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Karen M. Winkfield, MD, PhD; Narjust Florez, MD, FASCO; Gilberto de Lima Lopes Junior, MD, MBA, FASCO; Coral Olazagasti, MD; Vonetta M. Williams, MD, PhD

 Fighting Disparities and Saving Lives: An Exploration of Challenges and Solutions in Cancer Care

19th Annual New York GU Cancers Congress™

 podcast, co-hosted by Manojkumar Bupathi, MD, MS, executive cochair of the Genitourinary Cancer Research Executive Committee at Sarah Cannon Research Institute (SCRI) and medical oncologist with Rocky Mountain Cancer Centers specializing in solid tumors and genitourinary cancers, and Benjamin Garmezy, MD, associate director of genitourinary research and executive cochair of the Genitourinary Cancer Research Executive Committee at SCRI and medical oncologist at SCRI Oncology Partners specializing in genitourinary cancers, in a recent live session with US Oncology Network and the Pathways Task Force, delved into significant updates that were set to happen at the 2025 American Society of Clinical Oncology (ASCO), focusing on the genitourinary cancer landscape.

Bupathi and Garmezy were joined by John M. Burke, MD, a hematologist and medical oncologist at Rocky Mountain Cancer Centers, and Dhaval R. Shah, MBBS, a medical oncologist from Christiana Care.

A primary focus of the discussion was the phase 3 KEYNOTE-564 trial (NCT03142334), a pivotal trial for patients with renal cell carcinoma (RCC). This study investigated pembrolizumab (Keytruda) as adjuvant therapy for patients with clear cell RCC who had undergone surgical resection and presented with intermediate-high or high-risk features.

Garmezy highlighted the "clear separation of the curves" in disease-free survival (DFS), with an HR of 0.68, and a compelling 5% difference in long-term overall survival, signifying a benefit for "about 1 in 20 patients". Despite about 20% of patients discontinuing treatment due to toxicity, the overall safety profile of pembrolizumab was considered well-tolerated, with no statistically significant difference in quality of life compared with placebo.

Burke provided the panel with his perspective on evaluating such trials. He emphasized the importance of scrutinizing study design flaws, even in "randomized, double-blind, placebo-controlled, phase 3 clinical trials," which are often seen as the "epitome of great science". Key questions for consideration include the appropriateness of the control arm (placebo in KEYNOTE-564 was deemed appropriate), the validity of surrogate end points like DFS, and the presence of "informative censoring"—a form of bias that can skew results. Burke noted that informative censoring can occur if patients drop out of a trial due to disappointment with their randomized arm or due to drug toxicity, which can make the treatment arm's progression-free survival look better than it truly is.

The discussion also touched upon the consistency of KEYNOTE-564’s findings with other trials. Garmezy noted that while pembrolizumab showed positive results, other adjuvant studies involving atezolizumab (Tecentriq), nivolumab (Opdivo), and nivolumab plus ipilimumab (Yervoy) had no significant difference, potentially due to differences in drug type or duration of therapy (6 vs 12 months). Shah affirmed that despite these nuances, the overall survival benefit seen in KEYNOTE-564 justifies the use of adjuvant pembrolizumab for eligible patients, emphasizing adherence to the exact trial criteria.

Beyond kidney cancer, the podcast previewed discussions on the phase 3 NIAGARA trial (NCT03732677) for perioperative bladder cancer and the phase 3 TALAPRO-2 trial (NCT03395197) for first-line metastatic castrate-resistant prostate cancer (mCRPC). Bupathi highlighted the ongoing debate within the Pathways Committees regarding the integration of new data vs established practices, particularly concerning the timeline for new drugs to be incorporated into pathways. Burke clarified that while Pathways guides value-driven decisions, physicians retain the autonomy to prescribe off-pathway regimens, though financial implications might arise. The episode concluded with a look ahead to more data releases, underscoring the dynamic nature of oncology practice and the continuous evaluation of therapies for optimal patient care.

Choueiri TK, Tomczak P, Park SH, et al; KEYNOTE-564 Investigators. Overall survival with adjuvant pembrolizumab in renal-cell carcinoma. N Engl J Med. 2024;390(15):1359-1371. doi:10.1056/NEJMoa2312695

Dive into the latest in genitourinary oncology with "Oncology Decoded," featuring discussions on KEYNOTE-564 with RCC.

Unveiling Advances in GU Cancers: Insights from Oncology Decoded

Manojkumar Bupathi, MD, MS; and Benjamin Garmezy, MD, dove into the complexities of adjuvant therapy for kidney cancer, providing valuable insights for oncology clinicians in the latest episode of 

. The discussion began with a fundamental overview of adjuvant therapy, which aims to eradicate residual microscopic disease and mitigate the risk of cancer recurrence.

Bupathi, executive cochair of the Genitourinary Cancer Research Executive Committee at Sarah Cannon Research Institute (SCRI) and medical oncologist with Rocky Mountain Cancer Centers specializing in solid tumors and genitourinary cancers, and Garmezy, associate director of genitourinary research and executive cochair of the Genitourinary Cancer Research Executive Committee at SCRIand medical oncologist at SCRI Oncology Partners specializing in genitourinary cancers, underscored the curative potential of adjuvant therapy in kidney cancer.

The discussion also focused on 2 primary modalities of adjuvant therapy: targeted therapies and immunotherapy. Targeted therapies, particularly VEGF tyrosine kinase inhibitors, were discussed in the context of clear cell kidney cancer, the predominant subtype, where they inhibit the VEGF signaling pathway to impede cancer cell growth.

Bupathi and Garmezy spoke about results from the phase 3 KEYNOTE-564 trial (NCT03142334), which led to the FDA approval of pembrolizumab (Keytruda) for high-risk clear cell kidney cancer.

 The positive results from this trial are superior to those from others that explored different immunotherapy agents and regimens, none of which demonstrated a similar benefit. It was noted that there are differences in interpretations, heterogeneity in study designs, and patient populations for each trial.

Regarding risk stratification in the postnephrectomy setting, the hosts gave a critical evaluation of the role of nomograms in predicting recurrence. The benefits of adjuvant therapy against the potential for treatment-related toxicities were weighed, with an emphasis on the importance of individualized patient counseling.

Finally, they highlighted the management of disease progression following adjuvant pembrolizumab, with a focus on treatment sequencing and the role of second-line therapies. The relevance of extrapolating data from metastatic trials to the adjuvant setting was discussed, with a pragmatic approach to clinical decision-making.

Choueiri TK, Tomczak P, Park SH, et al; KEYNOTE-564 Investigators. Overall survival with adjuvant pembrolizumab in renal-cell carcinoma. 

. 2024;390(15):1359-1371. doi:10.1056/NEJMoa2312695

FDA approves pembrolizumab for adjuvant treatment of renal cell carcinoma. News release. FDA. November 17, 2021. Accessed April 24, 2025. https://tinyurl.com/yzxcjetz

Oncology Decoded hosts discuss adjuvant therapy in kidney cancer, including research, treatment strategies, and management of recurrence.

Beyond Surgery: The Evolving Landscape of Adjuvant Therapy in Kidney Cancer

, co-hosts Manojkumar Bupathi, MD, MS, executive co-chair of Genitourinary Cancer Research Executive Committee at Sarah Cannon Research Institute and medical oncologist with Rocky Mountain Cancer Centers specializing in solid tumors and genitourinary cancers; and Benjamin Garmezy, MD, associate director of Genitourinary Research and executive co-chair of Genitourinary Cancer Research Executive Committee at Sarah Cannon Research Institute (SCRI) and medical oncologist at SCRI Oncology Partners specializing in genitourinary cancers, engaged in a detailed discussion focused on adjuvant therapy for kidney cancer, providing key insights regarding available treatment options.

The discussion began with defining adjuvant therapy that aims to improve disease-free survival, overall survival, or both. The hosts explore effective ways to communicate the goals and potential benefits of adjuvant therapy to patients, acknowledging the challenge of recommending treatment to patients who may feel they are already “cured” after surgery.

The conversation transitioned to the specifics of adjuvant therapy in renal cell carcinoma (RCC), with a focus on clear cell RCC.Bupathi and Garmezy discussed the evolution of treatment strategies from VEGF tyrosine kinase inhibitors (TKIs) to immunotherapy.They highlighted the significance of the phase 3 KEYNOTE-564 trial (NCT03142334), which supported the approval of adjuvant pembrolizumab (Keytruda), a PD-1 inhibitor, for certain patients who are high-risk. Additionally, they highlighted other immunotherapy trials and the distinction between PD-1 and PD-L1 inhibitors.

The discussion also touched upon patient selection for adjuvant pembrolizumab, with the hosts sharing their individual approaches. Factors influencing treatment decisions include disease stage, risk of recurrence, patient comorbidities, and potential treatment toxicities.The importance of shared decision-making with patients is emphasized, particularly regarding the balance between potential benefits and risks of treatment.

Finally, practical guidance on managing treatment-related toxicities, including strategies for monitoring patients and addressing potential adverse effects, was mentioned. They also discuss the complexities of monitoring patients’ post-treatment, including the use of CT scans and the management of pulmonary nodules. The discussion extends to managing progressive disease in patients who have received adjuvant therapy, including the role of VEGF TKIs and clinical trials.

A recent Oncology Decoded podcast focuses on adjuvant therapy like pembrolizumab and optimal post-surgical care for patients with kidney cancer.

Adjuvant Therapy and Post-Surgical Management Options for Kidney Cancer

This episode of Oncology Decoded tackled the challenging landscape of non-clear cell renal cell carcinoma (nccRCC), a heterogeneous group of tumors representing about 20% to 25% of all kidney cancers. The episode provided expert insights into the diagnosis and management of this complex disease.

Manojkumar Bupathi, MD, MS, executive co-chair of Genitourinary Cancer Research Executive Committee at Sarah Cannon Research Institute; medical oncologist with Rocky Mountain Cancer Centers specializing in solid tumors and genitourinary cancers;

Benjamin Garmezy, MD, associate director of Genitourinary Research and executive co-chair of Genitourinary Cancer Research Executive Committee at Sarah Cannon Research Institute (SCRI); medical oncologist at SCRI Oncology Partners specializing in genitourinary cancers;

Stephanie A. Berg, DO, medical oncologist for the Lank Center of Genitourinary Oncology at Dana-Farber Cancer Institute.

The conversation centered around a case presentation: a 63-year-old female with papillary RCC, presenting with significant weight loss, cough, a large renal mass, and multiple pulmonary and bone metastases.

The panel emphasized the importance of accurate pathological diagnosis, highlighting the diverse subtypes within nccRCC, including papillary, chromophobe, translocation, and collecting duct carcinomas. They acknowledged the limitations of historical treatment approaches, which have yielded suboptimal response rates and progression-free survival (PFS).

The discussion then delved into the evolving treatment landscape, focusing on recent clinical trial data. The phase 2 PAPMET trial (NCT02761057) of cabozantinib (Cabometyx) vs sunitinib (Sutent) in patients with advanced RCC. The emergence of newer VEGF-selective TKIs, such as tivozanib (Fotivda), also showed promise in disease control.

The panel highlighted the growing role of immunotherapy (IO) in nccRCC, particularly the combination of cabozantinib and nivolumab (Opdivo), which showed encouraging response rates in non-chromophobe subtypes. Similarly, the combination of lenvatinib and pembrolizumab demonstrated significant PFS and overall response rates across various nccRCC subtypes, including chromophobe.

In the absence of clinical trials, the panel recommended a personalized approach to treatment, considering the patient's subtype, disease burden, and comorbidities. They generally favored IO-TKI combinations, such as lenvatinib plus pembrolizumab, for most patients with nccRCC, while acknowledging the potential role of ipilimumab (Yervoy) plus nivolumab (Opdivo) in select cases, particularly those with chromophobe histology and low disease burden.

The panel also addressed the role of radiation therapy in nccRCC, particularly for oligometastatic disease and oligoprogressive disease. They emphasized the importance of multidisciplinary collaboration with radiation oncologists to optimize treatment strategies.

Regarding molecular testing, the panel acknowledged its limited role in guiding treatment decisions at present but highlighted its potential to identify patients with specific genetic alterations, such as MET amplification or FH deficiency, who may benefit from targeted therapies or germline testing.

Finally, challenges of sequencing therapies in nccRCC were discussed, emphasizing the lack of definitive data and the need for individualized treatment decisions. They generally favored sequencing TKIs, such as tivozanib or sunitinib, after progression on IO-TKI combinations, but acknowledged the need for further research to optimize treatment sequencing.

Tripathi A, Tangen C, Li X, et al. Pathologic concordance rate and outcomes by histologic subtype in advanced papillary renal cell (pRCC) carcinoma: An analysis from the SWOG S1500 (PAPMET) trial. 

. 2023;41(suppl 16):4562. doi:10.1200/JCO.2023.41.16_suppl.4562

, LLC, is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

, LLC, designates this enduring material for a maximum of 0.5 

™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

You may immediately download your certificate.

A brief overview of the current RCC landscape was provided in the most recent Oncology Decoded podcast. 

Traversing the Complexities of Non-Clear Cell Renal Cell Carcinoma

In collaboration with KidneyCAN, CancerNetwork® spoke with Eric Jonasch, MD, a professor in the Department of Genitourinary Medical Oncology of the Division of Cancer Medicine, and the director of the von Hippel Lindau Center at the University of Texas MD Anderson Cancer Center in Houston, Texas, about the missions and goals of the Kidney Cancer Research Consortium.

Jonasch is the principal investigator of an effort, supported by a Department of Defense (DoD)–funded grant, that aims to improve the treatment of patients with renal cell carcinoma (RCC) by developing a network of clinical trial centers that have expertise in both developing and executing new research efforts.

“We want to do the clinical trials that the industry wouldn’t do otherwise and do the trials that are going to allow us to gain knowledge faster,” Jonasch said. “We do this by, number one, using novel agents; number 2, using more efficient and innovative clinical trial designs; and, number 3, incorporating correlative studies, including biopsies and various other circulating biomarkers analyses that allow us to get smarter faster.”

Many of the ongoing and recently completed trials in the kidney cancer space focused heavily on immune therapy, utilizing checkpoint-blocking antibodies like nivolumab (Opdivo) and pembrolizumab (Keytruda) or CTLA-4–blocking agents like ipilimumab (Yervoy). Of the studies moving the space forward, Jonasch highlighted an ongoing phase 1b/2 trial (NCT05501054) evaluating ipilimumab, nivolumab, and ciforadenant (CPI-444), an A2A inhibitor, in RCC along with other trials.

During the discussion, Jonasch mentioned the initiative to incorporate biopsies in treatment more frequently, particularly through giving a pre- and post-biopsy to see how the results change during therapy. This approach gives investigators an opportunity to see how cancer cells interact with immune cells.


Additionally, Jonasch stated that they wish to expand their efforts to the broader kidney cancer community, as currently, work in the consortium only takes place in 7 “ivory tower” institutions that may be difficult to access for some patients. One of the ways they’re combatting this barrier is through working with the Veterans Affairs hospital system. Once that effort is complete, Jonasch hopes the consortium will be able to start helping more patient groups.

KidneyCAN is a nonprofit organization with a mission to accelerate cures for kidney cancer through education, advocacy, and research funding. You can learn more about KidneyCAN’s work here: 

Beckermann K, Rini B, Haas N, George D, Jonasch E. Phase 1b/2 trial of ipilimumab, nivolumab, and ciforadenant (INC) (adenosine A2a receptor antagonist) in first-line advanced renal cell carcinoma. 

. 2023;28(suppl 1):S13–4. doi:10.1093/oncolo/oyad216.022.

KidneyCAN 

Eric Jonasch, MD, believes that the Kidney Cancer Research Consortium may broaden their reach to provide care to many different groups of patients.

Expanding and Advancing the Future of Renal Cell Carcinoma Treatment

CancerNetwork, in a partnership with KidneyCAN

spoke with 2 genitourinary oncologists, Elizabeth P. Henske, MD, and Jason Muhitch, PhD, about how advocacy and funding through interdisciplinary collaboration between patient advocates, researchers, and physicians have resulted in numerous clinical breakthroughs in kidney cancer.

Henske is a professor of medicine at the Harvard Medical School, an associate member of the Broad Institute of MIT and Harvard, director of the Center for LAM Research and Clinical Care, and a physician at Brigham and Women’s Hospital and Dana-Farber Cancer Institute. Muhitch is an associate professor of Oncology, co-chair of the Genitourinary Translational Research Group, deputy director of Graduate Studies, and a member of the Department of Immunology at Roswell Park Comprehensive Cancer Center at Roswell Park Comprehensive Cancer Center.

First, the state of kidney cancer advocacy was discussed, with Muhitch emphasizing multidisciplinary collaboration and the role of conferences, such as the 

 and the International Kidney Cancer Symposium, in bringing these groups together. Henske emphasized the strength of the advocacy network for kidney cancer, particularly as a mechanism for exchanging information, offering patient support and education, and facilitating research.

Next, funding was touched upon, with Henske expressing her interest in conveying the importance and urgency of kidney cancer research to Congress. Muhitch agreed, suggesting that the meetings with congressional offices offer opportunities to explain how funding can impact kidney cancer outcomes and scientist training, as well as the strength of patient advocacy in influencing Congress.

Muhitch and Henske then discussed the Kidney Cancer Research Program, which has enabled significant increases in funding for kidney cancer research, helped to facilitate clinical breakthroughs for common kidney cancer types, and set a foundation for exploring different kidney cancer variants. The discussion then turned to encouraging research for renal cell carcinoma , which Muhitch expressed can be attributed to partnership award recipients who went on to conduct research evaluating biomarkers predictive of patient responses to immunotherapies.

Regarding additional funding mechanisms, Henske and Muhitch discussed numerous private foundations providing smaller research grants. Henske explained that these smaller grants are instrumental in taking the first steps to explore rarer kidney cancer subtypes, with Muhitch explaining that the earlier funding can formulate research that leads to greater funding from the Kidney Cancer Research Program.

KidneyCAN is a nonprofit organization with a mission to accelerate cures for kidney cancer through education, advocacy, and research funding. Learn more about KidneyCAN’s mission and work 

KidneyCAN's 2025 Advocacy Days are March 10 to 11, 2025 and September 22 to 23, 2025. If you are interested in getting involved with KidneyCAN's advocacy efforts, please contact 

Two oncologists discuss the impact of advocacy in kidney cancer research, highlighting collaboration between researchers, advocates, and physicians.

Highlighting Advocacy Impacts on Funding for Kidney Cancer Research

2024 Kidney Cancer Research Summit (KCRS),

 spoke with various experts in the kidney cancer field about potential advancements in disease detection and updated efficacy data on immunotherapy and other treatment strategies in patients with renal cell carcinoma (RCC).

 a postdoctoral oncology research fellow at Dana-Farber Cancer Institute, discussed the implications of findings related to the use of an investigational tissue-informed liquid biopsy epigenomic profiling tool for detecting sarcomatoid differentiation in RCC.

 According to Semaan, this method may avoid the sampling errors and spatial heterogeneity challenges associated with traditional biopsy strategies.

 an assistant attending physician from Memorial Sloan Kettering Cancer Center, spoke about data from a 

real-world study evaluating treatment patterns and outcomes in those with metastatic RCC

following prior receipt of immunotherapy and tyrosine kinase inhibitors (TKIs).

 Data showed no differences in overall survival (OS) outcomes across different immunotherapy- and TKI-containing regimens. Based on these findings, Shah emphasized a need for additional novel therapeutic approaches to help improve outcomes in later-line settings of treatment.

 director of Clinical Research for the Lank Center of Genitourinary Oncology and medical oncologist specializing in genitourinary malignancies at Dana-Farber Cancer Institute, highlighted findings from his presentation on a phase 1b study (NCT04627064) evaluating treatment with abemaciclib (Verzenio) in a pretreated metastatic clear cell RCC population.

 Among 11 patients who received abemaciclib, 1 had stable disease, 8 had progressive disease, and 2 were not evaluable for response. Additionally, the median progression-free survival (PFS) and overall survival (OS), respectively, was 1.8 months (95% CI, 1.5-1.9) and 9.1 months (95% CI, 2.1-15.3).

Although abemaciclib monotherapy yielded no responses in the study, McGregor highlighted the potential clinical utility of administering the agent in combination with other therapies. Findings from his presentation suggested that CDK4/6 inhibitors may demonstrate a synergistic effect when combined with HIF-2α inhibitors, which is a potential strategy that investigators are evaluating with belzutifan (Welireg) and palbociclib (Ibrance) combination therapy as part of the phase 1/2 LITESPARK-024 trial (NCT05468697).

Semaan K, Zarif TE, Eid M, et al. Liquid biopsy epigenomic profiling for the detection of sarcomatoid renal cell carcinoma. Presented at the 2024 Kidney Cancer Research Summit; July 11-12, 2023; Boston, MA. Abstract 44.

Shah N, Sura S, Shinde R, et al. Real-world treatment patterns and clinical outcomes of metastatic renal cell carcinoma patients post immune-oncology (IO) and Vascular Endothelial Growth Factor (VEGF) receptor targeted therapies. Presented at the 2024 Kidney Cancer Research Summit; July 11-12, 2023; Boston, MA. Abstract 36.

McGregor BA, Xie W, Xu W, et al. Phase IB trial of abemaciclib in advanced renal cell carcinoma. Presented at: 2024 Kidney Cancer Research Summit; July 11-12, 2024. Boston, MA.

Kidney Cancer Research Summit (KCRS)

Experts discuss findings related to liquid biopsy profiling, later-line immunotherapy, and CDK4/6 inhibitor efficacy presented at the 2024 KCRS meeting.

Exploring New Possibilities in Kidney Cancer Detection and Therapy

 Santosh Rao, MD, spoke with CancerNetwork® about recent developments and initiatives that have helped to advance integrative and palliative care for patients with kidney cancer, including developments that read out of the Annual Society for Integrative Oncology (SIO) International Conference and evidence supporting the use of non-clinical tools such as acupuncture, reflexology, acupressure, and massages. 

Rao, medical director of integrative oncology for University Hospitals Connor Whole Health and president-elect for the SIO, outlined palliative care strategies employed at University Hospitals and described ongoing research and pain management guidelines that aim to improve integrative care in kidney cancer.

Don’t forget to subscribe to the “Oncology On-The-Go” podcast on 

Kidney Cancer Awareness Month

Santosh Rao, MD, discusses the formation of new guidelines informing the use of integrative oncology for patients with kidney cancer from the Society for Integrative Oncology.

Oncology On-The-Go Podcast: Integrative and Palliative Kidney Cancer Care 

 spoke with David H. Aggen, MD, PhD, of Memorial Sloan Kettering Cancer Center, Robert S. Alter, MD, of the John Theurer Cancer Center, Arnab Basu, MD, MPH, FACP, of the O’Neal Comprehensive Cancer, Mehmet Asim Bilen, MD, of Winship Cancer Institute, and Chung-Han Lee, MD, MPH, of Memorial Sloan Kettering Cancer Center, share their thoughts on recent advances in treatment options for metastatic renal cell carcinoma (RCC) and comment on emerging data in the field.

In an OncView™ program, David H. Aggen, MD, PhD, Robert S. Alter, MD, Arnab Basu, MD, MPH, FACP, Mehmet Asim Bilen, MD, and Chung-Han Lee, MD, MPH, offer their expert insights for the treatment of RCC.

Kidney Cancer

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