Eighteen months data for Opdivo (nivolumab) in Checkmate-057 trial for NSCLC- BMS

BMS announced longer term (18 month) survival data from CheckMate-057, an open-label, randomised Phase III study evaluating nivolumab (n=292) versus docetaxel (n=290) in previously-treated patients with advanced, non-squamous (NSQ) non-small cell lung cancer (NSCLC). Nivolumab continued to demonstrate superior overall survival (OS) – the study’s primary endpoint – with an estimated 39% of patients alive at 18 months (95% CI, 34–45) versus 23% for docetaxel, based on a minimum follow-up of 17.1 months.

Opdivo also continued to demonstrate a reduction in the risk of death by 28% (hazard ratio 0.72; 95% CI, 0.60–0.88). In the study, Grade 3/4 treatment-related adverse events were reported in 10% of patients treated with nivolumab versus 54% in the docetaxel arm. These data were presented on 28 September during the 2015 European Cancer Congress (Abstract #3010) and published in the New England Journal of Medicine.

See: Nivolumab versus Docetaxel in Advanced Nonsquamous Non-Small-Cell Lung Cancer. Borghaei H, Paz-Ares L, Horn L, Spigel DR, Steins M, Ready NE, et al. N Engl J Med. 2015 Oct 22.