Phase III, randomized trial (CheckMate 057) of nivolumab (NIVO) versus docetaxel (DOC) in advanced non-squamous cell (non-SQ) non-small cell lung cancer (NSCLC).

Lung Cancer—Non-Small Cell Metastatic
Session Type and Session Title: 
Clinical Science Symposium, Immunotherapy for Every Patient: Check Your Enthusiasm
Abstract Number: 


J Clin Oncol 33, 2015 (suppl; abstr LBA109)
Luis Paz-Ares, Leora Horn, Hossein Borghaei, David R. Spigel, Martin Steins, Neal Ready, Laura Quan Man Chow, Everett E. Vokes, Enriqueta Felip, Esther Holgado, Fabrice Barlesi, Martin Kohlhaeufl, Oscar Rodriguez, Marco Angelo Burgio, Jerome Fayette, Scott N. Gettinger, Christopher Harbison, Cécile Dorange, Friedrich Graf Finckenstein, Julie R. Brahmer; Hospital Universitario Virgen Del Rocio, Sevilla, Spain; Vanderbilt-Ingram Cancer Center, Nashville, TN; Fox Chase Cancer Center, Philadelphia, PA; Sarah Cannon Research Institute, Nashville, TN; Thoraxklinik-Heidelberg gGmbh, Heidelberg, Germany; Duke University Medical Center, Chapel Hill, NC; University of Washington, Seattle, WA; Department of Medicine, University of Chicago, Chicago, IL; Vall d'Hebron University Hospital, Barcelona, Spain; START Madrid, Centro Integral Oncológico Clara Campal, Madrid, Spain; Aix Marseille University - Assistance Publique Hopitaux De Marseille, Marseille, France; Hospital Schillerhoehe Gerlingen, Gerlingen, Germany; Instituto Nacional de Cancerología, Mexico City, Mexico; IRST-IRCCS, Meldola (FC), Italy; Centre Leon Berard, Lyon, France; Yale School of Medicine, New Haven, CT; Bristol-Myers Squibb, Princeton, NJ; Bristol‐Myers Squibb, Princeton, NJ; Bristol-Myers Squibb Co, Princeton, NJ; The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD

Abstract Disclosures


Background: Options for advanced non-SQ NSCLC patients (pts) who progress after platinum-based doublet chemotherapy (PT-DC) are limited, with minimal improvement in overall survival (OS). We report results from a randomized, global phase III study of NIVO, a fully human IgG4 programmed death-1 (PD-1) immune checkpoint inhibitor antibody, vs DOC in pts with advanced non-SQ NSCLC after failure of PT-DC and tyrosine kinase inhibitor, if eligible. Methods: Pts were randomized to NIVO 3 mg/kg Q2W (n=292) or DOC 75 mg/m2 Q3W (n=290) until progression or discontinuation due to toxicity/other reasons. Primary objective was OS; Secondary objectives were investigator-assessed objective response rate (ORR; per RECIST v1.1), progression-free survival (PFS), efficacy by PD-L1 expression, quality of life, and safety. Results: NIVO demonstrated superior OS (HR=0.73; 96% CI: 0.59, 0.89; P=0.00155) and improved ORR (19.2% vs 12.4%; P=0.0235). HR for PFS was 0.92 (95% CI: 0.77, 1.11; P=0.393). PD-L1 expression was associated with benefit from NIVO (Table). In PD-L1+ pts, NIVO showed improved efficacy across all endpoints at predefined 1%, 5%, and 10% cut- points. Grade 3–5 drug-related AEs occurred in 10.5% (30/287) of NIVO and 53.7% (144/268) of DOC pts. No deaths were related to NIVO vs 1 DOC-related death. After discontinuation, 42.1% of NIVO and 49.7% of DOC pts received subsequent systemic therapy. Conclusions: NIVO demonstrated superior OS vs DOC in pts with advanced non-SQ NSCLC after failure of PT-DC. The safety profile of NIVO 3 mg/kg Q2W was favorable vs DOC. NIVO demonstrated survival benefit across histologies in two randomized phase III trials. Clinical trial information: NCT01673867

Efficacy measureNIVO (n=292)DOC (n=290)
mOS, mo (95% CI)12.2 (9.7, 15.0)9.4 (8.0, 10.7)
1-yr OS, % (95% CI)50.5 (44.6, 56.1)39.0 (33.3, 44.6)
Median response duration,
mo (95% CI)
17.1 (8.4–not estimable)5.6 (4.4–7.0)
mPFS, mo (95% CI)2.3 (2.2, 3.3)4.2 (3.4, 4.9)
1-yr PFS, % (95% CI)18.5 (14.1, 23.4)8.1 (5.1, 12.0)
PD-L1-quantifiable pts
PD-L1 expressionNIVO, n
DOC, n
OS HR (95% CI)
<1%1081010.9 (0.66, 1.24)
≥1%1231230.59 (0.43, 0.81)
<5%1361381.01 (0.76, 1.33)
≥5%95860.43 (0.3, 0.63)
<10%1451451.00 (0.76, 1.31)
≥10%86790.4 (0.27, 0.59)