Bristol-Myers Squibb announced results from pooled analyses of survival data from four studies in patients with previously-treated advanced non-small cell lung cancer who were treated with Opdivo. 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 or equal to1% and less than1%, four-year overall survival rates were 19% and 11%, respectively. In the pooled analysis of the two phase 3 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 at the American Association for Cancer Research 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 was 8.7% in patients treated with Opdivo. The most common treatment-related AE was fatigue. Scott Antonia, M.D., Ph.D., director of the Duke Cancer Institute Center for Cancer Immunotherapy, commented, “These analyses in a large population of patients with previously-treated advanced non-small cell lung cancer show, for the first time, that response to Opdivo correlates to a survival benefit over many years. These long-term survival outcomes are particularly interesting given that, historically, the average five-year survival rate for this patient population is approximately 5%.”
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