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ARTICLE | Clinical News

Opdivo misses survival endpoint in Phase III for SCLC

October 19, 2018 5:59 PM UTC

Bristol-Myers Squibb Co. (NYSE:BMY) said Opdivo nivolumab missed the primary endpoint of improving overall survival (OS) in the Phase III CheckMate -331 trial to treat small cell lung cancer in patients who relapsed following platinum-based chemotherapy. The anti-PD-1 mAb has accelerated approval in the U.S. to treat metastatic SCLC with progression after platinum-based chemotherapy and at least one other line of therapy (see "Opdivo Gets Accelerated Approval in SCLC Population").

According to Opdivo's FDA accelerated approval letter, BMS is required to submit data by July 2019 from at least one randomized clinical trial demonstrating Opdivo's superiority in OS over available therapy in patients with stage IV SCLC...