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ASCO 2024 Treatment Advances in Bladder and Renal Cell Carcinoma

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07/31/2024
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HIGHLIGHTS FROM THE 2024 AMERICAN SOCIETY OF CLINICAL ONCOLOGY ANNUAL MEETING
Characterization of Complete Responders to Nivolumab + Gemcitabine-Cisplatin vs Gemcitabine-Cisplatin Alone and Patients with Lymph Node–only Metastatic Urothelial Carcinoma from the CheckMate 901 Trial
Matt D. Galsky, MD, FASCO
Matt Galsky presented a post hoc analysis of the CheckMate 901 trial, focusing on complete responders and patients with lymph node-only metastatic urothelial carcinoma treated with nivolumab plus gemcitabine-cisplatin versus GC alone. The combination therapy showed significant improvements in overall survival, progression-free survival, and complete response rates
S1600: Effects of Immune-Enhancing Nutrition on Radical Cystectomy Outcomes: Primary Results from the Randomized Phase III Double-Blind Clinical Trial
Jill Hamilton-Reeves, Ph.D., RD, CSO
Jill Hamilton-Reeves presented the primary results of the S1600 trial at ASCO 2024, assessing the effects of immune-enhancing nutrition on outcomes for bladder cancer patients undergoing radical cystectomy. The randomized, double-blind, phase III trial compared specialized immunonutrition (fortified with L-arginine, omega-3 fatty acids, and dietary nucleotides) to standard oral nutritional support
PROs from a Randomized, Phase 3 Trial of Enfortumab Vedotin plus Pembrolizumab Versus Platinum-Based Chemotherapy in Previously Untreated Locally Advanced or Metastatic Urothelial Cancer
Shilpa Gupta, MD
Shilpa Gupta presented patient-reported outcomes from the EV-302 trial, which compared enfortumab vedotin plus pembrolizumab with platinum-based chemotherapy in untreated locally advanced or metastatic urothelial cancer. The study showed that enfortumab vedotin plus pembrolizumab significantly improved progression-free and overall survival without compromising quality of life or functioning.
Impact of Exposure on Outcomes with Enfortumab Vedotin in Patients with Locally Advanced or Metastatic Urothelial Cancer
Daniel Petrylak, MD
Daniel Petrylak presented an analysis of the impact of enfortumab vedotin exposure on outcomes in patients with locally advanced or metastatic urothelial cancer. The study demonstrated that enfortumab vedotin monotherapy at 1.25 mg/kg 3Q4W showed consistent benefits and a manageable safety profile across multiple trials. Higher dose intensity was generally associated with a greater probability of response, and despite common dose modifications to manage adverse events, patients continued to benefit from the treatment.
Cost Effectiveness Analysis of Nadofaragene Firadenovec for the Treatment of High-Risk, BCG–unresponsive, NMIBC from a US Third-Party Payer Perspective
Min Yang, MD, PhD
Min Yang presented a cost-effectiveness analysis of nadofaragene firadenovec compared to pembrolizumab for the treatment of high-risk, BCG–unresponsive, non-muscle invasive bladder cancer (NMIBC) from a United States third-party payer perspective at ASCO 2024. Using a Markov model over a lifetime horizon, the analysis showed that nadofaragene firadenovec resulted in an incremental cost per quality-adjusted life year of $123,725 gained compared to pembrolizumab. 
Phase 3 Study of Disitamab Vedotin with Pembrolizumab vs Chemotherapy in Patients with Previously Untreated Locally Advanced or Metastatic Urothelial Carcinoma That Expresses HER2 (DV-001)
Matt Galsky, MD
Matt Galsky presented the DV-001 trial at ASCO 2024, which is an ongoing phase 3 study evaluating the combination of disitamab vedotin (DV) plus pembrolizumab versus chemotherapy in patients with previously untreated locally advanced or metastatic urothelial carcinoma (la/mUC) expressing HER2. Platinum-based chemotherapy has been the standard first-line therapy for la/mUC, but novel biomarker-informed strategies may improve outcomes.
Outcomes of Patients with BCG–unresponsive High-Risk Non–Muscle Invasive Bladder Cancer Who Demonstrated Nonresponse to Pembrolizumab in KEYNOTE-057: A Post Hoc Analysis
Roger Li, MD
Roger Li presented a post hoc analysis of the KEYNOTE-057 trial at ASCO 2024, evaluating outcomes of patients with BCG–unresponsive high-risk non–muscle-invasive bladder cancer who showed nonresponse to pembrolizumab. Among the 144 non-responding patients, those who underwent upfront or delayed radical cystectomy or received bladder-sparing therapies alone had similar oncologic outcomes, with comparable progression-free survival and overall survival rates.
Biomarker Analyses in Patients with Advanced Renal Cell Carcinoma from the Phase 3 CLEAR Trial
Toni Choueiri, MD
Toni Choueiri presented biomarker analyses from the phase 3 CLEAR trial, which assessed lenvatinib + pembrolizumab versus sunitinib in treatment-naïve patients with advanced renal cell carcinoma. The analysis revealed that lenvatinib + pembrolizumab significantly improved progression-free survival (PFS) and objective response rate (ORR) compared to sunitinib, regardless of PD-L1 status, RCC driver gene mutations, or gene signature subtypes.
Biomarker Analysis of the Phase 3 KEYNOTE-426 Study of Pembrolizumab plus Axitinib Versus Sunitinib for Advanced Renal Cell Carcinoma
Brian I. Rini, MD
Brian Rini presented findings from the KEYNOTE-426 study, highlighting that pembrolizumab + axitinib demonstrated improved clinical outcomes over sunitinib for advanced RCC, particularly in patients with higher T-cell inflamed gene expression and across various molecular subtypes. The analysis also indicated that pembrolizumab + axitinib's efficacy was consistent regardless of PD-L1 CPS or mutational status, emphasizing the potential for broad applicability in biomarker-directed treatments.
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
Laurence Albiges, MD, PhD
Laurence Albiges presented an analysis of circulating kidney injury molecule-1 (KIM-1) as a biomarker in the IMmotion010 trial, which evaluated adjuvant atezolizumab versus placebo in RCC patients at high risk of recurrence post-resection. High baseline KIM-1 levels were linked to poorer prognosis but improved disease-free survival with atezolizumab compared to placebo. 
Partitioned Overall Survival: Comprehensive Analysis of Survival States over 4 Years in CheckMate 9ER Comparing First-Line Nivolumab plus Cabozantinib Versus Sunitinib in Advanced Renal Cell Carcinoma
Charlene Mantia, MD
Charlene Mantia presented a four-year comprehensive survival analysis from the CheckMate 9ER trial comparing nivolumab plus cabozantinib to sunitinib in advanced renal cell carcinoma. The study found that nivolumab plus cabozantinib improved overall survival (49.2% vs. 40.2%) and treatment-free survival compared to sunitinib.
In It for the Long Run: Updated Outcomes From Phase III Trials
Camillo Porta, MD
Camillo Porta discussed updated outcomes from Phase III trials in bladder and kidney cancer at ASCO 2024. He highlighted the CheckMate 9ER trial's findings, emphasizing the modest advantage in treatment-free survival (TFS) with nivolumab+cabozantinib over TKI monotherapy, despite its limited impact on clinical decision-making. 
Subcutaneous Nivolumab Versus Intravenous Nivolumab in Patients with Previously Treated Advanced or Metastatic Clear Cell Renal Cell Carcinoma: Safety and Patient-Reported Outcomes of the Randomized Phase 3 CheckMate 67T Trial
Maria T. Bourlon, MD, MSc
Maria Bourlon presented findings from the CheckMate 67T trial, comparing subcutaneous and intravenous administration of nivolumab in previously treated advanced clear cell renal cell carcinoma patients. The study demonstrated non-inferiority of subcutaneous nivolumab in terms of pharmacokinetics and objective response rate compared to intravenous nivolumab.
Belzutifan in Patients with Advanced Clear Cell Renal Cell Carcinoma: Subgroup Analysis of the Phase 2 LITESPARK-013 Study
Michael Atkins, MD, FASCO
Michael Atkins presented a subgroup analysis of the phase II LITESPARK-013 trial at ASCO 2024, evaluating the efficacy of belzutifan in patients with advanced clear cell renal cell carcinoma (ccRCC). The analysis included patients treated with either 200 mg or 120 mg of belzutifan once daily. Durable antitumor responses were observed across various subgroups, with favorable outcomes seen in patients with certain prior treatment histories, IMDC risk groups, and disease characteristics.
Comparative Effectiveness of First-Line Ipilimumab plus Nivolumab Versus Immune Checkpoint Inhibitors + Tyrosine Kinase Inhibitors in Patients with Intermediate or Poor Risk Metastatic Clear Cell Renal Cell Carcinoma
Micah Ostrowski, MD
Micah Ostrowski presented a retrospective study comparing the effectiveness of first-line ipilimumab plus nivolumab versus immune checkpoint inhibitors plus tyrosine kinase inhibitors in patients with intermediate or poor-risk metastatic clear cell renal cell carcinoma. These findings provide valuable guidance to clinicians in selecting between these frontline treatment options in the absence of head-to-head clinical trials.
Zanzalintinib (XL092) plus Nivolumab in Non-Clear Cell Renal Cell Carcinoma: The Randomized Phase 3 STELLAR-304 Study
Sumanta K. Pal, MD, FASCO
Sumanta Pal presented the results of the randomized phase III STELLAR-304 trial at ASCO 2024, evaluating the combination of zanzalintinib (XL092) plus nivolumab in patients with non-clear cell renal cell carcinoma (nccRCC). The study aims to address the lack of effective treatments for nccRCC by investigating the efficacy and safety of zanzalintinib plus nivolumab compared to sunitinib, the current standard of care. The trial's primary endpoints include progression-free survival and objective response rate, with overall survival and safety as secondary endpoints.
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