joined by Petros Grivas, MD, PhD; and Ruben Raychaudhuri, MD, to talk about a pilot trial investigating neoadjuvant accelerated methotrexate, vinblastine,doxorubicin, and cisplatin (aMVAC) plus pembrolizumab (Keytruda) in patients with non-urothelial muscle-invasive bladder cancer, findings from which were presented at the 2025 Genitourinary Cancers Symposium. Dr Grivas is clinical director of the Genitourinary Cancers Program and a professor in the Clinical Research Division at Fred Hutchinson Cancer Center, as well as a professor in the Division of Hematology and Oncology at the University of Washington School of Medicine in Seattle. Dr Raychaudhuri is an assistant professor in the Clinical Research Division at Fred Hutchinson Cancer Center, as well as an assistant professor in the Division of Hematology and Oncology at the University of Washington School of Medicine. In their exclusive conversation, Drs Park, Grivas, and Raychaudhuri discussed key efficacy and safety findings from this study; the need for conducting dedicated research in bladder cancer patient populations with variant histologies; and the potential of biomarkers, such as HER2 expression, to improve the bladder cancer treatment paradigm in the future.

In this JCO Article Insights episode, Peter Li summarizes “Neoadjuvant Modified Infusional Fluorouracil, Leucovorin, and Oxaliplatin With or Without Radiation Versus Fluorouracil Plus Radiation for Locally Advanced Rectal Cancer: Updated Results of the FOWARC Study After a Median Follow-Up of 10 Years,” by Dr. Jianwei Zhang et al. published on December 13, 2024. TRANSCRIPT Peter Li: Hello and welcome to the JCO Article Insights. I'm your host Peter Li and today we will be discussing the Journal of Clinical Oncology article, “Neoadjuvant Modified Infusional Fluorouracil, Leucovorin, and Oxaliplatin With or Without Radiation Versus Fluorouracil Plus Radiation for Locally Advanced Rectal Cancer: Updated Results of the FOWARC Study After a Median Follow-Up of 10 Years,” by Dr. Jianwei Zhang et al.  For a reminder to the audience, the FOWARC study is a Chinese-based study that looked into the treatment of locally advanced rectal cancers with neoadjuvant chemotherapy based regimens with or without radiation. This study was first published back in 2019 where the three-year data showed no difference in three-year disease-free survival over survival between the three study arms. As a reminder of what those arms were, there were one historical control and two interventional arms. The control arm used 5-FU with radiation therapy with five cycles of 5-fluorouracil with radiation during cycles two to four followed by surgery and then seven cycles adjuvantly. Their first interventional arm was the same as the control arm with the addition of oxaliplatin on day 1of each cycle. And lastly, the third arm was FOLFOX only for four to six cycles followed by surgery and then six to eight cycles adjuvantly completing about a total of 12 weeks of chemotherapy.  They recruited about 495 patients with 165 patients randomized to each arm. They were relatively well balanced by age, clinical staging and distance from the anal verge. Median age was about mid-50s with a slight male predominance and patients were primarily stage 3 with 20% to 30% being stage 2. About 30% had clinical T4 disease and about 25% had clinical N2 disease. Median follow up time was 122.5 months or 10 years and their follow up endpoints were disease-free survival, overall survival and local recurrence, and they also performed subgroup analyses based on post surgical pathological staging. Survival was analyzed using Kaplan-Meier method with a significant threshold of p being less than 0.05. About 451 patients actually underwent surgery, which is about 91% of patients. The main reason for not going through surgery was due to refusal but one was due to toxicity and two were due to disease progression in the control arm. Follow up loss rate was about 10% in each group. Now looking at their primary endpoints in their initial study, local recurrence was about 8.8% in the control arm versus 7.9% in the FOLFOX radiation group versus 9.2% in the FOLFOX only group. Distant metastasis was about 30% in each arm and the sites of metastases were primarily in the lung and liver.   Now, following up with 10 years, there were only three new events in the chemoradiation group with local recurrence happening at 10.8% in the control arm versus 8% in the FOLFOX RT group versus 9.6% in the chemo only group. These findings were not statistically significant. In their subgroup analysis by pathological staging, they found that pathological CR or complete response had a lower rate of local recurrence compared to those with increasing pathological staging coming in at 3% versus 4.3% versus 11.6% versus 15.8% in pCR versus Stage 1, 2, 3 respectively. And they found no difference in each stage with each interventional arm. Looking at long term survival their 10-year disease free survival showed 52.5% in the 5-FU radiation group versus 62.6% in the FOLFOX RT group versus 60.5% in the chemotherapy only group with no statistically significant difference between three groups. By pathological staging, they found improved 10-year disease survival in those who achieved pathological complete response versus those who did not with 84.3% in the pCR group versus 78.7% versus 56.8% versus 27.7% in the stage 1 versus 2 versus 3 group. And again they found no statistical significance difference between each arm.   Now looking at the 10-year overall survival rates between the three arms, in the control arm the 10-year overall survival was 65.9% versus 72.3% in the FOLFOX RT group versus 73.4% in the chemo only group. By pathological stage, again, they showed a statistically significant difference in those who achieved pCR versus those who had pathological stage 1 to 3 disease with overall survival being 92.4% in those who achieved pCR versus 84.9% versus 68.6% versus 48.8% in stage 1, 2, 3 respectively. Now in the discussion, authors mentioned that with a median follow up of 10 years, FOLFOX alone had similar disease-free survival, local recurrence and distant metastasis and overall survival compared to those who received neoadjuvant chemoradiation, justifying the omission of radiation without compromising results or outcomes for each patient. There were no differences in subgroup analysis for disease free survival local recurrence or overall survival based on pathological staging. There were only three new events compared to the last follow up, with local recurrence happening only in the chemo radiation groups. Local recurrence rates at 10 years was about 10%. Compared to other clinical trials such as CAO, ARO or AIO-94, the rate of local recurrence was similar to those historical trials.  The authors also compared their findings to the PROSPECT study which looks at the use of total neoadjuvant chemo radiation versus chemotherapy alone, which boasted only about a 2% local recurrence rate. But as a reminder, high risk locally advanced rectal cancers were excluded, mainly those with T4 or N2 disease, which may explain the difference in terms of local recurrence in the PROSPECT versus this study. Another finding is that pathological complete responses are also an important prognostic marker with lower 10-year local recurrence rate, disease-free survival and overall survival with worse outcomes with increased pathological staging. Distant metastasis rates were still at 30%, with the most common site being lung then liver then lymph nodes consistent with other historical studies. Chemotherapy seemed to be better at reducing liver mets than lung metastasis per their findings. In their post hoc analysis of their own study, chemo radiation was also associated with higher incidence of low anterior resection syndrome and persistent ostomy compared to chemotherapy alone, meaning that they had better quality of life with the chemotherapy only approach.  In conclusion, a chemotherapy only approach can be safe and a feasible treatment for locally advanced rectal cancer without compromising outcomes. Omission of radiation may reduce the risk of overtreatment and improve quality of life for some of these patients. However, this does not necessarily exclude the role of radiation as it may still play a role in a response escalation approach for those who do not respond to chemotherapy alone.   This wraps up today's episode. Thank you for listening to JCO Article Insights. Please come back for more interviews and article summaries and be sure to leave us a rating and review so others can find our show. For more podcasts and episodes from ASCO, please visit asco.org/podcasts.   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.  

Drs. Traina and Isaacs share how they determine which patients are appropriate for neoadjuvant therapies and how to address residual disease, as well as potential treatment toxicities.

In this episode of SurgOnc Today®, Dr. Rebecca Snyder, from the UT MD Anderson Cancer Center, and Dr. Akhil Chawla, from Northwestern University, both members of the HPB disease site working group, are joined by Dr. Cristina Ferrone, from Cedars Sinai Medical Center, and Dr. Steven Gallinger, from the University of Toronto. We will discuss the details, similarities, and differences of their respective clinical trials for neoadjuvant therapy for pancreatic adenocarcinoma, ALLIANCE A021806, and NeoPancONE.   References/Resources: ALLIANCE A021806 NeoPancONE

Xinan Sheng. M.D., Professor in the Department of Genitourinary Oncology at Peking University Cancer Hospital &institute in Beijing, China joins us to discuss the update of this trial and impressive pCR rates.

Featuring perspectives from Dr Anthony El-Khoueiry, Dr Richard S Finn, Dr Aiwu Ruth He and Dr Stacey Stein, moderated by Dr Stephen “Fred” Divers, including the following topics: Adjuvant Systemic Therapy for Early-Stage Hepatocellular Carcinoma (HCC) — Dr El-Khoueiry Introduction (0:00) Faculty Presentation (3:08) IMbrave050: Adjuvant systemic treatment for high-risk resected HCC — Robin K (Katie) Kelley, MD and Thomas A Abrams, MD (13:43) Neoadjuvant systemic therapy for patients with borderline resectable HCC — Dr Abrams (20:15) Case: A man in his early 70s with locally advanced HCC and tumor thrombus that extends into the right atrium — Ghassan Abou-Alfa, MD, MBA (24:34) Recent Developments in the Management of Intermediate-Stage HCC — Dr Finn  Faculty Presentation (31:18) EMERALD-1 and LEAP-012 trials of TACE with immunotherapy — Drs Abrams and Kelley (42:15) Systemic treatment for patients with Child-Pugh B cirrhosis and HCC — Dr Kelley (48:29) Use of immunotherapy for patients with autoimmune disorders: A man in his early 30s with active colitis and metastatic HCC receives first-line lenvatinib — Drs Abrams and Abou-Alfa (53:05) Current First-Line Therapy for Advanced HCC — Dr He Faculty Presentation (1:00:39) Selection of first-line treatment regimen for advanced HCC — Drs Abrams, Kelley and Abou-Alfa (1:12:00) Role of single-agent immunotherapy in the treatment of advanced HCC — Dr Kelley (1:18:22) Management of HCC in patients with discordant tumor markers or mixed tumor histology — Dr Abrams (1:23:03) Promising Investigational Front-Line Strategies for Advanced HCC; Selection and Sequencing of Therapy for Relapsed/Refractory HCC — Dr Stein  Faculty Presentation (1:29:42) Choice of tyrosine kinase inhibitor as second-line systemic treatment for HCC; prevention, monitoring and mitigation of lenvatinib-associated side effects — Dr Kelley (1:42:59) Case: A man in his early 70s with metastatic HCC that has rapidly progressed on atezolizumab/bevacizumab — Dr Abou-Alfa (1:49:27) Supportive care measures to manage ascites in patients with HCC — Dr Abrams (1:55:20) CME information and select publications

Speaking of SurgOnc® has a new home! New episodes can now be found under the Society of Surgical Oncology's podcast, SurgOnc Today®, available on all major podcast platforms. Subscribe today to receive updates on new episode releases.  In this new episode of Speaking of SurgOnc®, Dr. Rick Greene discusses with Dr. Mark Truty the prognosis, and response to neoadjuvant chemotherapy, of resected invasive intraductal papillary mucinous cystic neoplasms compared with de novo pancreatic ductal adenocarcinoma, as reported in their article, "Outcomes of Neoadjuvant Chemotherapy for Invasive Intraductal Papillary Mucinous Neoplasm Compared with de Novo Pancreatic Adenocarcinoma."

Dr. Stéphanie Gaillard and Dr. Bill Tew share updates to the evidence-based guideline on neoadjuvant chemotherapy for newly diagnosed, advanced ovarian cancer. They highlight recommendations across ten clinical questions, addressing initial assessment, primary cytoreductive surgery, neoadjuvant chemotherapy (NACT), tests and/or procedures that should be completed before NACT, preferred chemotherapy regimens, timing of interval cytoreductive surgery (ICS), hyperthermic intraperitoneal chemotherapy (HIPEC), post ICS-chemotherapy, maintenance therapy, and options for those without a clinical response to NACT. They highlight the evidence supporting these recommendations and emphasize the importance of this guideline for clinicians and patients. Read the full guideline update, “Neoadjuvant Chemotherapy for Newly Diagnosed, Advanced Ovarian Cancer: ASCO Guideline Update” at www.asco.org/gynecologic-cancer-guidelines." TRANSCRIPT This guideline, clinical tools, and resources are available at http://www.asco.org/genitourinary-cancer-guidelines. Read the full text of the guideline and review authors' disclosures of potential conflicts of interest in the Journal of Clinical Oncology. Brittany Harvey: Hello and welcome to the ASCO Guidelines podcast, one of ASCO's podcasts delivering timely information to keep you up to date on the latest changes, challenges and advances in oncology. You can find all the shows, including this one at asco.org/podcasts. My name is Brittany Harvey and today I'm interviewing Dr. Stéphanie Gaillard from Johns Hopkins University and Dr. Bill Tew from Memorial Sloan Kettering Cancer Center, co-chairs on “Neoadjuvant Chemotherapy for Newly Diagnosed, Advanced Ovarian Cancer: ASCO Guideline Update.” Thank you for being here today, Dr. Gaillard and Dr. Tew. Dr. Bill Tew: Thank you for having us. Dr. Stéphanie Gaillard: Yeah, thank you. It's great to be here. Brittany Harvey: Great. Then, before we discuss this guideline, I'd like to note that ASCO takes great care in the development of its guidelines and ensuring that the ASCO Conflict of Interest policy is followed for each guideline. The disclosures of potential conflicts of interest for the guideline panel, including Dr. Gaillard and Dr. Tew, who have joined us here today, are available online with the publication of the guideline in the Journal of Clinical Oncology, which is linked in the show notes. So then to dive into the content here, first, Dr. Tew, could you describe what prompted this update to the neoadjuvant chemotherapy for ovarian cancer guideline? And what is the scope of this update? Dr. Bill Tew: Yeah. It's been almost a decade since ASCO first published its neoadjuvant chemotherapy guidelines for women with newly diagnosed ovarian cancer, and over that 10-year period, there's really been a major shift in how oncologists treat patients in the U.S. If you look at the National Cancer Database, between 2010 and 2021, the proportion of patients with advanced ovarian cancer who underwent primary surgery fell from about 70% to about 37%. And there's been a doubling in the amount of neoadjuvant chemotherapy used. So we wanted to take a look at that and really both highlight the appropriate patient populations for primary surgery versus new adjuvant chemotherapy, as well as review any studies that have been published since then. There's been, I think, about 61 trials published, nine randomized trials alone in the last 10 years. And the scope of the guideline was really not only the neoadjuvant chemotherapy and surgical questions, but also to touch upon some new treatments that have come to the forefront in newly diagnosed ovarian cancer, including heated intraperitoneal chemotherapy or HIPEC, as well as the integration of maintenance therapy, particularly bevacizumab and PARP inhibitors. Brittany Harvey: Understood. That's a large amount of new evidence to review in this Update. Then, next, Dr. Gaillard, I'd like to review the key recommendations across the 10 clinical questions that the guideline addressed. So, starting with: What is recommended regarding initial assessment for patients with newly diagnosed pelvic masses and/or upper abdominal or peritoneal disease? Dr. Stéphanie Gaillard: Sure. So in talking about the first guidelines, the first one that we addressed was how to do the initial assessment for these patients. And first, and probably most critically, it's important to recognize that these patients really should be evaluated by a gynecologic oncologist prior to initiation of any therapy, whether that means a primary cytoreductive surgery or neoadjuvant chemotherapy, because really, they are the best ones to determine the pathway that the patient should take. The initial assessment should involve a CA-125, a CT of the abdomen and pelvis with oral and IV contrast, if not contraindicated, and then also chest imaging, in which a CT is really the preferred modality. And that helps to evaluate the extent of disease and the feasibility of the surgical resection. Now, there may be some other tools that could be helpful to also refine this assessment. So, for example, a laparoscopy can really help to determine the feasibility of surgical resection as well as the extent of disease. Further imaging, such as diffusion-weighted MRI or FDG-PET scans can be helpful, as well as ultrasounds. And then also an endometrial biopsy. And that was newly added because there really has been a divergence of treatment for endometrial cancer versus ovarian cancer. And so it's really important to determine upfront where the source of the disease is coming from. Brittany Harvey: I appreciate you describing those recommendations surrounding initial assessment. So following this assessment, Dr. Tew, which patients with newly diagnosed advanced epithelial ovarian cancer should be recommended primary cytoreductive surgery? Dr. Bill Tew: The key thing here is if the GYN oncology surgeon feels that they have a high likelihood of achieving a complete cytoreduction with acceptable morbidity, the panel overwhelmingly agrees that primary cytoreduction surgery should be recommended over chemotherapy. And we know that surgery is really the cornerstone to achieving clinical remission. And our concern is that neoadjuvant chemotherapy may be overused in this fit population. Sometimes it is challenging to determine truly if a patient has a high likelihood of complete cytoreduction or what is acceptable morbidity. But an evaluation with performance status, fitness, looking at age or frailty, nutritional status, as well as a review of imaging studies to plan and determine for who is the right patient for primary surgery is key. Brittany Harvey: And then the title of this guideline, Dr. Gaillard, for which patients is neoadjuvant chemotherapy recommended? Dr. Stéphanie Gaillard: Yeah. So there's really two patient populations that we think are best suited to receive neoadjuvant chemotherapy. Those may be patients who are fit for a primary cytoreductive surgery, but they're unlikely to have a complete cytoreduction if they were to go to surgery directly. And so that's where neoadjuvant chemotherapy can be very helpful in terms of increasing the ability to obtain a complete cytoreduction. The second population is those who are newly diagnosed who have a high perioperative risk, and so they're not fit to go to surgery directly. And so it may be better to start with neoadjuvant chemotherapy and then do an interval cytoreductive surgery. Again, I just want to emphasize the importance of including a gynecologic oncologist when making these determinations for patients. Brittany Harvey: Absolutely. So then the next clinical question. Dr. Tew, for those patients with newly diagnosed stage 3 to 4 epithelial ovarian cancer, what tests and or procedures are recommended before neoadjuvant chemotherapy is delivered? Dr. Bill Tew: The key test is to confirm the proper diagnosis, and that requires histological confirmation with a core biopsy. And this was a point the panel strongly emphasized, which is a core biopsy is a much better diagnostic tool compared to cytology alone. But there will be cases, exceptional cases, where a core biopsy cannot be performed. And in those settings, cytology combined with serum CA-125 and CEA is acceptable to exclude a non-gynecologic cancer. The other reason why cord biopsy is strongly preferred is because we already need to start thinking about germline and somatic testing for BRCA1 and 2. This information is important as we start to think about maintenance strategies for our patients. And so having that information early can help tailor the first-line chemotherapy regimen. Brittany Harvey: So then you've described who should be receiving neoadjuvant chemotherapy, but Dr. Gaillard, for those who are receiving neoadjuvant chemo, what is the preferred chemotherapy regimen? And then what does the expert panel recommend regarding timing of interval cytoreductive surgery? Dr. Stéphanie Gaillard: Sure. So for neoadjuvant chemotherapy, we generally recommend a platinum taxane doublet. This is especially important for patients with high grade serous or endometrioid ovarian cancers, and that's really because this is what the studies had used in the neoadjuvant trials. We recognize, however, that sometimes there are individual patient factors, such as advanced age or frailty, or certain disease factors such as the stage or rare histology that may shift what is used in terms of chemotherapy, but the recommendation is to try to stick as much as possible to the platinum taxane doublet. And then in terms of the timing of interval cytoreductive surgery, this was something that the panel discussed quite a bit and really felt that it should be performed after four or fewer cycles of neoadjuvant chemotherapy, especially in patients who've had a response to chemotherapy or stable disease. Sometimes alternative timing of surgery can be considered based on some patient centered factors, but those really haven't been prospectively evaluated. The studies that looked at neoadjuvant chemotherapy usually did the interval cytoreductive surgery after three or four cycles of chemotherapy. Brittany Harvey: For those patients who are receiving interval cytoreductive surgery, Dr. Tew, earlier in the podcast episode, you mentioned a new therapy. What is recommended regarding hyperthermic intraperitoneal chemotherapy? Dr. Bill Tew: Yeah, or simply HIPEC as everyone refers to it. You know, HIPEC isn't really a new therapy. HIPEC is a one-time perfusion of cisplatin, which is a chemotherapy that has been a standard treatment for ovarian cancer for decades. But the chemotherapy is heated and used as a wash during the interval cytoreductive surgery. And since our last guideline, there has been a publication of a randomized trial that looked at the use of HIPEC in this setting. And in that study there was improved disease-free and overall survival among the patients that underwent HIPEC versus those that did not. So we wanted to at least emphasize this data. But we also wanted to recognize that HIPEC may not be available at all sites. It's resource-intensive. It requires a patient to be medically fit for it, particularly renal function and performance status. And so it's something that could be discussed with the patient as an option in the interval cytoreductive surgery. One other point, the use of HIPEC during primary surgery or later lines of therapy still is unknown. And the other point is this HIPEC trial came prior to the introduction of maintenance PARP inhibitors. So there's still a lot of unknowns, but it is a reasonable option to discuss with appropriate patients. Brittany Harvey: I appreciate you reviewing that data and what that updated recommendation is from the panel. So then, Dr. Gaillard, after patients have received neoadjuvant chemotherapy and interval cytoreductive surgery, what is the post ICS chemotherapy recommended? Dr. Stéphanie Gaillard: The panel recommends some post ICS chemotherapy, as you mentioned. This is typically to continue the same chemotherapy that was done as neoadjuvant chemotherapy and so preferably platinum and taxane. And typically we recommend a total of six cycles of treatment, although the exact number of cycles that is given post-surgery can be adjusted based on different patient factors and their response to treatment. Importantly, also, timing is a factor, and we recommend that postoperative chemotherapy begin within four to six weeks after surgery, if at all feasible. Brittany Harvey: Absolutely. Those timing recommendations are key as well. So then, Dr. Tew, you mentioned this briefly earlier, but what is the role of maintenance therapy? Dr. Bill Tew: Maintenance therapy could be a full podcast plus of discussion, and it's complicated, but we did want to include it in this guideline in part because the determination of whether to continue treatment after completion of surgery and platinum based therapy is key as one is delivering care in the upfront setting. So first off, when we say maintenance therapy, we are typically referring to PARP inhibitors or bevacizumab. And I would refer listeners to the “ASCO PARP Inhibitor Guideline” that was updated about two years ago, as well as look at the FDA-approved label indications. But in general, PARP inhibitors, whether it's olaparib or niraparib, single agent or olaparib with bevacizumab, are standard treatments as maintenance, particularly in those patients with a germline or somatic BRCA mutation or those with an HRD score positive. And so it's really important that we emphasize germline and somatic BRCA testing for all patients with newly diagnosed ovarian cancer so that one can prepare for the use of maintenance therapy or not. And the other point is, as far as bevacizumab, bevacizumab is typically initiated during the chemotherapy section of first-line treatment. And in the guidelines we gave specific recommendations as far as when to start bevacizumab and in what patient population. Brittany Harvey: Great. Yes. And the PARP inhibitors guideline you mentioned is available on the ASCO guidelines website and we can provide a link in the show notes for our listeners. So then, the last clinical question, Dr. Gaillard, what treatment options are available for patients without a clinical response to neoadjuvant chemotherapy? Dr. Stéphanie Gaillard: Yeah, this is a tough situation. And so it's important to remember that ovarian cancer typically does respond to chemotherapy initially. And so it's unusual to have progressive disease to neoadjuvant chemotherapy. So it's really important that if someone has progressive disease that we question whether we really have the right diagnosis. And so it's important to, I think at that point, obtain another biopsy and make sure that we know what we're really dealing with. In addition, this is where Dr. Tew mentioned getting the molecular profiling and genetic testing early in the course of disease. If that hasn't been done at this point in time, it's worth doing that in this setting so that that can also potentially help guide options for patients. And patients who are in those situations, really, the options are other chemotherapy regimens, clinical trials may be an option, or in some situations, if they have really rapidly progressing disease that isn't amenable to further therapy, then initiation of end-of-life care would be appropriate. Brittany Harvey: I appreciate you both for reviewing all of these recommendations and options for patients with advanced ovarian cancer. So then to wrap us up, in your view, what is both the importance of this guideline update and how will it impact clinicians and patients with advanced ovarian cancer? Dr. Bill Tew: Well, first off, I'm very proud of this guideline and the panel that I work with and Dr. Gaillard, my co-chair. The guideline really pulls together nicely all the evidence in a simple format for oncologists to generate a plan and determine what's the best step for patients. The treatment of ovarian cancer, newly diagnosed, is really a team approach - surgeons, medical oncologists, and sometimes even general gynecologists - and understanding the data is key, as well as the advances in maintenance therapy and HIPEC. Dr. Stéphanie Gaillard: For my part, I'd say we hope that the update really provides physicians with best practice recommendations as they navigate neoadjuvant chemotherapy decisions for their patients who are newly diagnosed with ovarian cancer. There is a lot of data out there and so we hope that we've synthesized it in a way that makes it easier to digest. And along that regard, I really wanted to give a special shout out to Christina Lacchetti, who just put in a tremendous effort in putting these guidelines together and in helping to coordinate the panel. And so we really owe a lot to her in this effort. Dr. Bill Tew: Indeed. And ASCO, as always, helps guide and build a great resource for the oncology community. Brittany Harvey: Absolutely. Yes, we hope this is a useful tool for clinicians. And I want to thank you both for the large amount of work you put in to update this evidence-based guideline. And thank you for your time today, Dr. Gaillard and Dr. Tew. Dr. Stéphanie Gaillard: Thank you. Dr. Bill Tew: Thank you for having us. Brittany Harvey: And thank you to all of our listeners for tuning in to the ASCO Guidelines Podcast. To read the full guideline, go to www.asco.org/gynecologic-cancer-guidelines. You can also find many of our guidelines and interactive resources in the free ASCO Guidelines app, which is available in the Apple App Store or the Google Play Store. If you have enjoyed what you've heard today, please rate and review the podcast and be sure to subscribe so you never miss an episode.   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.  

Among patients with colorectal cancer and synchronous liver metastases, the subgroup with a primary cancer in the rectum is especially challenging. Compared with colon cancer, most patients with stage IV rectal cancer will have locally advanced primary tumors at increased risk for obstructive and/or post-operative complications resulting in delays in systemic therapy. In this episode from the HPB team at Behind the Knife, listen in on the discussion about treatment sequencing for synchronous liver metastasis from rectal cancer Hosts Anish J. Jain MD (@anishjayjain) is a current PGY3 General Surgery Resident at Stanford University and a former T32 Research Fellow at the University of Texas MD Anderson Cancer Center. Timothy E. Newhook MD, FACS (@timnewhook19) is an Assistant Professor within the Department of Surgical Oncology. He is also the associate program director of the HPB fellowship at the University of Texas MD Anderson Cancer Center.  Jean-Nicolas Vauthey MD, FACS (@VautheyMD) is Professor of Surgery and Chief of the HPB Section, as well as the Dallas/Fort Worth Living Legend Chair of Cancer Research in the Department of Surgical Oncology at The University of Texas MD Anderson Cancer Center. Learning Objectives ·      Develop an understanding of the three treatment sequences for resection of disease in patients with synchronous liver metastasis from a primary rectal cancer (reverse, combined, and classic approach) ·      Develop an understanding of the benefits, risks, and nuances of each of the three treatment sequences ·      Develop an understanding of which patient cases each treatment sequence is ideal for as well as which cases they are not suitable for. Papers Referenced (in the order they were mentioned in the episode): 1)    Conrad C, Vauthey JN, Masayuki O, et al. Individualized Treatment Sequencing Selection Contributes to Optimized Survival in Patients with Rectal Cancer and Synchronous Liver Metastases. Ann Surg Oncol. 2017 Dec;24(13):3857-3864.  https://pubmed.ncbi.nlm.nih.gov/28929463/ 2)    Maki H, Ayabe RI, Nishioka Y, et al. Hepatectomy Before Primary Tumor Resection as Preferred Approach for Synchronous Liver Metastases from Rectal Cancer. Ann Surg Oncol. 2023 Sep;30(9):5390-5400. doi: 10.1245/s10434-023-13656-4. Epub 2023 Jun 7. Erratum in: Ann Surg Oncol. 2023 Sep;30(9):5405. https://pubmed.ncbi.nlm.nih.gov/37285096/ Additional Suggested Reading Mentha G, Majno PE, Andres A, Rubbia-Brandt L, Morel P, Roth AD. Neoadjuvant chemotherapy and resection of advanced synchronous liver metastases before treatment of the colorectal primary. Br J Surg. 2006 Jul;93(7):872-8.  https://pubmed.ncbi.nlm.nih.gov/16671066/ Please visit https://behindtheknife.org to access other high-yield surgical education podcasts, videos and more.   If you liked this episode, check out our recent episodes here: https://app.behindtheknife.org/listen

CME credits: 1.25 Valid until: 30-12-2025 Claim your CME credit at https://reachmd.com/programs/cme/novel-neoadjuvant-and-adjuvant-immunotherapy-strategies-for-gi-malignancies-the-evidence/29854/ The NCCN Clinical Practice Guidelines are crucial tool in the treatment of cancer and provide detailed recommendations for treatment selection. The guidelines are regularly updated as new therapies are approved or as drugs received expanded indications. Moreover, data are constantly evolving regarding the role of biomarkers and treatment choice. This activity has been designed to provide an overview of the NCCN guidelines for gastric, colorectal, and hepatocellular cancers and the optimal application of these recommendations to clinical practice.

Triple-negative breast cancer accounts for around 15% of breast cancers. Zhi-Ming Shao, MD, of Fudon University, joins JAMA Oncology Editor in Chief and JAMA Deputy Editor Nora Disis, MD, to discuss "Camrelizumab vs Placebo in Combination With Chemotherapy as Neoadjuvant Treatment in Patients with Early or Locally Advanced Triple-Negative Breast Cancer: The CamRelief Randomized Clinical Trial." Related Content: Camrelizumab vs Placebo in Combination With Chemotherapy as Neoadjuvant Treatment in Patients With Early or Locally Advanced Triple-Negative Breast Cancer

Lots of recent clinical trial updates to discuss: AQUILA: Daratumumab for high-risk smoldering multiple myeloma Checkmate 8HW: Nivo/Ipi for MSI-high/MMRd metastatic colorectal cancer DESTINY-Breast06: T-DXd in HER2-low MBC after hormonal treatment, but without previous chemo for MBC ARMANI: Switch maintenance ramucirumab-paclitaxel in metastatic gastric/GEJ cancer HELEN-006: Neoadjuvant nab-paclitaxel/trastuzumab/pertuzumab vs. TCHP in breast cancer SONIA: finally published!

In this episode of SurgOnc Today®'s Surgical Oncology Insight series, Dr. Shishir Maithel, Editor of Surgical Oncology Insight, discusses with Dr. Rita Mukhtar contemporary neoadjuvant therapy approaches to the treatment of breast cancer, with a focus on the interplay between imaging, systemic therapy, radiotherapy, and surgical management, as reported in her article, "The Neoadjuvant Approach to Treatment of Breast Cancer: Multidisciplinary Management to Improve Outcomes."

CME credits: 1.00 Valid until: 27-11-2025 Claim your CME credit at https://reachmd.com/programs/cme/clinical-evidence-driving-guidelines-for-immunotherapy-in-the-neoadjuvant-and-adjuvant-settings/29131/ This online CME activity, presented in collaboration with the National Comprehensive Cancer Network (NCCN), focuses on translating oncology guidelines into practical strategies for treating non-small cell lung cancer (NSCLC). Participants will learn how to integrate clinical trial data into guideline-concordant testing and treatment plans for patients with resectable and metastatic NSCLC. The program highlights the importance of evidence-based approaches in the perioperative setting and the use of immunotherapy and targeted therapies for advanced disease. Attendees will also explore emerging data that could influence future treatment guidelines and develop region-specific therapeutic strategies aligned with NCCN recommendations. As of November 12, 2024, a new Biologics License Application (BLA) for datopotamab deruxtecan (Dato-DXd) has been submitted to the FDA for accelerated approval in the US for patients with previously treated advanced EGFR-mutated NSCLC. The previously submitted BLA for patients with advanced nonsquamous NSCLC has been voluntarily withdrawn.

A large, expanded-cohort pooled analysis of neoadjuvant immunotherapy for patients with resectable Stage III melanoma has reported very high rates of durable survival. The findings from the world’s biggest center of expertise in melanoma were announced at ESMO Congress 2024. The study included patients from clinical trials and real-world studies who had pure immune checkpoint inhibitor neoadjuvant therapy, or combinations including BRAF/MEK targeted therapy. After giving her talk in Barcelona, lead investigator Georgina Long, AO, PhD, MBBS, FRACP, Professor and Co-Medical Director at the Melanoma Institute Australia, University of Sydney, gave Oncology Times reporter Peter Goodwin the details.

Important findings about the benefit of neoadjuvant therapies, especially those involving checkpoint inhibition, have been reported at the ESMO 2024 Congress. Rebecca Dent, MD, Scientific Chair of the meeting, as well as Medical Oncologist and Deputy Chief Executive Officer at the National Cancer Center in Singapore (with a special interest in all aspects of triple-negative breast cancer), shared the key areas of progress covered by the meeting.

Oncotarget #published this #editorial on September 30, 2024, in Volume 15, entitled “Lessons from the ACDC-RP trial: Clinical trial design for radical prostatectomy neoadjuvant therapy trials” by Rashid K. Sayyid and Neil E. Fleshner from the Division of Urologic Oncology, Princess Margaret Cancer Centre, University Health Network, Toronto, ON, Canada. DOI - https://doi.org/10.18632/oncotarget.28648 Correspondence to - Rashid K. Sayyid - rksayyid@gmail.com Video short - https://www.youtube.com/watch?v=APkPoTlXBWY Sign up for free Altmetric alerts about this article - https://oncotarget.altmetric.com/details/email_updates?id=10.18632%2Foncotarget.28648 Subscribe for free publication alerts from Oncotarget - https://www.oncotarget.com/subscribe/ Keywords - cancer, clinical trial, prostatic neoplasms, neoadjuvant therapy, chemotherapy; androgen receptor agonist About Oncotarget Oncotarget (a primarily oncology-focused, peer-reviewed, open access journal) aims to maximize research impact through insightful peer-review; eliminate borders between specialties by linking different fields of oncology, cancer research and biomedical sciences; and foster application of basic and clinical science. Oncotarget is indexed and archived by PubMed/Medline, PubMed Central, Scopus, EMBASE, META (Chan Zuckerberg Initiative) (2018-2022), and Dimensions (Digital Science). To learn more about Oncotarget, please visit https://www.oncotarget.com and connect with us: Facebook - https://www.facebook.com/Oncotarget/ X - https://twitter.com/oncotarget Instagram - https://www.instagram.com/oncotargetjrnl/ YouTube - https://www.youtube.com/@OncotargetJournal LinkedIn - https://www.linkedin.com/company/oncotarget Pinterest - https://www.pinterest.com/oncotarget/ Reddit - https://www.reddit.com/user/Oncotarget/ Spotify - https://open.spotify.com/show/0gRwT6BqYWJzxzmjPJwtVh MEDIA@IMPACTJOURNALS.COM

Important findings about the benefit of neoadjuvant therapies, especially those involving checkpoint inhibition, have been reported at the ESMO 2024 Congress. Rebecca Dent MD, Scientific Chair of the meeting, as well as Medical Oncologist and Deputy Chief Executive Officer at the National Cancer Center, Singapore (with a special interest in all aspects of triple-negative breast cancer), shared the key areas of progress covered by the meeting.

Please visit answersincme.com/ZFZ860 to participate, download slides and supporting materials, complete the post test, and obtain credit. In this activity, an expert in oncology discusses the role of immunotherapy in neoadjuvant treatment of early breast cancer. Upon completion of this activity, participants should be better able to: Recognize the rationale for adding immunotherapy to chemotherapy in the neoadjuvant treatment of early HR-positive, HER2-negative breast cancer; Identify the clinical implications of the latest data for neoadjuvant treatment with immunotherapy plus chemotherapy regimens in early HR-positive, HER2-negative breast cancer; Describe the role that neoadjuvant, immunotherapy-containing regimens might play in the future management of patients with early HR-positive, HER2-negative breast cancer, including high risk patients

Did you miss the ESMO Congress 2024? Listen here: NEJM Editor-in-Chief Eric Rubin and NEJM Evidence Associate Editor Oladapo Yeku discuss research that was presented at the 2024 European Society of Medical Oncology annual meeting. Visit NEJM.org to read the latest research.

Please visit answersincme.com/GWE860 to participate, download slides and supporting materials, complete the post test, and obtain credit. In this activity, an expert in head and neck surgery discusses optimizing the in-practice use of neoadjuvant immunotherapy in the treatment of resectable cutaneous squamous cell carcinoma (CSCC). Upon completion of this activity, participants should be better able to: Describe clinical factors that should be considered when evaluating whether a patient with CSCC is a candidate for neoadjuvant immunotherapy; Review the clinical profiles of approved and emerging neoadjuvant immunotherapies for patients with resectable CSCC; and Outline practical considerations to optimize treatment outcomes for patients with resectable CSCC. This activity is intended for US healthcare professionals only.

Please visit answersincme.com/GWE860 to participate, download slides and supporting materials, complete the post test, and obtain credit. In this activity, an expert in head and neck surgery discusses optimizing the in-practice use of neoadjuvant immunotherapy in the treatment of resectable cutaneous squamous cell carcinoma (CSCC). Upon completion of this activity, participants should be better able to: Describe clinical factors that should be considered when evaluating whether a patient with CSCC is a candidate for neoadjuvant immunotherapy; Review the clinical profiles of approved and emerging neoadjuvant immunotherapies for patients with resectable CSCC; and Outline practical considerations to optimize treatment outcomes for patients with resectable CSCC. This activity is intended for US healthcare professionals only.

Drs Armstrong and Tawagi discuss the NADINA trial of neoadjuvant nivolumab/ipilimumab vs adjuvant nivolumab in resectable, macroscopic, stage III melanoma.

This week's episode will be discussing updates from ASCO 2024 next with the practice changing NADINA trial presented on the Sunday of ASCO by Dr. Christian Blank during the plenary sessions:  A multicenter, randomized, phase 3 trial comparing the efficacy of neoadjuvant ipilimumab plus nivolumab with standard adjuvant nivolumab in macroscopic resectable stage III melanoma. We discuss the staging and prior standard of treatment for locally advanced melanoma, key findings from NADINA, and how these data may impact clinical practice.

In this episode of Lung Cancer Considered, host Dr. Narjust Florez moderates a discussion in Spanish about perioperative chemotherapy and immunotherapy and how recent research may affect clinical decision making in Latin America. Guest: Dr. Clarissa Baldotto graduated from the Fluminense Federal University and studied Clinical Oncology at the National Cancer Institute (INCA). She completed a Master's Degree in Clinical Cancerology at INCA and a PhD in Medical Sciences at the D'Or Institute for Research and Education (ID'Or). Guest: Dr. Paula Ugalde Figueroa graduated from the School of Medicine at the Federal University of Bahia in Salvador, BA, Brazil. With training in Brazil, the United States, and Canada, Dr. Ugalde has established herself as a research-driven thoracic surgeon. In 2021, she was appointed as a Director of the IASLC Board of Directors and continues to break barriers for many Latinas in oncology.

In this episode of SurgOnc Today®, Akhil Chawla, MD, from Northwestern University, and a member of the SSO HPB disease site working group, is joined by Bas Groot Koerkamp, MD, PhD, from Erasmus Medical Centre and Knut Jørgen Labori, MD, PhD, from Oslo University Hospital. They discuss the details, similarities, and differences of their respective clinical trials for neoadjuvant therapy for pancreatic adenocarcinoma, NORPACT-1 and PREOPANC2. References/Resources: NORPACT-1 results: https://www.sciencedirect.com/science/article/abs/pii/S2468125323004053?via%3Dihub NORPACT-1 editorial: https://pubmed.ncbi.nlm.nih.gov/38604195/ PREOPANC-2 protocol: https://bmccancer.biomedcentral.com/articles/10.1186/s12885-021-08031-z PREOPANC-2 results : https://www.annalsofoncology.org/article/S0923-7534(23)04228-X/fulltext

Interview with Lee W. Jones, PhD, author of Neoadjuvant Exercise Therapy in Prostate Cancer: A Phase 1, Decentralized Nonrandomized Controlled Trial. Hosted by Vivek Subbiah, MD. Related Content: Neoadjuvant Exercise Therapy in Prostate Cancer

Interview with Lee W. Jones, PhD, author of Neoadjuvant Exercise Therapy in Prostate Cancer: A Phase 1, Decentralized Nonrandomized Controlled Trial. Hosted by Vivek Subbiah, MD. Related Content: Neoadjuvant Exercise Therapy in Prostate Cancer

For malignant brain cancers, such as glioblastoma, treatment options have not significantly improved. The current standard of care involves surgery followed by radiation or chemotherapy.Dr. Kesari and his team are exploring a new approach. The PNI (Precision Immunotherapy in the Neoadjuvant setting) method uses targeted treatments based on the patient's tumor genetics before administering chemotherapy and radiation, when the immune system is stronger.The goal is to prime the body to recognize and target the cancer as a foreign entity, enabling the body's own immune system to combat the disease before it is weakened by chemotherapy and radiation.Learn more: 310-829-8265

CME credits: 0.50 Valid until: 28-06-2025 Claim your CME credit at https://reachmd.com/programs/cme/predicting-response-to-neoadjuvant-and-perioperative-chemoimmunotherapy/26322/ This educational activity highlights the latest advancements in perioperative immunotherapy for early-stage non-small cell lung cancer and emphasizes the importance of accurate staging, molecular profiling, and a multidisciplinary approach. By integrating recent clinical trial data and expert insights, healthcare professionals will learn to evaluate and apply emerging evidence to optimize individualized treatment strategies. Explore the evolving landscape of neoadjuvant and adjuvant chemoimmunotherapy while gaining critical knowledge to improve patient outcomes through collaborative, evidence-based care.

A combination of two checkpoint inhibitors used as neoadjuvant therapy for macroscopic, resectable Stage III melanoma brought a highly statistically significant improvement over the standard of care: surgery followed by checkpoint inhibition (therapeutic lymph node dissection followed by adjuvant therapy with nivolumab, pembrolizumab or, in BRAFmut melanoma, dabrafenib + trametinib). This research was reported from the ASCO 2024 Annual Meeting and highlighted the NADINA trial from the Netherlands. After his session at ASCO, the lead author of NADINA, Christian U. Blank, MD, PhD, from the Netherlands Cancer Institute and Antoni van Leeuwenhook Hospital, Amsterdam, the Netherlands, met up with Oncology Times reporter Peter Goodwin to discuss the findings.

Dr. Diwakar Davar and Dr. Jason Luke discuss advances in the neoadjuvant immunotherapy space that were presented at the 2024 ASCO Annual Meeting, including promising outcomes in high-risk melanoma from the NADINA trial, as well as other new treatment options for patients with advanced cancers.    TRANSCRIPT Dr. Diwakar Davar: Hello and welcome to the ASCO Daily News Podcast. I'm your guest host, Dr. Diwakar Davar, and I am an associate professor of medicine and the clinical director of the Melanoma Skin Cancer Program at the University of Pittsburgh's Hillman Cancer Center. I am delighted to have my colleague and friend Dr. Jason Luke on the podcast today to discuss key late-breaking abstracts and advances in immunotherapy that were presented at the 2024 ASCO Annual Meeting. Dr. Luke is an associate professor of medicine, the associate director of clinical research, and the director of the Cancer Immunotherapeutic Center at the University of Pittsburgh Hillman Cancer Center.   You will find our full disclosures in the transcript of this episode.  Jason, it's always a pleasure to hear your insights on the key trials in these spaces and to have you back as a guest on this podcast that highlights some of the work, especially advances, that were just presented. Dr. Jason Luke: Well, thanks very much for the invitation. I always love joining the podcast. Dr. Diwakar Davar: We'll start very quickly by talking about some advances and really interesting things that happened both in the context of melanoma but also in immunotherapy in general. And we'll start with what I think was certainly one highlight for me, which was LBA2, the late-breaking abstract on the NADINA trial. It was featured in the Plenary Session, and in this abstract, Dr. Christian Blank and colleagues reported on the results of this phase 3 trial of neoadjuvant ipi-nivo. This is the flipped dose of ipi1/nivo3 versus adjuvant nivolumab in PD-1 naive, macroscopic, resectable, high-risk stage 3 melanoma.  By way of background, neoadjuvant immunotherapy for those listening is an area of increasing interest for drug developers and development for both approved and novel agents. Neoadjuvant immunotherapy has been studied with multiple approved agents, including PD-1 monotherapy, PD-1 LAG-3, PD-1 CTLA-4, T-VEC, as well as investigational agents and multiple randomized and non-randomized studies. The benchmark pathologic response rates with these agents range from 17% PCR with PD-1 monotherapy, 45% to 55% PCR with PD-1 CTLA-4 combination therapy, and slightly higher 57% PCR with PD-1 LAG-3 has recently reported by Dr. Rodabe Amaria from MD Anderson. However, as we embark on phase 3 comparisons for various neoadjuvant compared to adjuvant immunotherapy trials and combinations, we're increasingly moving towards event-free survival as the primary endpoint for neoadjuvant versus adjuvant studies. And this was most recently studied in the context of SWOG S1801, a study that was led by Dr. Sapna Patel.  So, Jason, before we start on NADINA, can you briefly summarize the SWOG S1801 trial and the event-free survival statistic reported by Dr. Patel and her colleagues? Dr. Jason Luke: Well, absolutely. And these data were reported at ESMO about two years ago and then in the New England Journal last year. The S1801 study answered a very simple question: What would happen if you took three of the doses of standard adjuvant therapy with pembrolizumab and moved them prior to surgery? And on a high level, the study is as simple as that. And many of us were somewhat skeptical of this trial design because we thought that just moving the doses earlier may not actually have a major impact.  In the study, you alluded to the event-free survival statistic, and that alludes to what was considered an event. And so, without reading all of it, there were several different aspects that were included in terms of time, based on the date of randomization until the first of a series of events, such as disease progression, toxicity from treatment, if the patient was unable to go to surgery or had surgical complications, or if they had delay in starting the adjuvant therapy due to toxicity, and obviously, recurrence of melanoma or death from any cause. In that context, merely moving the 3 doses of pembrolizumab to the neoadjuvant setting saw an improvement in this two-year event free survival to 72% for the neoadjuvant therapy compared to 49% for the adjuvant therapy. That was quite an outstanding change. And again, noting the power of neoadjuvant treatment, really dictating the impact of anti PD-1, again, just with 3 doses moving from adjuvant into the neoadjuvant setting, and I think all of us were somewhat surprised to see that magnitude of a benefit. But it set up the current study very well, where we now look at combination therapy. Dr. Diwakar Davar: So let's move on to the phase 3 NADINA trial. Do you want to perhaps discuss the study design, particularly focusing on the EFS primary endpoint and maybe also touching on the different schedules? So, SWOG S1801 was a neoadjuvant study of 3 cycles of pembrolizumab and how did that compare and contrast to the neoadjuvant combination that was studied in NADINA? Dr. Jason Luke: Well, as you alluded to, NADINA investigated the regimen of nivolumab plus ipilimumab and compared that against adjuvant therapy with nivolumab alone. So, in the study, as you alluded, the dose and schedule of the two drugs used was nivolumab at 3 milligrams per kilogram, and ipilimumab with 1 milligram per kilogram. That was based on a series of signal finding and safety studies that had been previously done by the same group of authors identifying that as the optimal treatment regimen. And it's worth noting that's slightly different than the labeled indication that's generally used for those same drugs for metastatic melanoma, albeit that the NCCN also endorses this schedule. So, in the trial, 423 patients were randomized, 1:1 to receive either neoadjuvant therapy with those 2 doses of nivolumab plus ipilimumab as compared with standard adjuvant therapy with nivolumab following surgery.   Now, one interesting tweak was that there was an adaptive nature to the study, meaning that patients had a fiducial placed at the index lymph node, and after the neoadjuvant therapy in that arm, that lymph node was removed. And if the patient had a major pathological response, they did not go on to receive the adjuvant portion of the treatment. So it was adaptive because those patients who did very well to the neoadjuvant did not require the adjuvant portion. And in those patients who did not achieve a major pathological response, they could go on to have the adjuvant therapy. And that also included the BRAF therapy for those whose tumors were BRAF mutants.  It's also worth pointing out that the definition of event free survival was slightly different than in the S1801 study that was alluded to just a second ago. And here, EFS was defined from the date of randomization until progression due to melanoma or due to treatment. So that's slightly different than the definition in the S1801 trial. So, a somewhat complicated study, but I really applaud the authors because I think this study does mirror what we would likely be doing in actual clinical practice.  Dr. Diwakar Davar: So, just to briefly summarize the efficacy, and then to get your comments on this, the path response, the PCR rate was 47%. The major pathologic response rate, which is the proportion of patients with between 0% to 1/10% of residual viable tumors, was about 12%. And for a major pathologic response rate of 0% to 10% of 59%. And then the rest of the patients had either pathologic partial response, which was 10% to 50%, or pathologic non response or 50% or greater residual viable tumor, all assessed using central pathology grades. The one year RFS was 95% in the FDR patient population versus 76% in the pathologic partial response patient population, 57% in the pathologic non response patient population. So how do you view these results? Can you context the FDR rates and the EFS rates from NADINA relative to nivo-rela and also potentially SWOG 1801? Dr. Jason Luke: Well, I think these are very exciting results. I think that for those of us that have been following the field closely, they're actually not especially surprising because they mirror several studies that have come before them. When we put them in context with other studies, we see that these rates of major pathological response are consistent with what we've seen in phase 2 studies. They're relatively similar. Or I should say that the results from nivolumab and relatlimab, which was also pursued in a phase 2 study of somewhat similar design, are somewhat similar to this. So, combination immunotherapy does look to deliver a higher major pathological response than pembrolizumab alone, as was known in S1801. Which of course, the caveat being is these are cross control comparisons that we need to be careful about. So I think all of these are active regimens, and I think adding a second agent does appear to enhance the major pathologic response rates. When we look at the event free survival, we see something similar, which is that numerically it looks to be that combination immunotherapy delivers a higher event free survival rate. And that looks to be rather meaningful given the difference in the hazard ratios that were observed between these various studies. And here in the NADINA study, we see that 0.3 hazard ratio for EFS is just extremely impressive.  So the abstract then, from ourselves, out of these specific studies, what does this mean more broadly in the real world, where patients exist and the rest of the landscape for clinical trials? I think we can't take enough time to stop for a second and just think about what a revolution we've come forward in with immune checkpoint blockade and melanoma. When I started my career, now, more than 15 years ago, melanoma was the cancer that made cancer bad. And now here we say, in the highest risk of perioperative patients, we can deliver 2 doses of nivolumab and ipilimumab, and essentially half of the patients then don't need to go on, and more than half the patients don't need to go on to have a full surgery and don't need adjuvant therapy. And from what we could tell of a very, very low risk of every heavy recurrence of melanoma. Of course, there's the other half of patients where we still need to do better, but these are just fantastic results and I think highly meaningful for patients.   In the context of ongoing clinical trials, another abstract that was presented during the meeting was the update to the individualized neoantigen therapy, or V940 with pembrolizumab or against pembrolizumab alone. That's the KEYNOTE-942 study. In that study, they presented updated data at two and a half years for relapse free survival, noting a 75% rate without relapse. So those results are also highly intriguing. And these are in a similar population of very high risk patients. And so I think most of us believe that neoadjuvant therapy with this study in NADINA is now confirmed as the priority approach for patients who present with high-risk stage 3 disease. So that would be bulky disease picked up on a scan or palpable in a clinic. I think essentially all of us now believe patients should get preoperative immunotherapy. We can debate which approach to take, and it may vary by an individual patient's ability to tolerate toxicity, because, of course, multi agent immunotherapy does have increased toxicity relative to anti PD-1 alone. But we'll have to wait now for the full phase 3 results from the V940 individualized neoantigen therapy. And if those come forward, that will be an extremely attractive approach to think about for patients who did not achieve a major pathological response to neoadjuvant therapy, as well as of course to the other populations of patients with melanoma where we otherwise currently give adjuvant therapy stage 2B all the way through stage 4 resected. It's an amazing time to think about perioperative therapy in melanoma. Dr. Diwakar Davar: So this is clearly outstanding data, outstanding news. Congratulations to the investigators for really doing what is an investigative initiated trial conducted across multiple continents with a huge sample size. So this clearly appears to be, at this point in time at least, a de facto standard. But is this going to be FDA-approved, guideline-approved, or is it possible in your mind? Dr. Jason Luke: Well, that's an interesting question. This study was not designed with the intent to necessarily try to register this treatment regimen with the FDA. One would have to take a step back and say, with how powerful these data appear, it sort of seemed like it would be too bad if that doesn't happen. But all the same, I think the community and those of us who participate in guideline recommendations are fully supportive of this. So, I think we will see this move into compendium listings that support insurance approval, I think, very, very quickly. So, whether or not this actually becomes formally FDA approved or is in the guidelines, I think this should become the standard approach that is considered for patients, again presenting with high-risk stage 3 disease.  Dr. Diwakar Davar: Fantastic. So now we're going to go in and talk about a slightly different drug, but also from the melanoma context, and that is the safety and efficacy of RP1 with nivolumab in the context of patients with melanoma who are PD-1 failures. So, this is Abstract 9517. And in this abstract, our academic colleagues essentially talked about these data, and we'll start by describing what RP1 is. RP1 essentially is a HSV-1 based oncolytic immunotherapy. And RP1 expresses GM-CSF as well as a fusogenic protein, GALV-GP-R-. And in this abstract, Dr. Michael Wong from MD Anderson and colleagues are reporting the results of IGNYTE, which is a phase I trial of intratumoral RP1 co-administered with systemic nivolumab in patients with advanced metastatic treatment refractory cutaneous melanoma. And the data presented in this abstract represents data from a registration directed, abbreviated as RD, registration directed cohort of RP1 plus nivolumab in PD-1 refractory melanoma. So, let's start with the description of the cohort.  Dr. Jason Luke: Right. So, in this study, there were a total of 156 patients who were presented, and that included an initial safety and dose finding group of 16, as well as the RD cohort, as you noted, of 140 patients. And it's important to point out that this was a cohort that was selected for a very strict definition of progression on anti PD-1, or a combination immunotherapy as their immediately prior treatment. So, all of the patients in the cohort had exposure to anti PD-1, and 46% of them had anti PD-1 plus anti CTLA4, nivolumab and ipilimumab as their immediately prior therapy. This was also a group of relatively high-risk patients when one considers stage. So, within the stage 4 population, the entry here included 51% who had stage M1B, C, and D melanoma. And that is worth pointing out because this is an injectable therapy. So, trials like this in the past have tended to be biased towards earlier stage, unresectable or metastatic melanoma, meaning stage 3B, 3C, 3D and then stage 4m1a. Again, to emphasize the point here, these were pretreated patients who had a strict definition of anti PD-1 resistance, and over half of them, in fact, had high-risk visceral metastatic disease.  In that context, it's very interesting to observe that the overall response rate was described in the total population, as 31%, and that included 12% who achieved complete response. And so, again, to make sure it's clear, we're talking about a treatment where the oncolytic virus is injected into one or multiple sites of recurrent disease, and then the patients administer nivolumab as per standard. And so, I think these data are quite intriguing. Again, such a high- risk population and their maturity now, with a follow-up of over a year, I think, makes this look to be a very interesting treatment option.  Dr. Diwakar Davar: I guess on that topic of mature follow-up, it probably would be important for us to inform our audience that the top line data for the primary analysis was actually just released, I think, earlier today, and wherein the central confirmed objective response rate was 34% by modified RECIST and 33% by RECIST, clearly indicating that these responses, as you noted, very treatment refractory patient population, these responses were clearly very durable. So, you mentioned that there were responses seen in uninjected visceral lesions, responses seen in both PD-1 and PD-1 CTLA-4 refractory patients. Can you talk a little bit about the response rate in these high-risk subgroups, the uninjected visceral lesions, the patients who had both combination checkpoint and epidural refractory response rate by primary PD-1 resistance.  Dr. Jason Luke: Sure. You know, I think, again, to emphasize this point in the study, we saw that there were responses in the non-injected lesions, and I think it's really important to emphasize that. Some have referred to this as a putative abscopal like effect, similar to what is described in radiation. But it implies that local treatment with the oncolytic virus is triggering a systemic immune response. In the higher risk patient population, we'll note that whereas the overall response rate in PD-1 refractory patients was 34%, in the combination of PD-1 and CTLA-4 refractory patients, the response rate was 26%. So, [this is] still very good. And when we looked at that split by stage, as I alluded to before, in the population of patients that had, what you might call earlier unresectable diseases, so 3B through 4A, the response rate was 38%, and in the stage 4 M1b through M1d, it was 25%. So slightly lower, but still very good. And that would be as expected, because, of course, the patients with visceral metastatic disease have more advanced disease, but those response rates look quite good. Again, looking at the combination refractory population as well as the more high-risk disease. Dr. Diwakar Davar: So, clearly, these are very promising data and exciting times for multiple investigators in the field and the company, Replimune, as well. So, what are the next steps? I believe that a registration trial is planned, essentially, looking at this with the goal of trying to get this combination registered. Can you tell us a little bit about IGNYTE-3, the trial design, the control arm, and what you foresee this trial doing over the next couple of years?  Dr. Jason Luke: So, as this agent has been maturing, it's worth pointing out that the company that makes this molecule, called RP1, but I guess now we'll have to get used to this name vusolimogene oderparepvec as the actual scientific term, they have been having ongoing discussions with the FDA, and there is the potential that this agent could come forward on an accelerated path prior to the results being released from a phase 3 trial. That being said, the phase 3 confirmatory study, which is called the IGNYTE-3 study, is in the process of being launched now. And that's a study investigating this molecule in combination with nivolumab, as was alluded to earlier, and a randomized phase 3 design, where that combination is compared with a physician's choice, essentially a chemotherapy-based option.   In that study, it will be 400 patients with stage 3B through stage 4; patients will have progressed on anti PD-1, either as a combination or in sequence, and then come on the study to be randomized to either vusolimogene oderparepvec plus nivolumab versus that physician's choice. And the physician's choice includes chemotherapy agents, but also nivolumab plus relatlimab as another option, or an anti PD-1 monotherapy, if that's deemed to be a reasonable option by the treating investigator. And the primary endpoint of that study is overall survival. And unfortunately, in this highly refractory patient population, that's something that may not take long to identify with key secondary endpoints of progression free survival, as well as overall response rate. I'm quite enthusiastic about this study, given these data, which have now been centrally confirmed as you alluded to before. I think this is a very exciting area of investigation and really crossing my fingers that this may be perhaps the first locally administered therapy which does appear to have a systemic impact that can hold up in phase 3. Dr. Diwakar Davar: Very, very, very exciting results. And I guess it's worthwhile pointing out that this company also has got, I think, multiple studies planned with both RP1 and cutaneous squamous cell carcinoma in a solid organ transplant patient population where single agent activity has already been reported by Dr. Migden at prior meetings, as well as a novel trial of potentially RP2 metastatic uveal melanoma. So we'll now pivot to Abstract 6014. So, 6014 is a drug by a company known as Merus. Essentially, it's a very novel agent. Merus essentially is a company that is specialized in making bicyclics and tricyclics. And these are not bicycles or tricycles, but rather drugs that essentially are bispecific antibodies. And Merus essentially has come up with petosemtamab. I think we're going to have to figure out better names for all of these drugs at some point. But petosemtamab, or MCLA-158, essentially is a bicyclic, targeting both EGFR as well as LGR-5. So EGR-5, of course, is a known oncogenic driver in multiple tumor types, squamous, including non small cell lung cancer, cutaneous squamous cell carcinoma, but also head and neck squamous cell carcinoma. And LGR-5 essentially is leucine-rich repeat-containing G-protein coupled receptor 5, but it's a receptor in cancer stem cells and certainly highly expressed in head neck squam. And MCLA-158, or petosemtamab is a IgG one bispecific with ADCC-activity because of IgG1 backbone co-targeting EGFR and LGR5. Merus had earlier results that evaluated petosemtamab monotherapy. They defined the RP2D and second- and third-line head and neck blastoma patients with a respectable response rate of 37% investigator-assessed ORR with six months median DoR, and this was published by Ezra Cohen about a year or so ago.  In this abstract, Dr. Fayette and colleagues report on the results of the MCLA-158-CL01 trial, which is a trial of pembrolizumab plus petosemtamab in one front line head and neck squamous cell population. So maybe let's start with the description of the cohort. And it is a small trial, but we'll be able, I think, to dig into a little bit about why this might be exciting. Dr. Jason Luke: Yes. So, as alluded to, it's not the biggest trial as yet, but there were 26 patients with anti PD-1 treatment naive head and neck squamous cell carcinoma. And all the patients in the study did receive, as you alluded to, pembrolizumab plus petosemtamab. Based on the label for pembrolizumab, all the patients in this study were PDL-1 positive. So that's one point that it's worth pointing out to make sure that that's understood. This is the population of patients who would be expected to benefit from pembrolizumab in the first place. Now, in the abstract, they reported out only 10 response evaluable patients, but they updated that in the actual slides of presentation at the meeting. So among 24 patients that were alluded to, 67% were described as having had a response, although some of those were yet to be confirmed responses. And when it was evaluated by PDL-1 status, there didn't seem to be a clear enrichment of response in the PD-1 positive more than 20% group, as compared to the 1-19% group. That isn't especially surprising because that was a trend that one would see, presumably with pembrolizumab alone. But overall, I think these data are pretty exciting in terms of a preliminary study. Dr. Diwakar Davar: You know, you mentioned that the objective response rate was high, almost 60-something%. The prognosis of these patients is generally poor. The OS is typically thought of as between 6-15 months. And based on KEYNOTE-048, which was led by Dr. Burtness and colleagues, the standard of care in the setting is pembrolizumab +/- platinum based chemotherapy regimens. Allowing for the fact that we only have 10 patients here, how do you think these results stack up against KEYNOTE-048? And you made a very important point earlier, which was, by definition, pembro is on label only for the CPS. So PDL-1 score, at least in head and neck squamous cell carcinoma CPS and not TPS. But in the CPS 1% or greater patient population, where pembro is on label, how do these results stack up against the KEYNOTE-048 results. Dr. Jason Luke: Right. KEYNOTE-048 is considered the seminal study that dictates frontline treatment in head and neck cancer. And before we dive into this too far, we do want to acknowledge that here we're comparing 26 patients versus a phase 3 trial. So, we're not trying to get too far ahead of ourselves, but this is just a preliminary comparison. But in KEYNOTE-048, as you alluded to, two regimens were superior to chemotherapy. One was the pembrolizumab monotherapy, as well as pembrolizumab plus chemotherapy. So again, the study overall survival, of course, was much higher, the PDL-1 positive subgroup, which is what dictated the unlabeled use of this. But response to pembro monotherapy in that population of patients is still modest. We're talking about upwards of 20-30%. So, if you compare that to, again, preliminary evidence here from this trial of only 24 patients, that response rate of 60% seems extremely high. And so even if that were to come down somewhat in a larger data series of patients, that still looks to be quite promising as a treatment regimen, that might eventually even be chemotherapy sparing for this population of patients. I think this raises a lot of eyebrows that perhaps this dual targeting approach, EGFR and LDR-5, may bring something really important to the field that evolves it. Dr. Diwakar Davar: So, what are the next steps for petosemtamab? You mentioned that the activity was interesting. Are we going to see a larger trial? Any thoughts on where things are going to go?  Dr. Jason Luke: Well, based on the phase 2 data of petosemtamab alone, even without pembrolizumab, the molecule had already been given fast track designation by FDA, which means allowing for greater communication between the drug sponsor in the FDA and designing a seminal study design. One would assume that this trial will be rapidly expanded quite greatly, perhaps to 100 or 200 patients, to try to flush out what the real response rate is in a more meaningful number of patients. But I think these data will probably also trigger the design and probably near-term evaluation or expedited acceleration of a phase III clinical trial design that would potentially validate this against the current standard of care. So, I'm pretty excited. I think we'll see a lot more about this agent in the relatively near future. Dr. Diwakar Davar: So, finally, we'll pivot to the last abstract that we're going to talk about, which is Abstract 2504. It's a relatively interesting target, CCR8 monoclonal antibody. But this is the efficacy and safety of LM-108, and LM-108 is an anti CCR8 monoclonal antibody that is being developed by LaNova Medicine. And the results that are described, actually a pool set of results of combinations of LM-108 with anti PD-1, two separate anti PD-1, in patients with gastric cancer, mostly done ex-U.S., which is interesting because of this patient population, and it's a pool result of several, 3 phase 1 and 2 studies.  LM-108 is an Fc-optimized anti CCR8 monoclonal antibody that selectively depletes tumor infiltrating Tregs. The abstract reported a pooled analysis of three phase 1, 2 trials with 3 different NCT numbers that all evaluated the efficacy of LM-108 and anti PD-1 in patients with gastric cancer. So, let's start with the description of the cohort. Maybe, Jason, you can tell us a little bit about before you start, as you describe the cohort, sort of what we know, editorially speaking, about the difficulty with which Tregs depletion has been tried and obviously failed up until now in the tumor microenvironment. Dr. Jason Luke: Right. I think that's a really interesting comment. And so, for decades, in fact, targeting regulatory T-cell to alleviate immune exclusion in the tumor microenvironment has been of interest in immuno-oncology. And in preclinical mouse models, it seems quite clear that such an approach can deliver therapeutic efficacy. However, by contrast, in human clinical trials, various different Treg depleting strategies have been attempted, and there's really little to no evidence that depleting Tregs from human tumors actually can deliver therapeutic responses. And by that we're referring to CD-25 antibodies. The drug ipilimumab, the CTLA-4 antibody, was punitively described as a Tregs depleter preclinically, but that doesn't seem to be the case in patients. And so, in that background, this is quite an eye raiser that an anti CCR8 antibody could be driving this effect. Now, before we talk about the results of this trial, I will point out, however, that given the Fc-optimization, it's entirely possible that the Tregs are being depleted by this mechanism, but that more could also be going on. Because Fc gamma RII binding by this antibody that could be nonspecific also has the potential to trigger immune responses in the tumor microenvironment, probably mediated by myeloid cells. So I think more to come on this. If this turns out to be the first meaningful Tregs depletor that leads to therapeutic efficacy, that would be very interesting. But it's also possible this drug could have multiple mechanisms.  So, having said all of that, in the clinical trial, which was a pooled analysis, like you mentioned, of LM-108 in combination with anti PD-1 of a couple different flavors, there were 48 patients treated either with LM-108, with pembrolizumab, or with toripalimab, which is another anti PD-1 antibody. On the drug combination was, generally speaking, pretty well tolerated, noting grade 3 treatment related adverse events in the range of 38%, which is somewhat expected given combination immunotherapy. We talked about nivolumab and ipilimumab before, which, of course, gives even higher rates of immune-related adverse events, with the most common toxicities being anemia, lipase elevations, rash, ALC decrease; albeit, quite manageable. Dr. Diwakar Davar: So, what about the objective response rate? Can you contextualize the efficacy? And as you do that, maybe we'll think about what you'd expect in the context of, say, gastric cancer, especially in patients who've never really had a prior checkpoint inhibitor before. What do you think about the ORR? What do you think about the relative efficacy of this combination? Dr. Jason Luke: Well, so, in the study, they described overall response rate in the 36 patients as 36% and described immediate progression for survival of about 6.5 months. And so that was among patients who were treatment naive. And in second-line patients, they actually described an even higher response rate, although it was only 11 patients, but they're at 64%. And so, I think those data look to be somewhat interesting. When I was actually scrutinizing the actual data presented, it was of some interest to note that the quality of responses seemed to be about as good on the lower dose of LM-108, so 3 milligrams per kilogram as compared to 10 milligrams per kilogram. I think there's definitely more to learn here to try to optimize the dose and to fully understand what the overall efficacy of this treatment combination would be.  I would emphasize that in this disease, I think novel treatment strategies are certainly warranted. While anti PD-1 with chemotherapy has moved the needle in terms of standard of care treatment, it's really only a minor subset of patients who derive durable long-term benefit like we normally associate with immune checkpoint blockade. I think these are preliminary data. They're very intriguing.   You alluded to earlier that this population of patients was an Asian data set, and it is well known that the efficacy of chemotherapy and immunotherapy does appear to be somewhat enhanced in Asian populations, and that goes to distributions of metastasis and tumor microenvironment effects, etc. Very difficult to try to tease any of that out in this abstract, other than to look at these data and suggest that this is pretty interesting, both from a novel therapeutic approach, we talked about the Tregs consideration, but also straight up on the efficacy because I think if these data could hold up in a larger number of patients, and particularly in a western population of patients, I think it would be very intriguing. Dr. Diwakar Davar: Certainly, ASCO 2024 had a lot of interesting data, including data from targeted agents, the LAURA trial, ADCs. But just focusing on the immune therapy subset, we certainly saw a lot of great advances in patients who were treated with neoadjuvant as well as relapse refractory disease in the context of RP1 and then a couple of newer agents such as this petosemtamab as well as LM-108. And of course, we cannot forget to highlight the extended DMFS data from the pembro vaccine study from KEYNOTE-942.  Jason, as always, thank you for taking a little bit of time out of your extremely busy schedule to come and give us insights as to how these agents are impacting the landscape. We really value your input and so thank you very much.  Dr. Jason Luke: Thank you for the opportunity. Dr. Diwakar Davar: And thank you to our listeners for your time today. You will find the links to all the abstracts that we discussed in the transcript of this episode. And finally, if you value the insights that you hear on this podcast, please take a moment to rate, review and subscribe wherever you get your podcasts. So, thank you.   Disclaimer: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement.   Follow today's speakers:   Dr. Diwakar Davar   @diwakardavar   Dr. Jason Luke   @jasonlukemd      Follow ASCO on social media:    @ASCO on Twitter   ASCO on Facebook   ASCO on LinkedIn      Disclosures:       Dr. Diwakar Davar:     Honoraria: Merck, Tesaro, Array BioPharma, Immunocore, Instil Bio, Vedanta Biosciences    Consulting or Advisory Role: Instil Bio, Vedanta Biosciences    Consulting or Advisory Role (Immediate family member): Shionogi    Research Funding: Merck, Checkmate Pharmaceuticals, CellSight Technologies, GSK, Merck, Arvus Biosciences, Arcus Biosciences    Research Funding (Inst.): Zucero Therapeutics    Patents, Royalties, Other Intellectual Property: Application No.: 63/124,231 Title: COMPOSITIONS AND METHODS FOR TREATING CANCER Applicant: University of Pittsburgh–Of the Commonwealth System of Higher Education Inventors: Diwakar Davar Filing Date: December 11, 2020 Country: United States MCC Reference: 10504-059PV1 Your Reference: 05545; and Application No.: 63/208,719 Enteric Microbiotype Signatures of Immune-related Adverse Events and Response in Relation to Anti-PD-1 Immunotherapy       Dr. Jason Luke:    Stock and Other Ownership Interests: Actym Therapeutics, Mavu Pharmaceutical, Pyxis, Alphamab Oncology, Tempest Therapeutics, Kanaph Therapeutics, Onc.AI, Arch Oncology, Stipe, NeoTX    Consulting or Advisory Role: Bristol-Myers Squibb, Merck, EMD Serono, Novartis, 7 Hills Pharma, Janssen, Reflexion Medical, Tempest Therapeutics, Alphamab Oncology, Spring Bank, Abbvie, Astellas Pharma, Bayer, Incyte, Mersana, Partner Therapeutics, Synlogic, Eisai, Werewolf, Ribon Therapeutics, Checkmate Pharmaceuticals, CStone Pharmaceuticals, Nektar, Regeneron, Rubius, Tesaro, Xilio, Xencor, Alnylam, Crown Bioscience, Flame Biosciences, Genentech, Kadmon, KSQ Therapeutics, Immunocore, Inzen, Pfizer, Silicon Therapeutics, TRex Bio, Bright Peak, Onc.AI, STipe, Codiak Biosciences, Day One Therapeutics, Endeavor, Gilead Sciences, Hotspot Therapeutics, SERVIER, STINGthera, Synthekine    Research Funding (Inst.): Merck , Bristol-Myers Squibb, Incyte, Corvus Pharmaceuticals, Abbvie, Macrogenics, Xencor, Array BioPharma, Agios, Astellas Pharma , EMD Serono, Immatics, Kadmon, Moderna Therapeutics, Nektar, Spring bank, Trishula, KAHR Medical, Fstar, Genmab, Ikena Oncology, Numab, Replimmune, Rubius Therapeutics, Synlogic, Takeda, Tizona Therapeutics, Inc., BioNTech AG, Scholar Rock, Next Cure    Patents, Royalties, Other Intellectual Property: Serial #15/612,657 (Cancer Immunotherapy), and Serial #PCT/US18/36052 (Microbiome Biomarkers for Anti-PD-1/PD-L1 Responsiveness: Diagnostic, Prognostic and Therapeutic Uses Thereof)    Travel, Accommodations, Expenses: Bristol-Myers Squibb, Array BioPharma, EMD Serono, Janssen, Merck, Novartis, Reflexion Medical, Mersana, Pyxis, Xilio

Rick Greene, MD, discusses with Lorenzo Ferri, MD, PhD, the long-term survival outcomes of patients with esophageal and junctional adenocarcinoma treated with neoadjuvant docetaxel-based chemotherapy and en bloc transthoracic esophagectomy. Dr. Ferri is author of, "Docetaxel-Based Neoadjuvant Chemotherapy Followed by En Bloc Resection for Esophageal Adenocarcinoma: A 15-Year Retrospective Analysis from a Regional Upper Gastrointestinal Cancer Network." Dr. Ferri is Professor of Surgery and Oncology, McGill University; David S. Mulder Chair of Surgery Head, Division of Thoracic and Upper Gastrointestinal Surgery, McGill University Health Centre; and, Director, Upper G.I. Cancer Program, McGill University, Montreal, Canada.

Andrea Necchi gives us the lowdown of efficacy and toxicity of this combination.

Flora gives an overview of the budding landscape of neoadjuvant therapy in melanoma and provides insight on the nuances of this market. Apple Podcasts -   https://podcasts.apple.com/us/podcast/pharma-intelligence-podcasts/id923189836​ Google Podcasts - https://podcasts.google.com/feed/aHR0cHM6Ly9mZWVkcy5zb3VuZGNsb3VkLmNvbS91c2Vycy9zb3VuZGNsb3VkOnVzZXJzOjEwNjU1NDkyOC9zb3VuZHMucnNz​ TuneIn - https://tunein.com/podcasts/Business--Economics-Podcasts/Pharma-Intelligence-Podcasts-p1140128/​ Spotify Podcasts - https://open.spotify.com/show/3DTc3eIh4xI6pVOd6DdO67

Drs. Rosenberg and Morgans share their insights into neoadjuvant therapy in the management of patients with muscle invasive urothelial carcinoma, including patient‑ and treatment‑related factors that may influence decision making, bladder‑preservation, and the future of neoadjuvant therapy with immunotherapy and ADCs.

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/NQH865. CME/MOC/AAPA/IPCE credit will be available until April 21, 2025.New Chapters in the Immunotherapy Story for Melanoma: Collaborative Care and Next Steps With Adjuvant and Neoadjuvant Therapy 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 through educational grants from Bristol Myers Squibb and Merck & Co., Inc.Disclosure information is available at the beginning of the video presentation.

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/NQH865. CME/MOC/AAPA/IPCE credit will be available until April 21, 2025.New Chapters in the Immunotherapy Story for Melanoma: Collaborative Care and Next Steps With Adjuvant and Neoadjuvant Therapy 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 through educational grants from Bristol Myers Squibb and Merck & Co., Inc.Disclosure information is available at the beginning of the video presentation.

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/NQH865. CME/MOC/AAPA/IPCE credit will be available until April 21, 2025.New Chapters in the Immunotherapy Story for Melanoma: Collaborative Care and Next Steps With Adjuvant and Neoadjuvant Therapy 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 through educational grants from Bristol Myers Squibb and Merck & Co., Inc.Disclosure information is available at the beginning of the video presentation.

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/NQH865. CME/MOC/AAPA/IPCE credit will be available until April 21, 2025.New Chapters in the Immunotherapy Story for Melanoma: Collaborative Care and Next Steps With Adjuvant and Neoadjuvant Therapy 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 through educational grants from Bristol Myers Squibb and Merck & Co., Inc.Disclosure information is available at the beginning of the video presentation.

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/NQH865. CME/MOC/AAPA/IPCE credit will be available until April 21, 2025.New Chapters in the Immunotherapy Story for Melanoma: Collaborative Care and Next Steps With Adjuvant and Neoadjuvant Therapy 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 through educational grants from Bristol Myers Squibb and Merck & Co., Inc.Disclosure information is available at the beginning of the video presentation.

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/NQH865. CME/MOC/AAPA/IPCE credit will be available until April 21, 2025.New Chapters in the Immunotherapy Story for Melanoma: Collaborative Care and Next Steps With Adjuvant and Neoadjuvant Therapy 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 through educational grants from Bristol Myers Squibb and Merck & Co., Inc.Disclosure information is available at the beginning of the video presentation.

Please visit answersincme.com/TAR860 to participate, download slides and supporting materials, complete the post test, and obtain credit. In this activity, an expert in oncology discusses the integration of perioperative immunotherapy-based regimens for the treatment of resectable non–small-cell lung cancer (NSCLC). Upon completion of this activity, participants should be better able to: Recognize the rationale for the use of neoadjuvant followed by adjuvant immunotherapy-based regimens in patients with resectable NSCLC; Describe current evidence on the use of neoadjuvant plus adjuvant immunotherapy in patients with resectable NSCLC; and Outline practical strategies to integrate neoadjuvant plus adjuvant immunotherapy-based regimens into the treatment plan for appropriate patients with resectable NSCLC.

In this episode of SurgOnc Today®, Tina Hieken, MD, from the Mayo Clinic, in Rochester, Minnesota, interviews Jay Lee, MD, MHSc, from Duke University in Durham, North Carolina, and Julia Terhune, MD, from the University of Maryland in Baltimore, Maryland. They will discuss the current and evolving indications for adjuvant therapy in patients with stage III melanoma including vaccine trials.

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/CC/AAPA information, and to apply for credit, please visit us at PeerView.com/QRX865. CME/MOC/CC/AAPA credit will be available until February 27, 2025.A Practical Guide for Making Multidisciplinary Decisions About Neoadjuvant and/or Adjuvant Immunotherapy in Resectable NSCLC 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, Bristol Myers Squibb, and Merck & Co., Inc.Disclosure PolicyAll relevant conflicts of interest have been mitigated prior to the commencement of the activity.Faculty/Planner DisclosuresCo-Chair/PlannerJessica Donington, MD, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for Amgen; AstraZeneca; Bristol Myers Squibb; Genentech, Inc./F. Hoffmann-La Roche Ltd.; and Merck & Co., Inc.Grant/Research Support from AstraZeneca; Bristol Myers Squibb; Genentech, Inc./F. Hoffmann-La Roche Ltd.; and Merck & Co., Inc.Co-Chair/PlannerJonathan D. Spicer, MD, PhD, FRCSC, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for AstraZeneca; Bristol Myers Squibb; Chemocentryx; F. Hoffmann-La Roche Ltd.; Merck & Co., Inc.; Novartis Pharmaceuticals Corporation; Protalix Biotherapeutics; Regeneron; and Xenetic Biosciences.Grant/Research Support from AstraZeneca; Bristol Myers Squibb; CLS Therapeutics; F. Hoffmann-La Roche Ltd.; Merck & Co., Inc.; and Protalix Biotherapeutics.Faculty/PlannerPatrick M. Forde, MD, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for Amgen Inc.; Ascendis Pharma A/S; AstraZeneca; Bristol Myers Squibb; CureVac SE; F-star Therapeutics Inc.; Flame Pharmaceuticals Pvt Ltd; Fosun Pharma USA Inc.; G1 Therapeutics, Inc.; Genelux Corporation; Genentech, Inc.; Gritstone bio, Inc.; iTeos Therapeutics; Janssen Pharmaceuticals, Inc.; Merck & Co., Inc.; Novartis Pharmaceuticals Corporation; Regeneron Pharmaceuticals Inc.; Sanofi; Synthekine; Tavotek Biotherapeutics; and Teva Pharmaceuticals USA, Inc.Grant/Research Support from AstraZeneca; BioNTech SE; Bristol Myers Squibb; Novartis Pharmaceuticals Corporation; and Regeneron Pharmaceuticals 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/CC/AAPA information, and to apply for credit, please visit us at PeerView.com/QRX865. CME/MOC/CC/AAPA credit will be available until February 27, 2025.A Practical Guide for Making Multidisciplinary Decisions About Neoadjuvant and/or Adjuvant Immunotherapy in Resectable NSCLC 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, Bristol Myers Squibb, and Merck & Co., Inc.Disclosure PolicyAll relevant conflicts of interest have been mitigated prior to the commencement of the activity.Faculty/Planner DisclosuresCo-Chair/PlannerJessica Donington, MD, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for Amgen; AstraZeneca; Bristol Myers Squibb; Genentech, Inc./F. Hoffmann-La Roche Ltd.; and Merck & Co., Inc.Grant/Research Support from AstraZeneca; Bristol Myers Squibb; Genentech, Inc./F. Hoffmann-La Roche Ltd.; and Merck & Co., Inc.Co-Chair/PlannerJonathan D. Spicer, MD, PhD, FRCSC, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for AstraZeneca; Bristol Myers Squibb; Chemocentryx; F. Hoffmann-La Roche Ltd.; Merck & Co., Inc.; Novartis Pharmaceuticals Corporation; Protalix Biotherapeutics; Regeneron; and Xenetic Biosciences.Grant/Research Support from AstraZeneca; Bristol Myers Squibb; CLS Therapeutics; F. Hoffmann-La Roche Ltd.; Merck & Co., Inc.; and Protalix Biotherapeutics.Faculty/PlannerPatrick M. Forde, MD, has a financial interest/relationship or affiliation in the form of:Consultant and/or Advisor for Amgen Inc.; Ascendis Pharma A/S; AstraZeneca; Bristol Myers Squibb; CureVac SE; F-star Therapeutics Inc.; Flame Pharmaceuticals Pvt Ltd; Fosun Pharma USA Inc.; G1 Therapeutics, Inc.; Genelux Corporation; Genentech, Inc.; Gritstone bio, Inc.; iTeos Therapeutics; Janssen Pharmaceuticals, Inc.; Merck & Co., Inc.; Novartis Pharmaceuticals Corporation; Regeneron Pharmaceuticals Inc.; Sanofi; Synthekine; Tavotek Biotherapeutics; and Teva Pharmaceuticals USA, Inc.Grant/Research Support from AstraZeneca; BioNTech SE; Bristol Myers Squibb; Novartis Pharmaceuticals Corporation; and Regeneron Pharmaceuticals 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.

In this episode of the IJGC podcast, Editor-in-Chief Dr. Pedro Ramirez is joined by Professor Gemma Kenter to discuss EORTC 55994. Prof. Kener is emeritus professor in gynae-oncology and was head of the department gynae-oncology in Center of Gynaecological Oncology Amsterdam (Amsterdam University Medical Center and Dutch Cancer Center). Her scientific interest concerns treatment and translational research of carcinoma of the cervix.     Highlights: In Trial EORTC 55994 we found no difference in overall survival between neoadjuvant chemotherapy followed by radical surgery and concomitant chemoradiation in case of bulky cervical cancer.  Regions in the world with a high incidence of cancer of the cervix might have poor access to radiotherapy. For patients in these centers as well as for young women who want to perceive their ovarian function, neoadjuvant chemotherapy followed by radical surgery can be a good alternative.

Featuring perspectives from Prof Francois-Clement Bidard, Dr Erika Hamilton, Dr Komal Jhaveri, Dr Virginia Kaklamani and Dr Hope S Rugo, including the following topics: Introduction (0:00) Role of Genomic Assays in Treatment Decision-Making for Localized ER-Positive, HER2-Negative Breast Cancer — Dr Goetz (6:03) Integration of Ovarian Function Suppression into the Management of Breast Cancer in  Premenopausal Patients — Dr Burstein (33:34) Role of CDK4/6 Inhibitors and Other Novel Agents in Therapy for  ER-Positive Localized Breast Cancer — Dr Hurvitz (52:35) Optimizing the Use of Neoadjuvant and Adjuvant Therapy for Triple-Negative Breast Cancer — Dr O'Shaughnessy (1:16:18) Emerging Role of Circulating Tumor DNA Evaluation in the Management of Breast Cancer — Dr Pusztai (1:42:03) CME information and select publications