137O - Nivolumab in patients (pts) with advanced refractory squamous (SQ) non-small cell lung cancer (NSCLC): 2-year follow-up from CheckMate 063 and expl...

Date 15 April 2016
Event European Lung Cancer Conference 2016 (ELCC) 2016
Session ESMO-IASLC Best Abstracts: The evolving landscape of immunotherapy
Topics Immunotherapy
Non-small-cell lung cancer
Therapy
Presenter Suresh Ramalingam
Citation Journal of Thoracic Oncology (2016) 11 (supplement 4): S57-S166. S1556-0864(16)X0004-4
Authors S. Ramalingam1, H. Lena2, N.A. Rizvi3, J. Wolf4, F. Cappuzzo5, G. Zalcman6, P. Baas7, J. Mazieres8, B. Farsaci9, M.A. Blackwood-Chirchir10
  • 1Medical Oncology, Emory University Winship Cancer Institute, 30322 - Atlanta/US
  • 2Service De Pneumologie, Centre Hospitalier Universitaire de Rennes, 5033 - Rennes/FR
  • 3Hematology/oncology, Memorial Sloan Kettering Cancer Center, New York/US
  • 4Center For Integrated Oncology Köln-bonn, University Hospital of Köln, Cologne/DE
  • 5U.o. Oncologia Medica, Ospedale Civile - Istituto Toscano Tumori, 57100 - Livorno/IT
  • 6Service De Pneumologie, CHU de Caen, 14033 - Caen/FR
  • 7Thoracic Oncology, The Netherlands Cancer Institute  , 1066 CX - Amsterdam/NL
  • 8Thoracic Oncology, CHU Toulouse, Hôpital de Larrey, 31059 - Toulouse/FR
  • 9Oncology Biomarkers, Bristol-Myers Squibb, Princeton/US
  • 10Global Clinical Research, Bristol-Myers Squibb, Princeton/US

Abstract

Background

Pts with advanced platinum-refractory SQ NSCLC have limited treatment options. Based on results from phase 2 (CheckMate 063) and phase 3 (CheckMate 017) trials, nivolumab, a fully human IgG4 programmed death-1 immune checkpoint inhibitor antibody, is approved in both the United States and the European Union for use in pts with previously treated advanced SQ NSCLC. Here we report results from CheckMate 063 and CheckMate 017, including 18-mo OS and exploratory cytokine profiling analyses. Updated 2-y OS and safety data from CheckMate 063 will be presented.

Methods

In CheckMate 063, pts (N = 117) received nivolumab 3 mg/kg Q2W until progressive disease (PD)/unacceptable toxicity. The primary endpoint was independent radiology review committee-assessed ORR (RECIST v1.1). In CheckMate 017, pts were randomized 1:1 to receive nivolumab 3 mg/kg Q2W (n = 135) or docetaxel (doc) 75 mg/m2 Q3W (n = 137) until PD or discontinuation due to toxicity/other reasons. The primary endpoint was OS. Treatment beyond PD was permitted per protocol in both studies. A multivariate exploratory analysis of baseline serum cytokines in nivolumab-treated pts (n = 222) from CheckMate 063 and CheckMate 017 was performed. A SQ-cytoscore, generated to quantify the effect of the identified cytokine set on OS, was defined as “high” or “low” based on the median cut-off.

Results

Key efficacy and safety data are reported in the table. Among nivolumab-treated pts with high SQ-cytoscore (n = 102) vs low SQ-cytoscore (n = 120), median OS was 15.6 vs 5.3 mo (HR: 0.48, 95% CI: 0.36, 0.64; P 

Conclusions

Nivolumab demonstrated clinically meaningful efficacy with no new safety concerns in pts with advanced SQ NSCLC. Select serum cytokines at baseline (details to be presented) may be associated with OS benefit in pts with advanced SQ NSCLC; prospective validation of these preliminary findings is needed.

Clinical trial identification

CheckMate 063 = NCT01721759; CheckMate 017 = NCT01642004

Legal entity responsible for the study

Bristol-Myers Squibb

Funding

Bristol-Myers Squibb

Disclosure

H. Lena: Personal fees and non-financial support from Bristol-Myers Squibb, personal fees from AstraZeneca and from Merck Sharp & Dohme, and non-financial support from Roche and from Merck. N.A. Rizvi: Personal fees from Bristol Myers Squibb, Genentech/Roche, MedImmune/AstraZeneca, and Merck. J. Wolf: Personal fees in the form of advisory board lecture fees from AstraZeneca, Bristol-Myers Squibb, Boehringer Ingelheim, Clovis, Merck Sharp & Dohme, Novartis, Pfizer, and Roche. F. Cappuzzo: Personal fees from Bristol-Myers Squibb. G. Zalcman: Personal fees from BMS. P. Baas: Grants and other (advisor) from Bristol-Myers Squibb, Pfizer, and Merck Sharp & Dohme, as well as other (advisor) for Bayer. B. Farsaci: Employee of Bristol-Myers Squibb and has a patent Cytoscore method pending. M.A. Blackwood-Chirchir: Employee of Bristol-Myers Squibb. S. Ramalingam: Personal fees, advisory board meeting, from Bristol-Myers Squibb. All other authors have declared no conflicts of interest.