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).

Lung Cancer—Non-Small Cell Metastatic
Session Type and Session Title: 
Clinical Science Symposium, Immunotherapy in Lung Cancer: A Paradigm Shift
Abstract Number: 


J Clin Oncol 33, 2015 (suppl; abstr 8009)
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; 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

Abstract Disclosures


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 expressionNIVO (n)DOC (n)OS HR (95% CI)
≥ 1%63560.69 (0.45, 1.05)
< 1%54520.58 (0.37, 0.92)
≥ 5%42390.53 (0.31, 0.89)
< 5%75690.70 (0.47, 1.02)
≥ 10%36330.50 (0.28, 0.89)
< 10%81750.70 (0.48, 1.01)