Format

Send to

Choose Destination
J Clin Oncol. 2016 Sep 1;34(25):2980-7. doi: 10.1200/JCO.2016.66.9929. Epub 2016 Jun 27.

Nivolumab Monotherapy for First-Line Treatment of Advanced Non-Small-Cell Lung Cancer.

Author information

1
Scott Gettinger, Yale Cancer Center, New Haven, CT; Naiyer A. Rizvi and Matthew D. Hellmann, Memorial Sloan Kettering Cancer Center, New York, NY; Laura Q. Chow, University of Washington, Seattle, WA; Hossein Borghaei, Fox Chase Cancer Center, Philadelphia, PA; Julie Brahmer, The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD; Neal Ready, Duke University Medical Center, Durham, NC; David E. Gerber, University of Texas Southwestern Medical Center, Dallas, TX; Frances A. Shepherd, Princess Margaret Cancer Centre, Toronto; Rosalyn A. Juergens, Juravinski Cancer Centre at McMaster University, Hamilton; Scott A. Laurie, Ottawa Hospital Cancer Centre, Ottawa, Ontario, Canada; Scott Antonia, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL; Jonathan W. Goldman, University of California, Los Angeles, Los Angeles, CA; and Faith E. Nathan, Yun Shen, and Christopher T. Harbison, Bristol-Myers Squibb, Princeton, NJ. scott.gettinger@yale.edu.
2
Scott Gettinger, Yale Cancer Center, New Haven, CT; Naiyer A. Rizvi and Matthew D. Hellmann, Memorial Sloan Kettering Cancer Center, New York, NY; Laura Q. Chow, University of Washington, Seattle, WA; Hossein Borghaei, Fox Chase Cancer Center, Philadelphia, PA; Julie Brahmer, The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD; Neal Ready, Duke University Medical Center, Durham, NC; David E. Gerber, University of Texas Southwestern Medical Center, Dallas, TX; Frances A. Shepherd, Princess Margaret Cancer Centre, Toronto; Rosalyn A. Juergens, Juravinski Cancer Centre at McMaster University, Hamilton; Scott A. Laurie, Ottawa Hospital Cancer Centre, Ottawa, Ontario, Canada; Scott Antonia, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL; Jonathan W. Goldman, University of California, Los Angeles, Los Angeles, CA; and Faith E. Nathan, Yun Shen, and Christopher T. Harbison, Bristol-Myers Squibb, Princeton, NJ.

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.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT01454102.

PMID:
27354485
PMCID:
PMC5569692
DOI:
10.1200/JCO.2016.66.9929
[Indexed for MEDLINE]
Free PMC Article

Supplemental Content

Full text links

Icon for Atypon Icon for PubMed Central
Loading ...
Support Center