Meeting
2015 ASCO Annual Meeting
A phase III study (CheckMate 017) of nivolumab (NIVO; anti-programmed death-1 [PD-1]) vs docetaxel (DOC) in previously treated advanced or metastatic squamous (SQ) cell non-small cell lung cancer (NSCLC).
Authors
David R. Spigel
Sarah Cannon Research Institute/Tennessee Oncology, PLLC, Nashville, TN
David R. Spigel , Karen L. Reckamp , Naiyer A. Rizvi , Elena Poddubskaya , Howard Jack West , Wilfried Ernst Erich Eberhardt , Paul Baas , Scott Joseph Antonia , Adam Pluzanski , Everett E. Vokes , Esther Holgado , David Michael Waterhouse , Neal Ready , Justin F. Gainor , Osvaldo Rudy Aren , Leora Horn , Luis Paz-Ares , Christine Baudelet , Brian Joseph Lestini , Julie R. Brahmer
Organizations
Sarah Cannon Research Institute/Tennessee Oncology, PLLC, Nashville, TN, City of Hope National Medical Center, Duarte, CA, Memorial Sloan Kettering Cancer Center, New York, NY, N.N. Blokhin Russian Cancer Research Center, Moscow, Russia, Swedish Cancer Institute, Seattle, WA, Department of Medical Oncology, University Hospital Essen, West German Cancer Centre, Ruhrlandklinik, and University Duisburg-Essen, Essen, Germany, Antoni Van Leeuwenhoek Hospital, Amsterdam, Netherlands, H. Lee Moffitt Cancer Center & Research Institute, Tampa, FL, Centrum Onkologii - Instytut Im. Marii Sklodowskiej-Curie, Warsaw, Poland, University of Chicago Medical Center, Chicago, IL, Hospital de Madrid, Norte Sanchinarro, Spain, Oncology Hematology Care, Blue Ash, OH, Duke University Medical Center, Durham, NC, Massachusetts General Hospital Cancer Center, Boston, MA, Centro Internacional de Estudios Clinicos, Santiago, Chile, Vanderbilt University Medical Center, Nashville, TN, Hospital Universitario Virgen Del Rocio, Seville, Spain, Bristol-Myers Squibb, Princeton, NJ, The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD
Research Funding
Pharmaceutical/Biotech Company
Background: Treatment options are limited for patients (pts) with advanced SQ NSCLC who fail platinum-based doublet chemotherapy (PT-DC). We report results of a randomized, open-label, global phase III study of NIVO, a fully human IgG4 PD-1 immune checkpoint inhibitor antibody, vs DOC in pts with SQ NSCLC and with disease progression (PD) during/after one prior PT-DC regimen. Methods: Pts (N = 272) were randomized 1:1 to receive NIVO 3 mg/kg (n = 135) Q2W or DOC 75 mg/m2(n = 137) Q3W until PD, discontinuation due to toxicity, or other reasons. The primary objective was overall survival (OS). Secondary objectives included investigator-assessed objective response rate (ORR; RECIST v1.1), progression-free survival (PFS), efficacy by PD-L1 expression (PD-L1 testing not required for enrollment), quality of life, and safety. Results: Superior OS was observed with NIVO vs DOC (HR = 0.59; 95% CI: 0.44, 0.79; p = 0.00025). NIVO improved PFS vs DOC (HR = 0.62; 95% CI: 0.47, 0.81; p = 0.0004). ORR was 20% (27/135) for NIVO and 9% (12/137) for DOC (p = 0.0083). OS HRs favored NIVO regardless of PD-L1 expression (Table). Grade 3–4 drug-related AEs occurred in 7% (9/131) of NIVO and 55% (71/129) of DOC pts. No deaths were related to NIVO vs 3 DOC-related deaths. Conclusions: CheckMate 017 met its primary objective, demonstrating superior OS of NIVO vs DOC in pts with advanced, previously treated SQ NSCLC and demonstrated PFS and ORR superiority. Tumor PD-L1 status was neither prognostic nor predictive for efficacy endpoints. The safety profile of NIVO 3 mg/kg Q2W is acceptable and favorable vs DOC. NIVO represents a significant improvement in second-line therapy for SQ NSCLC. Clinical trial information: NCT01642004
| NIVO (n = 135) | DOC (n = 137) | ||
|---|---|---|---|
| mOS, mo (95% CI) | 9.2 (7.3, 13.3) | 6.0 (5.1, 7.3) | |
| 1-yr OS, % (95% CI) | 42 (34, 50) | 24 (17, 31) | |
| Median duration of response, mo (range) | Not Reached (2.9–20.5+) | 8.4 (1.4+–15.2+) | |
| mPFS, mo (95% CI) | 3.5 (2.1, 4.9) | 2.8 (2.1, 3.5) | |
| 1-yr PFS, % (95% CI) | 21 (14, 28) | 6 (3, 12) | |
| PD-1 expression | NIVO (n) | DOC (n) | OS HR (95% CI) |
| ≥ 1% | 63 | 56 | 0.69 (0.45, 1.05) |
| < 1% | 54 | 52 | 0.58 (0.37, 0.92) |
| ≥ 5% | 42 | 39 | 0.53 (0.31, 0.89) |
| < 5% | 75 | 69 | 0.70 (0.47, 1.02) |
| ≥ 10% | 36 | 33 | 0.50 (0.28, 0.89) |
| < 10% | 81 | 75 | 0.70 (0.48, 1.01) |
Disclaimer
This material on this page is ©2024 American Society of Clinical Oncology, all rights reserved. Licensing available upon request. For more information, please contact licensing@asco.org
Abstract Details
Session Type
Clinical Science Symposium
Session Title
Immunotherapy in Lung Cancer: A Paradigm Shift
Track
Lung Cancer
Sub Track
Metastatic Non–Small Cell Lung Cancer
Clinical Trial Registration Number
NCT01642004
Citation
J Clin Oncol 33, 2015 (suppl; abstr 8009)
DOI
10.1200/jco.2015.33.15_suppl.8009
Abstract #
8009
Abstract Disclosures
Similar Abstracts
Abstract
2023 ASCO Annual Meeting
Nivolumab and ipilimumab in advanced non small cell lung cancer previously treated with PD1 axis inhibition.
First Author: Scott N. Gettinger
Abstract
2023 ASCO Annual Meeting
Efficacy of nivolumab and relatlimab-rmbw in patients with advanced melanoma who were previously treated with PD-1 inhibitor: Real world experience.
First Author: Sekwon Jang
Abstract
2023 ASCO Annual Meeting
KontRASt-02: A phase III trial investigating the efficacy and safety of the KRASG12C inhibitor JDQ443 vs docetaxel in patients with previously treated, locally advanced or metastatic, KRAS G12C-mutated NSCLC.
First Author: Federico Cappuzzo
Abstract
2021 ASCO Annual Meeting
A randomized, phase 3 study of datopotamab deruxtecan (Dato-DXd; DS-1062) versus docetaxel in previously treated advanced or metastatic non-small cell lung cancer (NSCLC) without actionable genomic alterations (TROPION-Lung01).
First Author: Kiyotaka Yoh