Bristol-Myers Squibb(US:BMY) Businesswire·2024-01-22 22:00Clinical Trial Results - The CheckMate -9ER trial demonstrated superior progression-free survival (PFS) and objective response rates (ORR) for Opdivo plus CABOMETYX compared to sunitinib in patients with advanced or metastatic renal cell carcinoma (RCC) [1][2] - Median PFS was 16.4 months for Opdivo plus CABOMETYX vs 8.4 months for sunitinib, with a hazard ratio (HR) of 0.58 [2] - Median overall survival (OS) was 46.5 months for Opdivo plus CABOMETYX vs 36.0 months for sunitinib, with an HR of 0.77 [2] - ORR was 55.7% for Opdivo plus CABOMETYX vs 27.7% for sunitinib, with complete response (CR) rates of 13.6% vs 4.6% respectively [2] - The combination showed durable benefits across patient subgroups, including intermediate-/poor-risk and favorable-risk groups [3][4] Safety and Efficacy - No new safety concerns were identified in the follow-up analysis, with any-grade treatment-related adverse events (TRAEs) occurring in 97.5% of Opdivo plus CABOMETYX patients vs 93.1% for sunitinib [2] - Grade ≥3 TRAEs occurred in 67.5% of Opdivo plus CABOMETYX patients vs 55.3% for sunitinib [2] - The combination demonstrated durable and clinically meaningful benefits in health-related quality of life compared to sunitinib [1] Industry and Company Impact - The results reinforce the role of Opdivo plus CABOMETYX as a first-line treatment option for advanced RCC, with potential to improve long-term survival outcomes [5][6] - Bristol Myers Squibb and Exelixis continue to collaborate on advancing treatment regimens for advanced cancers, including genitourinary cancers [5][66] - The trial results highlight the ongoing need for effective therapeutic options for patients with advanced or metastatic RCC, particularly those with challenging-to-treat disease burdens [5][6]