BMS reports mixed Phase III data for Opdivo/Yervoy combo in first-line RCC

Bristol-Myers Squibb Co. (NYSE:BMY) reported mixed top-line data from the Phase III CheckMate -214 trial evaluating Opdivo nivolumab (BMS-936558, MDX-1106, ONO-4538) plus Yervoy ipilimumab in about 1,070 previously untreated, intermediate- and poor-risk patients with advanced or metastatic renal cell carcinoma (RCC). Opdivo plus Yervoy met the co-primary endpoint of improving objective response rate (ORR) vs. Sutent sunitinib (41.6% vs. 26.5%), but missed the co-primary endpoint of improving median progression-free survival (PFS) vs. Sutent (11.56 vs. 8.38 months). Median duration of response was not reached for Opdivo plus Yervoy vs. 18.17 months for Sutent.

BMS said it is "encouraged by the totality of the CheckMate -214 data" and plans to present full results, including data on the third co-primary endpoint of overall survival (OS), at an upcoming medical meeting. The open-label, international trial's secondary endpoint is safety...