Nivolumab monotherapy for first-line treatment of advanced non-small-cell lung cancer Journal Article

Authors: Gettinger, S.; Rizvi, N. A.; Chow, L. Q.; Borghaei, H.; Brahmer, J.; Ready, N.; Gerber, D. E.; Shepherd, F. A.; Antonia, S.; Goldman, J. W.; Juergens, R. A.; Laurie, S. A.; Nathan, F. E.; Shen, Y.; Harbison, C. T.; Hellmann, M. D.
Article Title: Nivolumab monotherapy for first-line treatment of advanced non-small-cell lung cancer
Abstract: Purpose Nivolumab, a programmed death-1 (PD-1) immune checkpoint inhibitor antibody, has demonstrated improved survival over docetaxel in previously treated advanced non-small-cell lung cancer (NSCLC). First-line monotherapy with nivolumab for advanced NSCLC was evaluated in the phase I, multicohort, Checkmate 012 trial. Methods Fifty-two patients received nivolumab 3 mg/kg intravenously every 2 weeks until progression or unacceptable toxicity; postprogression treatment was permitted per protocol. The primary objective was to assess safety; secondary objectives included objective response rate (ORR) and 24-week progression-free survival (PFS) rate; overall survival (OS) was an exploratory end point. Results Any-grade treatment-related adverse events (AEs) occurred in 71% of patients, most commonly: fatigue (29%), rash (19%), nausea (14%), diarrhea (12%), pruritus (12%), and arthralgia (10%). Ten patients (19%) reported grade 3 to 4 treatment-related AEs; grade 3 rash was the only grade 3 to 4 event occurring in more than one patient (n = 2; 4%). Six patients (12%) discontinued because of a treatment-related AE. The confirmed ORR was 23% (12 of 52), including four ongoing complete responses. Nine of 12 responses (75%) occurred by first tumor assessment (week 11); eight (67%) were ongoing (range, 5.3+ to 25.8+ months) at the time of data lock. ORR was 28% (nine of 32) in patients with any degree of tumor PD-ligand 1 expression and 14% (two of 14) in patients with no PD-ligand 1 expression. Median PFS was 3.6 months, and the 24-week PFS rate was 41% (95% CI, 27 to 54). Median OS was 19.4 months, and the 1-year and 18-month OS rates were 73% (95% CI, 59 to 83) and 57% (95% CI, 42 to 70), respectively. Conclusion First-line nivolumab monotherapy demonstrated a tolerable safety profile and durable responses in first-line advanced NSCLC. © 2016 by American Society of Clinical Oncology.
Journal Title: Journal of Clinical Oncology
Volume: 34
Issue: 25
ISSN: 0732-183X
Publisher: American Society of Clinical Oncology  
Date Published: 2016-09-01
Start Page: 2980
End Page: 2987
Language: English
DOI: 10.1200/jco.2016.66.9929
PROVIDER: scopus
PUBMED: 27354485
PMCID: PMC5569692
Notes: Conference Paper -- Presented in part at the European Cancer Congress Annual Meeting that took place September 25-29, 2015 in Vienna, Austria; and the American Society of Clinical Oncology Annual Meeting that took place May 29-June 2, 2015 in Chicago, IL -- Export Date: 3 October 2016 -- Source: Scopus
Citation Impact
MSK Authors
  1. Naiyer A Rizvi
    166 Rizvi
  2. Matthew David Hellmann
    282 Hellmann