Opdivo fails to meet primary endpoint in CHECKMATE 331 study versus chemotherapy for small cell lung cancer.- BMS

Bristol-Myers Squibb Company announced topline 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. 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.

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.