Overall survival and long-term safety of nivolumab (anti-programmed death 1 antibody, BMS-936558, ONO-4538) in patients with previously treated advanced non-small-cell lung cancer Journal Article


Authors: Gettinger, S. N.; Horn, L.; Gandhi, L.; Spigel, D. R.; Antonia, S. J.; Rizvi, N. A.; Powderly, J. D.; Heist, R. S.; Carvajal, R. D.; Jackman, D. M.; Sequist, L. V.; Smith, D. C.; Leming, P.; Carbone, D. P.; Pinder-Schenck, M. C.; Topalian, S. L.; Hodi, F. S.; Sosman, J. A.; Sznol, M.; McDermott, D. F.; Pardoll, D. M.; Sankar, V.; Ahlers, C. M.; Salvati, M.; Wigginton, J. M.; Hellmann, M. D.; Kollia, G. D.; Gupta, A. K.; Brahmer, J. R.
Article Title: Overall survival and long-term safety of nivolumab (anti-programmed death 1 antibody, BMS-936558, ONO-4538) in patients with previously treated advanced non-small-cell lung cancer
Abstract: Purpose: Programmed death 1 is an immune checkpoint that suppresses antitumor immunity. Nivolumab, a fully human immunoglobulin G4 programmed death 1 immune checkpoint inhibitor antibody, was active and generally well tolerated in patients with advanced solid tumors treated in a phase I trial with expansion cohorts. We report overall survival (OS), response durability, and long-term safety in patients with non-small-cell lung cancer (NSCLC) receiving nivolumab in this trial. Patients and Methods: Patients (N = 129) with heavily pretreated advanced NSCLC received nivolumab 1, 3, or 10 mg/kg intravenously once every 2 weeks in 8-week cycles for up to 96 weeks. Tumor burden was assessed by RECIST (version 1.0) after each cycle. Results: Median OS across doses was 9.9 months; 1-, 2-, and 3-year OS rates were 42%, 24%, and 18%, respectively, across doses and 56%, 42%, and 27%, respectively, at the 3-mg/kg dose (n = 37) chosen for further clinical development. Among 22 patients (17%) with objective responses, estimated median response duration was 17.0 months. An additional six patients (5%) had unconventional immune-pattern responses. Response rates were similar in squamous and nonsquamous NSCLC. Eighteen responding patients discontinued nivolumab for reasons other than progressive disease; nine (50%) of those had responses lasting > 9 months after their last dose. Grade 3 to 4 treatment-related adverse events occurred in 14% of patients. Three treatment-related deaths (2% of patients) occurred, each associated with pneumonitis. Conclusion: Nivolumab monotherapy produced durable responses and encouraging survival rates in patients with heavily pretreated NSCLC. Randomized clinical trials with nivolumab in advanced NSCLC are ongoing. © 2015 by American Society of Clinical Oncology.
Journal Title: Journal of Clinical Oncology
Volume: 33
Issue: 18
ISSN: 0732-183X
Publisher: American Society of Clinical Oncology  
Date Published: 2015-06-20
Start Page: 2004
End Page: 2012
Language: English
DOI: 10.1200/jco.2014.58.3708
PROVIDER: scopus
PUBMED: 25897158
PMCID: PMC4672027
DOI/URL:
Notes: Export Date: 3 August 2015 -- Source: Scopus
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MSK Authors
  1. Richard D Carvajal
    133 Carvajal
  2. Naiyer A Rizvi
    157 Rizvi
  3. Matthew David Hellmann
    168 Hellmann