Phase III CheckMate-331 study of Opdivo fails primary endpoint

Top-line results from the Phase III CheckMate-331 study evaluating Opdivo (nivolumab) versus the current standard of care, topotecan or amrubicin (where approved), in patients with small cell lung cancer (SCLC) who relapsed following platinum-based chemotherapy, did not meet its primary endpoint of overall survival (OS) versus chemotherapy.

The safety profile of Opdivoin this trial was consistent with that observed in previously reported monotherapy studies involving patients with SCLC, said Bristol-Myers Squibb (NYSE: BMY), whose share price edged 0.53% higher to $57.84 despite the disappointing results.

Dr Sabine Maier, development lead, thoracic cancers, at Bristol-Myers Squibb, commented: “Small cell lung cancer is a highly aggressive disease in which significant unmet need remains. We are focused on researching innovative oncology therapies to improve outcomes for patients with lung cancer.”