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


Authors: 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.; Crinò, L.; Rizvi, N.; Reck, M.; Hellmann, M. D.; Geese, W. J.; Li, A.; Blackwood-Chirchir, A.; Healey, D.; Brahmer, J.; Eberhardt, W. E. E.
Article Title: 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)
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. © 2017 by American Society of Clinical Oncology.
Keywords: cancer chemotherapy; cancer survival; controlled study; treatment outcome; treatment response; survival rate; major clinical study; overall survival; clinical trial; advanced cancer; cancer growth; drug safety; drug withdrawal; treatment duration; unspecified side effect; antineoplastic agents; cancer patient; cancer staging; follow up; antineoplastic agent; antineoplastic metal complex; randomized controlled trial; carcinoma, non-small-cell lung; lung neoplasms; cancer mortality; docetaxel; monoclonal antibody; lung tumor; antibodies, monoclonal; multicenter study; open study; taxoids; hazard ratio; phase 3 clinical trial; kaplan meier method; risk reduction; taxoid; non small cell lung cancer; kaplan-meier estimate; comparative effectiveness; nivolumab; humans; human; priority journal; article
Journal Title: Journal of Clinical Oncology
Volume: 35
Issue: 35
ISSN: 0732-183X
Publisher: American Society of Clinical Oncology  
Date Published: 2017-12-10
Start Page: 3924
End Page: 3933
Language: English
DOI: 10.1200/jco.2017.74.3062
PUBMED: 29023213
PROVIDER: scopus
PMCID: PMC6075826
DOI/URL:
Notes: Article -- Export Date: 2 January 2018 -- Source: Scopus
Altmetric Score
MSK Authors
  1. Naiyer A Rizvi
    157 Rizvi
  2. Matthew David Hellmann
    168 Hellmann