Podcasts about Huntsman Cancer Institute

In this episode of the Scope of Things, host Deborah Borfitz delivers the latest on an AI-powered trial screening tool that outperforms research staff, a strategy report on ways to boost cancer vaccine work, the continued absence of pregnant women in clinical trials, a program bringing studies directly to people in rural Utah, and efforts to integrate clinical trials into routine patient care in medically underserved areas of Oklahoma. Wes Michael, founder and president of Rare Patient Voice, also joins in to discuss how his company is connecting people undertaking research studies with participants eager to share their insights—and getting paid to do so. News Roundup  AI clinical trial screening tool Research letter in JAMA  Strategy report on cancer vaccines Commentary in Cambridge Prisms: Precision Medicine  Exclusion of pregnant women from trials Article in American Journal of Obstetrics and Gynecology Bringing cancer care and trials to Utah's rural residents Press release on Huntsman Cancer Institute website Integrating clinical research into primary care News on OU Health Sciences website Guest Wes Michael, president and founder of Rare Patient Voice The Scope of Things podcast explores clinical research and its possibilities, promise, and pitfalls. Clinical Research News senior writer, Deborah Borfitz, welcomes guests who are visionaries closest to the topics, but who can still see past their piece of the puzzle. Focusing on game-changing trends and out-of-the-box operational approaches in the clinical research field, the Scope of Things podcast is your no-nonsense, insider's look at clinical research today.

Dr. Neeraj Agarwal and Dr. Peter Hoskin discuss key abstracts in GU cancers from the 2025 ASCO Genitourinary Cancers Symposium, including novel therapies in prostate, bladder, and kidney cancer and the impact of combination therapies on patient outcomes. TRANSCSRIPT Dr. Neeraj Agarwal: Hello, and welcome to the ASCO Daily News Podcast. I'm Dr. Neeraj Agarwal, the director of the Genitourinary Oncology Program and professor of medicine at the Huntsman Cancer Institute at the University of Utah, and editor-in-chief of ASCO Daily News. Today, we'll be discussing practice-informing abstracts and other key advances in GU oncology featured at the 2025 ASCO Genitourinary Cancers Symposium. Joining me for this discussion is Dr. Peter Hoskin, the chair of this year's ASCO GU Symposium. Dr. Hoskin is a professor in clinical oncology in the University of Manchester and honorary consultant in clinical oncology at the Christie Hospital, Manchester, and University College Hospital London, in the United Kingdom. Our full disclosures are available in the transcript of this episode. Peter, thank you for joining us today. Dr. Peter Hoskin: Thank you so much, Neeraj. I am very pleased to be here. Dr. Neeraj Agarwal: The GU meeting highlighted remarkable advancements across the spectrum of GU malignancies. What stood out to you as the most exciting developments at the ASCO GU Symposium?  Dr. Peter Hoskin: The theme of this year's meeting was "Driving Innovation, Improving Patient Care," and this reflected ASCO GU's incredible milestone in GU cancer research over the years. We were thrilled to welcome almost 6,000 attendees on this occasion from over 70 countries, and most of them were attending in person and not online, although this was a hybrid meeting. Furthermore, we had more than 1,000 abstract submissions. You can imagine then that it fostered fantastic networking opportunities and facilitated valuable knowledge and idea exchanges among experts, trainees, and mentees. So, to start I'd like to come back to you for a second because the first day started with a focus on prostate cancer and some of the key clinical trials. And congratulations to you, Neeraj, on sharing the data from the TALAPRO-2 trial, which we were eagerly awaiting. I'd love to get your thoughts on the data that you presented. Could you tell us more about that trial, Abstract LBA18?  Dr. Neeraj Agarwal: Yes, Peter, I agree with you. It was such an exciting conference overall and thank you for your leadership of this conference. So, let's talk about the TALAPRO-2 trial. First of all, I would like to remind our audience that the combination of talazoparib plus enzalutamide was approved by the U.S. FDA in June 2023 in patients with metastatic castration-resistant prostate cancer harboring HRR gene alterations, after this combination improved the primary endpoint of radiographic progression-free survival compared to enzalutamide alone in the randomized, double-blind, placebo-controlled, multi-cohort phase 3 TALAPRO-2 trial. In the abstract I presented at ASCO GU 2025, we reported the final overall survival data, which was a key alpha-protected secondary endpoint in cohort 1, which enrolled an all-comer population of patients with mCRPC. So, at a median follow-up of around 53 months, in the intention-to-treat population, the combination of talazoparib plus enzalutamide significantly reduced the risk of death by 20% compared to enzalutamide alone, with a median OS of 45.8 months in the experimental arm versus 37 months in the control arm, which was an active control arm of enzalutamide. This improvement was consistent in patients with HRR alterations with a hazard ratio of 0.54 and in those with non-deficient or unknown HRR status, with a hazard ratio of 0.87. In a post hoc analysis, the hazard ratio for OS was 0.78 favoring the combination in those patients who did not have any HRR gene alteration in their tumors by both tissue and ctDNA testing. Consistent with the primary analysis, the updated rPFS data also favored the experimental arm with a median rPFS of 33.1 compared to 19.5 months in the control arm, and a hazard ratio of 0.667. No new safety signals were identified with extended follow-up. Thus, TALAPRO-2 is the first PARP inhibitor plus ARPI study to show a statistically significant and a clinically meaningful improvement in OS compared to standard-of-care enzalutamide as first-line treatment in patients with mCRPC unselected for HRR gene alterations. Dr. Peter Hoskin: Thank you, Neeraj. That's a great summary of the data presented and very important data indeed. There was another abstract also featured in the same session, Abstract 20, titled “Which patients with metastatic hormone-sensitive prostate cancer benefit more from androgen receptor pathway inhibitors? STOPCAP meta-analyses of individual participant data.” Neeraj, could you tell us more about this abstract? Dr. Neeraj Agarwal: Absolutely, I would be delighted to. So, in this meta-analysis, Dr. David Fischer and colleagues pooled individual participant data from different randomized phase 3 trials in the mHSPC setting to assess the potential ARPI effect modifiers and determine who benefits more from an ARPI plus ADT doublet. The primary outcome was OS for main effects and PFS for subgroup analyses. Prostate cancer specific survival was a sensitivity outcome. The investigators pooled data from 11 ARPI trials and more than 11,000 patients. Overall, there was a clear benefit of adding an ARPI on both OS and PFS, with hazard ratios of 0.66 and 0.51, respectively, representing a 13% and 21% absolute improvement at 5 years, respectively, with no clear difference by the class of agent. When stratifying the patients by age group, the effects of adding an ARPI on OS and PFS were slightly smaller in patients older than 75, than in those younger than 65, or aged between 65 and 75 years. Notably, in the trials assessing the use of abiraterone, we saw very little OS effects in the group of patients older than 75, however there was some benefit maintained in prostate-cancer specific survival, suggesting that other causes of death may be having an impact. The effects of the other ARPIs, or ‘lutamides' as I would call them, were similar across all three age subgroups on both OS and PFS. Therefore, the majority of patients with mHSPC benefit from the addition of ARPIs, and the benefits/risks of abiraterone and other ‘amides' must be considered in older patients.  Dr. Peter Hoskin: Thanks, Neeraj. Another great summary relevant to our day-to-day practice. Of course, there's ongoing collection of individual patient data from other key trials, which will allow robust comparison of ARPI doublet with triplet therapy (including docetaxel), guiding more personalized treatment.   Dr. Neeraj Agarwal: I agree with you, Peter, we need more data to help guide personalized treatment for patients with mHSPC and potentially guide de-escalation versus escalation strategies. Now, moving on to a different setting in prostate cancer, would you like to mention Abstract 17 titled, “Overall survival and quality of life with Lu-PSMA-617 plus enzalutamide versus enzalutamide alone in poor-risk, metastatic, castration-resistant prostate cancer in ENZA-p (ANZUP 1901),” presented by Dr. Louise Emmett? Dr. Peter Hoskin: Of course I will. So, ENZA-p was a multicenter, open-label, randomized, phase 2 trial conducted in Australia. It randomized 163 patients into adaptive doses (2 or 4 cycles) of Lu-PSMA-617 plus enzalutamide versus enzalutamide alone as first-line treatment in PSMA-PET-CT-positive, poor-risk, mCRPC. The interim analysis of ENZA-p with median follow-up 20 months showed improved PSA-progression-free survival with the addition of Lu-PSMA-617 to enzalutamide. Here, the investigators reported the secondary outcomes, overall survival, and health-related quality of life (HRQOL). After a median follow up of 34 months, overall survival was longer in the combination arm compared to the enzalutamide arm, with a median OS of 34 months compared to 26 months; with an HR of 0.55. Moreover, the combination improved both deterioration-free survival and health-related quality of life indicators for pain, fatigue, physical function, and overall health and quality of life compared to the control arm. Consistent with the primary analysis, the rPFS also favored the experimental arm with a median rPFS of 17 months compared to 14 months with a HR of 0.61. So, the addition of LuPSMA improved overall survival, and HRQOL in patients with high-risk mCRPC. Dr. Neeraj Agarwal: Thank you, Peter. Great summary, and promising results with Lu-177 and ARPI combination in first line treatment for mCRPC among patients who had two or more high risk features associated with early enzalutamide failure. Before we move on to bladder cancer, would you like to tell us about Abstract 15 titled, “World-wide oligometastatic prostate cancer (omPC) meta-analysis leveraging individual patient data (IPD) from randomized trials (WOLVERINE): An analysis from the X-MET collaboration,” presented by Dr. Chad Tang?  Dr. Peter Hoskin: Sure. So, with metastatic-directed therapy (MDT), we have a number of phase 2 studies making up the database, and the X-MET collaboration aimed to consolidate all randomized data on oligometastatic solid tumors. This abstract presented pooled individual patient data from all the published trials involving patients with oligometastatic prostate cancer who received MDT alongside standard of care (SOC) against SOC alone. The analysis included data from five trials, encompassing 472 patients with oligometastatic prostate cancer, and followed for a median of 41 months. Patients were randomly assigned in a 1:1 ratio to receive either MDT plus SOC or SOC alone. The addition of MDT significantly improved PFS. The median PFS was 32 months with MDT compared to 14.9 months with SOC alone, with an HR of 0.45. Subgroup analyses further confirmed the consistent benefits of MDT across different patient groups. Regardless of factors like castration status, receipt of prior primary treatment, stage, or number of metastases, MDT consistently improved PFS. In patients with mHSPC, MDT significantly delayed the time to castration resistance by nine months, extending it to a median of 72 months compared to 63 months in the SOC group with an HR of 0.58. In terms of OS, the addition of MDT improved the 48-month survival rate by 12%, with OS rates of 87% in the MDT+SOC group compared to 75% in the SOC alone group. Dr. Neeraj Agarwal: Thank you, Peter. These data demonstrate that adding MDT to systemic therapy significantly improves PFS, rPFS, and castration resistance-free survival, reinforcing its potential role in the treatment of oligometastatic prostate cancer. So, let's switch gears to bladder cancer and start with Abstract 658 reporting the OS analysis of the CheckMate-274 trial. Would you like to tell us about this abstract?  Dr. Peter Hoskin: Yes, sure, Neeraj. This was presented by Dr. Matt Milowsky, and it was additional efficacy outcomes, including overall survival, from the CheckMate-274 trial which evaluated adjuvant nivolumab versus placebo in patients with high-risk muscle-invasive bladder cancer after radical surgery. The phase 3 trial previously demonstrated a significant improvement in disease-free survival with nivolumab. With a median follow-up of 36.1 months, disease-free survival was longer with nivolumab compared to placebo across all patients with muscle-invasive bladder cancer, reducing the risk of disease recurrence or death by 37%. Among patients who had received prior neoadjuvant cisplatin-based chemotherapy, nivolumab reduced this risk by 42%, whilst in those who had not received chemotherapy, the risk was reduced by 31%. Overall survival also favored nivolumab over placebo, reducing the risk of death by 30% in all patients with muscle-invasive bladder cancer and by 52% in those with tumors expressing PD-L1 at 1% or higher. Among patients who had received prior neoadjuvant chemotherapy, nivolumab reduced the risk of death by 26%, whilst in those who had not received chemotherapy, the risk was reduced by 33%. Alongside this, the safety profile remained consistent with previous findings. Dr. Neeraj Agarwal: Thank you, Peter, for such a nice overview of this abstract. These results reinforce adjuvant nivolumab as a standard of care for high-risk muscle-invasive bladder cancer, offering the potential for a curative outcome for our patients. Dr. Peter Hoskin: I agree with you Neeraj. Perhaps you would like to mention Abstract 659 titled, “Additional efficacy and safety outcomes and an exploratory analysis of the impact of pathological complete response (pCR) on long-term outcomes from NIAGARA.” Dr. Neeraj Agarwal: Of course. Dr. Galsky presented additional outcomes from the phase 3 NIAGARA study, which evaluated perioperative durvalumab combined with neoadjuvant chemotherapy in patients with muscle-invasive bladder cancer. The study previously demonstrated a significant improvement in event-free survival and overall survival with durvalumab compared to chemotherapy alone, with a manageable safety profile and no negative impact on the ability to undergo radical cystectomy. Among the 1,063 randomized patients, those who received durvalumab had a 33% reduction in the risk of developing distant metastases or death and a 31% reduction in the risk of dying from bladder cancer compared to those who received chemotherapy alone. More patients who received durvalumab achieved a pathological complete response at the time of surgery with 37% compared to 28% in the chemotherapy-alone group. Patients who achieved a pathological complete response had better event-free survival and overall survival compared to those who did not. In both groups, durvalumab provided additional survival benefits, reducing the risk of disease progression or death by 42% and the risk of death by 28% in patients with a pathological complete response, while in those patients without a pathological complete response, the risk of disease progression or death was reduced by 23% and the risk of death by 16% when durvalumab was added to the chemotherapy. Immune-mediated adverse events occurred in 21% of patients in the durvalumab group compared to 3% in the chemotherapy-alone group, with grade 3 or higher events occurring in 3% compared to 0.2%. The most common immune-related adverse events included hypothyroidism in 10% of patients treated with durvalumab compared to 1% in the chemotherapy-alone group, and hyperthyroidism in 3% versus 0.8%. At the time of the data cutoff, these adverse events had resolved in 41% of affected patients in the durvalumab group and 44% in the chemotherapy-alone group. Dr. Peter Hoskin: Thank you, Neeraj, for the great summary. These findings further support the role of perioperative durvalumab as a potential standard of care for patients with muscle-invasive bladder cancer. Dr. Neeraj Agarwal: I concur with your thoughts, Peter. Before wrapping up the bladder cancer section, would you like to mention Abstract 664 reporting updated results from the EV-302 trial, which evaluated enfortumab vedotin in combination with pembrolizumab compared to chemotherapy as first-line treatment for patients with previously untreated locally advanced or metastatic urothelial carcinoma? Dr. Peter Hoskin: Yes, of course. Dr. Tom Powles presented updated findings from the EV-302 study, and in this abstract presented 12 months of additional follow-up for EV-302 (>2 y of median follow-up) and an exploratory analysis of patients with confirmed complete response (cCR). The study had a median follow-up of 29.1 months and previously demonstrated significant improvements in progression-free survival and overall survival with enfortumab vedotin and pembrolizumab. This is now the standard of care in global treatment guidelines. Among the 886 randomized patients, enfortumab vedotin and pembrolizumab reduced the risk of disease progression or death by 52% and the risk of death by 49% compared to chemotherapy. The survival benefit was consistent regardless of cisplatin eligibility or the presence of liver metastases. The confirmed objective response rate was higher with enfortumab vedotin and pembrolizumab at 67.5% compared to 44.2% with chemotherapy. The median duration of response was 23.3 months with enfortumab vedotin and pembrolizumab compared to 7.0 months with chemotherapy. A complete response was achieved in 30.4% of patients in the enfortumab vedotin and pembrolizumab group compared to 14.5% in the chemotherapy group, with the median duration of complete response not yet reached in the enfortumab vedotin and pembrolizumab group compared to 15.2 months in the chemotherapy group. Severe treatment-related adverse events occurred in 57.3% of patients treated with enfortumab vedotin and pembrolizumab compared to 69.5% in the chemotherapy group, while in patients who achieved a complete response, severe adverse events occurred in 61.7% of those treated with enfortumab vedotin and pembrolizumab compared to 71.9% with chemotherapy. Treatment-related deaths were reported in 1.1% of patients treated with enfortumab vedotin and pembrolizumab compared to 0.9% with chemotherapy, with no treatment-related deaths occurring in those who achieved a complete response. These findings clearly confirm the durable efficacy of enfortumab vedotin and pembrolizumab, reinforcing its role as the standard of care for the first-line treatment of patients with locally advanced or metastatic urothelial carcinoma, and no new safety concerns have been identified. Dr. Neeraj Agarwal: Thank you for this great summary. Moving on to kidney cancer, let's talk about Abstract 439 titled, “Nivolumab plus cabozantinib (N+C) vs sunitinib (S) for previously untreated advanced renal cell carcinoma (aRCC): Final follow-up results from the CheckMate-9ER trial.” Dr. Peter Hoskin: Sure. Dr. Motzer presented the final results from the phase 3 CheckMate-9ER trial, which compared the combination of cabozantinib and nivolumab against sunitinib in previously untreated advanced renal cell carcinoma. The data after more than five years follow-up show that the combination therapy provided sustained superior efficacy compared to sunitinib. In terms of overall survival, we see an 11-month improvement in median OS, 46.5 months for the cabo-nivo versus 35.5 months for sunitinib and a 42% reduction in the risk of disease progression or death, with median progression-free survival nearly doubling – that's 16.4 months in the combination group and 8.3 months with sunitinib. Importantly, the safety profile was consistent with the known safety profiles of the individual medicines, with no new safety concerns identified. Dr. Neeraj Agarwal: Great summary, Peter. These data further support the efficacy of cabo-nivo combination therapy in advanced renal cell carcinoma, which is showing a 11-month difference in overall survival. Dr. Peter Hoskin: Neeraj, before wrapping up this podcast, would you like to tell us about Abstract 618? This is titled “Prospective COTRIMS (Cologne trial of retroperitoneal lymphadenectomy in metastatic seminoma) trial: Final results.” Dr. Neeraj Agarwal: Sure, Peter. I would be delighted to. Dr Heidenrich from the University of Cologne in Germany presented the COTRIMS data evaluating retroperitoneal LN dissection in patients with clinical stage 2A/B seminomas. Seminomas are classified as 2A or B when the disease spreads to the retroperitoneal lymph nodes of up to 2 cm (CS IIA) or of more than 2 cm to up to 5 cm (CS 2B) in maximum diameter, respectively. They account for 10-15% of seminomas and they are usually treated with radiation and chemotherapy. However, radiation and chemo can be associated with long-term toxicities such as cardiovascular toxicities, diabetes, solid cancers, leukemia, particularly for younger patients. From this standpoint, Dr Heidenrich and colleagues evaluated unilateral, modified template, nerve-sparing retroperitoneal lymph node dissection as a less toxic alternative compared to chemo and radiation. They included 34 patients with negative AFP, beta-HCG, and clinical stage 2A/B seminomas. At a median follow-up of 43.2 months, the trial demonstrated great outcomes: a 99.3% treatment-free survival rate and 100% overall survival, with only four relapses. Antegrade ejaculation was preserved in 88% of patients, and severe complications such as grade 3 and 4 were observed in 12% of patients. Pathological analysis revealed metastatic seminoma in 85% of cases, with miR371 being true positive in 23 out of 24 cases and true negative in 100% of cases. It appears to be a valid biomarker for predicting the presence of lymph node metastases. These findings highlight retroperitoneal lymph node dissection is feasible; it has low morbidity, and excellent oncologic outcomes, avoiding overtreatment in 80% of patients and sparing unnecessary chemotherapy or radiotherapy in 10-15% of cases. Dr. Peter Hoskin: Great summary and important data on retroperitoneal lymphadenectomy in metastatic seminoma. These findings will help shape clinical practice. Any final remarks before we conclude today's podcast? Dr. Neeraj Agarwal: Before wrapping up this podcast, I would like to say that we have reviewed several abstracts addressing prostate, bladder, kidney cancers, and seminoma, which are impacting our medical practices now and in the near future. Peter, thank you for sharing your insights with us today. These updates are undoubtedly exciting for the entire GU oncology community, and we greatly appreciate your valuable contribution to the discussion and your leadership of the conference. Many thanks. Dr. Peter Hoskin: Thank you, Neeraj. Thank you for the opportunity to share this information more widely. I'm aware that whilst we have nearly 6,000 delegates, there are many other tens of thousands of colleagues around the world who need to have access to this information. And it was a great privilege to chair this ASCO GU25. So, thank you once again, Neeraj, for this opportunity to share more of this information that we discussed over those few days. Dr. Neeraj Agarwal: Thank you, Peter. And thank you to our listeners for joining us today. You will find links to the abstracts discussed today on the transcript of this episode. Finally, if you value the insights that you hear on the ASCO Daily News podcast, please take a moment to rate, review, and subscribe wherever you get your podcasts. Disclaimer: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience and conclusions. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity or therapy should not be construed as an ASCO endorsement.  Find out more about today's speakers:   Dr. Neeraj Agarwal    @neerajaiims    Dr. Peter Hoskin Follow ASCO on social media:      @ASCO on Twitter      ASCO on Bluesky  ASCO on Facebook      ASCO on LinkedIn      Disclosures: Dr. Neeraj Agarwal: Consulting or Advisory Role: Pfizer, Bristol-Myers Squibb, AstraZeneca, Nektar, Lilly, Bayer, Pharmacyclics, Foundation Medicine, Astellas Pharma, Lilly, Exelixis, AstraZeneca, Pfizer, Merck, Novartis, Eisai, Seattle Genetics, EMD Serono, Janssen Oncology, AVEO, Calithera Biosciences, MEI Pharma, Genentech, Astellas Pharma, Foundation Medicine, and Gilead Sciences Research Funding (Institution): Bayer, Bristol-Myers Squibb, Takeda, Pfizer, Exelixis, Amgen, AstraZeneca, Calithera Biosciences, Celldex, Eisai, Genentech, Immunomedics, Janssen, Merck, Lilly, Nektar, ORIC Pharmaceuticals, Crispr Therapeutics, Arvinas Dr. Peter Hoskin: Research Funding (Institution): Varian Medical Systems, Astellas Pharma, Bayer, Roche, Pfizer, Elekta, Bristol Myers  

Send us a text In this episode of Causes or Cures, Dr. Eeks chats with Dr. Timothy Yeatman about  the connection between diet, inflammation, and colon cancer. He'll explain why cancer can be thought of as a "poorly healing chronic wound" and describe his recent study highlighting how chronic inflammation, fueled by dietary choices, plays a key part in the progression of colorectal cancer. We'll explore the alarming rise of colon cancer in adults under 50 and any common patterns he's observed in this population. Dr. Yeatman will shed light on the immune tumor microenvironment, how it influences colon cancer, and its potential role in future treatments. Plus, we'll discuss natural approaches to prevention and treatment, including key lifestyle interventions, such as achieving the right balance of omega-3s and omega-6s.  Dr. Yeatman is the Associate Center Director for Translational Research and Innovation at Tampa General Hospital Cancer Institute and a Professor of Surgery at the University of South Florida. With a career spanning leadership roles at Intermountain Healthcare, the Huntsman Cancer Institute, and Moffitt Cancer Center, he has spearheaded groundbreaking research in colorectal cancer, genomics, and biomarker development. He founded the Guardian Research Network, led a $100M Moffitt-Merck collaboration, and co-founded M2Gen, a biotech company. His work has been funded by the National Cancer Institute since 1993, and he continues to advance cancer research and clinical innovation. You can contact Dr. Eeks at bloomingwellness.com.Follow Eeks on Instagram here.Or Facebook here.Or X.On Youtube.Or TikTok.SUBSCRIBE to her monthly newsletter here.Support the show

Kairos Pharma CEO John Yu joined Steve Darling from Proactive to share major updates on the company's latest cancer research developments. A significant milestone in its academic partnership with Cedars-Sinai Medical Center has been achieved, as Cedars-Sinai secured $600,000 in funding from the Department of Defense's Lung Cancer Research Program. This grant will accelerate work on an innovative therapy designed to address chemotherapy resistance and cachexia—a severe condition causing muscle loss and weight depletion in cancer patients. The funding will support efforts to develop a first-in-class treatment aimed at counteracting muscle atrophy, improving physical strength, and enhancing the effectiveness of existing cancer therapies. By targeting key biological pathways linked to cachexia, this therapy could provide much-needed support for cancer patients striving to maintain their health and resilience throughout treatment. In a further expansion of its clinical initiatives, Kairos Pharma has added the prestigious Huntsman Cancer Institute in Salt Lake City, Utah, as a new site for its ongoing Phase 2 clinical trial evaluating an advanced antibody therapy for castrate-resistant prostate cancer. This trial, backed by both Kairos Pharma and a grant from the National Cancer Institute, is assessing whether the therapy can overcome treatment resistance by targeting a key protein involved in disease relapse. With continued progress in both research and clinical trials, Kairos Pharma is reinforcing its commitment to pioneering new approaches in cancer treatment, offering hope to patients facing some of the most challenging forms of the disease. #proactiveinvestors #kairospharmalitd #nyseamerican #kapa #cancer #env105 #CancerResearch #ProstateCancer #LungCancer #ClinicalTrials #Biotech #Immunotherapy #Healthcare #PharmaInnovation #DrugDevelopment

Alcohol is a leading cause of cancer, a risk that should be clearly labeled on drinks Americans consume, U.S. Surgeon General Vivek Murthy proposed on Friday. The proposed advisory would require approval from congress, an approval that is rarely granted by the federal government. Dr. Katie Kerrigan, a Medical Oncologist at the Huntsman Cancer Institute, joins D2 to discuss the extent of alcohol on your physical health and its role in causing cancer.  

It is the start of the new year and Univeristy of Utah Hospitals and Huntsman Cancer Institute are short on every blood blood type needed to care for local patients. But, when local Utahns give blood to ARUP Blood Services, those donations go directly to Utah hospitals to meet the demand for life-saving blood transfusions.  That's because 100% of the blood and platelets given local through ARUP stay local.  In this episode of Utah Weekly Forum, FM100.3 Host Rebecca Cressman is joined by ARUP Blood Services Community Relations Supervisor Deborah Jordan who explains why its urgent that Utahns give blood now. Currently at least 75 donors per day are needed to meet the growing demand for blood transfusions to treat local patients recovering from trauma, surgery, complicated medical conditions, and cancer. ARUP has two locations in Sandy and at the University of Utah's Research Park open 7 days a week. Donors can call 801-584-5272 or visit UtahBlood.org.

The U.S. surgeon general wants to put warning labels on alcohol, namely about the increased risk of cancer from drinking alcohol.  We spoke with Huntsman Cancer Institute oncologist Dr. Katie Kerrigan, for insight.  

In this enlightening episode of the Silicon Slopes Podcast, we sit down with Mary Beckerle, CEO of Huntsman Cancer Institute, to discuss groundbreaking advancements in cancer research and treatment. Discover how the Utah Population Database and collaborative efforts with institutions like the University of Utah and Intermountain Healthcare are revolutionizing cancer care.00:00 - Inherited Cancer Susceptibility01:05 - Introduction and Personal Connection02:04 - Progress in Cancer Research03:03 - Advances in Cancer Treatment03:25 - Collaboration in Utah04:24 - Children's Cancer Research05:24 - Fertility Considerations05:46 - Unique Healthcare Partnership06:11 - Spirit of Collaboration07:08 - Localized Cancer Care08:00 - New Cancer Center in Vineyard09:05 - Educational Collaborations12:27 - BYU's Medical School13:01 - Addressing Rural Cancer Care14:10 - Huntsman at Home Program15:43 - Medical Data Challenges16:33 - Legacy of John Huntsman18:10 - Contributions to Cancer Genetics20:10 - Personalized Medicine21:46 - National Recognition22:42 - Silicon Slope Summit24:26 - John Huntsman's Vision26:31 - Personal Recollections27:03 - Career Path31:17 - Future of Cancer Treatment34:24 - Challenging Cancers35:06 - Lung Cancer Treatment36:10 - Evolution of Treatment Methods37:01 - CAR-T Cell Therapy38:51 - Typical Day of a CEO40:06 - AI in Cancer Research42:31 - AI and Health Initiatives45:26 - Talent Pipeline47:32 - Relationship with University of UtahIf you enjoyed this podcast and want to support us please share it with your friends.  Our website: https://www.siliconslopes.comShow Links: https://healthcare.utah.edu/huntsmancancerinstitute/Apple Podcasts - https://podcasts.apple.com/us/podcast/silicon-slopes-the-entrepreneur-capital-of-the-world/id1698150372Spotify Podcasts - https://open.spotify.com/show/2ZdYnWYKPXOqH2fgJ2UJ2N?si=5890c63a145a4a3eSocial:Twitter - https://twitter.com/siliconslopesInstagram - https://www.instagram.com/siliconslopes/LinkedIn - https://www.linkedin.com/company/silicon-slopes/YouTube - https://www.youtube.com/channel/UC8aEtQ1KJrWhJ3C2JnzXysw

Cancer patients in Utah County will soon be able to find comprehensive cancer treatments and care closer to home. That's because Huntsman Cancer Institute is building a new campus in Vineyard situated close to I-15, a Frontrunner station, and Utah Valley University. In this episode, FM100.3 Host and Breast Cancer Survivor Rebecca Cressman is joined by Dr. Mary Beckerle, CEO of Huntsman Cancer Institute, Vineyard Mayor Julie Fullmer, and Lehi cancer survivor Jenni Thompson who share how the new center will give Utahns easier access to innovative treatments, enhance research collaborations with BYU and UVU, and improve the lives of cancer patients and their families. To learn more, visit HuntsmanCancer.org/Vineyard

Synopsis: Explore the forefront of biotech innovation as host Rahul Chaturvedi interviews Dr. Dave Bearss, Co-Founder & CEO of Halia Therapeutics, in this engaging episode of Biotech 2050. Dr. Bearss shares the story behind Halia's pioneering genetic discoveries and their mission to tackle Alzheimer's disease. Learn about the science driving breakthrough therapies that target neuroinflammation, offering hope in the fight against neurodegenerative disorders. Packed with insights and inspiration, this episode is a must-listen for anyone interested in the future of healthcare and biotech innovation. Biography: Dr. David J. Bearss, a serial entrepreneur and pharmaceutical innovator, has over two decades of experience spanning academic and industrial roles. His expertise lies at the intersection of structure-based small-molecule drug discovery and the utilization of genetic model systems for drug discovery. Dr. Bearss's career is marked by significant achievements, with a strong foundation in translational research focused on drug advancement to the clinic and using genetic markers for predictive drug sensitivity. Notably, Dr. Bearss has discovered 16 compounds that have successfully navigated from discovery in the lab to IND into clinical development. His entrepreneurial experience is evident through his roles as the co-founder of eight biotechnology companies. More importantly, his unwavering commitment to advancing novel drug development truly sets him apart. Before taking on his role as chief scientific officer at Halia in January 2021 and assuming the CEO position in March 2022, Dr. Bearss served as the CEO of Tolero Pharmaceuticals, an organization later acquired by Sumitomo Dainippon Pharma in 2017. His tenure as chief scientific officer at Montigen Pharmaceuticals, followed by its acquisition by SuperGen Inc., demonstrates his dedication to driving early-stage drug discovery and development. At SuperGen, he continued to develop his expertise in these critical areas. Dr. Bearss's academic career is equally impressive. It led to his founding role as the Center for Investigational Therapeutics Co-Director at the Huntsman Cancer Institute. He also held academic positions as an Associate Professor in the Department of Oncological Sciences at the University of Utah and as an Associate Professor of Physiology and Developmental Biology at Brigham Young University, demonstrating his deep knowledge and expertise in these fields. Dr. Bearss's academic career began with a Ph.D. in cell biology from the University of Texas Health Science Center in San Antonio, Texas, and a post-doctoral fellowship at the Institute for Drug Development at the Cancer Therapy and Research Center also in Texas. He has won several awards for his entrepreneurial and scientific achievements, including the Utah Governor's Medal of Science and BIO Utah Entrepreneur of the Year.

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

In this episode, Holli and Brett discuss the integration of the Family Frailty Score as an assessment tool for patients undergoing advanced heart failure therapies. Various key considerations surrounding the tool are discussed, including multidisciplinary team involvement, socioeconomic challenges, patient and family support, and more. Featuring: Brett Snodgrass, DNP, FNP-C, ACHPN®, FAANP Holli Martinez FNP-BC, ACHPN®, FPCN Brett Snodgrass, DNP, FNP-C, ACHPN®, FAANP Brett Snodgrass has been a registered nurse since 1997 and a family nurse practitioner since 2007, practicing in multiple settings, including family practice, urgent care, emergency departments, administration, chronic pain, and palliative medicine. She is currently the Operations Director for Palliative Medicine at Baptist Health Systems in Memphis, TN. She is board certified with the American Academy of Nurse Practitioners. She is also a Fellow of the American Association of Nurse Practitioners and an Advanced Certified Hospice and Palliative Nurse. She is a nationally recognized nurse practitioner, speaker and teacher. Brett Is a chronic pain expert, working for more than 20 years with chronic pain patients in a variety of settings. She currently serves on the TN Chronic Pain Task Force. She is a director at large of the TN Pain Society. Past awards include AANP State Excellence Award for Tennessee for her work across the state on the TN Chronic Pain Task Force, as well as advocating for TN Full Practice Authority for Nurse Practitioners and the 2017 Memphis Business Journal Healthcare Hero Award. Holli Martinez FNP-BC, ACHPN®, FPCN Holli has been a nurse for 26 years with the last 17 as an advanced practice registered nurse. In addition to providing palliative care consultations to patients and families, Holli also serves as the Program Director for the Supportive and Palliative Care Program at the University of Utah Hospital and Huntsman Cancer Institute; an adjunct faculty member for the University of Utah College of Nursing; past Board president for the Hospice and Palliative Nurses Association and the Hospice and Palliative Nurses Foundation; and faculty member for UCoPE - Utah Certificate of Palliative Education and Senior Faculty for VitalTalk. She is Board certified as a Family Nurse Practitioner and an Advanced Certified Hospice and Palliative Nurse. Holli has been inducted as an HPNA Fellow in Palliative Care Nursing and has been honored with the Cambia Foundation Sojourns Award and the American Association of Nurse Practitioners State of Utah Award for Excellence.

Dr. Neeraj Agarwal and Dr. Rana McKay discuss promising studies in GU cancers featured at the 2024 ASCO Annual Meeting that highlighted improved outcomes in urothelial carcinoma, improved survival in renal cell carcinoma, and the role of ctDNA as a potential biomarker for predicting outcomes.   TRANSCRIPT Dr. Neeraj Agarwal: Hello and welcome to the ASCO Daily News Podcast. I'm Dr. Neeraj Agarwal, your guest host of the ASCO Daily News Podcast today. I am the director of the Genitourinary Oncology Program, a professor of medicine at the University of Utah's Huntsman Cancer Institute, and editor-in-chief of the ASCO Daily News.  I am delighted to welcome Dr. Rana McKay, a GU medical oncologist and associate professor at the University of California San Diego. Today, we'll be discussing some key GU abstracts featured at the 2024 ASCO Annual Meeting. Our full disclosures are available in the transcript of this episode. Rana, we're thrilled to have you on the podcast today to share your insights on key advances in GU oncology from ASCO24. Dr. Rana McKay: Thank you so much, Neeraj; it's a pleasure to be here. Dr. Neeraj Agarwal: So, Rana, let's start with some bladder cancer abstracts. Could you tell us about Abstract 4503, titled “Impact of exposure on outcomes with enfortumab vedotin in patients with locally advanced or metastatic urothelial cancer”? Dr. Rana McKay: Of course, I would be delighted to. First, I would like to remind our listeners that enfortumab vedotin (EV) was approved as a monotherapy for the treatment of locally advanced or metastatic urothelial cancer based on the results of EV-201 and EV-301 trials. In these pivotal studies, EV was initiated at a dose of 1.25 mg/kg, and dose modifications, such as reductions and interruptions, were used to manage adverse events. In the abstract presented at ASCO 2024, Dr. Daniel Petrylak and colleagues conducted a post-hoc exploratory analysis to evaluate the association between EV plasma exposure and outcomes. They used multiple pharmacokinetic samples collected during the first two cycles and pre-dose samples from 3 EV monotherapy studies, namely EV-101, EV-201, and EV-301, that were conducted in patients with previously treated locally advanced or metastatic urothelial carcinoma. Dose reductions to 1 mg/kg were required in 42.1% and 35.1% of patients in the EV-201 and EV-301 trials, respectively, and reductions to 0.75 mg/kg were required in 13.6% and 11.1% in the EV-201 and EV-301 trials, respectively. Higher EV exposure during the first two cycles was associated with a higher objective response rate. The ORR was 21.4% for the dose of 0.75 mg/kg, while it was 18.5% for the dose of 1.0 mg/kg. Interestingly, increasing the dosage to 1.25 mg/kg improved the ORR, which ranged from 40 to 51.1% across various studies. In the EV-301 trial, when comparing the efficacy of EV to chemotherapy, EV improved PFS and OS across all dose quartiles, and there was no evidence that recommended dose modifications impacted long-term efficacy outcomes. Dr. Neeraj Agarwal: Thank you, Rana, for this great summary. I would like to add that the meticulously conducted pharmacokinetic studies demonstrated that serum levels of EV correlated with responses. Importantly, patients who had to decrease the dose did not experience compromised outcomes as EV improved PFS and OS outcomes vs chemotherapy in across all exposure quartiles in the EV-301 trial where EV was compared with chemotherapy. These findings highlight the need to start at the recommended dose of 1.25 mg/kg and reduce it, if necessary, however, clinicians should not start at a lower dose.  Dr. Rana McKay: I totally agree with you, Neeraj. Now, moving on to a different setting in bladder cancer, what can you tell us about LBA4517, titled “Perioperative sacituzumab govitecan alone or in combination with pembrolizumab for patients with muscle-invasive urothelial bladder cancer: SURE-01/02 interim results”? Dr. Neeraj Agarwal: Of course! So, SURE was a multicohort, open-label, phase 2 study in patients with muscle-invasive bladder cancer assessing sacituzumab govitecan as a neoadjuvant therapy either alone in SURE-01 or as a combination with pembrolizumab followed by adjuvant pembro in SURE-02 in a flexible design allowing a bladder-sparing approach. In the abstract presented at ASCO 2024, Dr. Antonio Cigliola and colleagues report interim results of the SURE-01 study. Patients with cT2-4N0M0 urothelial carcinoma who were ineligible for or refused cisplatin-based neoadjuvant chemotherapy were planned to receive 4 cycles of neoadjuvant sacituzumab govitecan at a dose of 10 mg/kg followed by radical cystectomy.  An extensive assessment was performed at baseline and after the 4 cycles for response assessment. Patients with clinical complete response defined with negative MRI, cystoscopy and ctDNA assays refusing radical cystectomy were offered redo transurethral resection of the bladder tumor or repeat TURBT followed by observation in the absence of viable high-grade tumor in the bladder. The primary endpoint was pathological complete response rate, while secondary endpoints included pathological downstaging rate and safety. After the first 8 patients were enrolled, the protocol was amended due to the occurrence of grade 3 and 4 neutropenia and diarrhea in 75% and 50% of patients, respectively, and 2 deaths – one of which was deemed to be treatment-related due to sepsis. Key protocol changes included the reduction of the dose of sacituzumab govitecan to 7.5 mg/kg, the introduction of G-CSF as primary prophylaxis, and the exclusion of patients at high risk of febrile neutropenia per ASCO guidelines.  Among 21 patients who received at least one cycle of sacituzumab govitecan and included in the intention-to-treat population, 47.6% had a complete pathological response, and 52.4% had pathological downstaging. 11 patients underwent radical cystectomy, while 7 received repeat-TURBT due to complete clinical response or patient preference. Regarding the safety profile, grade 3 or more adverse events occurred in 42.5% of patients. Treatment-related adverse events leading to dose interruptions or discontinuations were more common before the protocol amendment. It is noteworthy that 3 patients died after treatment discontinuation, with one deemed treatment-related, as previously mentioned. Dr. Rana McKay: Thank you, Neeraj, for a great summary. The pathological complete responses observed show promising activity for sacituzumab govitecan as a neo-adjuvant therapy and a window for bladder-sparing approaches, which is definitely exciting news for our patients! However, although the 3 deaths encountered in a neo-adjuvant setting could be concerning, the improvement of the safety profile after protocol amendments is reassuring and supports the continuation of the study. Dr. Neeraj Agarwal: Before wrapping up the bladder cancer section, would you like to share your insights with our listeners on Abstract 4518, titled “Quantitative circulating tumor DNA (ctDNA) assessment in patients with advanced urothelial carcinoma treated with pembrolizumab or platinum-based chemotherapy from the phase 3 KEYNOTE-361 trial”?  Dr. Rana McKay: Sure. So, the KEYNOTE-361 trial was a randomized phase 3 study with 3 arms that included pembrolizumab plus chemotherapy, pembrolizumab monotherapy, or chemotherapy alone in patients with previously untreated advanced urothelial carcinoma. The results showed that neither the combination of pembrolizumab plus chemotherapy nor pembrolizumab monotherapy improved survival outcomes compared to the chemotherapy arm. So, in this exploratory analysis presented at ASCO24, Dr. Tom Powles and colleagues sought to assess the role of ctDNA as a potential biomarker between the pembrolizumab monotherapy arm and the chemotherapy arm. Tumor tissue mutations were evaluated using whole exome sequencing, and plasma ctDNA was assessed with the Guardant 360 assay. Changes in ctDNA from pre-treatment cycle 1 to on-treatment cycle 2, so 3 weeks post-baseline assessment, were quantified by the maximum variant allele frequency of tumor tissue-specific mutations.  Results showed that lower baseline ctDNA levels were associated with improved clinical outcomes of response in the pembrolizumab arm but not in the chemotherapy arm. This improvement in the pembrolizumab arm was also robust to adjustment for tumor mutational burden and PD-L1. Additionally, chemotherapy led to a ctDNA clearance rate of 41% compared to 11% in the pembrolizumab arm. Patients who had a large ctDNA reduction with pembrolizumab had significantly improved outcomes compared to those achieving a large reduction with chemotherapy with a hazard ratio of 0.25. However, this did not replicate in patients who did not achieve a large reduction, as these patients had similar outcomes across both arms. Let's switch gears to kidney cancer and start with Abstract 4508, reporting the final OS analysis from the JAVELIN Renal-101 trial. Neeraj, what would you like to tell us about this abstract? Dr. Neeraj Agarwal:  Well, as a quick reminder, the JAVELIN Renal-101 was a randomized phase 3 trial where patients with previously untreated advanced or metastatic clear cell renal cell carcinoma were randomized to receive either the combination of avelumab plus axitinib or sunitinib. In previous analyses, the combination of avelumab and axitinib significantly improved PFS compared to sunitinib and was subsequently approved by the FDA for the first-line treatment of patients with advanced RCC in 2019. This superiority in PFS was maintained across the different analyses; however, OS data remained immature. In the abstract presented at ASCO24 by Dr. Robert Motzer from Memorial Sloan Kettering Cancer Center and colleagues, the authors reported OS results at a median follow-up of around 73 months and a minimum of 68 months for all patients, which is the longest follow-up for any ICI-TKI combination in RCC. The final analysis in the overall population favored the combination of avelumab plus axitinib with a median OS of 44.8 months compared to 38.9 months with sunitinib, however, this did not reach statistical significance with a hazard ratio of 0.88. The PFS results and safety profile were consistent with previous analyses.  Dr. Rana McKay: Thank you, Neeraj, for such a nice overview of this abstract. These new data could make this regimen less optimal than other ICI-TKI combinations in the first-line mRCC setting.   Dr. Neeraj Agarwal: I concur, Rana. Moving on to perhaps one of the most exciting GU abstracts featured, Abstract 4506, titled “Circulating kidney injury molecule-1 biomarker analysis in IMmotion010: A randomized phase 3 study of adjuvant atezolizumab vs placebo in patients with renal cell carcinoma at increased risk of recurrence after resection.” Rana, what are your thoughts on this abstract? Dr. Rana McKay: Well, first, I would like to take a step back and remind our audience that in the IMmotion010 trial, patients with resected intermediate to high-risk RCC with clear cell and/or sarcomatoid component were randomized in a 1:1 ratio to receive either atezolizumab or placebo. Investigator-assessed disease-free survival, which was the primary endpoint, favored the atezolizumab arm but did not reach statistical significance. In the abstract featured at ASCO24, Dr. Laurence Albiges and colleagues build on data previously reported in the ASSURE and CheckMate 914 trials and report provocative findings regarding a molecule known as kidney injury molecule 1 or KIM-1, which is a type 1 membrane glycoprotein that has been identified as a minimally invasive potential peripheral blood circulating biomarker. The KIM-1 level of 86 pg/ml was identified as the optimized threshold for defining post-nephrectomy KIM-1 high vs KIM-1 low subgroups in the IMmotion010 trial. KIM-1 levels were measured at baseline or pre-treatment, at cycle 4 day 1, and at disease recurrence or discontinuation without disease recurrence. Baseline characteristics were balanced between the KIM-1 high and KIM-1 low groups, except perhaps for a slightly higher pathological stage in the KIM-1 high subgroup.  I would like to highlight 3 key takeaways from this abstract. First, KIM-1 high level was associated with significantly worse DFS with a hazard ratio of 1.75. Second, patients in the KIM-1 high subgroup receiving atezolizumab had a 28% reduction in the risk of recurrence or death compared to those receiving placebo, while those in the KIM-1 low subgroup had comparable outcomes across both treatment arms. Third, patients in the KIM-1 high subgroup receiving atezolizumab were significantly less likely to experience an on-treatment increase in KIM-1 levels, which was associated with worse DFS in both high and low KIM-1 subgroups, regardless of treatment arm. Thus, these findings support the use of KIM-1 as both a predictive and prognostic biomarker in patients with RCC. Dr. Neeraj Agarwal: Yes, Rana, this is amazing data! I would like to add that these results warrant larger and, ideally, prospective studies to validate the utility of KIM-1 as a noninvasive biomarker for identifying minimal residual disease after nephrectomy and for predicting outcomes to immune checkpoint inhibitors. Dr. Rana McKay: Also, in the field of biomarkers, 2 abstracts interrogating different biomarkers in a different setting, so in patients with advanced or metastatic RCC were presented. Neeraj, could you tell us more about these abstracts? Dr. Neeraj Agarwal: Of course! I think you are referring to Abstracts 4504 and 4505. In abstract 4504, Dr. Toni Choueiri and colleagues sought to assess the clinical implications of different biomarkers in the CLEAR trial, which was a randomized phase 3 trial that led to the approval of the combination of pembrolizumab plus lenvatinib in the first-line mRCC setting. On the other hand, in abstract 4505, Dr. Brian Rini presented biomarker results in KEYNOTE-426, which was also a randomized phase 3 trial based on which the combination of pembrolizumab plus axitinib was approved in patients with mRCC. The authors in both trials sought to investigate the role of biomarkers in predicting treatment outcomes from 3 different angles. Starting with PD-L1 expression, the superiority of the combination arms over sunitinib was not impacted by PD-L1 status in both trials. Moving on to RCC driver gene mutations on whole exome sequencing, such as VHL, SETD2, PBRM1, and BAP1, ICI combination therapies improved outcomes regardless of mutation gene status, and this improvement was statistically significant with PBRM1 mutations in KEYNOTE-426 compared to wild-type PBRM1, but this did not replicate in the CLEAR trial. Finally, using transcriptomic signatures derived from RCC trials, especially the IMmotion 151 and JAVELIN Renal 101 trials, where 7 clusters or molecular subtypes were identified, the combination arms outperformed sunitinib in all clusters in both trials and the magnitude of this benefit differed across clusters.  Dr. Rana McKay: Thank you for this very interesting summary and comparison of the results of these 2 abstracts. These findings support the use of ICI-based combinations in all patients with mRCC as a first-line option. Although these abstracts could not identify specific biomarkers that could guide us clinicians in treatment selection, they provide very interesting biological insights on these molecular biomarkers that are, however, not yet clinically actionable. Dr. Neeraj Agarwal: Very interesting point, Rana. Moving on to prostate cancer, let's start with abstract LBA5000 titled, “Cabazitaxel with abiraterone versus abiraterone alone randomized trial for extensive disease following docetaxel: The CHAARTED2 trial of the ECOG-ACRIN Cancer Research Group (EA8153).” Rana, what is your takeaway on this abstract? Dr. Rana McKay: As a reminder to our audience, the CHAARTED2 trial was a randomized open-label phase 2 study that compared the combination of cabazitaxel and abiraterone to abiraterone alone in patients with mCRPC previously treated with ADT plus docetaxel in the hormone-sensitive setting. The primary endpoint was progression-free survival. After a median follow-up of 47.3 months, Dr. Christos Kyriakopoulos and colleagues reported in LBA5000 that patients receiving the combination of cabazitaxel plus abiraterone had a 27% reduction in the risk of progression or death. However, there was no significant difference in overall survival between the two arms, with a median OS of 25 months in the cabazitaxel+abiraterone arm and 26.9 months in the abiraterone arm, although the study was underpowered for this endpoint. Regarding the toxicity profile, the combination of cabazitaxel and abiraterone was overall well tolerated with more cytopenias, as expected.  Dr. Neeraj Agarwal: Very nice summary of this abstract, Rana. I would like to add that the treatment landscape of patients with mHSPC has evolved since the design of the study and now includes combination therapies of ADT + ARPI with or without docetaxel, and ADT + docetaxel is no longer a standard of care, which limits the applicability of these results in clinical practice today.  Dr. Rana McKay: Excellent point, Neeraj. Let's discuss Abstract 5001, titled “CYCLONE 2: A phase 3 study of abemaciclib with abiraterone in patients with metastatic castration-resistant prostate cancer”. Dr. Neeraj Agarwal: Sure! In the abstract featured at ASCO24, Dr. Matthew Smith and colleagues report the primary results of the CYCLONE 2 trial, which was a randomized phase 2/3 study that investigated the combination of abemaciclib plus abiraterone versus abiraterone monotherapy in patients with mCRPC. Stratification factors included radiographic progression at study entry, presence of measurable disease, and prior docetaxel for mHSPC. Part 1 of the study established the recommended phase 2 dose of abemaciclib at 200 mg twice daily. In part 2, patients were randomized to placebo or abemaciclib, and an adaptive interim analysis using prespecified criteria was performed and recommended the expansion of the study to part 3. The primary endpoint was investigator-assessed radiographic progression-free survival by RECIST 1.1 and PCWG3 criteria in the intention-to-treat population. At the time of the primary analysis, adding abemaciclib to abiraterone did not improve rPFS, with a hazard ratio of 0.83. The median rPFS was 22 months for the combination arm and 20.3 months for the abiraterone arm. The combination was well tolerated, and the safety profile was consistent with the known adverse events. Dr. Rana McKay: So, the addition of abemaciclib to abiraterone did not improve outcomes in patients with mCRPC. These findings suggest that no further investigation is warranted for abemaciclib or CDK4/6 inhibitors in biomarker-unselected patients with prostate cancer.  Dr. Neeraj Agarwal: Rana, what's your take-home message on Abstract 5006, titled “Health-related quality of life results from PRESTO (AFT-19), a phase 3 randomized trial of intensification of androgen blockade in patients with high-risk biochemically relapsed castration sensitive prostate cancer”? Dr. Rana McKay: So, as a reminder to our audience, the PRESTO trial was a randomized phase 3 study that assessed the effects of intensified androgen receptor blockade in patients with biochemically recurrent prostate cancer following local therapies. Patients with a PSA doubling time of less than 9 months and no evidence of metastatic disease were randomized to receive either 52 weeks of ADT alone, ADT plus apalutamide, or ADT plus apalutamide plus abiraterone. In their paper published earlier this year in the Journal of Clinical Oncology, the authors showed that patients receiving ADT plus apalutamide with or without abiraterone had significantly longer PSA-progression-free survival than those receiving ADT alone. In the oral presentation featured at ASCO24, Dr. Ronald Chen and colleagues report health-related quality of life outcomes that were assessed using various questionnaires or scales at baseline, at cycle 7, which is around 6 months on treatment, and at the end of treatment. Results showed that this intensified approach with apalutamide did not significantly increase severe adverse events, did not lengthen the time to testosterone recovery, and did not meaningfully increase common treatment-related symptoms such as hormonal symptoms, sexual dysfunction, hot flash interference, and fatigue. Importantly, additional intensification with abiraterone did not further improve PSA-PFS but did increase the rate of serious adverse events, lengthened the time to testosterone recovery, and increased hot flash interference.  Dr. Neeraj Agarwal: So, in conclusion, the PRESTO trial supports using intensified androgen blockade with apalutamide to improve PSA-PFS in patients with high-risk biochemically recurrent prostate cancer without compromising health-related quality of life. However, adding abiraterone did not offer additional benefits and increased side effects.  Dr. Rana McKay: Let's move on to LBA5002 titled, “A randomized, double-blind, placebo-controlled trial of metformin in reducing progression among men on expectant management for low-risk prostate cancer: The MAST (Metformin Active Surveillance Trial) study.” Would you like to share your insights on this abstract with our listeners? Dr. Neeraj Agarwal: Absolutely. MAST was a randomized, double-blinded, placebo-controlled trial that investigated the impact of metformin on the progression of low-risk localized prostate cancer in patients choosing to undergo active surveillance. Eligible patients had biopsy-proven, low-risk, localized prostate cancer diagnosed within the past 6 months, characterized by a Gleason score of less than 6 observed in less than one-third of the total cores, less than 50% positivity in any one core, a PSA level of less than 10 ng/ml, and a clinical-stage between T1c and T2a. Patients were randomized in a 1:1 ratio to receive either metformin 850 mg twice daily or placebo for three years. All patients underwent repeat prostate biopsy at 18 and 36 months. The primary endpoint was time to progression, defined as the earliest occurrence of primary prostate cancer therapy, such as prostatectomy, radiation, hormonal therapy, or pathological progression on subsequent biopsies, which was defined as more than 1/3 of total cores involved, at least 50% of any one core involved, or Gleason pattern 4 or higher. The study included 407 patients, with 204 receiving metformin and 203 receiving a placebo. Results presented by Dr. Anthony Joshua showed no statistically significant difference in progression-free survival, including therapeutic and pathologic progression, with an unadjusted hazard ratio of 1.08.  Interestingly, there was a signal that patients with a BMI more than 30 had a detriment to taking metformin with a higher risk of progression compared to those receiving placebo with an unadjusted HR of 2.39 and a p-value of 0.01. Dr. Rana McKay: I would like to add that this study showed that metformin use does not prevent the progression of low-risk localized prostate cancer on active surveillance and could represent a potential detriment for patients with high BMI at study entry. Dr. Neeraj Agarwal: Yes, Rana, I concur. Any final remarks before we conclude today's podcast? Dr. Rana McKay:  Thank you, Neeraj; it's been wonderful being here with you today and you having me on the podcast to highlight these important advances and the amazing work that many investigators are conducting and the patients who were involved in the context of these trials. It's really excellent to see these updated results.   Dr. Neeraj Agarwal: Before we wrap up this podcast, I would like to say that we have reviewed a selection of abstracts addressing prostate, bladder, and kidney cancer, which are significantly impacting our medical practices now and in the near future. Rana, thank you for sharing your insights today. These updates are undoubtedly exciting for the entire GU oncology community, and we greatly appreciate your valuable contribution to the discussion. Many thanks. And thank you to our listeners for joining us today. You will find links to the abstracts discussed today on the transcript of this episode. Finally, if you value the insights that you hear on the ASCO Daily News Podcast, please take a moment to rate, review, and subscribe wherever you get your podcasts.   Find out more about today's speakers:    Dr. Neeraj Agarwal   @neerajaiims   Dr. Rana McKay  @DrRanaMcKay     Follow ASCO on social media:      @ASCO on Twitter      ASCO on Facebook      ASCO on LinkedIn         Disclosures:        Dr. Neeraj Agarwal:         Consulting or Advisory Role: Pfizer, Bristol-Myers Squibb, AstraZeneca, Nektar, Lilly, Bayer, Pharmacyclics, Foundation Medicine, Astellas Pharma, Lilly, Exelixis, AstraZeneca, Pfizer, Merck, Novartis, Eisai, Seattle Genetics, EMD Serono, Janssen Oncology, AVEO, Calithera Biosciences, MEI Pharma, Genentech, Astellas Pharma, Foundation Medicine, and Gilead Sciences     Research Funding (Institution): Bayer, Bristol-Myers Squibb, Takeda, Pfizer, Exelixis, Amgen, AstraZeneca, Calithera Biosciences, Celldex, Eisai, Genentech, Immunomedics, Janssen, Merck, Lilly, Nektar, ORIC Pharmaceuticals, Crispr Therapeutics, Arvinas      Dr. Rana McKay:   Consulting or Advisory Role: Janssen, Novartis, Tempus, Exelxis, Pfizer, Bristol-Myers Squibb, Astellas Medivation, Dendreon, Bayer, Sanofi, Merck, Vividion, Calithera, AstraZeneca, Myovant, Caris Life Sciences, Sorrento Therapeutics, AVEO, Seattle Genetics, Telix, Eli Lilly, Pfizer, Bayer, Tempus

We all know it's important to wear sunscreen before stepping outside in the sun, but how many of us do it consistently? Let's Get Moving Host Maria Shilaos speaks with Dr. Dekker Deacon with the Huntsman Cancer Institute to learn all about sunscreen, from what we should look for in a sunscreen product to how we can monitor for skin damage. Instagram: @movingmaria Facebook: Let's Get Moving with Maria Website: https://linktr.ee/letsgetmovingwithmaria

We've been talking all afternoon about Princess Kate's cancer diagnosis. Joining me live is  Dr. Kristen Kelley with the Huntsman Cancer Institute... to talk to us about what a cancer diagnosis can personally mean... no matter how famous you are.

Host: Charles Turck, PharmD, BCPS, BCCCP Guest: Neeraj Agarwal, MD, FASCO TALAPRO-2 was a recent phase 3 study conducted in the first-line metastatic castration-resistant prostate cancer (mCRPC) setting. Patients were randomized to receive either enzalutamide plus talazoparib or enzalutamide plus placebo, and the researchers found that there was a 37 percent reduction in risk of progression or death among those who received enzalutamide plus talazoparib. Dive further into the findings and their implications for patients with mCRPC with Dr. Charles Turck and Dr. Neeraj Agarwal, Professor of Medicine at the Huntsman Cancer Institute at the University of Utah.

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

Weighing the possible side effects of prostate cancer treatments while considering various treatment options can be a daunting challenge for men and their loved ones. We are excited to partner with BioProtect for this episode, with our distinguished guest, Dr. Jonathan Tward, a Radiation Oncologist and tenured professor in the Department of Radiation Oncology at the University of Utah Health. Dr. Tward will fill us in on a progressive new technology that aims to minimize both short and long-term side effects of radiation therapy for prostate cancer. Dr. Tward is a highly regarded authority and key opinion leader in the management of prostate cancer. He earned a Ph.D. in biochemistry at UCLA, a Medical Degree at Tufts University in Boston, and he completed his radiation oncology residency training at the University of Utah. He holds the Vincent P. and Janet Manzini Presidential Endowed Chair at Huntsman Cancer Institute in genitourinary malignancies. Dr. Tward specializes in delivering precisely targeted radiation therapy for numerous genitourinary malignancies, including prostate cancer. He utilizes various advanced technologies, including intensity-modulated radiotherapy, image-guided radiotherapy, stereotactic body radiotherapy, and low and high-dose-rate brachytherapy. Dr. Tward has contributed to over 100 published peer-reviewed journal articles. He also actively serves on the National Comprehensive Cancer Network clinical practice guidelines committees for prostate, bladder, and penile cancers. Disclaimer: The Prostate Health Podcast is for informational purposes only. Nothing in this podcast should be construed as medical advice. By listening to the podcast, no physician-patient relationship has been formed. For more information and counseling, you must contact your personal physician or urologist with questions about your unique situation. Links: Follow Dr. Pohlman on Twitter and Instagram - @gpohlmanmd  Get your free What To Expect Guide (or find the link on our podcast website)   Join our Facebook group  Follow Dr. Pohlman on Twitter and Instagram  Go to the Prostate Health Academy to sign up.  You can access Dr. Pohlman's free mini webinar, where he discusses his top three tips to promote men's prostate health, longevity, and quality of life here. Connect with Dr. Tward Dr. Jonathan D. Tward BioProtect BioTech Balloon Spacer Procedure Video Symmetry, Visibility, and Control: The Advantages of the BioProtect Balloon in Prostate Cancer Treatment - Edward Soffen VideoAvailable Rectal Spacer Options for Patients With Prostate Cancer Undergoing Radiation Therapy Video Urology Times Video  

You met the AgTruckTrader Pro Rodeo Team on our “Behind the Brand” Series, join us now for “The AgTruckTrader Team Gives Back. During this episode of this new series we talk with in the LOOP Podcast Host, NFBR Qualifier and breakaway roper Jordan Jo Hollabaugh. Jordan Jo takes her turn in the hot seat, as she is interviewed about her charitable efforts to support the Huntsman Cancer Foundation. Jordan is joined by Jen Murano, Director of Events for the Huntsman Foundation! Tune into today's episode and go to agtrucktraderprorodeo.com/charity for more information and to cast your vote for the organization you want to see supported. Huntsman Cancer Foundation (HCF) was founded by the Jon and Karen Huntsman family in 1995. HCF's singular mission is to guarantee the future of cutting-edge research at Huntsman Cancer Institute. Thanks to the support of our community of donors and fundraisers, advancements at Huntsman Cancer Institute pave the way for new clinical trials, safer and more effective treatments, and hope for an end to cancerBy funding efforts to understand the beginnings of cancer better and more effectively treat cancer, you help relieve suffering and improve the quality of life for cancer patients, survivors, and their families.As a member of the AgTruck Trader Pro Rodeo Team,we have a challenge for you all who are listening to this podcast series, to go to our website agtrucktraderprorodeo.com/charity and vote for the charity of your choice. At the end of this series the voting will cease on March 1st, and the charity that has the most votes will be announced LIVE on RFD-TV & the Cowboy Channel during AgRally on March 19th! Part of our sponsorship with AgTruckTrader includes a team pool of funds that we get each time a farmer/rancher/ rodeo fan uses our team QR code to register for their free AgPack ID and then purchases a truck or suv from a Certified Ag Dealer. Make sure to go vote for this charity to win by going to agtrucktraderprorodeo.com/charity for more information and to cast your vote for the organization you want to see supported. ____________________________________________________________________________________instagram @huntsmancancerevents | to Donate huntsmancancer.orgin the LOOP Podcast hosted by Jordan Jo Hollabaugh, is inspired by the western culture and breakaway roping lifestyle. This podcast highlights the raw, real, truth behind the box of the breakaway roping industry. Bringing you behind the scenes stories of what real life looks like everyday from; breakaway ropers, cowgirls, cowboys, producers, leaders, trailblazers, and the like, all sharing stories of the western culture and lifestyle that they live daily. Get in the LOOP Podcast with Jordan Jo Get the Newsletter at https://www.thebreakawayropingpodcast.com Like us on Facebook | https://www.facebook.com/intheloopbreakaway Tag us on Instagram | https://www.instagram.com/intheloopbreakaway Follow us on TikTok | https://www.tiktok.com/@jordanjo.hollabaugh Watch more on our Youtube Channel https://www.youtube.com/channel/UCjpVQcSSiobXsMiD89OvTvA

You're listening to a podcast from Cancer.Net. This cancer information website is produced by the American Society of Clinical Oncology, known as ASCO, the voice of the world's oncology professionals. The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. Guests' statements on this 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. Cancer research discussed in this podcast is ongoing, so data described here may change as research progresses. In this podcast, members of the Cancer.Net Editorial Board discuss the latest research, innovations, and discussions taking place across the field of genitourinary cancers, including prostate cancer, bladder cancer, kidney cancer, and testicular cancer. This podcast is led by Cancer.Net Associate Editor for Genitourinary Cancers, Dr. Petros Grivas. Dr. Grivas is the clinical director of the Genitourinary Cancers Program at University of Washington Medicine and a professor in the clinical research division at the Fred Hutchinson Cancer Research Center. He is joined by Dr. Neeraj Agarwal, Dr. Shilpa Gupta, Dr. Tian Zhang, and Dr. Timothy Gilligan. Dr. Agarwal is a Professor of Medicine, and a Presidential Endowed Chair of Cancer Research at the Huntsman Cancer Institute at the University of Utah. He directs the Genitourinary Oncology Program and Center of Investigational Therapeutics at the Huntsman Cancer Institute. He is also the Cancer.Net Specialty Editor for Prostate Cancer. Dr. Gupta is the Director of the Genitourinary Medical Oncology Program at Taussig Cancer Institute and Co-Leader of the Genitourinary Oncology Program at Cleveland Clinic. She is also the Cancer.Net Specialty Editor for Bladder Cancer. Dr. Zhang is an Associate Professor of Internal Medicine at UT Southwestern Medical Center and a medical oncologist at the Harold C. Simmons Comprehensive Cancer Center. She is also the Cancer.Net Specialty Editor for Kidney Cancer. Dr. Gilligan is a Medical Oncologist, Associate Professor of Medicine, and Vice-Chair for Education at the Cleveland Clinic Taussig Cancer Institute. He is also the Cancer.Net Specialty Editor for Testicular Cancer.  View full disclosures for Dr. Grivas, Dr. Agarwal, Dr. Gupta, Dr. Zhang, and Dr. Gilligan at Cancer.Net. Dr. Grivas: Hello. I'm Dr. Petros Grivas. I'm a medical oncologist in Seattle, a professor at the University of Washington and Fred Hutchinson Cancer Center. I'm really excited and thrilled today to host wonderful superstars in the field of GU Medical Oncology who will share insights about the highlights of kidney cancer, prostate cancer, and bladder, urothelial, urinary tract cancers that happened in 2023. And this highlight aims to inform our great audience about what are the clinically relevant insights, what patients should be aware, what patients should ask for when they go to the clinic, or overall, how they can be most well-informed and have the necessary tools to improve their care and feel well-supported in regards to education. So without further ado, we're going to cover in first prostate cancer, a very important update in this year. So all the people out there that are interested in hearing about prostate cancer will find this very, very useful and insightful. I'm very excited to host Professor, Dr. Neeraj Agarwal from University of Utah. Neeraj, do you want to introduce yourself? Dr. Agarwal: Of course. It's such an honor to be here. My name is Dr. Neeraj Agarwal. I'm a professor of medicine and director of genitourinary oncology program at the University of Utah Huntsman Cancer Institute. Dr. Grivas: Neeraj, thank you so much for accepting the invitation and being with us. I would like to ask you, what's your take on the current state of genetic testing in patients with prostate cancer? And when we say genetic testing, maybe you can clarify the distinction between germline and somatic and comment on both if you could. Thank you. Dr. Agarwal: Of course, a very important topic. I must tell you that it is very clear from all the guidelines that in patients with advanced prostate cancer or metastatic prostate cancer, meaning when prostate cancer has spread to different parts of the body, both germline testing to look for hereditary mutations in the DNA repair genes and testing for the same genes inside the tumor tissue are considered standard of care. So, a patient with advanced prostate cancer should have germline testing and somatic tumor tissue testing to look for mutations that can predispose them to have prostate cancer, and if they have genes in the tumor which can be targeted by the current approved drugs, like drugs which are already approved right now or which are in clinical trials. Unfortunately, less than 50% of patients in many areas of the country and in the world, less than 20% of patients are being tested. And even more, unfortunately, patients are less likely to be tested are those who are not well-resourced, who are not living in rich countries, if you will. They are poor- or low-resourced countries. Even with high-income countries, within those countries, patients who are living in relatively not-so-affluent neighborhoods, they are less likely to be tested. From racial perspective, patients who are Black or who are Hispanics are less likely to be tested. Based on how many drugs are out there in the clinic and emerging through clinical trials. And the fact that we can use many of these mutations for prognostication, to inform survival, to inform aggressiveness of the disease. It is not only to treat those patients, but also how to monitor the disease. The genetic testing is very important. Dr. Grivas: Thank you so much, Neeraj. It's very insightful. And I think you did a great job outlining the clinical relevance for both the patient in terms of treatment decision-making and therapy options, especially for advanced prostate cancer, as well as the broader family and implications for cancer prevention and cancer screening for the broader family members. So definitely a very important topic. Neeraj, the other question I have, if you could tell us more about this class of medications called PARP inhibitors. If you can comment on the currently approved PARP inhibitors, either as a single agent, what we call monotherapy or combination therapies for patients with prostate cancer in the United States, and who is eligible to receive those therapies? Dr. Agarwal: And this is such a nice segue to talk about PARP inhibitors as we were just talking about genetic testing of prostate cancer. So, PARP inhibitors are a class of drug which are instrumental, critical in treatment of patients who harbor mutations in those DNA repair genes. And two monotherapies, meaning using these PARP inhibitors as single agents have been already approved in the United States and several other countries. These are olaparib or rucaparib. Olaparib is approved after patients have had disease progression on novel androgen-blocking therapies or androgen blockers such as enzalutamide or abiraterone or apalutamide. And these PARP inhibitors such as olaparib or rucaparib can be used for those patients as single agent if they have these DNA repair mutations. Now, last year, we saw several combinations of PARP inhibitors with these androgen or novel hormonal therapy, as we call them. And these include abiraterone plus olaparib, abiraterone plus niraparib, and talazoparib plus enzalutamide from various phase 3 trials. Now, I'd like to bring to your attention that these PARP inhibitor combinations are approved with different indications in the United States and in the European Union. And they continue to get approved in various other countries. So the combination of abiraterone and a PARP inhibitor, whether it is olaparib or niraparib, they are approved for patients who have new metastatic castrate-resistant prostate cancer, and they have BRCA1 or BRCA2 mutations in the cancer cells or they have germline BRCA1 and BRCA2 mutations. Enzalutamide and talazoparib combination is approved in the United States for patients with metastatic castration-resistant prostate cancer with BRCA1 and BRCA2 mutations, but also several other DNA repair gene mutations. And that's a big difference as far as approval is concerned in the U.S. In the European Union, for our patients who are listening from European Union, the combination of abiraterone and olaparib and enzalutamide and talazoparib are approved for patients with metastatic castrate-resistant prostate cancer where chemotherapy is not clinically indicated, regardless of whether they have mutations in the DNA repair genes or not. And the combination of abiraterone and niraparib is only approved for patients with metastatic castrate-resistant prostate cancer with BRCA1 and BRCA2 mutation. So I just wanted to outline the different indications in the United States and in the Europe. Dr. Grivas: Thank you so much, Neeraj. So eloquent and very relevant to multiple patients globally, as you pointed out, with some differences in terms of the regulatory approval and availability of those agents in different countries. So great insights. Maybe we'll ask you 1 more question again since we are doing the highlights of the year. Another very important area of therapeutic development has to do with these novel agents that target the prostate cancer cells, and we call them theragnostics as a broader term. And I will let you explain what that means maybe in lay terms for our audience. And specifically, if you can comment on the recently presented PSMAforetrial at the ESMO meeting in Madrid with lutetium-177 PSMA. What are the implications of these results for our patients, and what is the role of lutetium therapy in this particular therapy setting? Dr. Agarwal: Of course, very important and pertinent topic indeed. As our patients may know that lutetium-177 therapy, or simply speaking, lutetium therapy, has already been approved for patients with metastatic castrate-resistant prostate cancer who have had disease progression on this novel hormonal therapy and a chemotherapy with docetaxel or cabazitaxel. And this indication is already there in the U.S. and in various other countries. And patients are eligible to receive lutetium therapy as long as their disease has progressed on docetaxel or one of the taxane chemotherapy and a novel hormonal therapy. Now, in the European Society of Medical Oncology meeting, Dr. Oliver Sartor presented the data on PSMAfore trial where lutetium therapy was used before chemotherapy. In this trial lutetium therapy was compared with another novel hormonal therapy after disease progression on 1 novel hormonal therapy. And there was approximately 6-month improvement in progression-free survival, meaning there was a delay in disease progression by 5 to 6 months in patients who were receiving lutetium therapy. And at the time of the report, there was no improvement in overall survival, with the caveat that 84% patients who were receiving novel hormonal therapy, actually, they switched over to lutetium therapy after disease progression. So, overall, survival data may not be met. Having said that, we already know that lutetium therapy is an effective therapy, and it has a definitive role in treatment of our patients with metastatic castrate-resistant prostate cancer. Dr. Grivas: Thank you, Neeraj. That's very, very important data. And I'm so glad we have many more therapy options for our patients with prostate cancer. So involvement and accrual in clinical trials, I'm sure you will agree, is a very important and high priority. And I always encourage people with prostate cancer to ask about clinical trials that are relevant to their situation. Dr. Agarwal: Yeah. I'd just like to add a point regarding lutetium therapy that there was a phase 2 trial in from Australia which compared lutetium therapy with cabazitaxel therapy after disease progression and docetaxel chemotherapy. And efficacy of both agents were not very different. So just wanted to make that point. Dr. Grivas: Thank you, Neeraj. It's a very important point. And obviously, always want to think about pace and preference, convenience, distance from the cancer centers, all the relevant points, how we can individualize suggestions or recommendations for our patients. Thank you so much, Neeraj, for your wonderful input, insights, and all the work you do in the field. Dr. Agarwal: Thank you very much for having me. Dr. Grivas: Of course, of course. And now we're going to transition to a different cancer type. We're going to talk about bladder cancer and urothelial cancer in general, urinary tract cancer. And we're delighted and excited to have Dr. Shilpa Gupta from Cleveland Clinic, who's a professor there of oncology. Shilpa, I want to introduce yourself? Dr. Gupta: I'm Shilpa Gupta. I'm a genitourinary medical oncologist and the director of the GU Program at Cleveland Clinic. I'm really excited to be doing this podcast with you all. Dr. Grivas: Thank you, Shilpa. You have done amazing work in the field, pushing the field forward. You are part of those transformative studies. I will ask you in the beginning where I'm going to focus my first question for people who have advanced or metastatic bladder cancer or urinary tract cancer or upper or lower tract. And we saw really exciting, impressive data at the recent ESMO Congress in Madrid a couple of months ago. And I know you were there and were enjoying to see the improvement in patient outcomes that comes with better quality of life for patients in the last several years. And the question I have for you, if you want to summarize the key data in the first-line treatment, patients who have no prior treatment for metastatic urothelial cancer, what are the key data we showed at the ESMO meeting? Dr. Gupta: Thank you, Petros. As you said, this is a really exciting time for both patients as well as the physicians treating bladder cancer because of all the new developments which we've seen after decades. So at ESMO 2023, we saw the key data from the EV-302 trial, which was a phase 3 trial, which randomized patients to the standard of care, platinum-based chemotherapy, gemcitabine-cisplatin or gemcitabine-carboplatin, versus a novel drug, which is an antibody-drug conjugate called enfortumab vedotin and the immunotherapy pembrolizumab. And the primary endpoint was to see if patients lived longer and this delayed progression. And we saw that in this the progression-free survival, we saw that it was 12.5 months with enfortumab vedotin and pembrolizumab compared to 6.3 months, which means that the risk of progression or death was decreased by 55% with this new combination. And the benefit was seen across all the various factors, especially patients with liver metastases, visceral metastases, whether or not they had contraindications to receiving cisplatin or not or PD-L1 expression. So this is the first time we saw such a remarkable benefit with any treatment that beat platinums. And the overall survival was also doubled: 16 months in chemotherapy versus 31.5 months with this combination. So the risk of death was reduced by 53%. And we also saw that the overall response rates were 68% with this compared to 44% with chemo. And 29% of patients had complete responses. And this was really remarkable because we have not seen such data before. And in the same session, we also saw another phase 3 trial that was presented, which was the Checkmate 901 trial, in which the investigators tested whether the addition of immunotherapy called nivolumab to the standard of care, gemcitabine and cisplatin was better than gemcitabine and cisplatin alone. So this was a study only looking for patients who can receive cisplatin. So patients were randomized to 6 cycles of gemcitabine cisplatin versus nivolumab, gemcitabine cisplatin for up to 6 cycles. And after that, they continued nivolumab maintenance every month for up to 2 years. And in this, the primary endpoint of overall survival was also met, although the difference was not as huge as the other study. It was 18.9 months with chemotherapy versus 21.7 months with the combination. And progression-free survival was also improved by just 0.3 months with the combination. And the objective response rates were higher with the combination, 57% versus 43%, and there were 21% complete responses. So the bottom line is that both these trials showed us that the frontline treatment is not going to be just platinums anymore moving forward. We will have the option of the enfortumab vedotin and pembrolizumab for all comers, patients who can get platinums, and nivolumab and gemcitabine cisplatin for patients who are cisplatin eligible. Dr. Grivas: Thank you, Shilpa. Wonderful summary. Really, really exciting time to see the field moving forward and translate those results to longer life for our patients. In that context, I will also ask you—I asked Neeraj before about genetic testing in prostate cancer. I will ask you a similar question about genetic testing in bladder cancer. Again, reminding the audience about the distinction between germline testing, which is the DNA we are born with, and somatic testing, which is the cancer-specific genomic changes. Could you comment on the importance of genetic testing in bladder cancer? Dr. Gupta: Yes. Absolutely, Petros. Genetic testing in urothelial cancer is very important because for the first time a few years ago, we saw a drug targeting the fibroblastic growth factor receptor or FGFR alterations. This drug is called erdafitinib. It is the first targeted therapy to be approved in urothelial cancer. It is only seen in up to 20% of patients who harbor these alterations for whom this option may be viable. And we saw initially that erdafitinib was approved in patients who harbor these alterations in the phase 2 BLC2001 trial where it showed response rates of 40% and encouraging progression-free survival, and overall survival. And then we also saw in a phase 3 trial called the THOR trial where patients who harbored these alterations by genetic testing, erdafitinib was much better than chemotherapy, prolonged survival by almost 4.2 months compared to chemotherapy. So unless we are testing, we won't find this. So it is really important to test all our advanced disease patients so we are not depriving them of this additional targeted therapy. Dr. Grivas: Thank you, Shilpa. Very important message for our patients to definitely discuss the value of genetic testing. And if we think about therapy implications, specifically genomic changes, DNA changes in these FGFR-2 and FGFR-3 genes are very relevant and important for potential therapy with this agent called erdafitinib. Shilpa, a quick comment. We saw data from THOR cohort 2 comparing erdafitinib with this inhibitor of this FGFR that we just talked about compared to pembrolizumab, which is an immunotherapy drug inhibiting a checkpoint of the immune system. Could you quickly comment on that? And I think both options are available for our patients and sometimes just comes down to the sequence based on a particular patient case. Dr. Gupta: So Petros, as we had thought that patients who harbor these alterations in their tumors, they may benefit from using targeted therapy before immunotherapy. That was the premise of the cohort 2 of the THOR trial, that patients will do better if they received erdafitinib first after progressing on 1 prior line of therapy, which is not an immunotherapy. So patients were randomized to erdafitinib versus pembrolizumab. Of course, all of them had to have the FGFR alterations. The primary endpoint was overall survival. Initially, like I said, the study assumed that there'll be 46% improvement in overall survival with erdafitinib over pembrolizumab. However, the study was a negative study. There was no difference in the overall survival. And what that means for our patients is that erdafitinib right now is positioned for patients who've had prior platinums and immunotherapies. So erdafitinib should not be used before immunotherapy. So I think this is the first study that really settles the question of sequencing for our patients. And I think the message is that in a patient's journey, they should be getting all these therapies. We just now know that it's better to use pembrolizumab before erdafitinib and not vice versa. Dr. Grivas: Thanks, Shilpa. And then really, really interesting to see these trials being reported. And as you said, individual discussion with the patients and the response rate may be another factor to consider. If someone wants to have a more rapid control of the cancer of the disease, we may potentially think about an agent with high response rate and vice versa. So I think to your point, individual decisions. And I think patients asking those questions is very important in the clinic to help select the right patient for the right treatment for the right patient. Dr. Gupta: Yeah. Absolutely, Petros. They did see that the response rates were 40% with the erdafitinib versus 21% with the immunotherapy. So using that information can sometimes guide us if a patient has high disease burden. Dr. Grivas: Thank you, Shilpa. That was very insightful. And thank you for all you are doing for the patients and the field in general. You really, really have helped the field move forward. So congratulations and thank you. And we're going to transition to another superstar in the field of GU cancers. Very excited to host Dr. Tian Zhang. Dr. Zhang is in UT Southwestern in Dallas. Tian, you want to introduce yourself? Dr. Zhang: Hi, Petros. Thank you so much. Tian Zhang, I'm a GU medical oncologist and associate professor at UT Southwestern Medical Center in Dallas. Dr. Grivas: Wonderful. Thanks, Tian. Again, the same comments. All the work you're doing in the field is tremendous. Thanks for joining us today. Tian, we saw some very interesting data at the ESMO meeting. And since we're doing the highlights of the year, I think the predominance of the data we saw at the ESMO meeting was about this drug called belzutifan, where I will ask you to enlighten us what exactly this is. And particularly, we saw 3 different trials. I would probably ask you to focus more on the LITESPARK-005. What was the trial design and what was the primary goal of the study? When patients go on this drug, what they should be aware in terms of side effects? And what was all this discussion that the take-home message at the end of ESMO regarding belzutifan? Thank you. Dr. Zhang: Sure. We'll parse that one at a time. Belzutifan, I hope many of our audience knows is a small molecule inhibitor of the HIF complex, a hypoxia-inducible factor complex, which is implicated in the development of kidney cancers. And this biology actually contributed to the Nobel Prize in 2019. Understanding the structure of the HIF complex and how to target it. For a long time, HIF was thought to be un-targetable. And so the fact that there were small molecules identified actually here in Dallas at UT Southwestern that inhibits the dimerization of the HIF complex is really novel and shows us the bench-to-bedside translatability of these preclinical discoveries. And so there were a couple of molecules that were discovered here on campus and they paved the way for what became molecules that have now made it to clinic, in particular belzutifan. And so we've had belzutifan now approved for Von Hippel-Lindau Syndrome over the last 2 years or so. So many of us are familiar with using this drug in the clinic. It's an oral agent that's able to target the HIF complex and block it and really control the spread of clear cell kidney cancers, in particular in Von Hippel-Lindau disease.  LITESPARK-005, the trial that you're alluding to, there was a registrational trial for belzutifan across other kidney cancer populations. And this trial was the 1 that made, I think, the biggest impact of the 3 trials that were presented at ESMO this year.  LITESPARK-005 was a phase 3 trial of patients who had metastatic or locally advanced clear cell kidney cancer who had progressed after prior systemic therapies, not more than 3 prior lines. And they were randomized to either belzutifan at the 120 milligrams daily dose or everolimus at the 10 milligrams daily dose. And the primary endpoint was delay of progression. So progression-free survival as well as overall survival. So we saw the primary endpoint of these was met for progression-free survival. There was about a 26% risk reduction for progression for patients treated with belzutifan versus those that were treated with everolimus. The objective response rate I would highlight is also significant for the patients treated with belzutifan. There was actually a 3.5% complete response rate and objective responses. So including partial responders was about 23%. I would say that patients who are treated with belzutifan need to be aware of the side effects of anemia and also hypoxia [low levels of oxygen in the body]. And in fact, higher grades of anemia can occur in up to a third of patients and higher rates of hypoxia. So low oxygen saturations can occur in up to 10% or so of patients. And so that's really important when we're thinking about those toxicities and how we might hold or support the side effects with growth factors, for example, for the anemia. Otherwise, it's quite well tolerated as a single agent. As you alluded to, there was 1 controversial aspect of this particular trial because the control cohort was treated with everolimus. And everolimus as a single agent may not be what people use at this point in the refractory setting. But it is an acceptable approved treatment option for patients in the refractory kidney cancer setting, and therefore, it was chosen as the control cohort. And belzutifan did improve compared to a known standard of treatment. So I think that's really important to add to our armamentarium in refractory disease. Dr. Grivas: Wonderful, Tian. Thank you so much for a really, really comprehensive and detailed review. We'll have to see whether it will be available for patients with advanced clear-cell kidney cancer. To your point, it's already available for patients with this condition that you mentioned, the Von Hippel-Lindau genetic condition. So it's great to see more options available for our patients. Maybe I'll ask you another quick trial to comment on Tian, and I'll ask you individual questions to make it easier, to your point, for the audience to follow. And I'm referring to the RENOTORCH trial. This was conducted in China, and I think it was practice-changing there. Could you tell us the study design? Dr. Zhang: RENOTORCH was another phase 3 randomized trial. It was conducted all in China of patients with unresectable metastatic clear cell kidney cancer, no systemic prior therapy, and also intermediate- and poor-risk disease by IMDC criteria. So these were all first-line metastatic disease, and patients were randomized to either toripalimab, which is their PD-1 inhibitor, plus axitinib versus sunitinib. So this is a trial design that mirrors many of our prior trials in the first-line metastatic setting that have led to approvals of VEGF IO [immunotherapy] combinations. But this is the first one that was carried out purely in the Chinese population and important for the Chinese population to gain access to these types of combinations. Dr. Grivas: Thank you, Tian. Very important to see this global approach, as you mentioned, oncology and see trials from different countries. What were the main findings of this trial? Dr. Zhang: Sure. The primary endpoint was progression-free survival of the 2 cohorts. And they randomized about 420 patients. About 80% per cohort had intermediate-risk disease. And the combination of axitinib with toripalimab did improve progression-free survival. So it had a 35% risk reduction for progression over time. So it did meet its primary endpoint. Dr. Grivas: Thank you, Tian. It's great to see progress in the field. As I mentioned, new agents, positive trials. Could you comment a little bit on the side effect profile and the significance of this trial for our patients worldwide? Dr. Zhang: Sure. When we're talking about VEGF IO combinations very similarly as to the prior trials that we've seen in the toxicity profiles, we're thinking a lot about the immunotherapy toxicities of rashes and colitis [inflammation of the colon], endocrinopathies [hormone problems], as well as the rare inflammatory reactions of the liver, lungs, or kidney, but also added in the small molecule effects of hypertension, hand-foot syndrome, and mucositis [mouth sores] and taste changes. So very important to think through those side effect profiles as our patients are being treated with these combinations. Dr. Grivas: Thank you so much, Tian. Great to see, again, this progress made worldwide. And I think it speaks to the idea of how we can have equitable healthcare delivery across the globe, right, and have agents accessible in different parts of the world. Dr. Zhang: Absolutely. In fact, I would just add that the Chinese population haven't actually had access to drugs like cabozantinib. And this is their first phase 3 grade 1 evidence for a combination of VEGF with IO combination. So it's really important that these trials are carried out in the populations where we try to find the effect and see that the consistent benefit is there so that those patients have access to all of these treatment options. Dr. Grivas: Thank you, Tian. I appreciate your wonderful insights and all your amazing contributions in the field and your research. It's really, really inspiring to see. And I'm going to transition now. Last but not least, we're having the honor of hosting professor, Dr. Tim Gilligan, who is in Cleveland Clinic, and Tim is a world-known expert in urinary cancers, including testicular cancer. Tim, would you like to introduce yourself? Dr. Gilligan: Yes. Hi. So I think you just did. Tim Gilligan, an oncologist at Cleveland Clinic. I chaired the NCCN panel on testis cancer and edit the UpToDate sections on testis cancer with their help. Dr. Grivas: Fantastic. Thanks, Tim, for being with us today. And all the work you have done for our patients with GU cancers, testicular cancer, and a lot of work is being done with the NCCN and other guidelines. And you are co-chairing the NCCN guidelines, to your point. Tim, a lot of discussion is happening nowadays across cancer types regarding the role of what we call biomarkers, which are potential features that can help us select patients for the right treatment or help us estimate the prognosis, how long people live. Could you comment a little bit on this biomarker called microRNA in patients with testis cancer? How do you envision this being developed in the future? Is it ready for prime time or not yet? Dr. Gilligan: And that's an important question. It's not ready for prime time yet, but we are making progress. There are a couple of areas where it could be very useful. So for example, in stage I testicular cancer, we tell patients to go on surveillance because they're usually cured with orchiectomy [surgical removal of the tumor and testicle], but there is a risk of relapse, and that risk of relapse is highly variable. And our current risk stratification systems for predicting who's going to relapse, who has stage 1 disease, are helpful, but they're far from perfect. And so there was data presented this year that mRNA may be more accurate at predicting for men with stage I non-seminomas who's destined to relapse. And so the implication of that would be if you are positive for mRNA, this particular mRNA for non-seminoma and you have stage I disease, normal scans, normal markers, you could identify a high-risk group of patients who maybe should get a cycle of BEP chemotherapy rather than waiting. If you know they're going to relapse, you're going to have to get them 3 cycles of BEP, why not just treat them right away? Or maybe RPLND [retroperitoneal lymph node dissection] could be helpful in that setting. We don't know. But we would need to do studies validating that approach. There is data showing that it does predict relapse, but it's not at the point of saying, "Are the patients really going to do better with immediate treatment and which treatment is going to be best for them?" But I thought that was an important finding and really an example of how we think we're going to use it, which is to find relapse a lot earlier and so that we can give a less toxic treatment. And the benefit of that is that we know more and more that chemotherapy is toxic and resulted in second cancers. For men who get multiple cycles of cisplatin-based chemotherapy, or if they get radiation therapy, they're at higher risk of dying of other cancers than the general population. So if this could help us find early relapses, treat it more gently, less aggressively, have late, less toxicity, and the same cure rate. That would be great. So we're not there yet, but I think we're going to get there. Dr. Grivas: Thanks, Tim. Very, very helpful to know. So this microRNA 371 that we talk about is not ready for prime time, but you definitely see promise for the future, and more trials, more studies are being done. Again, illustrating the importance of clinical trials that can help us evaluate the added value of a particular biomarker, including this particular microRNA that we talked about. Dr. Gilligan: Before you change the subject on getting to crude biomarkers, there was also an interesting abstract showing that for stage I seminoma. If we actually use our current markers, we may be able to predict much more accurately. And it'll be interesting to see if that changes. They looked at the variables of lymphovascular invasion, invasion of the hilum of the testis, whether or not preoperative markers were elevated, LDH, and beta HCG. What was interesting to me about that paper was that this is about 900 patients. It was pretty large. That if you had all 4 risk factors, the relapse rate was about 64%. Whereas your average relapse risk for stage I seminoma is about 15%. We put everyone on surveillance. If we started if that model is persuasive to the community and starts getting used, then maybe patients with those 4 risk markers who most of whom are going to relapse, according to this data, maybe you want to treat those people and not put them on surveillance. So that'll be interesting to follow up on too. Dr. Grivas: Thanks, Tim. And you are referring to currently available blood tests, right, that can be used, and we use them in clinical practice. So we just put them together, try to get a sense of the chance of cancer coming back, what we call recurrence, and how long people may live. That can help us make a therapy decision. Thank you, Tim. This is very, very interesting. And I'm glad to see the progress in the field. I think you alluded to that before, but there is a trend discussing when we have a removal of the testicle for a patient with testis cancer, what to do next, depending on the stage, those markers that the blood tests you told us about. What about the role of surgery for removal of lymph nodes, for example? And do you see a trend going forward that in many selective cases, certain scenarios, we may potentially select surgery as opposed to chemotherapy or radiation to avoid these potential complications down the road? And if so, which are those patients who may benefit from surgery? Dr. Gilligan: Yeah, an important question. I think surgery, there's been a growing interest in using surgery rather than chemotherapy in order to avoid late effects. So retroperitoneal lymph node dissection (RPLND) is the most obvious example of that. There is data now showing that most patients with stage II seminoma can be cured with retroperitoneal lymph node dissection. We used to treat those patients with chemotherapy or radiation, but as I've noted, both of those are associated with an increased risk of second cancers down the line. So there are papers on both sides of the Atlantic showing that you can cure most people. However, it is important to note that the relapse rate after surgery is significantly higher than the relapse rate after chemotherapy or radiation. If you take a stage II patient and treat them with chemotherapy or radiation, you're going to cure well over 90% of them. Whereas the relapse risk with surgery, depending on what you find at surgery, is going to be higher. So on average, it's going to be in the realm of 20%, maybe as high as 30%, depending on which paper you look at. And if you take patients who have PN2 disease, so a lymph node is 2 centimeters or bigger, 25% or more of those patients are relapsing after surgery. So it's important for patients to understand that this treatment has the benefit of avoiding chemotherapy for most patients, but it also has a higher risk of relapse than the old treatments. We still think it's attractive because if you can avoid chemotherapy in 3 out of 4 patients or 4 out of 5 patients, that's a benefit to those patients. And also, if you go in and find a significant amount of cancer at surgery, you can give 2 cycles of chemotherapy right away and almost eliminate the risk of relapse, which is less chemo than they would be getting upfront, which would be 3 or 4 cycles. So one of the emphasis now is really trying to avoid late toxicities if we can. You sometimes see that even in the metastatic setting in terms of resecting residual masses and situations where we maybe in the past would have thought about second-line chemotherapy. I think people are more thinking about opportunities to use surgery instead to try to limit the quantity of chemo that we're giving. Those are much trickier decisions than the stage II decisions, but definitely a growing interest in surgery rather than chemo. Dr. Grivas: Thank you so much. It's really, really exciting to see that testis cancer was really transformed in the past with developments of therapies like chemotherapy, radiation therapy, and surgery. And it's great to see this evolving down the road. And I think all of the above that you mentioned evolves through the conduction of clinical trials. And as I mentioned before, I think it's so important to give the opportunity for patients and families to review clinical trial options. I think it's critical to try to help them, but also help other patients, the community, the society in general. So I always try to underline the importance of clinical trials across the board. And on that note, I think we had such a successful year, 2023 across GU cancers. It's so great to see the progress being made. All of us are looking forward for more exciting research being done in 2024 and beyond. And on that note, I want to thank so much Dr. Agarwal, Dr. Gupta, Dr. Zhang, and Dr. Gilligan for wonderful insights and all the great work they're doing in the field of GU cancers. As the editor for the GU Cancers for the wonderful Cancer.Net, I'm so proud of this team and really, really looking forward to further podcasts like this and how we can better serve the educational mission for ASCO, working with the wonderful staff at Cancer.Net. Thank you so much, all of you, for your time today and all you are doing. Dr. Gupta: Thank you, Petros. Dr. Zhang: Thank you, Petros. ASCO: Thank you, Dr. Grivas, Dr. Agarwal, Dr. Gupta, Dr. Zhang, and Dr. Gilligan. You can learn more about new research in genitourinary cancers at www.cancer.net. Cancer.Net Podcasts feature trusted, timely, and compassionate information for people with cancer, survivors, and their families and loved ones. Subscribe wherever you listen to podcasts for expert information and tips on coping with cancer, recaps of the latest research advances, and thoughtful discussions on cancer care. And check out other ASCO Podcasts to hear the latest interviews and insights from thought leaders, innovators, experts, and pioneers in oncology. Cancer.Net is supported by Conquer Cancer, the ASCO Foundation, which funds lifesaving research for every type of cancer, helping people with cancer everywhere. To help fund Cancer.Net and programs like it, donate at CONQUER.ORG/Donate.

Drs. Neeraj Agarwal and Jeanny Aragon-Ching discuss several key abstracts to be presented at the 2024 ASCO GU Cancers Symposium, including sequencing versus upfront combination therapies for mCRPC in the BRCAAway study, updates on the CheckMate-9ER and CheckMate-214 trials in ccRCC, and a compelling real-world retrospective study in mUC of patients with FGFR2 and FGFR3 mutations. TRANSCRIPT Dr. Neeraj Agarwal: Hello, everyone, and welcome to the ASCO Daily News Podcast. I'm Dr. Neeraj Agarwal, your guest host of the podcast today. I am the director of the Genitourinary Oncology Program and a professor of medicine at the University of Utah's Huntsman Cancer Institute, and editor-in-chief of ASCO Daily News. I am delighted to welcome Dr. Jeanny Aragon-Ching, a genitourinary oncologist and the clinical program director of Genitourinary Cancers at the Inova Schar Cancer Institute in Virginia. Today, we will be discussing key posters and oral abstracts that will be featured at the 2024 ASCO Genitourinary Cancer Symposium, which is celebrating 20 years of evolution in GU oncology this year.  You will find our full disclosures in the transcript of this podcast, and disclosures of all guests on the podcast at asco.org/DNpod.  Jeanny, it's great to have you on the podcast today to highlight some key abstracts for our listeners ahead of the GU meeting. Dr. Jeanny Aragon-Ching: Thank you so much, Neeraj. It's an honor to be here. Dr. Neeraj Agarwal: Jeanny, as you know, this year we are celebrating the 20th anniversary of the ASCO GU Cancers Symposium, and judging from this year's abstracts, it's clear that this meeting continues to play a major role in advancing GU cancer research. Dr. Jeanny Aragon-Ching: Indeed, Neeraj. This year's abstracts reflect the important strides we have made in GU cancers. So, let's start with the prostate cancer abstracts. What is your takeaway from Abstract 19 on BRCAAway, which will be presented by Dr. Maha Hussein, and of which you are a co-author? As our listeners know, several PARP inhibitor combinations with second-generation androgen receptor pathway inhibitors, or ARPIs, have recently been approved as first-line treatment for patients with metastatic castrate-resistant prostate cancer, or metastatic CRPC, and the question of sequencing PARP inhibitors and ARPIs instead of combining them has emerged. From that perspective, the results of the BRCAAway trial are very important. Can you tell us a little bit more about this abstract, Neeraj?  Dr. Neeraj Agarwal: I totally agree with you, Jeanny. The BRCAAway study attempts to answer the crucial questions regarding sequencing versus upfront combination of therapies in the mCRPC setting. It is a phase 2 trial of abiraterone versus olaparib versus abiraterone with olaparib in patients with mCRPC harboring homologous recombination repair mutations. Enrolled patients had mCRPC disease and no prior exposure to PARP inhibitors or ARPIs or chemotherapy in the mCRPC setting and had BRCA1 or BRCA2 or ATM mutations. As previously mentioned, these patients were randomized to 3 arms: abiraterone monotherapy at 1000 milligrams once daily, or olaparib monotherapy at 300 milligrams twice daily, or the combination of abiraterone and olaparib. The primary endpoint was progression-free survival per RECIST 1.1 or Prostate Cancer Working Group 3-based criteria or clinical assessment or death, so, whichever occurred first was deemed to be progression.   Secondary endpoints included measurable disease response rates, PSA response rate, and toxicity. This was a relatively small trial with 21 patients in the combination arm, 19 patients in the abiraterone monotherapy arm, and 21 patients in the olaparib monotherapy arm. It should be noted that 26% of patients had received docetaxel chemotherapy in the hormone-sensitive setting, and only 3% of patients had any prior exposure to an ARPI, and these were darolutamide or enzalutamide or in the non-metastatic CRPC setting.  The results are very interesting. The median progression-free survival was 39 months in the combination arm, while it was 8.4 months in the abiraterone arm and 14 months in the olaparib arm. An important finding that I would like to highlight is that crossover was also allowed in the monotherapy arms. Of the 19 patients receiving abiraterone, 8 crossed over to receive olaparib, and of the 21 patients receiving olaparib, 8 crossed over to the abiraterone arm. The median PFS from randomization was 16 months in both groups of patients who received abiraterone followed by olaparib or those who received olaparib followed by abiraterone. This is striking when compared to 39 months in patients who started therapy with the combination therapy of abiraterone with olaparib. Dr. Jeanny Aragon-Ching: Thank you so much for that wonderful summary, Neeraj. So the key message from this abstract is that combining olaparib and abiraterone upfront seems to be associated with improvement in PFS compared to just sequencing those agents. Dr. Neeraj Agarwal: Exactly, Jeanny. I would like to add that these results are even more important given that in real-world practice, only half of the patients with mCRPC receive a second-line treatment. Based on these results, upfront intensification with a combination of an ARPI plus a PARP inhibitor in the first-line mCRPC setting seems to have superior efficacy compared to sequencing of these agents. Dr. Jeanny Aragon-Ching: Thank you so much. Now, moving on to a different setting in prostate cancer, there were a couple of abstracts assessing transperineal biopsy compared to the conventional transrectal biopsy for the detection of prostate cancer. So let's start with Abstract 261. Neeraj, can you tell us a little bit more about this abstract? Dr. Neeraj Agarwal: Sure, Jeanny. So, in Abstract 261 titled "Randomized Trial of Transperineal versus Transrectal Prostate Biopsy to Prevent Infection Complications," Dr. Jim Hugh and colleagues led a multicenter randomized trial comparing these 2 approaches, so, transperineal biopsy without antibiotic prophylaxis with transrectal biopsy with targeted prophylaxis in patients with suspected prostate cancer. The primary outcome was post-biopsy infection. Among the 567 participants included in the intention-to-treat analysis, no infection was reported with the transperineal approach, while 4 were detected with the transrectal approach, with a p-value of 0.059. The rates of other complications, such as urinary retention and significant bleeding, were very low and similar in both groups. The investigators also found that detection of clinically significant cancer was similar between the 2 techniques and concluded that the transperineal approach is more likely to reduce the risk of infection without antibiotic prophylaxis. Dr. Jeanny Aragon-Ching: So the key takeaway from this abstract sounds like office-based transperineal biopsy is well-tolerated and does not compromise cancer detection, along with better antibiotic stewardship and health care cost benefits.  Moving on to Abstract 273, also comparing these two approaches, what would be your key takeaway message, Neeraj?  Dr. Neeraj Agarwal: In this Abstract 273, titled "Difference in High-Risk Prostate Cancer Detection between Transrectal and Transperineal Approaches," Dr. Semko and colleagues found that the transperineal biopsy based on MRI fusion techniques was also characterized by a higher possibility of detecting high-risk prostate cancer and other risk factors as well, such as perineural and lymphovascular invasion or the presence of cribriform pattern, compared to the conventional transrectal method. Dr. Jeanny Aragon-Ching: Thank you, Neeraj. So we can see that the transperineal approach is gaining more importance and could be associated with more benefits compared to the conventional methods.   Let's now switch gears to kidney cancer, Neeraj. Dr. Neeraj Agarwal: Sure, Jeanny. Let's start by highlighting Abstract 361, which discusses patient-reported outcomes of the LITESPARK-005 study. So what can you tell us about this abstract, Jeanny?  Dr. Jeanny Aragon-Ching: Thank you, Neeraj. So as a reminder to our listeners, based on the LITESPARK-005 trial, it was a Phase 3 trial looking at belzutifan, which is an inhibitor of hypoxia inducible factor 2 alpha or I'll just call HIF-2 alpha for short, was very recently approved by the FDA as a second-line treatment option for patients with advanced or metastatic clear cell renal cell carcinoma after prior progression on immune checkpoint and antiangiogenic therapies. The title of Abstract 361 is "Belzutifan versus Everolimus in Patients with Previously Treated Advanced RCC: Patient-Reported Outcomes in the Phase 3 LITESPARK-005 Study," and this will be presented by Dr. Tom Pells at the meeting. At a median follow-up of 25.7 months, the median duration of treatment with belzutifan was 7.6 months, while it was only 3.9 months with everolimus. At the time of data cutoff date for the second interim analysis, 22.6% of patients remained on belzutifan while only 5% remained on everolimus. In the quality of life questionnaires, the time of deterioration to various quality of life scores, as assessed by standardized scales, was significantly longer in patients randomized to the belzutifan arm compared to those in the everolimus arm. Also, patients in the everolimus arm had worse physical functioning scores. Dr. Neeraj Agarwal: Yes, Jeanny. In addition to the improved outcomes associated with belzutifan, patient-reported outcomes indicate better disease-specific symptoms and better quality of life among patients treated with belzutifan compared to everolimus. This is great news for patients with advanced renal cell carcinoma.  Now, Jeanny, can you please tell us about the two abstracts that reported longer follow-up of CheckMate 9ER and CheckMate 214 trials in untreated patients with advanced or metastatic renal cell carcinoma? Dr. Jeanny Aragon-Ching: Yes, Neeraj. So you are referring to Abstracts 362 and 363. Let's start with Abstract 362. This abstract reports the results after a median follow-up of 55 months in the CheckMate 9ER trial, comparing the combination of nivolumab and cabozantinib to sunitinib in patients with advanced RCC without any prior treatment, so first-line therapy. The primary endpoint was PFS per RECIST 1.1 as assessed by an independent central review. So there were key secondary outcomes including overall survival (OS), objective response rates, and safety. Consistent with prior analysis at a median follow-up time of 18.1 and 44 months, the combination of nivolumab and cabozantinib at a median follow up of 55.6 months continues to show a significant reduction in the risk of progression or death by 42% and in the risk of death by 23% compared to sunitinib.  Dr. Neeraj Agarwal: And Jeanny, what can you tell us about the efficacy results of this combination by IMDC risk categories? Dr. Jeanny Aragon-Ching: Similar to prior results in patients with intermediate to poor risk IMDC risk category, the combination treatment maintained significant efficacy and reduced the risk of progression or death by 44% and the risk of death by 27%. To put it simply, the update now shows a 15-month improvement in overall survival with the cabozantinib-nivolumab combination compared to sunitinib, which is amazing. Also, in patients with favorable IMDC risk group, which represented truly a small number of patients in the trial, there was a strong trend for improvement of outcomes as well. I would like to point out that no new safety concerns were identified. Dr. Neeraj Agarwal: So, it looks like the key message from this abstract is that with longer follow-up, the combination of nivolumab and cabozantinib maintains a meaningful long-term efficacy benefit over sunitinib, supporting its use for newly diagnosed patients with advanced or metastatic renal cell carcinoma.   Let's move on to Abstract 363, which compares nivolumab with ipilimumab to sunitinib in first-line advanced renal cell carcinoma. What would you like to tell us about this abstract, Jeanny? Dr. Jeanny Aragon-Ching: Yes, Neeraj. The title of this abstract is "Nivolumab plus Ipilimumab versus Sunitinib for the First-Line Treatment of Advanced RCC: Long-Term Follow-Up Data from the Phase 3 CheckMate 214 Trial." In this abstract, Dr. Tannir and colleagues report outcomes with the longest median follow-up in first-line advanced RCC setting for any clinical trial. So the median follow-up now is about 18 months. The primary endpoints were OS, PFS, and objective response rates, as assessed by an independent review according to RECIST 1.1 criteria in the intermediate to poor risk IMDC risk group, which is the intent-to-treat (ITT) analysis, while secondary outcomes included the same outcomes in the ITT population of patients. Although the progression-free survival was similar in both arms, the combination of nivolumab-ipilimumab reduced the risk of death by 28% compared to sunitinib in the ITT population of patients. When stratifying the results by IMDC risk groups, the combination arm of nivolumab-ipilimumab showed significant improvement in the intermediate to poor risk group, but there was no difference in the favorable risk group. But in the study, no new safety signals were identified. Dr. Neeraj Agarwal: Thank you, Jeanny, for such a comprehensive description of the results of these two studies. I'd like to add that the median overall survival of patients with metastatic renal cell carcinoma in the ITT population in the CheckMate 214 trial has now reached 53 months, which would have been unimaginable just a decade ago. This is wonderful news for our patients. So the key takeaway from these two abstracts would be that immune checkpoint inhibitor-based combinations remain the backbone of first-line advanced renal cell carcinoma treatment.  Dr. Jeanny Aragon-Ching: Absolutely, Neeraj. This is wonderful news for all of our patients, especially for those who are being treated for first-line therapy.  Now, let's move on to the bladder cancer abstracts. We have two exciting abstracts from the UNITE database. What are your insights on Abstract 537, titled "Outcomes in Patients with Advanced Urethral Carcinoma Treated with Enfortumab Vedotin After Switch-Maintenance of Avelumab in the UNITE Study"? Dr. Neeraj Agarwal: As our listeners know, enfortumab vedotin is an antibody-drug conjugate that binds to a protein called Nectin 4 expressed on bladder cancer cells. In this abstract, Dr. Amanda Nizam and colleagues describe outcomes in 49 patients receiving third-line enfortumab vedotin after prior progression on platinum-based therapy and maintenance avelumab. At a median follow-up of 8.5 months, the median progression-free survival was 7 months and the median overall survival was 13.3 months with enfortumab vedotin in this treatment-refractory setting, the objective response rates were 54%. The message of this study is that enfortumab vedotin is an effective salvage therapy regimen for those patients who have already progressed on earlier lines of therapies, including platinum-based and immunotherapy regimens. Dr. Jeanny Aragon-Ching: Thank you, Neeraj, for that comprehensive review.  I want to focus on another patient population in the UNITE database, which is the use of fibroblast growth factor receptor (FGFR) alterations. Can you tell us more about the sequencing now of erdafitinib and enfortumab vedotin in these patients with metastatic urothelial cancer, as discussed in Abstract 616? Dr. Neeraj Agarwal: Sure, Jeanny. As a reminder, erdafitinib is a fibroblast growth factor receptor kinase inhibitor approved for patients with locally advanced or metastatic urothelial carcinoma harboring FGFR2 or FGFR3 alterations after progression on platinum-based chemotherapy. However, the optimal sequencing of therapies in these patients is unclear, especially with enfortumab vedotin being approved in the salvage therapy setting and now in the frontline therapy setting.  So in this retrospective study, all patients with metastatic urothelial carcinoma had FGFR2 or FGFR3 alterations. Dr. Cindy Jiang and colleagues report outcomes in 24 patients receiving enfortumab vedotin after erdafitinib, 15 patients receiving erdafitinib after enfortumab vedotin, and 55 patients receiving enfortumab vedotin only. This is a multicenter national study. Interestingly, patients receiving both agents had a longer overall survival in a multivariate analysis, regardless of the treatment sequencing, than patients receiving enfortumab vedotin alone or only with a hazard ratio of 0.52. The objective response rate of enfortumab vedotin in the enfortumab vedotin monotherapy arm was 49%. When these agents were sequenced, the objective response with enfortumab vedotin was 32% after erdafitinib and 67% when used before erdafitinib. Dr. Jeanny Aragon-Ching: Thank you so much, Neeraj. I think these are important real-world data results, but I would like to point out that larger and prospective studies are still needed to confirm these findings, especially regarding the outcome of erdafitinib after enfortumab vedotin, particularly when the latter is used in the first-line setting. Dr. Neeraj Agarwal: I totally agree, Jeanny. Now, let's discuss some abstracts related to disparities in the management of patients with genitourinary cancers.  Dr. Jeanny Aragon-Ching: Sure, actually, I would like to discuss 2 abstracts related to disparities in patients with prostate cancer. So the first one, Abstract 265, titled "Patient-Provider Rurality and Outcomes in Older Men with Prostate Cancer." In this study, Dr. Stabellini, Dr. Guha and the team used a SEER Medicare-linked database that included more than 75,000 patients with prostate cancer. The primary outcome was all-cause mortality, with secondary outcomes included prostate cancer-specific mortality. The investigators showed that the all-cause mortality risk was 44% higher in patients with prostate cancer from rural areas who had a provider from a non-metropolitan area compared to those who were in a metropolitan area and had a provider also from a metropolitan area. Dr. Neeraj Agarwal: Those are very important data and highlight the healthcare disparities among the rural population with prostate cancer that still exist.  So what is your key takeaway from Abstract 267, titled "Rural-Urban Disparities in Prostate Cancer Survival," which is a population-based study? Dr. Jeanny Aragon-Ching: Of course. This abstract discusses, actually, a very similar issue regarding access to healthcare among rural versus urban patients. In this study, Dr. Hu and Hashibe and colleagues and team at the Huntsman Cancer Institute assessed all-cause death and prostate cancer-related death risk in a retrospective study in which patients with prostate cancer based on rural versus urban residencies looked at 18,000 patients diagnosed with prostate cancer between 2004 and 2017. 15% lived in rural counties. Similar to the prior abstract we talked about, patients living in rural areas had about a 19% higher risk of all-cause mortality and a 21% higher risk of prostate cancer-specific mortality in comparison to patients living in urban areas. Dr. Neeraj Agarwal: So Jeanny, we can say that both of these abstracts, led by different groups of investigators, highlight that patients with prostate cancer living in rural areas have inferior survival outcomes compared to those living in urban areas, and it is time to focus on the disparities experienced by the rural population with prostate cancer.  Dr. Jeanny Aragon-Ching: Yeah, absolutely Neeraj. I concur with your thoughts.  So, any final thoughts before we wrap up the podcast today? Dr. Neeraj Agarwal: Yes, before concluding, Jeanny, I want to express my gratitude for your participation and the valuable insights you have shared today. Your contributions are always appreciated, and I sincerely thank you for taking the time to join us today.   As we bring this podcast to a close, I would like to highlight the significant advances happening in the treatment of patients with genitourinary cancers during our upcoming 2024 ASCO GU meeting. Many studies featuring practice-impacting data will be presented by investigators from around the globe. I encourage our listeners to not only participate at this event to celebrate these achievements, but to also play a role in disseminating these cutting-edge findings to practitioners worldwide. By doing so, we can collectively maximize the benefit for patients around the world.  And thank you to our listeners for joining us today. You will find links to the abstracts discussed today in the transcript of this episode. Finally, if you value the insights that you hear on the ASCO Daily News Podcast, please take a moment to rate, review, and subscribe wherever you get your podcasts. Thank you very much.  Disclaimer: The purpose of this podcast is to educate and inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guest speakers express their own opinions, experience, and conclusions. Guest statements on the podcast do not necessarily reflect the opinions of ASCO. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement.  Find out more about today's speakers:     Dr. Neeraj Agarwal  @neerajaiims  Dr. Jeanny Aragon-Ching    Follow ASCO on social media:     @ASCO on Twitter     ASCO on Facebook     ASCO on LinkedIn       Disclosures:      Dr. Neeraj Agarwal:       Consulting or Advisory Role: Pfizer, Bristol-Myers Squibb, AstraZeneca, Nektar, Lilly, Bayer, Pharmacyclics, Foundation Medicine, Astellas Pharma, Lilly, Exelixis, AstraZeneca, Pfizer, Merck, Novartis, Eisai, Seattle Genetics, EMD Serono, Janssen Oncology, AVEO, Calithera Biosciences, MEI Pharma, Genentech, Astellas Pharma, Foundation Medicine, and Gilead Sciences    Research Funding (Institution): Bayer, Bristol-Myers Squibb, Takeda, Pfizer, Exelixis, Amgen, AstraZeneca, Calithera Biosciences, Celldex, Eisai, Genentech, Immunomedics, Janssen, Merck, Lilly, Nektar, ORIC Pharmaceuticals, Crispr Therapeutics, Arvinas     Dr. Jeanny Aragon-Ching:    Honoraria: Bristol-Myers Squibb, EMD Serono, Astellas Scientific and Medical Affairs Inc., Pfizer/EMD Serono  Consulting or Advisory Role: Algeta/Bayer, Dendreon, AstraZeneca, Janssen Biotech, Sanofi, EMD Serono, MedImmune, Bayer, Merck, Seattle Genetics, Pfizer, Immunomedics, Amgen, AVEO, Pfizer/Myovant, Exelixis,   Speakers' Bureau: Astellas Pharma, Janssen-Ortho, Bristol-Myers Squibb, Astellas/Seattle Genetics. 

In this interview, Oncology Data Advisor Editorial Board member Dr. Stephen Freedland, Professor of Urology at Cedars-Sinai Medical Center, speaks with Dr. Neeraj Agarwal, Director of the Genitourinary (GU) Medical Oncology Group at Huntsman Cancer Institute, about his recent publication of the TALAPRO-2 study. Dr. Agarwal delves into the results of the trial, which investigated the efficacy of talazoparib plus enzalutamide for first-line metastatic castration-resistant prostate cancer (mCRPC), and their practice-changing significance.

In this podcast, Dr. Neeraj Agarwal (US), presidential endowed chair of cancer research at the Huntsman Cancer Institute, University of Utah, shares the results of the LITESPARK-013 Phase 2 trial - "Safety and efficacy of two doses of belzutifan in patients with advanced renal cell carcinoma", that he presented at ESMO 2023. Firstly, Dr. Agarwal shares the rationale of the study, which compared belzutifan 200mg and 120mg doses in patients with advanced clear cell RCC that progressed on anti-PD-1/L1 therapy to evaluate the safety and efficacy of these two doses in a larger, randomised trial. Dr. Agarwal said that there was no difference in efficacy outcomes of belzutifan 200 mg and 120 mg orally once daily. Progression-free survival and overall survival were similar, as were the safety profiles between the two doses. But, according to Dr. Neeraj, when they took a deep dive into the belzutifan 200mg once daily dose, it was associated with a higher rate of overall dose modifications and drug discontinuation. Based on these results, he concluded that belzutifan 120mg once daily dose in patients with clear cell RCC should remain the dose. 

Recent advancements have certainly improved thyroid cancer outcomes, but are all treatments and surgeries essential? Jason Hunt, MD, the clinical director of neck and throat surgical oncology at Huntsman Cancer Institute and University of Utah Health, breaks down the risks of overdiagnosis and overtreatment. Learn the pivotal questions to ask your doctor and understand when the contemporary "wait and see" strategy might be your best path forward.

Breast cancer is the second leading cause of cancer death for women in the United States (US) and the leading cause of cancer death for women in the state of Utah. One in eight women in the US will develop breast cancer in her lifetime. Mammography has been shown to reduce breast cancer mortality and thus is a critical screening tool that can increase the chance of early detection and treatment. This episode highlights a Utah Women & Leadership Project (UWLP) research snapshot that charts current Utah mammography rates and discusses mammography more generally. Dr. Susan Madsen, Founding Director of the UWLP, is joined by Dr. Sarah Colonna, a physician with the Center for Excellence in Women's Health, Huntsman Cancer Institute, and Marie Nagata, Program Manager for the Breast & Cervical Cancer Early Detection Program for the Utah Department of Health and Human Services.Support the show

Guy Roche has volunteered for many years organizing charity golf tournaments to raise crucial funds needed for cancer research at Huntsman Cancer Institute. This year's "Golf Classic" on July 10th in Provo will have an even greater impact as it's now part of "5 For the Fight", a crowdfunding charity created by Qualtrics to increase the number of scientists working in cancer research. In this episode of Utah Weekly Forum, FM100.3 Host Rebecca Cressman is joined by Qualtrics Head of Social Impact Lori Kuhn and Guy Roche who explain how an extraordinary golf tourney is making it possible for everyone to donate to help defeat cancer. For more information, visit 5forthefight.org.See omnystudio.com/listener for privacy information.

Utah has the highest rates of skin cancer in the nation according to QuoteWizard and the Huntsman Cancer Institute. Dr. Tammy Stump sheds light on factors that make Utahns more susceptible.See omnystudio.com/listener for privacy information.

Utah ranks third lowest in the nation for breast cancer screening.. among women 40 and older.  It's the leading cause of cancer death among Utah women. Doctor Phoebe Freer joins Jeff and details some factors that contribute to women in Utah not getting their mammograms.See omnystudio.com/listener for privacy information.

An essential act of well-being, the practice of storytelling creates a social connection that fosters a sense of community and mutual support in both the storyteller and listener. During the Second Annual ONS Storytelling session held at the 48th Annual ONS Congress® in April 2023, ONS members Sarah Lewis, MNE, RN, OCN®, palliative care nurse navigator at Oregon Health and Science University in Portland; Crystal Johnson, RN, BSN, OCN®, patient engagement liaison at Genmab who lives in Ohio; Susie Maloney, MS, APRN, AOCN®, AOCNS®, senior director of the Medical Affairs Company and principal of Oncology Nursing Advisors, LLC, in Dayton, OH; and Brenda Sandoval Tawakelevu, BSN, RN, OCN®, nursing professional development practitioner at the Huntsman Cancer Institute in Salt Lake City, UT, engaged in the practice of storytelling around the theme of renewal in the context of oncology nursing. In this episode, the four oncology nurses share their tales with hosts Anne Ireland, DNP, RN, AOCN®, CENP, and Jaime Weimer, MSN, RN, AGCNS-BC, AOCNS®, oncology clinical specialists at ONS. Music Credit: “Fireflies and Stardust” by Kevin MacLeod  Licensed under Creative Commons by Attribution 3.0  Earn 0.5 contact hours of nursing continuing professional development (NCPD) by listening to the full recording and completing an evaluation at myoutcomes.ons.org by April 28, 2025. The planners and faculty for this episode have no relevant financial relationships with ineligible companies to disclose. ONS is accredited as a provider of NCPD by the American Nurses Credentialing Center's Commission on Accreditation.  Learning outcome: The learner will report an increase in knowledge related to how nurses learn from one another through storytelling.  Episode Notes  Complete this evaluation for free NCPD.  Oncology Nursing Podcast episodes:  Episode 101: Why We Love Oncology  Episode 90: The Year of the Nurse  ONS Voice articles:  Behind Our Masks, I See You, I Hear You  Mrs. Jones Gave Me the ‘Ah-Ha' Moment That Guided My Entire Nursing Career  As Oncology Nurses, We Are the Fish  Connect With Your Patients on a Human Level as Well as a Healthcare Level  Our Patients Give Us Peace in Unexpected Circumstances  Beyond the Bedside: Oncology Nurses Have Endless Opportunities in Unexpected Careers  Nursing Representation Is Critical in All Industries—Even Those Outside of Health Care  Clinical Journal of Oncology Nursing article: How Can Nurses Stay Resilient and Engaged During a Long and Ever-Changing Career Path?  ONS books:  Continuing the Legacy: More Voices of Oncology Nurses  Reflections on COVID-19 and Cancer Care: Stories by Oncology Nurses  Reflections on COVID-19 and Cancer Care: Stories by Oncology Nurses (volume 2)  ONS Career Development Learning Library  To discuss the information in this episode with other oncology nurses, visit the ONS Communities.  To find resources for creating an ONS Podcast Club in your chapter or nursing community, visit the ONS Podcast Library.  To provide feedback or otherwise reach ONS about the podcast, email pubONSVoice@ons.org.  Highlights From Today's Episode  Sarah Lewis  “An opportunity presented in spring 2021 to join the outpatient palliative care team as a registered nurse and after much careful consideration, I decided to take the leap. It seemed like it was a good time for a change, it seemed like a ‘dream' position, and I knew I could always go back to bone marrow transplant if it didn't work out. I was surprised when so early after I switched positions my decision was affirmed, and my oncology nursing career reinvigorated.” Timestamp (TS) 04:06  “I learned early on in my oncology nursing career the power of education but will always appreciate the real-life lesson my patient taught me that day. It not only reinforced my decision to step into this brand-new role, but it also re-energized my practice and spirit to continue to perform this awesome work we oncology nurses have the privilege to do every day.” TS 06:32  Crystal Johnson  “Being an oncology nurse, you inevitably become an extension of your patient's family. Often, we are with our patients throughout every step of their oncologic journey: initial diagnosis, first chemo, symptom management, remission, relapse, progression and, ultimately end-of-life transition.” TS 07:24  “From the moment I cared for my first oncology patient, I knew I had found my calling, but being able to be a part of something and inspire others in a way that is able to reach far greater than the patients I've cared for throughout my career is the reason I continue to show up every single day. Trusting that what we do makes a difference, and we can continue to cultivate a culture of hope within a community that is forever linked together by an unimaginable bond that no one asked to share.” TS 10:44  Susie Maloney  “One thing I've learned when teaching in countries with different cultures is that it is important to respect the people and be educated on what their beliefs happen to be. It is not our job to ‘teach them our Western ways.' This can be a challenge, however, particularly when some beliefs or practices are not evidence based.” TS 12:28  “When working in impoverished countries, it is important to consider what is within their achievable means. We would not teach about the latest therapies that are used in the United States if there is no chance of patients having access to such therapies or medications.” TS 15:28  Brenda Sandoval Tawakelevu  “Although I have many fond memories or patients and families that I have loved and cared for, I wouldn't be truthful if I didn't tell you I've also had many doubts about oncology nursing during some of the very rough seasons of life that we all experience. I've been at the crossroads, and I have seen the two roads the poet Robert Frost has so beautifully written about. This hasn't occurred just once but many times through the years as I have experienced the highs and the lows of ‘this road less traveled' of oncology nursing.” TS 18:40  “Now, eight years have passed, and I keep going day by day in the wonderful field of oncology. The flames of passion continue to grow, and that passion has been shared with hundreds of students and nurses that have been in my path over the years. I invite each one of you to choose to connect, choose to find your own balance in the field of oncology nursing, choose to heal your own wounds life has left upon you, and most of all, continue to choose oncology nursing.” TS 26:26 

Season 5 Episode 18: This episode features conversations with recipients of the Utah Governor's Medal for Science and Technology. The three medal winners are Lora Gibbons (K-12 education), Dr. Julie Valentine, Ph.D., RN, SANE-A, FAAN (Academic/Research), and Dr. David Bearss (Industry). Listen as Pete Codella, managing director of business services at the Governor's Office of Economic Opportunity, interviews the award winners as they discuss their background, experience, and what it means to be recognized this year by Gov. Cox with the Governor's Science Medal. Gibbons informs listeners about how she became involved in STEM education in elementary schools and her experiences helping students assemble science fair projects. She also elaborates on how the gender gap in STEM has narrowed, how more women are earning degrees than men, and what receiving the 2023 Governor's Medal for Science and Technology in the K-12 education category means to her.  Next, Valentine tells listeners how her experience as a nurse and her groundbreaking research on sexual assault is influencing statewide improvements to address sexual violence and shares what changes she has seen in Utah due to her research. She also discusses how Utah compares to other states regarding sexual assault and what being recognized with Gov. Cox's Medal for Science and Technology in the academic and research category means to her. Bearss explains how he became involved in researching and developing new therapeutics that enhance lives and what area of his research has been most impactful. He also tells listeners what lessons he learned from participating in clinical studies, details his work with the Huntsman Cancer Institute, and shares what receiving the Governor's Medal for Science and Technology in the industry category means to him.  

Charlotte Bell has been practicing yoga since 1982, and began teaching in 1986. She has established and taught regular classes along Utah's Wasatch Front, and in California and Hawaii. She also teaches workshops, teacher trainings, and yoga for cancer patients and their families at Huntsman Cancer Institute in Salt Lake City. She has taught at national yoga conferences and international yoga teacher trainings and on women's river trips on the Green and Colorado rivers. Certified by B.K.S. Iyengar in 1989, she enjoys learning from teachers of many different yogic perspectives. Charlotte's asana teaching has been most influenced by her two guiding teachers, Donna Farhi and Judith Hanson Lasater. She received her 500-hour certification from Yoga Alliance in 2000, and is currently registered at the organization's highest level, E-RYT-500. Vipassana meditation practice has had the most profound influence on Charlotte's work. She began her practice in 1986, and has attended many 10-and 30-day meditation retreats since then. Her practice has been guided by her spiritual mentors, Pujari and Abhilasha Keays of the Last Resort in Cedar Breaks, Utah, since 1985. In recent years, she has made an annual trip to Spirit Rock Meditation Center in Woodacre, California, to sit an 18-day combined metta (kindness) and insight meditation retreat. Charlotte teaches mindfulness classes online, and at the Utah Museum of Fine Arts and Red Butte Garden. All these influences combine to form an evolving style of yoga that acknowledges the alignment principles of the Iyengar system while applying mindful attention to gain insight into the truth of each individual's asana practice rather than striving for preconceived goals. She encourages students to explore and trust their own experience in their asana practice, and enjoys learning new perspectives from her students. In addition to teaching yoga and meditation, Charlotte writes feature stories for several publications, including Catalyst Magazine, Yoga U Online and the Hugger Mugger Yoga blog. Her articles have appeared in Yoga Journal and Yoga International. She has written feature articles for the Telluride Bluegrass Festival's program since the early 1990s, and has participated in research and writing for a book about the festival's history. In 2007 Rodmell Press (now a part of Shambhala Publications) published her first book, Mindful Yoga, Mindful Life: A Guide for Everyday Practice.The book blends the principles of mindfulness with the practice of Patanjali's Eight Limbs of Yoga. Her second book, Yoga for Meditators, was published by Rodmell Press in 2012 and was one of 10 books recommended in Yoga Journal magazine's “Yoga Books of 2012” list. Her most recent book, Hip-Healthy Asana: A Yoga Practitioner's Guide to Protecting the Hips and Avoiding SI Joint Pain, was published in 2018 by Shambhala Publications. Charlotte plays oboe and English horn in the Salt Lake Symphony; the woodwind quintet, Scherzando Winds; the chamber folk ensemble, blue haiku; and with blue haiku, Kate MacLeod and Hal Cannon in the folk sextet, Red Rock Rondo. Red Rock Rondo's 2009 DVD has won two Emmy awards and an award from the National Educational Television Association.

This week we sit down with Alison Gulbis, PharmD, BCOP, Kamakshi Rao, PharmD, BCOP, FASHP, and Zahra Mahmoudjafari, PharmD, MBA, BCOP, FHOPA to discuss their work on the Oncology Workforce Collaborative. Alison is a Clinical Pharmacy Manager at the University of Texas MD Anderson Cancer Center in Houston, TX. She obtained her PharmD at the University of Florida and completed her PGY1 and PGY2 residencies at the Medical University of South Carolina. She has been in clinical practice for 19 years at MD Anderson and manages a team of clinical pharmacy specialists in pediatric hematology/oncology and adult stem cell transplant.Kamakshi is an Interim Director of Pharmacy at the University of North Carolina Medical Center in Chapel Hill. She oversees Adult Ambulatory and Acute Clinical Services as well as the hospital's academic enterprises, including resident and student training programs.  Additionally, she leads the department's growing efforts around diversity, equity, and inclusion. She spent 20 years in direct patient care, working with patients undergoing bone marrow transplants at the North Carolina Cancer Hospital before moving into her current role.Zahra is a Clinical Pharmacy Manager in the Division of Hematologic Malignancies and Cellular Therapeutics at the University of Kansas Health System (TUKHS). She earned her PharmD and MBA from the UMKC School of Pharmacy and the Henry W. Bloch School of Management. She completed residency training at The Ohio State University Medical Center and The Huntsman Cancer Institute at the University of Utah. She has been a board-certified oncology pharmacist since 2012. In 2022, she was the recipient of the ASTCT Pharmacy Special Interest Group Lifetime Achievement Award and ASCO's 40 Under 40 in Cancer award.You can read more here: https://accpjournals.onlinelibrary.wiley.com/doi/10.1002/jac5.1693

Whether you're in pain or you're stressed, music can help make a difference in how you feel. Let's Get Moving Host Maria Shilaos speaks with Heather Fellows, State-Certified Music Therapist from the Huntsman Cancer Institute, to learn how music therapy works and what music can do to heal our mind.See omnystudio.com/listener for privacy information.

Guest host Dr. Neeraj Agarwal and Dr. Christian Kollmannsberger discuss practice-changing abstracts that were presented at the 2023 ASCO Genitourinary Cancers Symposium, including results from the TALAPRO-2, PROpel, TRITON3, ARASENS, KEYNOTE-057, CheckMate 274, and CheckMate 9ER studies. TRANSCRIPT Dr. Neeraj Agarwal: Hello and welcome to the ASCO Daily News Podcast. I'm Dr. Neeraj Agarwal, the director of the Genitourinary Oncology Program, and professor of Medicine at the Huntsman Cancer Institute at the University of Utah, and editor-in-chief of the ASCO Daily News.  Today, we will be discussing practice-changing abstracts and other key advances in GU Oncology featured at the 2023 ASCO Genitourinary Cancers Symposium. Joining me for this discussion is Dr. Christian Kollmannsberger, the chair of this year's ASCO GU. Dr. Kollmannsberger is a GU medical oncologist at the BC Cancer Vancouver Cancer Center and a clinical professor at the University of British Columbia.  Our full disclosures are available in the transcript of this episode, and the disclosures of all guests on the podcast can be found on our transcripts at asco.org/DNpod.  Christian, thank you for joining us on the podcast today.  Dr. Christian Kollmannsberger: Thank you very much, Neeraj. It's a real pleasure to be here and have this discussion. Dr. Neeraj Agarwal: Thank you. So, Christian, the GU meeting featured remarkable progress in various GU malignancies. Could you please share some of the prominent topics that made the headlines this year and give us an overall feel of ASCO GU this year? Dr. Christian Kollmannsberger: Absolutely. I think it was a great meeting with over 5,800 attendees from more than 70 countries. And most of the attendees were in person, so it was a great event. ASCO GU is truly the premier global event to feature the very best of GU cancer research and treatment. The theme of this year's meeting was "Today's Science, Tomorrow's Treatment," and that was reflected in the novel scientific and clinical findings that were presented and will potentially lead to changes in our daily clinical practice. It also reminds us how quickly the development today is and how quickly novel scientific progress is immediately translated into clinical practice, particularly oncology.   I was very impressed by the meeting's emphasis on diversity, interactivity, networking, multidisciplinary collaboration, and evidence-based care. We introduced several new features such as a “Meet the Professor session, a women's networking event, etc. And the first day really kicked off with a very rich focus on prostate cancer and much attention given to PARP inhibitors in our first session. As an example, LBA 17 was the first late-breaking abstract presented. And congratulations to you, Neeraj, on delivering this exciting data on the TALAPRO-2 trial, which were eagerly awaited. Let's start with that. Can you tell us about this trial? Dr. Neeraj Agarwal: Yes, of course. So the TALAPRO-2 trial was a phase 3 randomized trial where patients in newly diagnosed metastatic CRPC settings were randomized to standard of care enzalutamide plus placebo versus enzalutamide plus talazoparib PARP inhibitor. And as we know, Christian, the rationale has been that dual inhibition of PARP and AR may enhance the efficacy of each. And there's a laboratory preclinical rationale and based on which other studies have been done in the past. So, without getting into too much detail into the rationale for the trial, I'll come right to the results of the trial. So, this was the first-line mCRPC setting where rPFS was the primary endpoint as assessed by the independent radiology assessment. And in this trial, patients were recruited regardless of the homologous recombination repair gene alterations. So, patients were recruited and they were prospectively tested for whether they had these HRR gene alterations or not, but all comer population was included in this trial. And after a median follow-up of approximately 23 months, the trial read out, and we found that trial made the primary endpoint was improved radiographic progression-free survival with the rPFS being about 22 months in the enzalutamide arm and not reached in the combination arm with a 37% reduction in risk of progression or death.  If you look at the subgroup analysis of patients who were HRR+, there was a 54% reduction risk of progression or death. If you look at patients who were stratified in HRR- or unknown group, there was a 30% reduction risk of progression or death. If you specifically look at an exploratory analysis we did to look for patients who were HRR- by prospective tumor tissue testing; there was a 34% reduction in risk of death with a hazard ratio of 0.66 favoring the combination arm. So overall, the rPFS primary endpoint was met in all groups. We also see significant delay in PSA progression in the combination arm by more than nine months. We also see delays in the time to cytotoxic chemotherapy. We saw delay in progression or death on subsequent neoplastic therapy after the protocol treatment. We saw delays in deterioration of quality of life and global health status. All these were significant and happened on the talazoparib plus enzalutamide arm.  So overall, if you look at the totality of the data, these all favored the combination of talazoparib plus enzalutamide compared to enzalutamide alone. I want to highlight that overall survival is immature at 31% maturity with a hazard issue of 0.89, currently favoring enzalutamide plus talazoparib. But we'll have to look at more mature data as time passes.  Dr. Christian Kollmannsberger: Wow. Thank you, Neeraj. So, it sounds like that was a very positive trial, and it's potentially practice-changing. One of the concerns is always safety and toxicity. So can you tell us whether there were any new safety signals, and can you tell us more about the common adverse events that were noticed in TALAPRO-2? Dr. Neeraj Agarwal: No discussion is complete without talking about safety results, so I'm glad you asked me, Christian. The most common dose-affecting toxicity, if you will - so toxicities which led to dose modification and dose discontinuation of talazoparib were cytopenias, as we expect from this class of agents. So anemia, neutropenia, thrombocytopenia, these were the common toxicities. In fact, rate with anemia was 46.5%. Neutropenia and cytopenia were much less common.  I would like to highlight one fact which also came up during the discussion section after our oral presentation. The qualifying criteria for entry in this trial was a hemoglobin of 9-gram percent. And 49% of patients had grade 1 to 2 anemia at baseline, that is before starting treatment with talazoparib. So, we knew that if you mandate dose reduction, a lot of patients will not get adequate dosing of talazoparib. So, we waited for grade 3 anemia and then instituted dose reduction. And that I thought personally was a good strategy because the grade 3 anemia happened after a median duration of three months, 3.3 months to be more precise. And then, these patients underwent protocol-mandated dose reduction, following which the dose discontinuations were quite low actually. Only 8.3% patients discontinued talazoparib because of anemia, and the median dose intensity or median relative dose intensity of talazoparib in the talazoparib arm remained quite high at more than 80%, which translates to a talazoparib dose of 0.4 milligram daily when the starting dose was 0.5 milligram. So those were the hallmark of toxicities.   I do like to mention that those grade 3, 4 toxicities which are more known to affect the quality of life of our patients, such as grade 3, 4 anorexia, fatigue, nausea and vomiting, they were quite rare, happening in 1 to 4% patients who were on talazoparib. So overall, regarding the side effects, they were manageable, there were no new safety signals, and we could maintain adequate talazoparib dosing with dose reduction, which happened quite early during the protocol treatment.  Dr. Christian Kollmannsberger: Thank you, Neeraj. Very impressive results indeed. The patient population included in TALAPRO-2 was very similar to those included in the PROpel phase 3 trial, which tested the combination of abiraterone and olaparib in the first-line mCRPC setting. So, I'd like to just mention that we also saw LBA16 on the PROpel study, which was the final overall survival in PROpel, which was presented by Noel Clarke. So PROpel, as you know, was a randomized phase 3 trial evaluating efficacy and safety of olaparib plus abiraterone versus placebo plus abiraterone as first-line therapy for mCRPC in the first-line metastatic castration resistance setting. The enrollment in that study was independent of known defects in the homologous recombination repair gene pathway in contrast to other studies, such as MAGNITUDE, which tested the biomarker upfront. A total of 796 patients were randomly assigned to either olaparib plus abiraterone or placebo plus abiraterone. And we saw similar results, significant radiographic progression-free survival with olaparib plus abiraterone in PROpel, which was the primary endpoint similar to TALAPRO-2, and that was published last year in the New England Journal of Medicine Evidence.  Now, this abstract presented here at ASCO GU reported on overall survival with an overall survival majority of 47.9% and showed that with the addition of the PARP inhibitor olaparib to abiraterone, a statistically non-significant but clinically meaningful improvement in overall survival of about seven months were achieved compared to standard of care in abiraterone alone. The numbers were 42.1 versus 34.7 months in the all-comers population of patients in the first-line mCRPC setting. Importantly, I think the median overall survival of more than 42 months really represents the longest reported median overall survival thus far in a phase III trial for first-line metastatic castration-resistant prostate cancer. Although the median overall survival for the non-HRR group remains not statistically significant, with a hazard ratio of 0.89. Dr. Neeraj Agarwal: Such a great synopsis of the PROpel result data. Thank you, Christian, for highlighting these results. As we know, the combination is already approved by the EMA, the European Medical Agency, for patients in the first-line mCRPC setting who are not candidates for docetaxel chemotherapy. If this combination is approved by the FDA, we may have one more therapeutic option for our patients in first-line mCRPC.  So, just continuing on the PARP inhibitors, there was one more oral presentation with PARP inhibitor rucaparib by Dr. Alan Bryce from the Mayo Clinic, Arizona. This was Abstract 18 on the primary result of the TRITON3 trial. So to complete our PARP inhibitor section, I would like to summarize the result of the TRITON3 trial, which was a randomized phase III trial evaluating rucaparib versus physician choice, which notably included docetaxel in addition to abiraterone or enzalutamide in patients with chemotherapy-naive mCRPC with BRCA1, BRCA2 or ATM alterations. These patients had disease progression after having one novel hormonal therapy, or we call them second-generation androgen pathway inhibitors in any setting. So these patients had to have disease progression on a novel hormonal therapy.   In the BRCA subgroup and the subsequent intention to treat the population, the primary endpoint tested first was radiographic progression-free survival, and overall survival was the key secondary endpoint. The subgroup of patients with BRCA-altered disease had a median rPFS of 11.2 months with rucaparib compared to 6.4 months with physician choice of treatment - looks like almost doubling of the rPFS with the rucaparib. In the overall ITT population, median rPFS was 10.2 months with rucaparib and 6.4 months with the physician's choice of treatment. Although the overall survival data are immature, we still see a trend for improved overall survival with rucaparib. Regardless, the study clearly demonstrates the value of rucaparib for treating BRCA1 and BRCA2-altered mCRPC after disease progression on an androgen receptor pathway inhibitor. So these were the impressive results from the TRITON3 trial.  But before we switch to non-prostate abstract, I would like to complete the prostate cancer discussion by talking about the Abstract 15, which was based on the results of the ARASENS trial presented by Dr. Maha Hussain. As we know, ARASENS is a randomized phase 3 trial evaluating the efficacy and safety of darolutamide plus androgen deprivation therapy plus docetaxel versus androgen deprivation therapy or ADT plus docetaxel. So the triplet of ADT plus darolutamide plus docetaxel being compared to ADT plus docetaxel chemotherapy in patients with newly diagnosed metastatic castration-sensitive prostate cancer. A total of 1,300 patients were randomly assigned to the doublet versus triplet. As presented in the last ASCO GU meeting exactly one year ago, the primary endpoint of the study was met with a significant improvement in overall survival and a 32% reduction in risk of death for patients on the triplet therapy with ADT plus docetaxel plus darolutamide versus ADT plus docetaxel chemotherapy. So triplet therapy was already approved based on these data.  The abstract presented by Dr. Hussain this year is a post-talk analysis where Dr. Hussain and colleagues investigated the impact of triplet therapy across patients with high volume versus low volume per chartered criteria and higher risk versus low risk using latitude trial criteria. And investigators knew that these results would be highly attractive to practicing oncologists who are now choosing treatment based on volume of disease or risk of disease, more commonly, volume of disease.  So, let's come to what was presented this ASCO GU. So, after 1,305 patients in ARASENS, the majority had high-volume disease and high-risk disease. Among patients with high-volume disease, the addition of darolutamide reduced the risk of death by 30% compared with ADT and docetaxel, with a hazard ratio of 0.69. In the risk groups, the addition of darolutamide seems to favor both high-risk and low-risk groups. Among patients with low-volume disease, there was a trend towards improvement in overall survival with the addition of darolutamide, but it did not reach statistical significance. The great news was that there was no new safety signal. So, to summarize these data, the triplet of darolutamide plus ADT plus docetaxel showed superior overall survival compared to doublet of ADT plus docetaxel, with an important caveat that triplet was not compared with any of the modern doublets of ADT plus a second generation androgen receptor pathways inhibitor such as abiraterone, apalutamide, or enzalutamide, or even darolutamide. So, I wish there was a third arm of ADT plus darolutamide.  Having said that, triplet can be considered a standard of care now based on these data for patients with metastatic hormone sensory prostate cancer, where we would be using ADT plus docetaxel chemotherapy. And from this meeting data, this efficacy of triplet can be applied to high-volume disease and all risk disease. And we just need more time to see how the data pans out in low-volume patients with metastatic hormone-sensitive prostate cancer.  Dr. Christian Kollmannsberger: Yes, I completely agree, Neeraj. I think all the data presented in these abstracts are really impressive and will impact our daily clinical practice and our patients more or less immediately. I think the use of PARP inhibitors, whether as a monotherapy or in combination with androgen receptor pathway inhibitors, as well as now the option of triplet therapy in the metastatic castration sensitive setting really offer patients with metastatic prostate cancer new treatment strategies and most importantly, improved survival outcomes. And it is impressive to see how we have pushed the prognosis and the outcomes for our patients with prostate cancer, I would say, in the last five to ten years. And similar to last year, I think the entire Prostate Cancer Day at ASCO GU 2023 was full with impressive data and featured dynamic content throughout the day. Dr. Neeraj Agarwal: Indeed. So, let's move on to bladder cancer. Christian, what are your key takeaways from the bladder cancer studies presented at the meeting? Dr. Christian Kollmannsberger: I think there were interesting abstracts in both the non-muscle-invasive and the muscle-invasive setting and the metastatic setting. So, for example, Abstract 442 was presented by Dr. Andrea Necchi on the cohort B of the phase 2 KEYNOTE-057 trial. As a background here, the standard treatment for high-risk non-muscle-invasive bladder cancer involves transurethral resection of the bladder tumor, a TURBT, followed by intravesical BCG therapy to eradicate any residual disease. And patients who fail to adequately respond to BCG are usually recommended to undergo radical cystectomy. So in the cohort B of the phase 2  KEYNOTE-057 trial that investigated the safety and efficacy of pembrolizumab as a single agent for patients with BCG-unresponsive, high-risk non-muscle-invasive bladder cancer who were ineligible or declined to undergo radical cystectomy, enrolled patients received standard-dose pembrolizumab of 200 milligrams every three weeks for up to 35 cycles. So very common as we do it with other disease sites. And at a median follow-up of 45.4 months, the primary endpoints of disease-free survival at twelve months was 43.5%. The median disease-free survival duration was 7.7 months. These are encouraging results, and we should keep in mind that a radical cystectomy has immense impact on our patients' quality of life. So I think it is important that we do these trials.  Now in order to address potential biases in this phase II trial, such as the underlying heterogeneity of transurethral resection of bladder tumor quality, and to obtain a more comprehensive understanding of pembrolizumab's efficacy relative to a particular control group, we need further evaluation of pembrolizumab in a randomized trial before we can really go for regulatory approval. But overall, I think for the first time in a long time that we seem to be able to move the needle in non-muscle-invasive bladder cancer. Dr. Neeraj Agarwal: Thank you, Christian, for this great overview. Could you please also share the findings presented by Dr. Matt Galsky on Abstract 443? Dr. Christian Kollmannsberger: Of course, Neeraj. Abstract 443, presented by Matt Galsky, reported the extended follow-up results from the CheckMate 274 trial, which looked at another very important field where we haven't made that much progress, which is the adjuvant setting. And CheckMate 274 examined adjuvant nivolumab compared to placebo for patients with high-risk resected muscle-invasive urothelial carcinoma. In this trial, nivolumab was given at 240 milligrams every two weeks or placebo every two weeks for up to one year of treatment. After following up with patients for a median of 36.1 months, the study found that those who received nivolumab had a median DFS of 22 months compared to only 10.9 months for those who received placebo among the ITT patients. So basically, a doubling of the DFS with the addition of adjuvant nivolumab.  The results were particularly notable for patients with high PD-L1 expressions or PD-L1 expression of 1% or more, as those who are treated with nivolumab had a median DFS of 52.6 months, which was six times higher than the DFS in the control group where patients received placebo, which was only 8.4 months. And I think that is truly impressive. One year of adjuvant therapy with nivolumab continues to show a sustained disease-free survival benefit over a period of three years in both the ITT and the PD-L1-high patient population. In my view, these results reinforce the utility of nivolumab in the adjuvant urothelial carcinoma setting after surgery. And it will be interesting to see how the overall survival pans out in this study.  So, Neeraj, moving on to kidney cancer, what were your key takeaways from these studies on kidney cancer presented in this meeting?  Dr. Neeraj Agarwal: So, there were exciting results presented from multiple studies in this area as well. For example, Abstract 603 presented by Dr. Mauricio Burotto, senior author was, Dr. Toni Choueiri on the three-year follow-up from the phase 2 CheckMate-9ER trial. So, in this trial, patients were randomized one-to-one to nivolumab 240 milligrams every two weeks, plus cabozantinib 40 milligrams daily versus sunitinib 50 milligrams daily for four weeks, and it was a six-week cycle for sunitinib until disease progression or unacceptable toxicity. So this was the design of the phase 3 CheckMate-9ER trial. And after a median follow-up of three years, the benefit of nivolumab plus cabozantinib remained consistent with previous follow-ups. So, as we know, these data have been presented in the past, also published in the New England Journal of Medicine. But this meeting was a clear follow-up of these data.  Notably, the median overall survival of patients treated with cabozantinib plus nivolumab in the ITT population, which included all favorable intermediate and poor IMDC score patients, was significantly improved at 49.5 months compared to 35.5 months in the sunitinib arm. It is so heartening to see that median overall survival breaching the four-year mark in our patients with metastatic RCC in a consistent fashion. We saw similar data with the combination of ipilimumab plus nivolumab recently. And as these trials are maturing, we are probably going to see more combinations breaching this four-year mark. So importantly, no new safety signals emerged with the additional follow-up in either arm. And I think these results provide further support for the use of cabozantinib plus nivolumab as a first-line treatment option for patients with metastatic or advanced renal cell carcinoma. Dr. Christian Kollmannsberger: Indeed, I think it is extremely impressive what we've seen over the last 15 years in metastatic kidney cancer, going from a median overall survival of about a year to now more than four years. I think that is a great achievement, and we can see it on a daily basis in our clinical practice.  Now, before we wrap up, I would like to highlight another potentially practice-changing trial, LBA602, which titled, “Results from Phase 3 Study of 89Zr-DFO-Girentuximab for PET/CT Imaging of Clear Cell Renal Cell Carcinoma: The ZIRCON Trial” presented by Dr. Brian Shuch. The background of this is that the detection of renal masses poses a challenge due to the limitations of diagnostic options such as imaging and biopsy. And we often, in clinical practice, are confronted with "What exactly is this?" And what's even more importantly, “What's the histology of this?” And a non-invasive, accurate method is needed for pre-treatment risk stratification. Girentuximab, a monoclonal antibody that targets carbonic anhydrase IX expressed on clear cell renal cell carcinoma, can obviously now aid in the differentiation between clear cell renal cell carcinomas and other renal lesions when radiolabeled with this new agent.  The ZIRCON trial was open-label and designed to include patients with renal masses up to 7 cm in size or clear tumor stage cT1 who were scheduled for partial nephrectomy within 90 days of planned TLX250-CDx administration. The enrolled patients received a single intravenous dose of girentuximab on day 0 and underwent FDG PET/CT imaging on day 5 before their scheduled surgery. And the co-primary endpoints were to assess the sensitivity and specificity of girentuximab PET/CT imaging for detecting clear cell renal cell carcinoma in patients with indeterminate renal masses, with histology as the reference standard, which I think is a great way to test these agents because you get 100% validation.  In the primary analysis of 284 patients, the average sensitivity and specificity across all three central readers were 86% and 87%, respectively, exceeding the prespecified thresholds. The positive and negative predictive values were 93.4% and 78%, respectively. And with very few related adverse events reported, the study affirms that girentuximab PET/CT is safe and effective in identifying clear cell renal cell carcinoma in patients with indeterminate renal masses. And the findings hold potential for developing optimal management strategies for patients with indeterminate renal masses. I think this is important that we add a non-invasive method to this because we are confronted on a regular basis with patients who either cannot tolerate a biopsy or where the biopsy is indeterminate. And this could potentially be a great tool to help us with our pre-treatment planning of our treatment strategy. Dr. Neeraj Agarwal: Wow. So, it looks like a new PET scan using a unique tracer and antibody to detect the clear cell renal cell carcinoma with high specificity and sensitivity. It reminds me of drawing a crude analogy from the PSMA PET scan in prostate cancer. And hopefully, we will be able to use these newer scans that we call TLX250-CDx PET/CT scan. I hope they have a simpler name for this very soon. Or maybe follow up for patients who had kidney cancer, localized kidney cancer taken out by radical surgery, and then we are following them. And sometimes, we don't know if a small lung nodule is metastatic or not. And these kinds of imaging studies may help us down the line in monitoring those patients as well. So indeed, very exciting progress not only in the therapeutic area now but also in diagnostic fields at this GU ASCO.   So with that, we have seen multiple abstracts on prostate, bladder, and kidney cancer with real impact on how we practice medicine. Thank you, Christian, for sharing your insight with us today. It is an exciting time in GU Oncology, and we appreciate you taking the time to contribute to the discussion. Thank you so much.   Dr. Christian Kollmannsberger: Thank you, Neeraj, thank you for having me. And I completely agree it remains an exciting time in GU oncology.   Dr. Neeraj Agarwal: And thank you to our listeners for joining us today. You will find links to the abstracts discussed today on the transcripts of this episode.  Finally, if you value the insights that you hear on the ASCO Daily News Podcast, please take a moment to rate, review, and subscribe wherever you get your podcasts.   Disclaimer: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement.   Find out more about today's speakers:   Dr. Neeraj Agarwal  @neerajaiims Dr. Christian Kollmannsberger Follow ASCO on social media:    @ASCO on Twitter    ASCO on Facebook    ASCO on LinkedIn    Disclosures:   Dr. Neeraj Agarwal:    Consulting or Advisory Role: Pfizer, Bristol-Myers Squibb, AstraZeneca, Nektar, Lilly, Bayer, Pharmacyclics, Foundation Medicine, Astellas Pharma, Lilly, Exelixis, AstraZeneca, Pfizer, Merck, Novartis, Eisai, Seattle Genetics, EMD Serono, Janssen Oncology, AVEO, Calithera Biosciences, MEI Pharma, Genentech, Astellas Pharma, Foundation Medicine, and Gilead Sciences   Research Funding (Institution): Bayer, Bristol-Myers Squibb, Takeda, Pfizer, Exelixis, Amgen, AstraZeneca, Calithera Biosciences, Celldex, Eisai, Genentech, Immunomedics, Janssen, Merck, Lilly, Nektar, ORIC Pharmaceuticals, crispr therapeutics, Arvinas   Dr. Christian Kollmannsberger: None disclosed  

Discussing the management using the algorithm of Prostate Cancer – with Dr. Neeraj Agarwal, Director of Genitourinary Oncology Program - Professor of Medicine at Huntsman Cancer Institute at University of Utah. Website: http://www.oncbrothers.com/ Twitter: https://twitter.com/oncbrothers Contact us at info@oncbrothers.com

Guys, if you're 45 or older, are you putting off that colonoscopy? You're not alone, but it really is important. The Who Cares guys discuss their own experience and hesitations with the procedure. Nathaniel Ferre, a community health educator at Huntsman Cancer Institute joins to discuss the top reasons why men don't get colonoscopies and the potential risks of not getting one. Learn more about how you can prevent the second most deadly cancer in men and why a colonoscopy may not be as bad as you think.

Brandon Howard is now the Chief Operating Officer for MotosAmerica Motos America where he combines his love for motorcycles and people. Brandon serves with me on the Board of Trustees for Davis Technical College, Kaysville, Utah.  Brandon Howard Joins Motos America as Chief Operating Officer – Motos America Brandon Howard Graduated with honors from Western Culinary Institute (Le Cordon Blue), Portland, OR. 1992. Brandon competed in the 1992 World Culinary Olympics, Frankfurt Germany with the US Oregon Culinary Team (Silver Medal). Along with over 25 years of business development he has led the culinary development and successful operational development for several prominent Utah restaurant locations including, Jake's, Market Street Grill and Oyster Bar, Park City Mountain Resort, Panini, The Point (Huntsman Cancer Institute), La Caille (AAA Four Diamond Award), Snowbird Ski Resort and most recently at Wingers. During Brandon's 28-year career he has had the opportunity to work with globally acclaimed Culinary Leaders. Alice Waters (Chez Panisse), John Ash (Fetzer Wine/ Coyote Grill), and Master Chef Keith Keogh (Disney) to name a few. Brandon has been awarded several local and national awards including the coveted Silver Plate Award (Chaîne des Rôtisseurs) and is featured in “The Best Chefs of America” since 2013. In addition to the above-mentioned achievements, Brandon has had the honor of hosting several premiere culinary events for prominent world leaders and mainstream celebrities. British Prime Minister Margret Thatcher, Vice President Dick Cheney, Davis Love III, Steve Young, Clarence Tomas, and Gordon B. Hinckley among many more. Brandon supports several social and nonprofit organizations through ongoing service. Huntsman Cancer Institute, Juvenile Diabetes Research Foundation, Pro Start, and Red Barn Farm. (Red Barn Farm is a therapeutic community for substance abusers and behavioral change).

Intro: Dr. Thomas Varghese Jr. is the Associate Chief Medical Quality Officer and Chief Value Officer at the Huntsman Cancer Institute, and Chief of General Thoracic Surgery at the University of Utah. Dr. Varghese is a national leader in minimally invasive applications for general thoracic surgery, recognized by Castle Connolly as one of America's “Top Docs”, and is ranked in the top 10% of the nation by Press Ganey for patient satisfaction scores. His research interests bridge the world of Educational Research and Health Services Research, specifically in the arena of optimizing performance at the patient, surgeon and system levels. He created the Strong for Surgery program, which is now a formal Quality Improvement program of the American College of Surgeons, and active at 331 clinical sites across the nation and 3 state surgical collaboratives.Dr. Varghese holds national leadership positions in the Society of Thoracic Surgeons, Thoracic Surgery Directors Association, American College of Surgeons, and the Society of University Surgeons. Dr. Varghese is active on social media and is the Deputy Editor of Digital Media and Digital Scholarship for the Annals of Thoracic Surgery.Questions We Asked: Where did your passion for leadership come from? Who were your mentors and what made that relationship special? Have you found your mentors formally or informally? How can you create a good formalized mentorship program? How do mentors effectively help their mentees find their career path? How do you create a good mentor/mentee relationship? How can those in the majority be allies to minority groups in medicine and science? How do you be comfortable saying “I don't know”? Quotes & Ideas: “Never stop looking for best practices” You can and should have different mentors for the various areas of your life (academic, career, social, spiritual, etc.) “Mentorship is someone with a particular knowledge or skills that shares them with someone else who does not have it on their own.” “A mentor does not always have to be older than you.” Identify OKR (objectives and key results) and set a time deadline for it “An ally is someone who builds a culture of inclusion” and “A leader is someone who betters the culture of those they lead”. Leaders need to be allies. “Are we better today than we were yesterday, and are we going to be better tomorrow than we were today and how do we achieve that.” “Diversity doesn't end because you hire the next diverse faculty. You have to make sure they thrive in their position.” “You don't know, doesn't necessarily mean you don't act.” “MD means make decisions.” “We are living in the greatest time in history.” “Seek your tribe members” Books Suggestions: The 4 Disciplines of Execution by Sean Covey Peter Drucker Start With Why by Simon Sinek Adam Grant 

We are heading into triple digits this weekend, and it is reported that more than 1 out of every 3 Americans reports getting sunburned each year. Today as we dive into our Be Ready Utah coverage, we are talking  how to prepare for extreme sun exposure to reduce your risk of skin damage.  that if you get caught during it.  Doug Grossman, MD, PhD, co-leader of the melanoma center at Huntsman Cancer Institute and professor in the department of dermatology at the University of Utah. See omnystudio.com/listener for privacy information.

In this lively debate pertaining to all things multiple myeloma, Chadi hosts three guests with varying positions and viewpoints: Vincent Rajkumar, MD, Mayo Clinic; Manni Mohyuddin, MD, Huntsman Cancer Institute; and Cindy Chmielewski (@myelomateacher), patient research advocate. The group discuss the burning unanswered questions in multiple myeloma research and treatment – including problems related to clinical trial funding and design, control arms and “bad” trials, global disparities and drug access, standard-of-care changes during the course of a trial, and many more intricate dilemmas impacting the multiple myeloma world today. Check out Chadi's website for all Healthcare Unfiltered episodes and other content. www.chadinabhan.com/ Watch all Healthcare Unfiltered episodes on Youtube. www.youtube.com/channel/UCjiJPTpIJdIiukcq0UaMFsA

Hey. How are you? How's your mental health? Yes, really.In this month's episode, I invited my mental health neighbor and forever dance partner in science, Krystle Osby. We talk about our mental health journeys so far as it pertains to our graduate school career. So for you academics out there, maybe there is something that we say that you relate to. I then introduce her Johnny Mathis' "When Sunny Gives Blue" as we discuss how doctors would identify and diagnose depression in the 1950s and onward as protocols were updated. More info on Krystle belowKrystle Osby is a PhD graduate student studying mutations in endometrial cancer at Huntsman Cancer Institute and University of Utah. She has a B.S. in Biotechnology from Cal State San Marcos, and experience working as a biochemist post-bacc. She is passionate about science communication and increasing patient access to knowledge and health resources, with an emphasis on historically minoritized and at-risk communities.Follow her!Intagram @k_raqTwitter: @KrystleographySong of the Sound: Present by KhalidFollow Us.Instagram: @scientificallysoundTikTok: @scientificallysoundemail: 4thescientificallysound@gmail.com

Dr. Neeraj Agarwal, of the University of Utah Huntsman Cancer Institute, tells host Dr. John Sweetenham, of the UT Southwestern Harold C. Simmons Comprehensive Cancer Center, about the first study to examine the quality of diagnosis and treatment of breast cancer in sex and gender minority patients and other key studies on disparities associated with access to clinical trials and rising drug costs.  Transcript Dr. John Sweetenham: Hello, I'm John Sweetenham, the associate director for Clinical Affairs at UT Southwestern Harold C. Simmons Comprehensive Cancer Center and host of the ASCO Daily News podcast.  I'm delighted to welcome my friend and colleague Dr. Neeraj Agarwal, the director of the Genitourinary Cancers Program and a professor of medicine at the University of Utah's Huntsman Cancer Institute. Dr. Agarwal also serves as editor-in-chief of the ASCO Daily News.  Today, he'll be sharing his insights on compelling studies that will be featured at the 2022 ASCO Annual Meeting, addressing access to clinical trials, disparities associated with high deductible health plans, rising drug costs, and more.  Our full disclosures are available in the show notes and disclosures of all guests on the podcast can be found on our transcripts at asco.org/podcasts.  Neeraj, it's great to have you back on the podcast.  Dr. Neeraj Agarwal: Thanks, John.  Dr. John Sweetenham: Neeraj, let's begin with Abstract 6503. This study looks at the impacts of high deductible health plans on delays in metastatic cancer diagnosis. What do you think about this study and why should it be on our radar?  Dr. Neeraj Agarwal: Well, John, in high deductible health plans, patients are liable for the cost of all cancer-related care, with the exception of screening tests, until their annual deductible is met. Due to increased out-of-pocket costs, patients may postpone seeing a physician for concerning symptoms or diagnostic testing, leading to delayed diagnosis.  So, in this study, Mr. Nicholas Trad and J. Frank Wharam assessed the impact of high deductible health plans on the timing of metastatic cancer detection.  The authors leveraged a nationally representative cohort of more than 340,000 privately insured members whose employers mandated a switch from a low deductible of less than $500 plan to a high deductible plan of more than $1,000.  So, the group consisted of more than 1 million individuals in a contemporary time frame, whose employers offered only low deductible plans. Participants were matched based on multiple baseline characteristics, time to metastatic cancer diagnosis, and the before and after switching to high deductible health plans was investigated using a weighted Cox proportional-hazards model.  After matching, there were no systematic differences between the 2 groups with regards to baseline characteristics, and there were no differences in time to metastatic cancer diagnosis prior to the switch to high deductible health plans.  However, after the employer-mandated switch to the high deductible health plans, these participants had lower odds of metastatic cancer diagnosis, which was significant, statistically speaking, and indicates delayed detection of metastatic cancer diagnosis relative to the control group.  Dr. John Sweetenham: This is certainly concerning data, Neeraj. What's your key takeaway from this study?  Dr. Neeraj Agarwal: So, the key takeaway from the study is that compared with conventional health plans, high deductible health plans are associated with delayed detection of metastatic cancer, implying that patients postpone seeking care for concerning symptoms or even defer diagnostic testing when they're exposed to high-cost sharing.  Dr. John Sweetenham: Thanks, Neeraj. So, let's continue with this theme of the financial burden of cancer care for our patients. Of course, we're all aware of the rising costs of targeted oral therapies, and this was addressed in Abstract 6504, where the study looks at the rising costs of targeted oral treatments among Medicare beneficiaries. And the study reported a substantial increase in the total cost and out-of-pocket costs of these medicines. Can you tell us more about this abstract?  Dr. Neeraj Agarwal: Yes! So, due to the rapidly rising cost of targeted oral anticancer medicines, Drs. Meng Li and Ya-Chen T. Shih examined recent trends and the financial burden of these oral medicines among patients with cancer with Medicare Part D insurance. So, eligible patients in the SEER-Medicare database had to be 65 years and older and had to have one primary cancer diagnosis.  The investigators estimated the trends in the share of patients who used targeted oral anticancer medicines, the percentage of users reaching catastrophic coverage, and the total and patient out-of-pocket spending on these medicines in the catastrophic phase in a year.  So, from 2011 to 2016, the uptake of these oral anti-cancer medicines increased from approximately 4% to 9%. The percentage of those who reached catastrophic coverage increased from 55% to 60%.  Among those who reached the catastrophic phase, the mean total annual gross spending on oral anti-cancer medicine increased 4-fold from approximately $16,000 to $64,000. And the mean out-of-pocket spending for the patients rose from approximately $600 to $2600.  Dr. John Sweetenham: Yes, this is more evidence that the financial toxicity generated from an increase in spending and out-of-pocket costs is going to have serious impacts on our patients. Would you agree with that, Neeraj?  Dr. Neeraj Agarwal: Yes, John. The key takeaway from this study is that the financial burden of these oral anti-cancer medicines continues to increase. In the relatively short period of time, we see here, 5 years from 2011 to 2016, there was a 4-fold increase in the total cost and out-of-pocket cost of these medicines. And in my view, these findings warrant immediate actions to rein in drug prices and cap out-of-pocket spending for our patients.  Dr. John Sweetenham: Absolutely. It's very difficult to know where this will end unless we see some kind of slowdown in these rising costs. I'm going to change gears just a little bit now to address the access to clinical trials, which is the subject of Abstract 6505.  This study looks at the implementation of the Affordable Care Act Medicaid expansion, which was associated with an almost threefold increase in the proportion of patients using Medicaid in cancer clinical trials by early 2020. What are your thoughts on this study?  Dr. Neeraj Agarwal: As you said, the Affordable Care Act Medicaid expansion resulted in increased use of this platform across the nation. However, its impact on access to clinical trials has not been examined.  So, in this study, Dr. Joseph Unger and Dr. Dawn Hershman examined the number and proportion of patients insured by Medicaid at enrollment over time using data from the SWOG Cancer Research Network.  In addition, they also examined all patients, 18 to 64 years old, enrolled in treatment trials between 1992 to 2020 using Medicaid versus private insurance.  So, the implementation of the Affordable Care Act Medicaid expansion was associated with a nearly threefold increase from 7% to 21% in the proportion of patients using Medicaid in cancer clinical trials by early 2020.  The increase per year of Medicaid uses for patients in these treatment trials from states that implemented the Affordable Care Act Medicaid expansion was 27% compared to 7% for patients from other states who did not implement this platform of Affordable Care Act Medicaid expansion.  So, the key takeaway from the study is that better access to clinical trials for more vulnerable patients is critical to improving confidence in how generalizable these trial findings are. In addition, these results suggest that the recently enacted Cancer Treatment Act may continue to improve access to clinical trials for those with Medicaid insurance or those who are vulnerable patients.  Dr. John Sweetenham: Yes, I think this is a really important study which adds to the growing literature on the benefits of the Affordable Care Act and Medicaid expansion on cancer care in general, in this case, specifically related to clinical trials. So, so important, I think.  On that theme of equity, I think the next 2 abstracts we're going to discuss address specific aspects of equity, which I think are both interesting and really important. So, Abstract 6510 has interesting research which conveys an urgent need to ensure equitable patient-reported access and implementation and to address the greater reported symptom burden among minority patients. Why do you think this study is important?  Dr. Neeraj Agarwal: The routine collection of patient-reported outcomes for patients with cancer is an evidence-based practice and a critical component of high-quality cancer care, but the real-world adherence and reporting patterns are poorly understood.  In this study, Dr. Samuel Takvorian and Dr. Ravi Parikh examined differences in adherence to the collection of patient-reported outcomes and reported symptoms by race and ethnicity.  This was a retrospective cross-sectional study using de-identified electronic health record data from an National Cancer Institute (NCI)-designated Comprehensive Cancer Center. The participants included adults seen in follow-up at 1 of the 2 medical oncology practices—one was in academics and one was in the community—from June 2019 to February 2020. Using ordinary least-squares regression, the authors modeled patient adherence as a function of race or ethnicity, and this was adjusted for age, sex, insurance, median area income, ECOG, performance status, and many other patient-related characteristics.  The results show that adjusted mean PRO adherence and reported symptoms varied by race and ethnicity, with Black and Hispanic patients being less likely to complete PRO questionnaires, but reporting significantly higher symptom burden compared to the White patients.  Dr. John Sweetenham: Right. So, it seems that more work is needed to ensure equitable access and adherence to PRO questionnaires so we can better address the symptom burden of our minority patients.  Dr. Neeraj Agarwal: Correct, John. In this large cohort reflecting real-world PRO collection patterns, Black and Hispanic patients were less likely than White patients to complete these PRO questionnaires, but more likely to report more severe symptoms. And I think there is an urgent need to ensure equitable PRO access and implementation and to address the greater reported symptom burden among minority patients.  Dr. John Sweetenham: Let's continue the theme of health equity and cancer care equity into the use of telemedicine. Of course, we saw a massive expansion of telemedicine for patients with cancer during the COVID-19 pandemic.  But studies are emerging now to show that there have been substantial disparities among the Black, uninsured, non-urban, and less affluent patients who are less likely to use telemedicine services.  Abstract 6511 reminds us that telemedicine may expand access to specialty care, but the proliferation of these services may widen cancer care disparities if vulnerable populations don't have equitable access. Can you tell us more about this abstract?  Dr. Neeraj Agarwal: These are indeed very interesting findings, John. The COVID-19 pandemic was associated with declines in in-person clinical visits, with a concurrent increase in the use of telemedicine.  In this study, Dr. Gregory S. Calip assessed demographic and socioeconomic factors associated with telemedicine use among patients initiating treatment for 21 common cancers at community oncology clinics.  This was a retrospective study and made use of the nationwide Flatiron electronic health record derived de-identified database of patients with cancer. The authors focused on differences in telemedicine use across race and ethnicity, insurance coverage, rural versus urban areas, and socioeconomic status.  They used logistic regression models for this analysis, which was adjusted for clinical characteristics to examine differences in telemedicine use among these different cohorts.  Results indicate Black patients were significantly less likely to use telemedicine services compared to White patients. Telemedicine use was also significantly lower among patients without documented insurance than well-insured patients. It was also lower in patients from rural and suburban areas versus patients who were living in urban areas. Lastly, telemedicine use was significantly lower in patients in the least affluent areas than those in the most affluent areas.  So, during the COVID-19 pandemic, nearly one-fifth of patients initiating cancer treatment using telemedicine services—among these patients, we see substantial disparities. So, Black, uninsured, non-urban, and less affluent patients were less likely to use telemedicine services.  So, the take home message from this study is that while telemedicine may expand access to care, the proliferation of these services may actually widen cancer care disparities if vulnerable populations do not have equitable access to these services.  Dr. John Sweetenham: Thanks, Neeraj. So, the final study that we'll discuss today also looks at another aspect of disparities, and that's Abstract 6517. It's a case-controlled study of health care disparities in sex and gender minority patients with breast cancer. What are the key takeaways from this study?  Dr. Neeraj Agarwal: Disparities and the quality of diagnosis and treatment of breast cancer in sex and gender minority populations are largely undefined. Only 24% of studies funded by the National Cancer Institute capture data on sexual orientation and only 10% capture data on gender identity.  In this case-control study, Drs. Eric Eckhert and Allison W. Kurian matched sex and gender minority patients with breast cancer to cisgender heterosexual controls in the Stanford University health care database. Ninety-two sex and gender minority patients were identified who were then matched by year of diagnosis, age, stage of cancer, presence of estrogen receptor (ER), and HER-2/neu receptor status to cisgender heterosexual controls within this database.  Additional data on demographics, diagnosis, treatment, and relapse were then manually abstracted from the electronic health care records. The sex and gender minority cohort were comprised of 80% lesbians, 13% bisexuals, and 6% transgender men.  One of the most pertinent findings was a significant, almost twice as much delay in time to diagnosis from the onset of symptoms in these minority patients versus control. Although there was no difference in the receipt of surgery or surgical radiation or new adjuvant therapy, sex, and gender minority patients were significantly less likely to undergo chest reconstruction surgery, and if they were estrogen receptor-positive, they were significantly less likely to complete at least 5 years of ER directed therapy.  Please also note that sex and gender minority patients used more alternative medicine, had a higher rate of documented refusal of recommended oncology treatments, and they experienced a higher recurrence rate.  So, the key takeaway from this study is that—this is the first study, I really want to congratulate the investigators who examined the quality of diagnosis and treatment of breast cancer in sex and gender minority patients. Several novel potential health care disparities are identified in these patients, which should be further evaluated in population-based studies to inform further interventions.  Dr. John Sweetenham: Neeraj, it's always a pleasure to talk with you and have an opportunity to spend some time with you. Thanks very much for sharing your insights on these compelling studies today. Our listeners will find the links to these abstracts in the transcripts of this episode.  Dr. Neeraj Agarwal: Thanks, John.  Dr. John Sweetenham: And thanks to our listeners for your time today. If you're enjoying the content on the ASCO Daily News podcast, please take a moment to rate, review and subscribe wherever you get your podcasts.    Disclosures:  Dr. John Sweetenham  Consulting or Advisory Role: EMA Wellness  Dr. Neeraj Agarwal:  Consulting or Advisory Role: Pfizer, Medivation/Astellas, Bristol-Myers Squibb, AstraZeneca, Nektar, Lilly, Bayer, Pharmacyclics, Foundation Medicine, Astellas Pharma, Lilly, Exelixis, AstraZeneca, Merck, Novartis, lily, Eisai, Seattle Genetics, EMD Serono, Janssen Oncology, AVEO, Calithera Biosciences, MEI Pharma, Genentech, Astellas Pharma, Foundation Medicine, and Gilead Sciences    Research Funding (Institution): Bayer, Bristol-Myers Squibb, Takeda, Pfizer, Exelixis, Amgen, AstraZeneca, Calithera Biosciences, Celldex, Eisai, Genentech, Immunomedics, Janssen, Merck, Lilly, Nektar, ORIC Pharmaceuticals, ORIC Pharmaceuticals, CRISPR therapeutics, and Arvinas     Disclaimer:   The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions.  Guests on this podcast express their own opinions, experience, and conclusions. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement. 

In this episode of the Psychedelic Therapy Frontiers podcast, Dr. Steve Thayer and Dr. Reid Robison joined by Dr. Eric Garland. Dr. Garland is the Distinguished Endowed Chair in Research, Distinguished Professor, and Associate Dean for Research in the University of Utah College of Social Work, Director of the Center on Mindfulness and Integrative Health Intervention Development (C-MIIND), Associate Director of Integrative Medicine in Supportive Oncology and Survivorship at the Huntsman Cancer Institute, and Research Health Scientist in Whole Health at the Salt Lake Veterans Administration Medical Center. Dr. Garland the most prolific author of mindfulness research in the world.  We had him on the podcast today to talk about the mindfulness-based therapy intervention he created called Mindfulness Oriented Recovery Enhancement (MORE). Learn more about Dr. Garland here: https://drericgarland.com/ (1:57) Dr. Garland introduces himself(2:39) What is bio-behavioral clinical research (5:11) The mechanisms of addiction and how Mindfulness Oriented Recovery Enhancement (MORE) was designed to treat them(9:44) Compassion for those who struggle with addiction(13:58) The critical importance of savoring(20:37) Technique for helping people savor healthy pleasure (29:28) MORE's affect on neurotransmitters (34:12) MORE increasing feelings of self-transcendence(43:32) Nondual Awareness Dimensional Assessment (45:51) The scientific rigor of the psychedelic renaissance and caution agains the hype(55:00) How to get trained in MOREEmail us questions and feedback at psychfrontiers@novamind.ca Learn more about our podcast at https://www.psychedelictherapyfrontiers.com/Learn more about Novamind at https://www.novamind.ca/Follow us on Instagram: https://www.instagram.com/drstevethayer/https://www.instagram.com/innerspacedoctor/https://www.instagram.com/novamind_inc/Disclaimer: The content of this podcast does not constitute medical advice or mental health treatment. Consult with a medical/mental health professional if you believe you are in need of mental health treatment.

In honor Women's History Month, Humanities Radio is featuring women professors who are doing incredible work. Kim Kaphingst, professor of communication, is a health communication researcher and the director of Cancer Communication Research at the Huntsman Cancer Institute (https://uofuhealth.utah.edu/huntsman/labs/kaphingst/). She is currently conducting a study comparing two models of delivering cancer genetic services to primary care patients.

Dr. Neeraj Agarwal, ASCO Daily News editor-in-chief, and director of the Genitourinary Cancers Program at the University of Utah's Huntsman Cancer Institute, highlights key studies on disparities in GU cancers featured at the 2022 ASCO Genitourinary Cancers Symposium. Transcript:   ASCO Daily News: Hello and welcome to the ASCO Daily News Podcast. I'm Geraldine Carroll, a reporter for the ASCO Daily News. In today's episode, Dr. Neeraj Agarwal, the ASCO Daily News editor in chief, will highlight compelling studies on disparities in GU cancers featured at the 2022 ASCO Genitourinary (GU) Cancers Symposium. Dr. Agarwal has no conflicts relating to the topic of this episode and his full disclosures are available in the show notes. Disclosures of all guests on the podcast can be found in our transcripts at asco.org/podcasts.  Dr. Neeraj Agarwal: Hello and welcome to the ASCO Daily News Podcast. I'm Dr. Neeraj Agarwal, the director of the Genitourinary Cancers Program and professor of medicine at the University of Utah Huntsman Cancer Institute. So, I'd like to start with Abstract 20 presented by Dr. Alicia Morgans from the Dana-Farber Cancer Institute. Multiple population-based studies have reported a higher incidence of prostate cancer in Black men. [This disease] usually presents with aggressive features, at an earlier age, and is associated with higher mortality rates compared to White men. In contrast, multiple reports suggest that Black men with advanced prostate cancer also have better survival outcomes to novel hormonal therapies compared to White men. Using electronic medical records retrieved from a urology specialty database, Dr. Alicia Morgans investigated whether improved survival outcomes in Black men treated with enzalutamide are due to better responses compared to White men. So eligible patients, who are chemotherapy and abiraterone naive and included 214 Black men and 1,332 White men with advanced prostate cancer.    Reserves from a multivariate analysis were adjusted for baseline characteristics and indicated a statistically significant delay in clinical progression-free survival for Black men treated with enzalutamide compared to White men. This supports the argument that given equal access to care, Black men may respond similarly or better than White men to treatment for advanced prostate cancer. The next abstract addressing disparities in GU cancers was Abstract 444 presented by Dr. Samuel Washington from UCSF School of Medicine. Radical cystectomy remains the gold standard for muscle-invasive bladder cancer, yet confers significant health care costs. Prior work on the impact of cost commonly relied on comparisons by insurance status and income. Few studies have examined the relationship between the net worth of the household and the encounter type, such as outpatient versus inpatient encounters. As we also know, outpatient encounters are usually cheaper or less expensive than more expensive inpatient encounters.    So, in this intriguing and novel study, Dr. Samuel Washington presented a real-world analysis of demographics, household net worth, health plan cost, out-of-pocket cost, and total health care cost accrued from the day of admission to 90 days after radical cystectomy for muscle-invasive bladder cancer. This was the largest study of its kind and included more than 140,000 commercially insured patients to examine variations in health care utilization by net worth in 90 days after radical cystectomy. Results are very interesting and indicate that patients with lower household net worth were at a greater risk for an acute inpatient encounter and thus higher medical cost, while patients with greater household net worth had greater odds of office visits or outpatient encounters, which are associated with lower cost. So, these findings indicate that a lower household network continues to be a significant factor in health care utilization and higher health care costs, even within a commercially insured patient population. So very interesting findings indeed and these findings definitely should pay for further future studies involving or looking at this aspect of disparities. Thank you very much for your kind attention.    ASCO Daily News: That was Dr. Neeraj Agarwal of the University of Utah's Huntsman Cancer Institute. If you've enjoyed this series, please take a moment to rate and review us wherever you get your podcasts.     Disclosures:   Dr. Neeraj Agarwal:   Consulting or Advisory Role: Pfizer, Medivation/Astellas, Bristol-Myers Squibb, AstraZeneca, Nektar, Lilly, Bayer, Pharmacyclics, Foundation Medicine, Astellas Pharma, Lilly, Exelixis, AstraZeneca, Merck, Novartis, lily, Eisai, Seattle Genetics, EMD Serono, Janssen Oncology, AVEO, Calithera Biosciences, MEI Pharma, Genentech, Astellas Pharma, Foundation Medicine, and Gilead Sciences      Research Funding (Institution): Bayer, Bristol-Myers Squibb, Takeda, Pfizer, Exelixis, Amgen, AstraZeneca, Calithera Biosciences, Celldex, Eisai, Genentech, Immunomedics, Janssen, Merck, Lilly, Nektar, ORIC Pharmaceuticals, ORIC Pharmaceuticals, CRISPR therapeutics, and Arvinas      Disclaimer: The purpose of this podcast is to educate and to inform this is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement.    

Dr. Neeraj Agarwal, ASCO Daily News editor-in-chief, and director of the Genitourinary Cancers Program at the University of Utah's Huntsman Cancer Institute, shares key takeaways from the practice-changing ARASENS trial in mHSPC, featured at the 2022 ASCO Genitourinary Cancers Symposium.   Transcript: ASCO Daily News: Hello, and welcome to the ASCO Daily News podcast. I'm Geraldine Carroll, a reporter for the ASCO Daily News. Today in our continuing coverage of the 2022 ASCO Genitourinary (GU) Cancer Symposium. Dr. Neeraj Agarwal, the editor in chief of the ASCO Daily News will share key takeaways from the practice-changing ARASENS trial, which showed promising results in metastatic hormone-sensitive prostate cancer. Dr. Agarwal has no conflicts relating to the topic of this episode and his full disclosures are available in this show notes. Disclosures of all guests on the podcast can be found in our transcripts at asco.org/podcasts. Dr. Neeraj Agarwal: Hello and welcome to the ASCO Daily News podcast. I'm Dr. Neeraj Agrawal, the director of the Genitourinary Cancers Program and professor of medicine at the University of Utah Huntsman Cancer Institute. Let's discuss the results of the practice-changing ARASENS trial in patients with metastatic castration-sensitive prostate cancer as presented at the 2022 ASCO GU Symposium. This abstract, Abstract 13, was presented by Dr. Matthew Smith from the Massachusetts General Hospital and Hartford Medical School. ARASENS is a randomized phase 3 trial evaluating the efficacy and safety of darolutamide, a novel hormonal therapy, plus ADT (antiandrogen therapy) plus docetaxel versus placebo plus ADT plus docetaxel in patients with metastatic castration-sensitive prostate cancer. Randomization was stratified by the extent of disease and alkaline phosphatase levels, below versus upper limit of normal or above. It is important to know that this study only included patients that were eligible for ADT and docetaxel chemotherapy, to begin with. The primary endpoint was overall survival with multiple secondary endpoints, including time to CRPC (castration-resistant prostate cancer), time to pain progression, time to first symptomatic skeletal event, and time to start off the next anti-neoplastic therapy, and safety. A total of 1,306 patients were randomly assigned to triplet therapy with darolutamide plus ADT plus docetaxel versus placebo plus ADT plus docetaxel. Baseline characteristics were well balanced between the treatment arms. Analysis of the primary endpoint was pre-specified. After, 533 events had occurred results show the primary endpoint of this study was met with a significant improvement in overall survival and a 32.5% reduction in risk of death for patients on the triplet therapy on for darolutamide plus ADT plus docetaxel versus placebo plus ADT plus docetaxel. It is important to know that the triplet therapy improved overall survival, despite 76% of patients in the control arm having received the next life-prolonging therapy. Subgroup analysis indicates consistent benefit across the 3 specified groups. Secondary endpoints also were favored by the triplet therapy combination over the control arm. While this study offers an additional excellent option for our patients with metastatic cancer-sensitive prostate cancer in older populations, the use of docetaxel may be a significant limitation to this triplet combination. In addition, and importantly, this study did not answer the question of whether adding docetaxel chemotherapy to the ADT plus novel hormonal therapy backbone will also improve survival. With the advent of multiple doublets and triplet combinations in recent years, as we saw in the form of ADT plus enzalutamide ADT plus apalutamide in the recent years, it is very important to find biomarkers that may predict response to these treatment options, which will allow personalization of therapy with that. I would like to conclude this podcast on the ARASENS trial. Thank you very much for your kind attention. ASCO Daily News: You've been listening to Dr. Neeraj Agarwal of the University of Utah's Huntsman Cancer Institute. Thanks for joining us today. If you're enjoying the content on the podcast, please take a moment to rate and review us wherever you get your podcasts. Disclosures: Dr. Neeraj Agarwal: Consulting or Advisory Role: Pfizer, Medivation/Astellas, Bristol-Myers Squibb, AstraZeneca, Nektar, Lilly, Bayer, Pharmacyclics, Foundation Medicine, Astellas Pharma, Lilly, Exelixis, AstraZeneca, Merck, Novartis, lily, Eisai, Seattle Genetics, EMD Serono, Janssen Oncology, AVEO, Calithera Biosciences, MEI Pharma, Genentech, Astellas Pharma, Foundation Medicine, and Gilead Sciences Research Funding (Institution): Bayer, Bristol-Myers Squibb, Takeda, Pfizer, Exelixis, Amgen, AstraZeneca, Calithera Biosciences, Celldex, Eisai, Genentech, Immunomedics, Janssen, Merck, Lilly, Nektar, ORIC Pharmaceuticals, ORIC Pharmaceuticals, CRISPR therapeutics, and Arvinas Disclaimer: The purpose of this podcast is to educate and to inform this is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement.

Dr. Neeraj Agarwal, ASCO Daily News editor-in-chief, and director of the Genitourinary Cancers Program at the University of Utah's Huntsman Cancer Institute, shares key takeaways from the PROpel and MAGNITUDE trials in mCRPC, featured at the 2022 ASCO Genitourinary Cancers Symposium.   Transcript: ASCO Daily News: Hello and welcome to the ASCO Daily News Podcast. I'm Geraldine Carroll, a reporter for the ASCO Daily News. Today, in our continuing coverage of the 2022 ASCO Genitourinary (GU) Cancers Symposium, Dr. Neeraj Agarwal, the editor-in-chief of the ASCO Daily News will highlight promising advances in metastatic castration-resistant prostate cancer. Dr. Agarwal has no conflicts relating to the topic of this episode, and his full disclosures are available in the show notes. Disclosures of all guests on the podcast can be found in our transcripts at asco.org/podcasts.   Dr. Neeraj Agarwal: Hello and welcome to the ASCO Daily News Podcast. I'm Dr. Neeraj Agarwal, the director of the Genitourinary Cancer Program, and professor of medicine at the University of Utah Huntsman Cancer Institute, and editor in chief of the ASCO Daily News. I'd like to start with the PROpel trial followed by a discussion on the MAGNITUDE trial. So, Abstract 11 was on the results of the PROpel trial and presented by Dr. Fred Saad from the University of Montreal. PROpel is a randomized phase 3 trial, which evaluated the efficacy and safety of olaparib, a PARP inhibitor plus abiraterone versus this placebo plus abiraterone in the first-line metastatic castration-resistant prostate cancer setting. Patients were allowed to have docetaxel chemotherapy is given in a metastatic castration-sensitive prostate cancer setting. Enrollment in the study was independent of the effects in the homologous recombination repair pathway. The primary endpoint was investigator-assessed radiographic progression-free survival (PFS) with multiple secondary endpoints, including overall survival and safety.   Approximately 800 patients were randomly assigned to the novel combination of olaparib plus abiraterone or placebo plus abiraterone. Baseline characteristics were well-balanced between the treatment arms, including homologous recombination repair or HRR mutation status. At the pre-planned interim analysis results show the trial meets its primary endpoint with significant improvement in radiographic PFS for all patients receiving the combination therapy versus control, regardless of the presence of homologous recombination repair gene mutations. Median PFS was 24.8 months versus 16.6 months for patients receiving olaparib plus abiraterone versus placebo plus abiraterone respectively with the hazard ratio of 0.66, and a P < 0.0001. This translates into a 34% reduction in risk of progression or death. Overall survival results are still immature with only 29% [of patients experiencing events] thus far. It is interesting that even patients deemed negative for homologous recombination repair gene mutations showed significant improvement in radiographic PFS when treated with the combination of olaparib plus abiraterone versus placebo plus abiraterone.   Regarding the adverse effects, they were what you would expect from the combination of a PARP inhibitor, such as olaparib and abiraterone. We saw a higher sequence of all great events of anemia, fatigue, and nausea in the combination arm. While anemia was the only grade 3-4 adverse event observed at a significantly high frequency in the combination arm. It is also important [that] we get a better understanding of the molecular mechanism by which patients who are homologous recombination repair mutation-negative are benefiting from the combination treatment as well.   The next trial in this context, or this team, was the MAGNITUDE trial. Abstract 12 was presented by Dr. Kim Chi from British Columbia Cancer Center in Vancouver, Canada. MAGNITUDE is a randomized phase 3 trial evaluating the efficacy and safety of niraparib plus abiraterone plus placebo plus abiraterone in the first-line metastatic castration-resistant prostate cancer setting. The study population was slightly different from what we saw in PROpel trial. Taxane chemotherapy, as well as novel hormonal therapy, was allowed in metastatic castration-sensitive prostate cancer, as well as a prior novel hormonal therapy was allowed in the non-metastatic castration-resistant prostate cancer.   Also, patients were allowed up to 4 months of treatment with abiraterone in the first-line metastatic castrate-resistant prostate cancer. Prospective selection of patients with, and without homologous recombination repair (HRR) gene mutations were required. The primary endpoint was radiographic PFS by central review with multiple secondary endpoints, including overall survival and safety. A pre-specified fertility analysis was planned after enrolling 233 patients who were randomly assigned to niraparib plus abiraterone or placebo plus abiraterone. Evaluation of fertility was based on the composite PFS of PSA or radiographic progression, whichever occurred first. The pre-planned fertility analysis showed no benefit in the biomarker negative cohort. And thus the trial did not pursue further enrollment of those patients who were not positive for homologous recombination repair gene mutations.   Coming to the HRR positive cohort, 423 patients were randomly assigned to either niraparib plus abiraterone or placebo plus abiraterone. At the pre-planned interim analysis primary endpoint was met with a significant improvement in radiographic PFS for BRCA1 and BRCA2 and all patients who are homologous recombination repair mutation-positive, receiving the novel combination of niraparib plus abiraterone. Overall survival results are still immature. It is important to note that in the patients who are HRR positive, approximately 50% were BRCA1 and 2 positive. And these patients clearly derived the most benefit with a combination with an approximate 47% reduced risk of death. And if you look at other patients who are biomarker positive, there was a clear benefit and a significant improvement in median PFS (radiographic progression-free survival) with a hazard ratio of 0.73, which translates to a 27% reduction in the risk of death or progression. With the caveat of subgroup analysis, being underpowered following groups of patients seem to derive less benefit with the combination than the overall cohort with the combination of niraparib plus abiraterone. And these patients included patients who were age 65 or younger, or less than age 65, patients with visceral metastatic disease, patients with prior abiraterone or taxane chemotherapy, [and] patients who had a PSL level below the median, and patients with non-BRCA homologous recombination repair mutations.   In conclusion, the combination of niraparib plus abiraterone shows a significant improvement in the radiographic PFS for patients who are HRR positive in the first-line metastatic CRPC. Based on the available data in the public domain, without any doubt that both PROpel and MAGNITUDE trials established a combination of a PARP inhibitor with abiraterone in the first-line metastatic CRPC setting for patients who are positive for HRR mutation improve radiographic progression-free survival. Even though overall survival data are immature for both trials, I expect both combinations will be approved by the U.S. Food and Drug Administration in the near future and will be available to our patients. Regarding the HRR negative cohort in the PROpel trial, which also seems to derive significant benefit with the combination of abiraterone plus olaparib, I'm looking forward to the data on confirmation of HRR negative status by tissue-based genomic profiling results in the full-length publication which we expect to be published soon. If indeed confirmed by the tissue-based genomic profiling, I see the combination of abiraterone plus olaparib to be a reasonable option in the patients who are HRR negative in the first-line metastatic CRPC setting.   With this, I would like to conclude my discussion on the 2 practice-changing trials presented in the 2022 ASCO GU meeting, which were the PROpel and MAGNITUDE trials. Thank you very much for your kind attention. ASCO Daily News: That was Dr. Neeraj Agarwal of the University of Utah's Huntsman Cancer Institute. Thanks for joining us today. If you're enjoying the content on the podcast, please take a moment to rate and review us wherever you get your podcast.   Disclosures: Dr. Neeraj Agarwal: Consulting or Advisory Role: Pfizer, Medivation/Astellas, Bristol-Myers Squibb, AstraZeneca, Nektar, Lilly, Bayer, Pharmacyclics, Foundation Medicine, Astellas Pharma, Lilly, Exelixis, AstraZeneca, Merck, Novartis, lily, Eisai, Seattle Genetics, EMD Serono, Janssen Oncology, AVEO, Calithera Biosciences, MEI Pharma, Genentech, Astellas Pharma, Foundation Medicine, and Gilead Sciences Research Funding (Institution): Bayer, Bristol-Myers Squibb, Takeda, Pfizer, Exelixis, Amgen, AstraZeneca, Calithera Biosciences, Celldex, Eisai, Genentech, Immunomedics, Janssen, Merck, Lilly, Nektar, ORIC Pharmaceuticals, ORIC Pharmaceuticals, CRISPR therapeutics, and Arvinas Disclaimer: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement.  

Topic: Why see a uveal melanoma oncologist and how to talk with your oncologist about clinical trials? A Cure in Sight is joined by Dr. Justin Moser, a medical oncologist in the Phoenix, Arizona area. He shares helpful tips to keep in mind when having discussions with a medical oncologist, and why it's vital for patients to be seen and under the watch and care of a medical oncologist either familiar with uveal melanoma protocols for scans and care, or someone who is willing to learn from another oncologist in the field. Dr. Moser explains some of the process behind selecting a clinical trial for a patient experiencing metastatic spread, and how you as a patient can ask for less known trials that are not entirely ready for Uveal melanoma yet, but are planned to have a few spots for uveal melanoma spread. Thank you Dr. Moser for your time and research!   Dr. Justin Moser is a medical oncologist and hematologist and associate clinical investigator at HonorHealth Research Institute, clinical assistant professor at the University of Arizona College of Medicine – Phoenix, and an adjunct faculty member at the Translational Genomics Research Institute (TGen). He is an expert in the treatment of melanoma and other skin cancers and co-leads the Cutaneous Oncology Tumor Site Strategy Group for HonorHealth.   Dr. Moser graduated from the University of Iowa Carver College of Medicine with distinctions in research and teaching. He completed his Internal Medicine Residency at Mayo Clinic in Rochester, Minnesota and his fellowship in Hematology/Oncology at the Huntsman Cancer Institute. He has strong passion for developing new treatments for patients with cancer and was a visiting fellow at the Cancer Therapy Evaluation Program at the National Cancer Institute.   Dr. Moser's has a special focus on patients with rare skin cancers, such as uveal melanoma, squamous cell carcinoma, Merkle cell carcinoma and basal cell carcinoma, as patients with these cancers often have fewer treatment options available.   For more information on the HonorHealth Research Institute Melanoma and Skin Cancer Clinic or to make an appointment please call our Nurse Navigators at 480-323-1364 or email clinicaltrials@honorhealth.com. Be sure to follow us on Instagram @acureinsight, for more stories, tips, and ideas to help you navigate this journey with OM! *A Cure in Sight is a 501c3 organization. All donations made can help fund our podcast to educate patients, fund research, aid patients, and more! Donate $10 $15 $20 today to help A Cure in Sight in their quest to find a cure. LINK TO PAYPAL OR VENMO  This podcast was hosted by Danet Peterson and produced by Agora Media.  

Not everyone is in to celebrating birthdays, I get it.  Whether you are one who loves to celebrate or not, perhaps we may all be open to a few reasons as to why birthdays are meant to be celebrated.Today on Holly's Highlights we will cover 3 reasons why you should celebrate your birthday. We'll also identify the challenge to celebrating birthdays and ideas on how to overcome that challenge. Finally we will all be encouraged to celebrate our special loved ones on their birthday.To make a donation towards the fight against cancer, please visit https://hope.huntsmancancer.org/sportsfest22/harding-heroes. 100% of all donations go to Huntsman Cancer Institute. Thank you for your consideration and support.Support the show (https://www.patreon.com/hollyshighlights)

This episode features Carlie Gluch, a registered nurse working at the bone marrow transplant unit of the Huntsman Cancer Institute. She discusses her work with patients receiving blood and marrow transplants, working with this population, and ways nurses can support these patients. We also hear from the newly established Utah Chapter of the American Association of Critical-Care Nurses, including participating in its chapter and planned activities. The College of Nursing at Brigham Young University presents nursing careers and professional insight to undergraduate students. This is the forty-seventh show in The College Handoff series and was recorded in October 2021.