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Bristol-Myers Says Phase 3 CheckMate -331 Study Fails To Meet Primary Endpoint

Bristol-Myers Squibb Company (BMY) today announced results from the Phase 3 CheckMate -331 study evaluating Opdivo or nivolumab versus the current standard of care, topotecan or amrubicin (where approved), in patients with small cell lung cancer or SCLC who relapsed following platinum-based chemotherapy. The study did not meet its primary endpoint of overall survival or 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.

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