Bristol-Myers Squibb says late-stage study of Opdivo in lung cancer hits main goal

Bristol-Myers Squibb announced that a Phase III trial of the anti-PD1 immune checkpoint inhibitor Opdivo (nivolumab) versus docetaxel in previously treated patients with advanced, squamous cell non-small-cell lung cancer (NSCLC) was stopped early after meeting its endpoint.

The company indicated that the CheckMate-017 trial's independent Data Monitoring Committee concluded that Opdivo demonstrated superior overall survival compared to docetaxel. Bristol-Myers Squibb noted that results "for the first time indicate a survival advantage with an anti-PD1 immune checkpoint inhibitor in lung cancer."

The study randomised 272 patients with advanced or metastatic squamous cell NSCLC to receive either Opdivo or docetaxel. The trial's main goal is overall survival, while secondary endpoints include objective response rate and progression-free survival. Bristol-Myers Squibb said that it will share the data with health authorities. For related analysis, read ViewPoints: Bristol-Myers Squibb passes through key Opdivo checkpoint with Merck & Co. hot on its heels.

Last month, the FDA granted accelerated approval to Opdivo for the treatment of patients with unresectable or metastatic melanoma and disease progression following Yervoy (ipilimumab) and, if BRAF V600 mutation positive, a BRAF inhibitor. The therapy is the second PD-1 inhibitor cleared by the FDA for the treatment of unresectable or metastatic melanoma following the approval of Merck & Co.'s Keytruda (pembrolizumab) in September last year. Merck is looking to expand clearance of the therapy to include the treatment of NSCLC, with a filing reportedly expedited to around midyear. For related analysis, see ViewPoints: Could Merck & Co. deliver another stealthy US approval for Keytruda – this time in NSCLC?

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