Bristol-Myers Squibb Phase 3 CheckMate -331 Study Does Not Meet Primary Endpoint of Overall Survival

Bristol-Myers Squibb Company announced topline results from the Phase 3 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. The study did not meet its primary endpoint of overall survival (OS) with Opdivo versus chemotherapy. The safety profile of Opdivo in this trial was consistent with that observed in previously reported monotherapy studies involving patients with SCLC. Sabine Maier, M.D., development lead, thoracic cancers, 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. We thank the patients, their families, and the physicians involved in the CheckMate -331 study.”

Bristol-Myers Squibb has a broad development program in thoracic malignancies, including SCLC, non-small cell lung cancer and malignant pleural mesothelioma. As part of this program, the Company is investigating the role of Opdivo plus Yervoy and Opdivo monotherapy versus placebo in the frontline setting as a maintenance therapy for patients with SCLC who do not progress on first-line chemotherapy. – Medical Buyer Bureau