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 |
| DOI/URL: | |
| 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 |
Altmetric
Citation Impact
BMJ Impact Analytics
Related MSK Work