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 Article (Clinical Trial, Phase III;Journal Article;Multicenter Study)

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; identifier: NCT01642004) or nonsquamous (CheckMate 057; 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 in the 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.

Full Text

Duke Authors

Cited Authors

  • Horn, L; Spigel, DR; Vokes, EE; Holgado, E; Ready, N; Steins, M; Poddubskaya, E; Borghaei, H; Felip, E; Paz-Ares, L; Pluzanski, A; Reckamp, KL; Burgio, MA; Kohlhäeufl, M; Waterhouse, D; Barlesi, F; Antonia, S; Arrieta, O; Fayette, J; Crinò, L; Rizvi, N; Reck, M; Hellmann, MD; Geese, WJ; Li, A; Blackwood-Chirchir, A; Healey, D; Brahmer, J; Eberhardt, WEE

Published Date

  • December 10, 2017

Published In

Volume / Issue

  • 35 / 35

Start / End Page

  • 3924 - 3933

PubMed ID

  • 29023213

Pubmed Central ID

  • PMC6075826

Electronic International Standard Serial Number (EISSN)

  • 1527-7755

Digital Object Identifier (DOI)

  • 10.1200/JCO.2017.74.3062


  • eng

Conference Location

  • United States