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Poster display session

2446 - Nivolumab vs Investigator’s Choice (IC) in Patients With Recurrent or Metastatic (R/M) Squamous Cell Carcinoma of the Head and Neck (SCCHN): Treatment Effect on Clinical Outcomes by Best Overall Response in CheckMate 141

Date

10 Sep 2017

Session

Poster display session

Presenters

Lisa Licitra

Citation

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

Authors

L. Licitra1, R.L. Ferris2, G. Blumenschein Jr3, K.J. Harrington4, J. Guigay5, S. Kasper6, N.F. Saba7, R. Haddad8, N. Kiyota9, M. Monga10, M. Lynch11, L. Li12, M.L. Gillison13, J. Fayette14

Author affiliations

  • 1 Head And Neck Medical Oncology Department, Fondazione IRCCS Istituto Nazionale dei Tumori and University of Milan, 20133 - Milan/IT
  • 2 Medical Oncology, University of Pittsburgh Cancer Institute, 15232 - Pittsburgh/US
  • 3 Department Of Thoracic/head And Neck Medical Oncology, MD Anderson Cancer Center, Houston/US
  • 4 Head Of Division Of Radiotherapy And Imaging, Royal Marsden NHS Foundation Trust/The Institute of Cancer Research, London/GB
  • 5 Université Côte D’azur, Centre Antoine Lacassagne, FHU OncoAge, 6100 - Nice/FR
  • 6 Department Of Medical Oncology, West German Cancer Center, University Hospital, 45122 - Essen/DE
  • 7 Department Of Hematology And Medical Oncology, Winship Cancer Institute of Emory University, 30322 - Atlanta/US
  • 8 Medical Oncology, Dana-Farber/Harvard Cancer Center, 02115 - Boston/US
  • 9 Outpatient Care Unit, Kobe University Hospital Cancer Center, 650-0017 - Kobe/JP
  • 10 Oncology Clinical Development, Bristol-Myers Squibb, 08540 - Princeton/US
  • 11 Global Clinical Development, Bristol-Myers Squibb, 08540 - Princeton/US
  • 12 Global Biometric Sciences, Bristol-Myers Squibb, 08540 - Princeton/US
  • 13 Department Of Thoracic/head And Neck Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston/US
  • 14 Medical Oncology, Centre Léon Bérard, 69008 - Lyon/FR
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Resources

Abstract 2446

Background

In CheckMate 141, nivolumab monotherapy significantly prolonged overall survival (OS) vs IC (median [95% CI]: 7.5 [5.5, 9.1] mo vs 5.1 [4.0, 6.0] mo) and doubled response rate (13.3% vs 5.8%) in patients (pts) with R/M SCCHN. Here, we describe clinical outcomes by best overall response for the nivolumab and IC arms.

Methods

CheckMate 141 (NCT02105636) was a randomized, open-label, phase 3 trial in which pts (N = 361) with R/M SCCHN who progressed on or within 6 mo of platinum-based therapy were randomized 2:1 to nivolumab 3 mg/kg every 2 weeks (n = 240) or IC of methotrexate, docetaxel, or cetuximab (n = 121). We analyzed the primary endpoint of OS and additional endpoint of safety by best overall response (complete or partial response [CR/PR], stable disease [SD], or progressive disease [PD]), assessed by investigators per RECIST 1.1 every 6 weeks beginning at week 9.

Results

The minimum follow-up was 11.4 mo. Baseline demographics were similar across response groups and treatment arms. Median duration of therapy for nivolumab-treated pts with CR/PR, SD, and PD was 12.5 mo, 4.2 mo, and 1.6 mo, respectively. Estimates of median OS, 12-mo, and 18-mo survival rates favored nivolumab vs IC in the CR/PR and SD response groups (Table). The incidence of grade 3–4 treatment-related adverse events was lower for nivolumab vs IC within each of the response groups (CR/PR, SD, and PD).Table:

1055P

CR/PRSDPD
NivolumabICNivolumabICNivolumabIC
(n = 32)(n = 7)(n = 55)(n = 43)(n = 100)(n = 42)
Median OS, mo(95% CI)NR13.610.47.15.74.5
(NR, NR)(8.9, NR)(8.7, 15.2)(5.4, 9.5)(4.8, 7.8)(3.6, 5.8)
HR (95% CI)0.08 (0.01, 0.47)0.53 (0.33, 0.85)0.74 (0.51, 1.09)
12-mo OS rate, % (95% CI)96.857.146.129.421.411.9
(79.2, 99.5)(17.2, 83.7)(32.4, 58.7)(16.4, 43.7)(13.9, 30.1)(4.4, 23.6)
18-mo OS rate, % (95% CI)86.138.132.611.73.04.8
(67.0, 94.6)(6.1, 71.6)(20.0, 45.8)(3.6, 25.0)(0.6, 8.9)(0.5, 17.2)

NR = not reached

Conclusions

Pts with CR/PR and SD had improved median OS and survival rates with nivolumab relative to single-agent standard therapy. Nivolumab’s safety profile was favorable vs IC, including for pts with CR/PR whose median duration of therapy was greater than a year.

Clinical trial identification

NCT02105636

Legal entity responsible for the study

Bristol-Myers Squibb

Funding

Bristol-Myers Squibb

Disclosure

L. Licitra: Reports consultant/advisory support from Eisai, Bristol-Myers Squibb, MSD, Merck-Serono, Boehringer-Ingelheim, Novartis, AstraZeneca, Bayer Roche and honoraria/consultation fees from Eisai, Bristol-Myers Squibb, MSD, Merck Serono, Debiopharm, Sobi, AstraZeneca. R.L. Ferris: Reports other from Amgen, other from AstraZeneca/MedImmune, other from Bristol-Myers Squibb, other from EMD Serono, other from Lilly, other from Merck, other from Pfizer, other from VentiRx Pharmaceuticals, during the conduct of the study. G. Blumenschein Jr: Reports grants from Merck, AstraZeneca, Celgene, AbbVie, Genentech, Xcovery, Novartis, Bayer, Bristol-Myers Squibb, GSK, during the conduct of the study; other from Bristol-Myers Squibb, Bayer, Celgene, Clovis, AbbVie, Ariad, AstraZeneca, Merck, outside the submitted work. K.J. Harrington: Reports honoraria and advisory board roles from AstraZeneca, Bristol-Myers Squibb, Merck, MSD, Pfizer and research grants from MSD J. Guigay: Grants to institution: Bristol-Myers Squibb, Boehringer-Ingelheim, GlaxoSmithKline, Merck Serono. S. Kasper: Reports personal fees from Bristol-Myers Squibb, outside the submitted work. N.F. Saba: Reports personal fees from Bristol-Myers Squibb, personal fees from Pfizer, personal fees from Merck, personal fees from Lilly, outside the submitted work. R. Haddad: Reports grants from Bristol-Myers Squibb, Merck, Celgene, Pfizer, AstraZeneca, personal fees from Bristol-Myers Squibb, Merck, AstraZeneca, Pfizer, Celgene, Eisai, during the conduct of the study. N. Kiyota: Reports research grants from ONO Pharma, during the conduct of the study; research grants from Nippon Boehringer Ingelheim, AstraZeneca, Eisai, outside the submitted work; honoraria from ONO PHARMA, Bristol-Myers Squibb, Merck Serono, Eisai and Bayer. M. Monga: Reports other from Bristol-Myers Squibb, during the conduct of the study. M. Lynch: Dr Lynch in an employee of Bristol-Myers Squibb. L. Li: Employee of Bristol-Myers Squibb. M.L. Gillison: Reports personal fees from Celgene, Lilly, Amgen, GlaxoSmithKline; grants and personal fees from Bristol-Myers Squibb, Merck, AstraZeneca, grants from Kyowa, during the conduct of the study. J. Fayette: Reports personal fees from Bristol-Myers Squibb and AstraZeneca, outside the submitted work.

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