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Developmental therapeutics

4998 - Efficacy of BMS-986016, a Monoclonal Antibody That Targets Lymphocyte Activation Gene-3 (LAG-3), in Combination With Nivolumab in Pts With Melanoma Who Progressed During Prior Anti–PD-1/PD-L1 Therapy (mel prior IO) in All-Comer and Biomarker-Enriched Populations


10 Sep 2017


Developmental therapeutics


Immunotherapy;  Melanoma


Paolo Ascierto


Annals of Oncology (2017) 28 (suppl_5): v605-v649. 10.1093/annonc/mdx440


P.A. Ascierto1, P. Bono2, S. Bhatia3, I. Melero4, M.S. Nyakas5, I. Svane6, J. Larkin7, C. Gomez-Roca8, D. Schadendorf9, R. Dummer10, A. Marabelle11, C. Hoeller12, M. Maurer13, C.T. Harbison14, P. Mitra13, S. Suryawanshi13, K. Thudium13, E. Muñoz Couselo15

Author affiliations

  • 1 Department Of Medical Oncology, Istituto Nazionale Tumori Fondazione "G. Pascale", 80131 - Napoli/IT
  • 2 Department Of Oncology, Comprehensive Cancer Center, Helsinki University Hospital  , FI-00029 - Helsinki/FI
  • 3 Department Of Medicine, University of Washington, Seattle Cancer Care Alliance, Fred Hutchinson Cancer Research Center, 98109 - Seattle/US
  • 4 Department Of Immunology, Clinica Universidad de Navarra, 31008 - Pamplona/ES
  • 5 Clinical Research Unit, Oslo University Hospital, 0450 - Oslo/NO
  • 6 Department Of Clinical Medicine, Copenhagen University Hospital, 2730 - Herlev/DK
  • 7 Department Of Medical Oncology, The Royal Marsden Hospital, NHS Foundation Trust, SW3 6JJ - London/GB
  • 8 Clinical Research Unit, Institut Universitaire du Cancer -Toulouse- Oncopole, 31059 - Toulouse/FR
  • 9 Department Of Medical Oncology, Westdeutsches Tumorzentrum, University Hospital Essen & German Cancer Consortium, Essen/DE
  • 10 Department Of Dermatology, UniversitätsSpital Zürich, Skin Cancer Center University Hospital, 8091 - Zürich/CH
  • 11 Drug Development Department (ditep), Institute Gustave Roussy, 94805 - Villejuif Cedex/FR
  • 12 Department Of Dermatology, Medical University of Vienna, 1090 - Vienna/AT
  • 13 Early Assets, Bristol-Myers Squibb, 08540 - Princeton/US
  • 14 Early Assets, Bristol-Myers Squibb, Princeton/US
  • 15 Department Of Medical Oncology, Vall d'Hebron Institute of Oncology, 08035 - Barcelona/ES


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Abstract 4998


Simultaneous blockade of LAG-3 and PD-1 may synergistically restore T-cell activation and enhance antitumor immunity. In a phase 1/2a study (NCT01968109), BMS-986016 (anti–LAG-3) + nivolumab (anti–PD-1) showed promising antitumor activity in the mel prior IO cohort (Ascierto et al. J Clin Oncol. 2017;35(suppl) [abstr 9520]). Here, we describe updated efficacy and safety in a larger mel prior IO cohort in all-comer and biomarker-enriched populations.


Pts in the mel prior IO cohort received BMS-986016 80 mg + nivolumab 240 mg Q2W. Primary objectives were safety and objective response rate (ORR), disease control rate (DCR), and duration of response (DOR) per RECIST v1.1. Biomarker and efficacy correlations were also evaluated.


As of June 15, 2017, 68 pts were treated; 57% had prior anti–CTLA-4 and 46% had ≥ 3 lines of prior therapy. In 61 efficacy-evaluable pts, ORR was 11.5% (1 complete, 6 partial [1 unconfirmed] responses); DCR was 49%. Median DOR was not reached (min [0.1+], max [39.3+]). ORR was ≥ 3.5-fold higher in pts with LAG-3 expression ≥ 1% vs 


This is the largest report of outcomes in pts treated with anti–LAG3 + anti–PD-1. BMS-986016 + nivolumab is well tolerated with a safety profile similar to nivolumab monotherapy and provides encouraging efficacy in a heavily pretreated, anti–PD-1/PD-L1 progressed melanoma population. Enhanced responses correlated with LAG-3 expression, irrespective of PD-L1 expression.

Clinical trial identification


Legal entity responsible for the study

Bristol-Myers Squibb


Bristol-Myers Squibb


P.A. Ascierto: Grants/personal fees from BMS, Roche-Genentech, and Array (all consultant/advisory role and research funds), personal fees from Novartis, Amgen, Merck Serono, Pierre Fabre, and MSD (all consultant/advisory role) outside the submitted work. P. Bono: Honoraria from Pfizer, BMS, Orion Pharma, Novartis and MSD; research grant from Novartis, outside the submitted work; Stock Ownership: Tilt Biotherapeutics. S. Bhatia: Grants from Bristol-Myers-Squibb during the conduct of the study (research funding to institution (UW)) I. Melero: Grants/personal fees from BMS, Roche, Alligator, and Tusk; personal fees Bayer, AstraZeneca, Merck, Novartis, outside the submitted work. I-M. Svane: Grants from BMS (fee paid to my institution for covering of expenses for patients included in the study) J. Larkin: Grants from BMS, MSD, Pfizer, Novartis; Personal fees from Esai, BMS, MSD, GSK, Kymab, Pfizer, Novartis, Roche, Genentech, Secarna, Pierre Fabre, and EUSA Pharma not related to the submitted work. D. Schadendorf: Personal fees and other from Novartis and GSK during conduct of study; personal fees from Amgen, Boehringer Ingelheim and Leo Pharma, personal fees and other from Roche, Merck/MSD and BMS outside the submitted work R. Dummer: Consultancy - BMS A. Marabelle: Personal fees from roche/genentech, personal fees from BMS, personal fees from Merck, personal fees from Pfizer, personal fees from Astra Zeneca, outside the submitted work C. Hoeller: Study fees from BMS, during the conduct of the study; personal fees from BMS, Astra-Zeneca, Amgen, MSD, Novartis, Pierre Fabre, Roche, outside the submitted work M. Maurer, C.T. Harbison, P. Mitra, S. Suryawanshi, K. Thudium: BMS employee, owner of BMS stock. All other authors have declared no conflicts of interest.

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