Bristol-Myers Squibb Co. 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 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 ≥1% and <1%, four-year overall survival 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 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 (in 21.7% of patients).
“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,” Scott Antonia, director of the Duke Cancer Institute Center for Cancer Immunotherapy, said in a statement. “These long-term survival outcomes are particularly interesting given that, historically, the average five-year survival rate for this patient population is approximately 5%.”
These pooled analyses were conducted to evaluate the long-term benefit (with a minimum follow-up of four years) of Opdivo and impact of response or disease control on subsequent long-term overall survival.
The pooled analysis of CheckMate -017 and CheckMate -057 represents the longest follow-up from phase 3 randomized trials of previously treated advanced non-small cell lung cancer patients treated with Immuno-Oncology therapy.
OS was estimated for patients with NSCLC across histologies treated with Opdivo in pooled analyses from CheckMate -017, -057, -063, and -003 (n=664), and for patients randomized to Opdivo (n=427) or docetaxel (n=427) in pooled analyses from CheckMate -017 and -057. Other analyses of CheckMate -017 and -057 included estimation of OS in patients alive at six months by response status at six months, and OS in all responders (complete or partial response) from the time of response.
