CheckMate-057
Trial question
What is the role of nivolumab in patients with advanced non-squamous non-small cell lung cancer?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
45.0% female
55.0% male
N = 582
582 patients (263 female, 319 male)
Inclusion criteria: patients with non-squamous non-small cell lung cancer that had progressed during or after platinum-based doublet chemotherapy
Key exclusion criteria: autoimmune disease, symptomatic ILD, systemic immunosuppression, prior treatment with immune-stimulatory antitumor agents including checkpoint-targeted agents, or docetaxel
Interventions
N=292 nivolumab (intravenous dose of 3 mg/kg every 2 weeks)
N=290 docetaxel (intravenous dose of 75 mg/m² every 3 weeks)
Primary outcome
Overall survival
12.2
9.4
12.2 months
9.1 months
6.1 months
3.0 months
0.0 months
Nivolumab
Docetaxel
Significant
increase ▲
Significant increase in overall survival (12.2 months vs. 9.4 months; HR 1.37, 95% CI 1.13 to 1.69)
Secondary outcomes
No significant difference in median progression free survival (2.3 months vs. 4.2 months; HR 0.92, 95% CI 0.77 to 1.1)
Significant increase in objective response (19% vs. 12%; OR 1.7, 95% CI 0.27 to 3.13)
Safety outcomes
No significant differences in all-causality and any-grade adverse events, but fewer grade 3-4 adverse events were reported with nivolumab than docetaxel.
Conclusion
In patients with non-squamous non-small cell lung cancer that had progressed during or after platinum-based doublet chemotherapy, nivolumab was superior to docetaxel with respect to overall survival.
Reference
Borghaei H, Paz-Ares L, Horn L et al. Nivolumab versus Docetaxel in Advanced Nonsquamous Non-Small-Cell Lung Cancer. N Engl J Med. 2015 Oct 22;373(17):1627-39.
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