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NSCLC, metastatic 1

3182 - Randomized results of fixed-duration (1-yr) vs continuous nivolumab in patients (pts) with advanced non-small cell lung cancer (NSCLC)


08 Sep 2017


NSCLC, metastatic 1


David Spigel


Annals of Oncology (2017) 28 (suppl_5): v460-v496. 10.1093/annonc/mdx380


D.R. Spigel1, M. McLeod2, M.A. Hussein3, D.M. Waterhouse4, L. Einhorn5, L. Horn6, B. Creelan7, S. Babu8, N.B. Leighl9, F. Couture10, J. Chandler11, G. Goss12, G. Keogh13, E.B. Garon14, K.B. Blankstein15, D.B. Daniel16, M. Mohamed17, A. Li18, N. Aanur18, R. Jotte19

Author affiliations

  • 1 Medical Oncology, Sarah Cannon Research Institute/Tennessee Oncology, PLLC, 37203 - Nashville/US
  • 2 Medical Oncology, Florida Cancer Specialists, Leesburg/US
  • 3 Oncology, Florida Cancer Specialists, Leesburg/US
  • 4 Oncology/hematology, OHC (Oncology Hematology Care), Cincinnati/US
  • 5 Hematology/oncology , Indiana University, Indianapolis/US
  • 6 Thoracic Oncology, Vanderbilt Ingram Cancer Center, Nashville/US
  • 7 Thoracic Oncology, H. Lee Moffitt Cancer Center, Tampa/US
  • 8 Oncology/hematology, Fort Wayne Medical Oncology and Hematology, Fort Wayne/US
  • 9 Department Of Medical Oncology, The Princess Margaret Cancer Centre, ON M5G1X6 - Toronto/CA
  • 10 Oncology/hematology, CISSS Chaudiéere-Appalaches, Levis/CA
  • 11 Oncology/hematology, The West Clinic, P.C., Memphis/US
  • 12 Medical Oncology, The Ottawa Hospital, University of Ottawa, Ottawa/CA
  • 13 Oncology/hematology, Charleston Hematology Oncology Associates, Charleston/US
  • 14 Oncology/hematology, UCLA Medical Center, Santa Monica/US
  • 15 Oncology/hematology, Hunterdon Healthcare, Flemington/US
  • 16 Oncology, Tennessee Oncology, Chattanooga/US
  • 17 Oncology/hematology, Cone Health Cancer Center at Wesley Long, Greensboro/US
  • 18 Oncology, Bristol-Myers Squibb, Princeton/US
  • 19 Oncology/hematology, The US Oncology Network/Rocky Mountain Cancer Centers, Denver/US


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Abstract 3182


Nivolumab, the anti-programmed death (PD)-1 antibody, has demonstrated durable responses and survival benefit in pts with advanced NSCLC, with some pts continuing to derive benefit even after discontinuation of nivolumab (due to adverse events [AEs] or a stopping rule). This raises the question of whether continuous nivolumab treatment is necessary for long-term benefit. CheckMate 153 (NCT02066636), an ongoing phase IIIB/IV study conducted primarily in the community setting, is evaluating the clinical benefit of a fixed-duration (1 yr) of nivolumab treatment vs continuous treatment in pts with previously treated advanced NSCLC. Pts who remained on nivolumab treatment for 1 yr were randomized to either continue receiving treatment or to stop treatment.


Pts with stage IIIB/IV NSCLC and ≥1 prior systemic therapy were enrolled and treated with nivolumab 3 mg/kg IV Q2W. The primary objective of the study overall was the incidence of high-grade (grade 3–5) select treatment-related AEs. Pts still on treatment at 1 yr were randomized 1:1 either to continue nivolumab until progressive disease, unacceptable toxicity, or withdrawal of consent (continuous-treatment arm), or to discontinue treatment, with the possibility of resuming treatment upon disease progression (fixed-duration arm). Prespecified exploratory objectives included safety and efficacy in the 2 randomized arms.


As of April 2016, 1375 pts were enrolled and treated; 218 pts were randomized after 1 yr of treatment to the continuous-treatment arm (n = 111) or the fixed-duration arm (n = 107). Of these 218 pts, 133 (61%) had received ≥2 prior therapies and 10 (5%) had baseline ECOG PS 2. Data from an upcoming database lock (at which time, the expected post-randomization follow-up ≥10.7 mo) will be presented for randomized pts and will include overall survival, progression-free survival, and safety. In addition, data from pts who were re-treated in the fixed-duration arm will be presented.


The results from CheckMate 153 represent the first insights from a randomized trial evaluating the impact of stopping treatment with a PD-1/PD-L1 inhibitor at 1 yr vs continuing treatment in pts with advanced, previously treated NSCLC.

Clinical trial identification


Legal entity responsible for the study

Bristol-Myers Squibb


Bristol-Myers Squibb


D.R. Spigel: Served as a consultant or advisor for Genentech/Roche (Inst), Novartis (Inst), Celgene (Inst), Bristol-Myers Squibb (Inst), Lilly (Inst), AstraZeneca (Inst), Pfizer (Inst), Clovis Oncology (Inst), Boehringer Ingelheim (Inst); travel funding from Genentech/Roche, Novartis, Celgene, Bristol-Myers Squibb, Lilly, AstraZeneca, Pfizer, Clovis Oncology, Biodesix, Boehringer Ingelheim, Peregrine Pharmaceuticals; owns stock in Foundation Medicine, Illumina; received institutional research funding from Genentech/Roche, Novartis, Celgene, Bristol-Myers Squibb, Lilly, AstraZeneca, Pfizer, Clovis Oncology, Boehringer Ingelheim, Peregrine Pharmaceuticals, Oncogenex, OncoMed, Amgen, Verastem, Daiichi Sankyo, University of Southwestern Medical Center – Simmons Cancer Center, Merck. D.M. Waterhouse: Served as consultant for BMS and Lilly; participated in speakers\' bureau for BMS, Celgene, Genentech/Roche, and Lilly. L. Einhorn: Served as a consultant for Celgene and ZIOPHARM Oncology; owns stock or other ownership interests with Amgen and Biogen Idec. L. Horn: Served as consultant for BMS, Merck, Bayer, Xcovery, GNE, BI, and Lilly; received honoraria for Biodesix; institution received research funding for AstraZeneca. B. Creelan: Participated on a speakers\' bureau for AstraZeneca and BMS; received research funding for Boehringer Ingelheim; travel funding from AstraZeneca, Merck Sharp & Dohme. S. Babu: Received research funding, consultancy fees, and travel honoraria from Alexion Pharmaceuticals. N.B. Leighl: Received honoraria from Pfizer; received institutional research funding from Novartis; travel funding from AstraZeneca and Merck, Sharp & Dohme. J. Chandler: Served as consultant for BMS; participated in speakers’ bureau for Janssen; received research funding from BMS, EMD Serono, GNE/Roche, GSK, Lilly, and Onyx; travel funding from BMS and Janssen. G. Goss: Received honoraria from AZ, BI, BMS, Lilly, Pfizer; served as a consultant or advisor for AZ, BI, BMS; and received travel funding from AZ, BI, BMS, Pfizer. E.B. Garon: Institution received research funding from Merck, Genentech, AstraZeneca, Novartis, Pfizer, Lilly, Bristol-Myers Squibb, and Boehringer Ingelheim. A. Li, N. Aanur: Employed by BMS and owns stock in BMS. R. Jotte: Received honoraria from Bristol-Myers Squibb and Lilly; participated in speakers’ bureau for Bristol-Myers Squibb and Lilly. All other authors have declared no conflicts of interest.

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