In an interim analysis, CheckMate -274 met primary endpoints of disease-free survival in both all randomized patients and in patients whose tumor cells express PD-L1 ≥1%
Opdivo has now demonstrated clinically meaningful efficacy in the adjuvant treatment of three tumor types, including bladder cancer, melanoma and esophageal/gastroesophageal junction cancer
San Francisco, CA (UroToday.com) — Bristol Myers Squibb announced that 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 (DFS) versus placebo in both all randomized patients and in patients whose tumor cells express PD-L1 ≥1% (programmed death-ligand 1). CheckMate -274 is the first and only Phase 3 trial in which immunotherapy has reduced the risk of relapse in the adjuvant setting for these patients. The safety profile of Opdivo was consistent with previously reported studies in solid tumors.