Pooled data from two clinical trials showed that nivolumab (Opdivo®) resulted in a fivefold increase in five-year overall survival (OS; primary endpoint) compared with docetaxel in patients with advanced non-small cell lung cancer (NSCLC). The data were presented at the World Lung Conference on Lung Cancer in Barcelona, Spain.
The CheckMate 017 and CheckMate 057 trials included 854 patients with advanced NSCLC whose disease had progressed during or after first-line platinum-based chemotherapy. Patients were randomized 1:1 to nivolumab 3 mg/kg every two weeks or docetaxel 75 mg/m2 every three weeks until disease progression or unacceptable toxicity. In the pooled analysis, researchers evaluated data from a total of 427 patients in each treatment group.
Improved survival with nivolumab
At five-year follow-up, 50 patients in the nivolumab group and nine in the docetaxel cohort were alive. Five-year OS rates were 13.4% in the nivolumab cohort and 2.6% in the docetaxel group. Median OS was 11.1 months and 8.1 months, respectively (hazard ratio [HR] = 0.68; 95% CI, 0.59-0.78). Five-year progression-free survival rates were 8% in the nivolumab group and 0% in the docetaxel group. Median PFS was 2.5 months and 3.5 months, respectively (HR=0.79; 95% CI, 0.68-0.92).
Median duration of response was 19.9 months (95% CI, 11.4-30.8) with nivolumab and 5.6 months (95% CI, 4.4-7.0) with docetaxel. At five years, 32.2% of those who received nivolumab maintained a response.
The researchers observed no new safety concerns associated with nivolumab after longer-term follow-up. Between three- and five-year follow-up, eight (26%) patients receiving nivolumab reported a treatment-related adverse event, the most common of which were related to skin (n=4; 13%).