• David P Carbone, Martin Reck, Luis Paz-Ares, Benjamin Creelan, Leora Horn, Martin Steins, Enriqueta Felip, Michel M van den Heuvel, Tudor-Eliade Ciuleanu, Firas Badin, Neal Ready, T Jeroen N Hiltermann, Suresh Nair, Rosalyn Juergens, Solange Peters, Elisa Minenza, John M Wrangle, Delvys Rodriguez-Abreu, Hossein Borghaei, George R Blumenschein, Liza C Villaruz, Libor Havel, Jana Krejci, Jesus Corral Jaime, Han Chang, William J Geese, Prabhu Bhagavatheeswaran, Allen C Chen, Mark A Socinski, and CheckMate 026 Investigators.
• From the Ohio State University Comprehensive Cancer Center, Columbus (D.P.C.); LungenClinic Grosshansdorf, Airway Research Center North, German Center for Lung Research, Grosshansdorf (M.R.), and Thoraxklinik, Heidelberg University Hospital, Heidelberg (M.S.) - both in Germany; Hospital Universitario Doce de Octubre, Centro Nacional de Investigaciones Oncológicas and Universidad Complutense, Madrid (L.P.-A., J.C.J.), Vall d'Hebron University Hospital, Barcelona (E.F.), and Hospital Universitario Insular de Gran Canaria, Las Palmas (D.R.-A.) - all in Spain; H. Lee Moffitt Cancer Center, Tampa, FL (B.C.); Vanderbilt University Medical Center, Nashville (L. Horn); Antoni van Leeuwenhoek Ziekenhuis, Amsterdam (M.M.H.), and University of Groningen, Universitair Medisch Centrum Groningen, Groningen (T.J.N.H.) - both in the Netherlands; Prof. Dr. Ion Chiricuta Institute of Oncology and University of Medicine and Pharmacy Iuliu Hatieganu, Cluj-Napoca, Romania (T.-E.C.); Baptist Health Lexington, Lexington, KY (F.B.); Duke University, Durham, NC (N.R.); Lehigh Valley Health Network, Allentown (S.N.), Fox Chase Cancer Center, Philadelphia (H.B.), and University of Pittsburgh Medical Center Cancer Center, Pittsburgh (L.C.V., M.A.S.) - all in Pennsylvania; Juravinski Cancer Centre, Hamilton, ON, Canada (R.J.); Oncology Department, Lausanne University Hospital, Lausanne, Switzerland (S.P.); Santa Maria Hospital, Terni, Italy (E.M.); Hollings Cancer Center, Charleston, SC (J.M.W.); Department of Thoracic-Head and Neck Medical Oncology, University of Texas M.D. Anderson Cancer Center, Houston (G.R.B.); Klinika Pneumologie a Hrudní Chirurgie, Nemocnice Na Bulovce, Prague, Czech Republic (L. Havel, J.K.); and Bristol-Myers Squibb, Princeton, NJ (H.C., W.J.G., P.B., A.C.C.).
• N. Engl. J. Med. 2017 Jun 22; 376 (25): 2415-2426.

BackgroundNivolumab has been associated with longer overall survival than docetaxel among patients with previously treated non-small-cell lung cancer (NSCLC). In an open-label phase 3 trial, we compared first-line nivolumab with chemotherapy in patients with programmed death ligand 1 (PD-L1)-positive NSCLC.MethodsWe randomly assigned, in a 1:1 ratio, patients with untreated stage IV or recurrent NSCLC and a PD-L1 tumor-expression level of 1% or more to receive nivolumab (administered intravenously at a dose of 3 mg per kilogram of body weight once every 2 weeks) or platinum-based chemotherapy (administered once every 3 weeks for up to six cycles). Patients receiving chemotherapy could cross over to receive nivolumab at the time of disease progression. The primary end point was progression-free survival, as assessed by means of blinded independent central review, among patients with a PD-L1 expression level of 5% or more.ResultsAmong the 423 patients with a PD-L1 expression level of 5% or more, the median progression-free survival was 4.2 months with nivolumab versus 5.9 months with chemotherapy (hazard ratio for disease progression or death, 1.15; 95% confidence interval [CI], 0.91 to 1.45; P=0.25), and the median overall survival was 14.4 months versus 13.2 months (hazard ratio for death, 1.02; 95% CI, 0.80 to 1.30). A total of 128 of 212 patients (60%) in the chemotherapy group received nivolumab as subsequent therapy. Treatment-related adverse events of any grade occurred in 71% of the patients who received nivolumab and in 92% of those who received chemotherapy. Treatment-related adverse events of grade 3 or 4 occurred in 18% of the patients who received nivolumab and in 51% of those who received chemotherapy.ConclusionsNivolumab was not associated with significantly longer progression-free survival than chemotherapy among patients with previously untreated stage IV or recurrent NSCLC with a PD-L1 expression level of 5% or more. Overall survival was similar between groups. Nivolumab had a favorable safety profile, as compared with chemotherapy, with no new or unexpected safety signals. (Funded by Bristol-Myers Squibb and others; CheckMate 026 ClinicalTrials.gov number, NCT02041533 .).

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