Key findings on renal cell carcinoma (RCC) presented at the 2025 American Society of Clinical Oncology Genitourinary Cancers Symposium include the final results of the CheckMate 9ER and COSMIC-313 studies, promising data on the HIF-2 alpha inhibitor casdatifan, and a small trial of tislelizumab showing positive results in fumarate hydratase (FH)-deficient RCC, as reported by Dr Eric Jonasch of the University of Texas MD Anderson Cancer Center.
He begins by discussing the CheckMate 9ER study of nivolumab plus cabozantinib vs sunitinib for the treatment of RCC. At 67.6 months, progression-free survival (PFS) and overall survival (OS) remained favorable for the combination.
Next, he discusses the final OS results from the phase 3 COSMIC-313 study of cabozantinib, ipilimumab, and nivolumab vs placebo, ipilimumab, and nivolumab. At a median follow-up of 14.9 months, the triplet still showed an advantage in PFS but no advantage in OS or complete response rate, and a high rate of grade 3 toxicities.
Dr Jonasch next focuses on a phase 1b study of the HIF-2 alpha inhibitor casdatifan that observed an overall response rate (ORR) in the 20%-30% range, suggesting that this investigational agent is likely to move forward into phase 3 trials.
Finally, he discusses a phase 2 study of tislelizumab in 20 patients with unresectable advanced or metastatic FH-deficient RCC. The study showed a 90% ORR, suggesting that this therapy may be effective for this rare and aggressive disease.