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# BMS Opdivo Trial Misses Primary Endpoint in Lung Cancer
- URL: https://www.fdaweb.com/bms-opdivo-trial-misses-primary-endpoint-in-lung-cancer/
- Published: 2018-10-12T12:00:00.000Z
- Updated: 2026-09-15T00:37:51.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5142576

Bristol-Myers Squibb has reported disappointing topline results from its Phase 3 CheckMate -331 study evaluating Opdivo (nivolumab) versus the current standard of care, topotecan or amrubicin, 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 for patients treated with Opdivo versus chemotherapy. Opdivo’s safety profile in the trial was consistent with that seen in previously reported monotherapy studies, the company says. Bristol-Myers adds that it is continuing investigating the role of Opdivo plus Yervoy and Opdivo monotherapy versus placebo in frontline setting as a maintenance therapy for patients with SCLC who do not progress on first-line chemotherapy.