BMS provides long-term survival results from pooled analyses of Opdivo in previously-treated NSCLC patients

Bristol-Myers Squibb Company announced results from pooled analyses of survival data from four studies (CheckMate -017, -057, -063 and -003; n=664) in patients with previously-treated advanced non-small cell lung cancer (NSCLC) who were treated with Opdivo (nivolumab). In the pooled analysis of the four studies, 14% of all Opdivo-treated patients were alive at four years. Notably, in patients with PD-L1 greater than 1% and <1%, four-year overall survival (OS) rates were 19% and 11%, respectively.

In the pooled analysis of the two phase III trials, CheckMate -017 and -057, the four-year OS rate for Opdivo-treated patients was 14% compared to 5% for docetaxel-treated patients. Additionally, exploratory landmark analysis of OS found that of patients who had a complete or partial response at six months, 58% of those treated with Opdivo were alive four years later vs. 12% of patients treated with docetaxel. Of patients who had stable disease at six months, 19% of those treated with Opdivo were alive four years later vs. 2% of patients treated with docetaxel. The data were presented Abstract CT195) at the American Association for Cancer Research (AACR) Annual Meeting 2019 in Atlanta.

Long-term safety data for Opdivo from all four studies were consistent with the known adverse event profile and did not reveal any new safety signals. The discontinuation rate due to treatment-related adverse events (AEs) was 8.7% in patients treated with Opdivo. The most common treatment-related AE was fatigue (in 21.7% of patients).