Nivolumab Offers Better Overall Survival than Chemo in Refractory Nonsquamous NSCLC

The PD-1 immune checkpoint inhibitor nivolumab (Opdivo) offers superior overall survival (OS) to docetaxel chemotherapy among patients with advanced nonsquamous non-small cell lung cancer (NSCLC) that has become refractory to first-line platinum-based doublet chemotherapy, according to updated findings from the randomized, open-label, international phase III CheckMate 057 study. The findings were published in TheNew England Journal of Medicine.¹

The findings “show that people with lung cancer not only live longer when treated with the immunotherapy drug nivolumab, but their quality of life is better and toxicities are fewer and less severe,” reported study coauthor David Gerber, MD, Associate Professor of Internal Medicine at UT Southwestern in Dallas.

Patients were randomly assigned to receive nivolumab (3 mg/kg every 2 weeks) or docetaxel (75 mg/m² every 3 weeks). At an interim analysis with a minimum follow-up of 13.2 months, median OS was 12.2 months among 292 patients administered nivolumab versus 9.4 months among 290 patients in the docetaxel study arm-a 27% lower risk of death (mortality hazard ratio [HR], 0.73; 96% CI, 0.59 to 0.89; P = .002).

The 1-year OS rate was 51% among patients in the nivolumab study arm versus 39% among those in the docetaxel group, the coauthors noted.

With additional follow-up (minimum, 17.2 months), the median overall survival was 12.2 months versus 9.4 months for nivolumab versus docetaxel, respectively, the coauthors reported.

Subgroup analyses showed that HRs favored nivolumab over chemotherapy for most patient subgroups. Exceptions included patients who were receiving third-line therapy (66 patients), those who lived except for patients who were receiving third-line therapy; never-smokers; and patients with EGFR mutation-positive status.

Overall, any-grade toxicity rates were similar between the study arms, but grade 3/4 adverse events were less common among patients receiving nivolumab (10%) than those taking docetaxel (54%), the coauthors reported. The most frequently reported nivolumab-related toxicities of any grade included fatigue (16% of patients), nausea (12%), diminished appetite (10%), and asthenia (10%).

Nivolumab targets the programmed cell death-1 (PD-1) cell surface protein that stops a patient’s immune system from mounting attacks on cancer cells.

The US Food and Drug Administration (FDA) approved nivolumab for squamous NSCLC in March 2015. Nivolumab is also approved for the treatment of refractory metastatic or unresectable melanoma.

References:

• Borghaei H, Paz-Ares L, Horn L, et al. (2015). Nivolumab versus Docetaxel in Advanced Nonsquamous Non–Small-Cell Lung Cancer. The New England Journal of Medicine.