Bristol-Myers Squibb's Opdivo Misses Primary Endpoint in Ph III Study in Small Cell Lung Cancer

October 12, 2018

Bristol-Myers Squibb Company (NYSE:BMY) announced on 8/12/18 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.

CheckMate -331 is an open-label, randomized Phase 3 study evaluating Opdivo monotherapy versus chemotherapy in patients with relapsed small cell lung cancer (SCLC) following platinum-based chemotherapy. Patients were randomized to two treatment arms: an experimental arm assessing Opdivo; and an active comparator arm evaluating topotecan (or amrubicin, upon investigator’s choice, where locally approved for second-line SCLC treatment). The primary objective was overall survival. Secondary endpoints included progression-free survival and objective response rate.

Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to uniquely harness the body’s own immune system to help restore anti-tumor immune response. Data released in April of 2017 indicated that long term survival rates of non-small cell lung cancer patients were superior to those of typical chemotherapy.

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