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Bristol-Myers Squibb Announces Phase 3 CheckMate -331 Study Does Not Meet Primary Endpoint of Overall Survival with Opdivo Versus Chemotherapy in Patients with Previously Treated Relapsed Small Cell Lung Cancer

(Bristol-Myers) Oct 12, 2018 - Bristol-Myers Squibb Company today 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.

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H. Jack West, MD (Posted: October 12, 2018)

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Disappointing result, especially since treatment with either topotecan or amrubicin in relapsed SCLC represents a very low bar for any competing idea. This represents an area where the standard of care is particularly unimpressive, so for nivolumab to have failed to beat chemotherapy here represents a major disappointment. With the positive OS data seen with IMpower133 that added atezolizumab to standard first line chemotherapy in NSCLC, we are likely to see immunotherapy move overwhelmingly into the first line setting, but here nivolumab suffers in comparison by failing to beat even a weak competitor.

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