Nivolumab versus docetaxel in previously treated patients with advanced non-small-cell lung cancer: Two-year outcomes from two randomized, open-label, phase III Trials (CheckMate 017 and CheckMate 057)

Leora Horn, David R. Spigel, Everett E. Vokes, Esther Holgado, Neal Ready, Martin Steins, Elena Poddubskaya, Hossein Borghaei, Enriqueta Felip, Luis Paz-Ares, Adam Pluzanski, Karen L. Reckamp, Marco A. Burgio, Martin Kohlhäeufl, David Waterhouse, Fabrice Barlesi, Scott Antonia, Oscar Arrieta, Jérôme Fayette, Lucio CrinòNaiyer Rizvi, Martin Reck, Matthew D. Hellmann, William J. Geese, Ang Li, Anne Blackwood-Chirchir, Diane Healey, Julie Brahmer, Wilfried E.E. Eberhardt

Research output: Contribution to journalArticle

Abstract

Purpose: Nivolumab, a programmed death-1 inhibitor, prolonged overall survival compared with docetaxel in two independent phase III studies in previously treated patients with advanced squamous (CheckMate 017; ClinicalTrials.gov identifier: NCT01642004) or nonsquamous (CheckMate 057; ClinicalTrials.gov identifier: NCT01673867) non-small-cell lung cancer (NSCLC). We report updated results, including a pooled analysis of the two studies. Methods: Patients with stage IIIB/IV squamous (N = 272) or nonsquamous (N = 582) NSCLC and disease progression during or after prior platinum-based chemotherapy were randomly assigned 1:1 to nivolumab (3 mg/kg every 2 weeks) or docetaxel (75 mg/m2 every 3 weeks). Minimum follow-up for survival was 24.2 months. Results: Two-year overall survival rates with nivolumab versus docetaxel were 23% (95% CI, 16% to 30%) versus 8% (95% CI, 4% to 13%) in squamous NSCLC and 29% (95% CI, 24% to 34%) versus 16% (95% CI, 12% to 20%) in nonsquamous NSCLC; relative reductions in the risk of death with nivolumab versus docetaxel remained similar to those reported in the primary analyses. Durable responses were observed with nivolumab; 10 (37%) of 27 confirmed responders with squamous NSCLC and 19 (34%) of 56 with nonsquamous NSCLC had ongoing responses after 2 years' minimum follow-up. No patient in either docetaxel group had an ongoing response. In the pooled analysis, the relative reduction inthe risk of death with nivolumab versus docetaxel was 28% (hazard ratio, 0.72; 95% CI, 0.62 to 0.84), and rates of treatment-related adverse events were lower with nivolumab than with docetaxel (any grade, 68% v 88%; grade 3 to 4, 10% v 55%). Conclusion: Nivolumab provides long-term clinical benefit and a favorable tolerability profile compared with docetaxel in previously treated patients with advanced NSCLC.

Original languageEnglish (US)
Pages (from-to)3924-3933
Number of pages10
JournalJournal of Clinical Oncology
Volume35
Issue number35
DOIs
StatePublished - Dec 10 2017

    Fingerprint

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Cite this

Horn, L., Spigel, D. R., Vokes, E. E., Holgado, E., Ready, N., Steins, M., Poddubskaya, E., Borghaei, H., Felip, E., Paz-Ares, L., Pluzanski, A., Reckamp, K. L., Burgio, M. A., Kohlhäeufl, M., Waterhouse, D., Barlesi, F., Antonia, S., Arrieta, O., Fayette, J., ... Eberhardt, W. E. E. (2017). Nivolumab versus docetaxel in previously treated patients with advanced non-small-cell lung cancer: Two-year outcomes from two randomized, open-label, phase III Trials (CheckMate 017 and CheckMate 057). Journal of Clinical Oncology, 35(35), 3924-3933. https://doi.org/10.1200/JCO.2017.74.3062