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J Clin Oncol. 2015 Jun 20;33(18):2004-12. doi: 10.1200/JCO.2014.58.3708. Epub 2015 Apr 20.

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.

Author information

1
Scott N. Gettinger and Mario Sznol, Yale Cancer Center, New Haven, CT; Leora Horn, David P. Carbone, and Jeffrey A. Sosman, Vanderbilt University Medical Center; David R. Spigel, Sarah Cannon Research Institute/Tennessee Oncology, Nashville, TN; Leena Gandhi, David M. Jackman, and F. Stephen Hodi, Dana-Farber Cancer Institute; Rebecca S. Heist and Lecia V. Sequist, Massachusetts General Hospital Cancer Center; David F. McDermott, Beth Israel Deaconess Medical Center, Boston, MA; Scott J. Antonia and Mary C. Pinder-Schenck, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL; Naiyer A. Rizvi, Richard D. Carvajal, and Matthew D. Hellmann, Memorial Sloan Kettering Cancer Center, New York, NY; John D. Powderly, Carolina BioOncology Institute, Huntersville, NC; David C. Smith, University of Michigan, Ann Arbor, MI; Philip Leming, Christ Hospital Cancer Center, Cincinnati, OH; Suzanne L. Topalian, Drew M. Pardoll, and Julie R. Brahmer, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins, Baltimore, MD; and Vindira Sankar, Christoph M. Ahlers, Mark Salvati, Jon M. Wigginton, Georgia D. Kollia, and Ashok K. Gupta, Bristol-Myers Squibb, Princeton, NJ. scott.gettinger@yale.edu.
2
Scott N. Gettinger and Mario Sznol, Yale Cancer Center, New Haven, CT; Leora Horn, David P. Carbone, and Jeffrey A. Sosman, Vanderbilt University Medical Center; David R. Spigel, Sarah Cannon Research Institute/Tennessee Oncology, Nashville, TN; Leena Gandhi, David M. Jackman, and F. Stephen Hodi, Dana-Farber Cancer Institute; Rebecca S. Heist and Lecia V. Sequist, Massachusetts General Hospital Cancer Center; David F. McDermott, Beth Israel Deaconess Medical Center, Boston, MA; Scott J. Antonia and Mary C. Pinder-Schenck, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL; Naiyer A. Rizvi, Richard D. Carvajal, and Matthew D. Hellmann, Memorial Sloan Kettering Cancer Center, New York, NY; John D. Powderly, Carolina BioOncology Institute, Huntersville, NC; David C. Smith, University of Michigan, Ann Arbor, MI; Philip Leming, Christ Hospital Cancer Center, Cincinnati, OH; Suzanne L. Topalian, Drew M. Pardoll, and Julie R. Brahmer, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins, Baltimore, MD; and Vindira Sankar, Christoph M. Ahlers, Mark Salvati, Jon M. Wigginton, Georgia D. Kollia, and Ashok K. Gupta, Bristol-Myers Squibb, Princeton, NJ.

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.

PMID:
25897158
PMCID:
PMC4672027
DOI:
10.1200/JCO.2014.58.3708
[Indexed for MEDLINE]
Free PMC Article

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