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Head and neck cancer, excluding thyroid

2324 - Treatment Beyond Progression With Nivolumab in Patients With Recurrent or Metastatic (R/M) Squamous Cell Carcinoma of the Head and Neck (SCCHN) in the Phase 3 Checkmate 141 Study: A Biomarker Analysis and Updated Clinical Outcomes


11 Sep 2017


Head and neck cancer, excluding thyroid


Cancers in Adolescents and Young Adults (AYA);  Immunotherapy;  Head and Neck Cancers


Robert Haddad


Annals of Oncology (2017) 28 (suppl_5): v372-v394. 10.1093/annonc/mdx374


R. Haddad1, G. Blumenschein Jr2, J. Fayette3, J. Guigay4, A.D. Colevas5, L. Licitra6, S. Kasper7, E.E. Vokes8, F. Worden9, N.F. Saba10, M. Tahara11, F. Concha-Benavente12, M. Monga13, M. Lynch14, L. Li15, J.W. Shaw16, M.L. Gillison2, K.J. Harrington17, R.L. Ferris12

Author affiliations

  • 1 Department Of Medical Oncology, Dana-Farber/Harvard Cancer Center, 02115 - Boston/US
  • 2 Department Of Thoracic/head And Neck Medical Oncology, MD Anderson Cancer Center, Houston/US
  • 3 Medical Oncology, Centre Léon Bérard, Lyon/FR
  • 4 Medical Oncology, Centre Antoine Lacassagne, FHU OncoAge, Université Côte d’Azur, Nice/FR
  • 5 Department Of Medicine, Stanford University, Stanford/US
  • 6 Head And Neck Medical Oncology Department, Fondazione IRCCS Istituto Nazionale dei Tumori and University of Milan, Milan/IT
  • 7 Department Of Medical Oncology, West German Cancer Center, University Hospital, Essen/DE
  • 8 Medical Oncology, University of Chicago Medical Center, Chicago/US
  • 9 Medical Oncology, University of Michigan, Ann Arbor/US
  • 10 Department Of Hematology And Medical Oncology, Winship Cancer Institute of Emory University, 30322 - Atlanta/US
  • 11 Division Of Head And Neck Medical Oncology, National Cancer Center Hospital East, 277-8577 - Kashiwa/JP
  • 12 Otolaryngology Department, University of Pittsburgh Medical Center Cancer Center, Pittsburgh/US
  • 13 Oncology Clinical Development, Bristol-Myers Squibb, 08540 - Princeton/US
  • 14 Global Clinical Development, Bristol-Myers Squibb, 08540 - Princeton/US
  • 15 Global Biometric Sciences, Bristol-Myers Squibb, 08540 - Princeton/US
  • 16 Worldwide Health Economics And Outcomes Research, Bristol-Myers Squibb, 08540 - Princeton/US
  • 17 Radiotherapy And Imaging, Royal Marsden NHS Foundation Trust/The Institute of Cancer Research, London/GB


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Abstract 2324


Treatment responses to immune checkpoint inhibitors may occur after initial radiologic evidence of progression. In CheckMate 141 (NCT02105636), a randomized phase 3 study in patients (pts) with R/M SCCHN, nivolumab (nivo) significantly prolonged overall survival (OS) vs single-agent of investigator’s choice (HR = 0.70 [97.73% CI: 0.51, 0.96]). We provide a biomarker analysis and updated clinical outcomes of nivolumab treatment beyond first disease progression.


This analysis is based on a Sept 2016 database lock (minimum follow-up: 11.4 mo). Progression was assessed per RECIST 1.1. Treatment beyond first progression was permitted in the nivo arm for pts who met protocol defined criteria. Pts without progression or tumor assessment to determine progression were excluded. Immune cell phenotyping was conducted by flow cytometry for pts with samples available for both day 1 (D1) and D43 of treatment, and associated with clinical response status.


Of 240 pts randomized to nivo, 146 (61%) experienced progression. Among them, 62 (42%) received ≥1 dose of nivo after progression (TBP group), and 84 (58%) were not treated beyond progression (NTBP group). Median OS was 12.7 mo (95% CI: 9.7, 14.6) in the TBP group. After initial progression, 15 (24%) pts in the TBP group had a reduction in target lesion size, with >30% reduction in 3 pts. Of these 15 pts, 8 were HPV+, 4 had PD-L1 ≥1%, and 5 had >20% increase in target lesion at first progression. Frequencies of grade 3–4 treatment-related adverse events were similar in the TBP and NTBP groups. At D1 and D43, the percentage of CD8+ T cells in peripheral blood for TBP pts (n = 5) was similar to that for responders (n = 15), which was significantly higher vs NTBP pts (n = 9). At D1, the percentage of PD-1+ CD8+ effector T cells was significantly lower in responders and TBP pts vs NTBP pts. At D1, TBP pts, similar to responders, had a significantly lower PD-1+ Treg percentage vs NTBP pts.


Nivo treatment beyond progression in some pts with R/M SCCHN was tolerable and associated with tumor size reductions. Certain immune cell profiles in the TBP group appear similar to those of responders.

Clinical trial identification


Legal entity responsible for the study

Bristol-Myers Squibb


Bristol-Myers Squibb


R. Haddad: Grants to my institution from Bristol-Myers Squibb, Merck, Celgene, Pfizer, and AstraZeneca; personal fees from Bristol-Myers Squibb, Merck, AstraZeneca, Pfizer, Celgene, and Eisai. G. Blumenschein Jr: Research grants from: Merck, AstraZeneca, Celgene, AbbVie, Benentech, Xcovery, Novartis, Bayer, Bristol-Myers Squibb, GlaxoSmithKline; Consulting fees from: Bristol-Myers Squibb, Bayer, Celgene, Clovis, AbbVie, Ariad, AstraZeneca, Merck. J. Fayette: Personal fees from Bristol-Myers Squibb and AstraZeneca. J. Guigay: Research grants to my institution from: Bristol-Myers Squibb, Boehringer Ingelheim, GlaxoSmithKline, and Merck Serono. A.D. Colevas: Research grants outside of the submitted work from: Bristol-Myers Squibb, IRX Therapeutics, Threshold Pharmaceuticals, AstraZeneca, and Innate Pharma. L. Licitra: Consulting/grants to institution/travel fees: Merck-Serono; Consulting/grants to institution: Eisai, MSD, Merck-Serono, Boehringer Ingelheim, Novartis, AstraZeneca, Roche; Consulting/travel fees: Bayer, Debiopharm, Sobi; Consulting: Bristol-Myers Squib. S. Kasper: Personal fees for advisory board participation from Bristol-Myers Squibb. E.E. Vokes: Consulting/advisory role with: AbbVie, Amgen, AstraZeneca, Bristol-Myers Squibb, Boehringer-Ingelheim, Celgene, Eli Lilly, Genentech, Leidos, Merck, Regeneron, Serono, Takeda, VentiRx. N.F. Saba: Advisory board participation/personal fees: Bristol-Myers Squib, Lilly, Merck; Member of DSMC/personal fees: Pfizer. M. Tahara: Ad board/Research funding: Ono Pharmaceuticals, MSD, AstraZeneca, Pfizer; Ad board/Lecture honorarium: Bristol-Myers Squib, Bayer; Lecture honorarium/Research funding: Eisai; Lecture honorarium: Otsuka; Research funding: Boehringer-Ingelheim, Novartis, NanoCarrier. M. Monga, M. Lynch: Bristol-Myers Squibb employee. L. Li: Bristol-Myers Squibb employee. J.W. Shaw: Bristol-Myers Squibb employee and shareholder. M.L. Gillison: Honoraria, Consulting, Travel, Accommodations, and Expenses: Celgene, Lilly, Amgen, GlaxoSmithKline, Bristol-Myers Squibb, AstraZeneca, Merck; Research funding to my institution: Bristol-Myers Squibb, Merck, AstraZeneca, Kyowa. K.J. Harrington: Honoraria: AstraZeneca, Bristol-Myers Squib, Merck, MSD, Pfizer; Advisory Board membership: AstraZeneca, Bristol-Myers Squib, Merck, MSD, Pfizer; Research Grants: MSD. R.L. Ferris: Research funding: AstraZeneca/MedImmune, Bristol-Myers Squibb, VentiRx; Clinical Trial: AstraZeneca/MedImmune, Bristol-Myers Squibb, Merck; Advisory Board: Amgen, AstraZeneca/MedImmune, Bristol-Myers Squibb, EMD Serono, Lilly, Marck, Pfizer. All other authors have declared no conflicts of interest.

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