Medline ® Abstract for Reference 3
of 'Immunotherapy of non-small cell lung cancer with immune checkpoint inhibition'
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).
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, CrinòL, Rizvi N, Reck M, Hellmann MD, Geese WJ, Li A, Blackwood-Chirchir A, Healey D, Brahmer J, Eberhardt WEE
J Clin Oncol. 2017;35(35):3924. Epub 2017 Oct 12.
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 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.
Leora Horn, Vanderbilt-Ingram Cancer Center; David R. Spigel, Sarah Cannon Research Institute/Tennessee Oncology, Nashville, TN; Everett E. Vokes, University of Chicago, Chicago, IL; Esther Holgado, Hospital De Madrid, Norte Sanchinarro, Madrid; Enriqueta Felip, Hospital Universitari Vall d'Hebron, Barcelona; Luis Paz-Ares, Hospital Universitario Virgen Del Rocio, Seville, Spain; Neal Ready, Duke University Medical Center, Durham, NC; Martin Steins, Thoraxklinik-Heidelberg gGmbH, Heidelberg; Martin Kohlhäeufl, Robert-Bosch-Krankenhaus, Stuttgart; Martin Reck, LungenClinic Grosshansdorf, Airway Research Center North, German Center for Lung Research, Grosshansdorf; Wilfried E.E. Eberhardt, University Hospital and Ruhrlandclinic, University of Duisburg-Essen, Essen, Germany; Elena Poddubskaya, N.N. Blokhin Russian Cancer Research Center, Moscow, Russia; Hossein Borghaei, Fox Chase Cancer Center, Philadelphia, PA; Adam Pluzanski, Centrum Onkologii-Instytut Im. Marii Sklodowskiej-Curie, War