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Bristol-Myers Squibb Announces CheckMate -451 Study Did Not Meet Primary Endpoint of Overall Survival with Opdivo Plus Yervoy Vs. Placebo as A Maintenance Therapy in Patients with Extensive-Stage Small Cell Lung Cancer After Completion of First-Line Chemotherapy

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  1. This is a big miss. Though even a positive result would need to be weighed for significance relative to the positive results for chemo/atezolizumab in the first line IMpower133 trial, the fact that this trial failed to improve survival compared to placebo in the maintenance setting is a great disappointment, especially on top of the recently reported (though only as a press release thus far) negative result on the CheckMate-331 trial of nivolumab alone vs. 2nd line chemo for relapsed SCLC. This result leads me to be far less inclined to consider either nivo or nivo/ipi as a very compelling option in relapsed SCLC, despite the FDA approval of nivo in this setting (actually 3rd line) earlier this year, or based on the Checkmate-032 phase II trial, which seems in retrospect to be yet another reminder of the power of selection bias. Should the emerging results also cloud our view on the utility of nivolumab +/- ipilimumab in NSCLC? Not enough to counter strong data, but we don’t have particularly strong data in first line NSCLC at this time.

    These negative results on CheckMate-451 also do not challenge the current concept of integrating immunotherapy into first line treatment for SCLC rather than deferring it as maintenance or 2nd line treatment. Though some are disappointed by the only relatively modestly positive results of IMpower133 with carbo/etoposide +/- atezolizumab, the significant improvement in OS should be sufficient to consider this approach the current standard of care for eligible patients. And the recent results with nivo +/- ipi in SCLC only underscore that significant gains in survival for patients with SCLC are quite hard to come by.

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