BMS Reports Opdivo Positive Data in Urothelial Carcinoma

Bristol Myers Squibb (BMS) says CheckMate-274, a pivotal Phase 3 trial evaluating Opdivo (nivolumab) after surgery in patients with high-risk, muscle-invasive urothelial carcinoma, met its primary endpoints of improving disease-free survival versus placebo in both all randomized patients and in patients whose tumor cells express PD-L1 (programmed death-ligand 1) greater than or equal to 1%. CheckMate-274 is the only Phase 3 trial in which immunotherapy has reduced the risk of relapse in the adjuvant setting for these patients, the company says. Opdivo’s safety profile was consistent with previously reported studies in solid tumors, it adds.

BMS says it plans to complete a full evaluation of the data to present the results at an upcoming medical conference, and submit data to health authorities. “The CheckMate-274 trial will continue as planned to allow for future analyses of secondary endpoints, including overall survival and disease-specific survival,” it says