Two year survival data from CheckMate 057 and 017 trials for Opdivo (nivolumab) versus docetaxel in NSCLC- BMS

Bristol-Myers Squibb Company announced two-year overall survival data from two pivotal Phase III studies evaluating Opdivo (nivolumab) versus docetaxel in previously treated metastatic non-small cell lung cancer (NSCLC). Nivolumab continued to demonstrate improved overall survival (OS), the primary endpoint for both studies, at the landmark two-year time point. In CheckMate -057, a trial in previously treated non-squamous NSCLC, 29% of patients treated with nivolumab were alive at two years (n=81/292) versus 16% of those treated with docetaxel (n=45/290) (HR: 0.75 [95% CI: 0.63, 0.91]). In CheckMate -017, a trial in previously treated squamous NSCLC, 23% of patients treated with nivolumab were alive at two years (n=29/135) versus 8% of those treated with docetaxel (n=11/137) (HR: 0.62 [95% CI: 0.47, 0.80]).

In Checkmate -057 and -017, treatment-related adverse events (AEs) occurred in 71% and 61% of nivolumab-treated patients. The safety profile of nivolumab at two years was consistent with previous reports of data from both studies. These data will be presented at the 52nd Annual Meeting of the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, IL, on 3–7 June 2016.