Overall survival was longer with nivolumab than with docetaxel among patients with advanced nonsquamous non-small cell lung cancer (NSCLC) that had progressed during or after platinum-based chemotherapy, results from the CheckMate 057 trial published online ahead of print in The New England Journal of Medicine have shown.1
For the open-label, international, phase 3 study, researchers enrolled 582 patients nonsquamous NSCLC that had progressed during or after platinum-based doublet chemotherapy.
Participants were randomly assigned 1:1 to receive nivolumab 3 mg/kg every 2 weeks or docetaxel 75 mg/m2 every 3 weeks.
Results showed that median overall survival was 12.2 months (95% CI: 9.7-15.0) in the nivolumab group and 9.4 months (95% CI: 8.1-10.7) in the docetaxel group (HR = 0.73; 96% CI: 0.59-0.89; P=0.002), representing a 27% lower risk of death with nivolumab.
Researchers found that the 1-year overall survival rate was 51% (95% CI: 45-56) with nivolumab vs 39% (95% CI: 33-45) with docetaxel and the 18-month overall survival rate was 39% (95% CI: 34-45) and 23% (95% CI: 19-28), respectively.
The study also demonstrated a higher 1-year progression-free survival rate with nivolumab than with docetaxel (19% vs 8%); however, progression-free survival did not favor nivolumab over docetaxel.
In regard to safety, grade 3 or 4 treatment-related adverse events occurred in 10% of patients in the nivolumab group compared with 54% of those in the docetaxel group.
Nivolumab is a fully human IgG4 programmed death 1 (PD-1) immune-checkpoint-inhibitor antibody that disrupts PD-1–mediated signaling and may restore antitumor immunity. It is already approved by the U.S. Food and Drug Administration (FDA) for the treatment of patients with unresectable or metastatic melanoma and metastatic squamous NSCLC.
- Borghaei H, Paz-Ares L, Horn L, et al. Nivolumab versus docetaxel in advanced nonsquamous non-small cell lung cancer [published online ahead of print September 27, 2015]. N Engl J Med. doi: 10.1056/NEJMoa1507643.