Nivolumab versus docetaxel in advanced squamous-cell non-small-cell lung cancer

Julie Brahmer, Karen L. Reckamp, Paul Baas, Lucio Crinò, Wilfried E.E. Eberhardt, Elena Poddubskaya, Scott Antonia, Adam Pluzanski, Everett E. Vokes, Esther Holgado, David Waterhouse, Neal Ready, Justin Gainor, Osvaldo Arén Frontera, Libor Havel, Martin Steins, Marina C. Garassino, Joachim G. Aerts, Manuel Domine, Luis Paz-AresMartin Reck, Christine Baudelet, Christopher T. Harbison, Brian Lestini, David R. Spigel

Research output: Contribution to journalArticlepeer-review

Abstract

BACKGROUND Patients with advanced squamous-cell non-small-cell lung cancer (NSCLC) who have disease progression during or after first-line chemotherapy have limited treatment options. This randomized, open-label, international, phase 3 study evaluated the efficacy and safety of nivolumab, a fully human IgG4 programmed death 1 (PD-1) immune-checkpoint-inhibitor antibody, as compared with docetaxel in this patient population. METHODS We randomly assigned 272 patients to receive nivolumab, at a dose of 3 mg per kilogram of body weight every 2 weeks, or docetaxel, at a dose of 75 mg per square meter of body-surface area every 3 weeks. The primary end point was overall survival. RESULTS The median overall survival was 9.2 months (95% confidence interval [CI], 7.3 to 13.3) with nivolumab versus 6.0 months (95% CI, 5.1 to 7.3) with docetaxel. The risk of death was 41% lower with nivolumab than with docetaxel (hazard ratio, 0.59; 95% CI, 0.44 to 0.79; P<0.001). At 1 year, the overall survival rate was 42% (95% CI, 34 to 50) with nivolumab versus 24% (95% CI, 17 to 31) with docetaxel. The response rate was 20% with nivolumab versus 9% with docetaxel (P = 0.008). The median progression-free survival was 3.5 months with nivolumab versus 2.8 months with docetaxel (hazard ratio for death or disease progression, 0.62; 95% CI, 0.47 to 0.81; P<0.001). The expression of the PD-1 ligand (PD-L1) was neither prognostic nor predictive of benefit. Treatment-related adverse events of grade 3 or 4 were reported in 7% of the patients in the nivolumab group as compared with 55% of those in the docetaxel group. CONCLUSIONS Among patients with advanced, previously treated squamous-cell NSCLC, overall survival, response rate, and progression-free survival were significantly better with nivolumab than with docetaxel, regardless of PD-L1 expression level.

Original languageEnglish (US)
Pages (from-to)123-135
Number of pages13
JournalNew England Journal of Medicine
Volume373
Issue number2
DOIs
StatePublished - Jul 9 2015

ASJC Scopus subject areas

  • Medicine(all)

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