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Selected Works of Suresh G. Nair, MD
Article
First-Line Nivolumab in Stage IV or Recurrent Non-Small-Cell Lung Cancer.
The New England journal of medicine
  • David P Carbone, MD, PhD
  • Martin Reck, MD, PhD
  • Luis Paz-Ares, MD
  • Benjamin Creelan, MD
  • Leora Horn, MD
  • Martin Steins, MD, PhD
  • Enriqueta Felip, MD
  • Michel M van den Heuvel, MD
  • Tudor-Eliade Ciuleanu, MD
  • Firas Badin, MD
  • Neal Ready, MD
  • T Jeroen N Hiltermann, MD
  • Suresh G. Nair, MD, Lehigh Valley Health Network
  • Rosalyn Juergens, MD, PhD
  • Solange Peters, MD, PhD
  • Elisa Minenza, MD
  • John M Wrangle, MD
  • Delvys Rodriguez-Abreu, MD
  • Hossein Borghaei, DO
  • George R Blumenschein Jr, MD
  • Liza C Villaruz, MD
  • Libor Havel, MD
  • Jana Krejci, MD
  • Jesus Corral Jaime, MD
  • Han Chang, PhD
  • William J Geese, PhD
  • Prabhu Bhagavatheeswaran, PhD
  • Allen C Chen, MD
  • Mark A Socinski, MD
Link
Publication/Presentation Date
6-22-2017
Abstract

BACKGROUND: Nivolumab 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.

METHODS: We 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.

RESULTS: Among 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.

CONCLUSIONS: Nivolumab 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 .).

Disciplines
PubMedID
28636851
Document Type
Article
Citation Information

Carbone, D. P., Reck, M., Paz-Ares, L., Creelan, B., Horn, L., Steins, M., & ... Socinski, M. A. (2017). First-Line Nivolumab in Stage IV or Recurrent Non-Small-Cell Lung Cancer. The New England Journal Of Medicine, 376(25), 2415-2426. doi:10.1056/NEJMoa1613493