Mid-trial evaluation by an independent Data Monitoring Committee found overall survival with Opdivo (nivolumab) in the Checkmate-017 trial was significantly better than the control arm. BMS now plans to submit results to the FDA for approval of the PD-1 inhibitor in lung cancer.
Bristol-Myers Squibb Company (NYSE:BMY) today announced that an open-label, randomized Phase 3 study evaluating versus docetaxel in previously treated patients with advanced, squamous cell non-small cell lung cancer was stopped early because an assessment conducted by the independent Data Monitoring Committee concluded that the study met its endpoint, demonstrating superior overall survival in patients receiving compared to the control arm. The company will share these data—which for the first time indicate a survival advantage with an anti-PD1 immune checkpoint inhibitor in lung cancer—with health authorities.
Complete press release by BMS: http://bit.ly/14NW37U