TY - JOUR
T1 - Nivolumab versus investigator's choice in patients with recurrent or metastatic squamous cell carcinoma of the head and neck
T2 - Efficacy and safety in CheckMate 141 by age
AU - Saba, Nabil F.
AU - Blumenschein, George
AU - Guigay, Joel
AU - Licitra, Lisa
AU - Fayette, Jerome
AU - Harrington, Kevin J.
AU - Kiyota, N.
AU - Gillison, Maura L.
AU - Ferris, Robert L.
AU - Jayaprakash, Vijayvel
AU - Li, Li
AU - Brossart, P.
N1 - Funding Information:
The authors thank the patients and their families as well as the clinical study teams for making this study possible. All authors contributed to and approved the manuscript; writing and editorial assistance was provided by Brooke Middlebrook, BS, of Evidence Scientific Solutions, funded by Bristol-Myers Squibb . K. J. Harrington acknowledges support from the Royal Marsden/the Institute of Cancer Research , National Institute of Health Research Biomedical Research Centre, and Oracle Cancer Trust . R. L. Ferris is supported by the P50 CA097190-14 , P30 CA047904-28 , and R01 CA206517 grants. The University of Texas MD Anderson Cancer Center is supported by the National Institutes of Health (grant P30 CA016672 ).
Funding Information:
The authors thank the patients and their families as well as the clinical study teams for making this study possible. All authors contributed to and approved the manuscript; writing and editorial assistance was provided by Brooke Middlebrook, BS, of Evidence Scientific Solutions, funded by Bristol-Myers Squibb. K. J. Harrington acknowledges support from the Royal Marsden/the Institute of Cancer Research, National Institute of Health Research Biomedical Research Centre, and Oracle Cancer Trust. R. L. Ferris is supported by the P50 CA097190-14, P30 CA047904-28, and R01 CA206517 grants. The University of Texas MD Anderson Cancer Center is supported by the National Institutes of Health (grant P30 CA016672). This study was sponsored by Bristol-Myers Squibb (Princeton, NJ, USA) and ONO Pharmaceutical Company, Ltd. (Osaka, Japan). Bristol-Myers Squibb was involved in the study concept and design, quality control of data, data analysis and interpretation, statistical analysis, and manuscript preparation, editing, and review.
Funding Information:
N. F. S. reports funding for research from Bristol-Myers Squibb and Exelexis, and other from Aduro, Bristol-Myers Squibb, GSK, Lilly, Merck, and Pfizer. G. B. reports grants from Adaptimmune, AstraZeneca, Bayer, Bristol-Myers Squibb, Celgene, Exelixis, Genentech, GlaxoSmithKline, Hoffman-La Roche, Immatics, Immunocore, Incyte, Kite Pharma, Macrogenics, Medimmune, Merck, Novartis, Torque, and Xcovery; and other from AbbVie, Adicet, Amgen, Ariad, AstraZeneca, Bayer, Bristol-Myers Squibb, Celgene, Clovis, Genentech, Hoffman-La Roche, Merck, Novartis, and Xcovery. J. G. reports grants from Bristol-Myers Squibb and Merck KGaA; advisory board fees from AstraZeneca, Bristol-Myers Squibb, Innate Pharma, Nanobiotix, and Merck KGaA; and other from Bristol-Myers Squibb and Merck KGaA. L. Licitra received grants from AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene International, Eisai, Exelixis, Inc., Hoffmann–La Roche Ltd., IRX Therapeutics, MedPace, Inc., Merck Serono, MSD, Novartis, Pfizer, and Roche; honoraria/consultation fees from Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Debiopharm, Doxa Pharma SRL, Eisai, Health & Life SRL, Immuno-Oncology Hub, Incyte Biosciences Italy SRL, Ipsen Innovation, Kura Oncology, Merck Serono, MSD, Nanobiotics SA, Novartis, Roche, and SOBI; and other from Bayer, Bristol-Myers Squibb, Debiopharm, Merck Serono, MSD, and SOBI. J. F. reports grants from AstraZeneca and Bristol-Myers Squibb; honoraria/consultation fees from AstraZeneca, Biogen, Bristol-Myers Squibb, Merck Sharp & Dohme, Merck Serono, Innate Pharma; personal fees from AstraZeneca, Bristol-Myers Squibb, and Merck Sharpe & Dohme. K. J. H. reports grants from AstraZeneca and Merck Sharp & Dohme; personal fees from AstraZeneca, Amgen, Bristol-Myers Squibb, Merck Sharp & Dohme, Merck Serono, and Pfizer. M. L. G. reports grants from AstraZeneca, Bristol-Myers Squibb, Kyowa, and Merck; and personal fees from Amgen, AstraZeneca, Bristol-Myers Squibb, Celgene, GlaxoSmithKline, Lilly, and Merck. R. L. F. reports grants and clinical trial support from AstaZeneca/MedImmune, Bristol-Myers Squibb, Merck, Tesaro, and VentiRx Pharmaceuticals; advisory board/consultation fees from Amgen, AstraZeneca/MedImmune, Bain Capital Life Sciences, Bristol-Myers Squibb, EMD Serono, GlaxoSmithKline, Iovance Biotherapeutics, Inc., Lilly, Merck, Numab Therapeutics AG, Oncorus, Inc., Ono Pharmaceutical Co. Ltd., Pfizer, PPD (Benitec, Immunicum), Regeneron Pharmaceuticals, Inc., Tesaro, Torque Therapeutics Inc., and TTMS. N. K. reports grants from ONO, AstraZeneca, and Pfizer; honoraria from ONO, Bristol-Myers Squibb, Merck Serono, Eisai, and Bayer. L. Li is an employee of and holds stock in Bristol-Myers Squibb. V. J. is an employee of Bristol-Myers Squibb and a former employee of AstraZeneca. All other authors report no conflict of interest.
Funding Information:
This study was sponsored by Bristol-Myers Squibb (Princeton, NJ, USA) and ONO Pharmaceutical Company, Ltd. (Osaka, Japan).
Publisher Copyright:
© 2019 The Authors
PY - 2019/9
Y1 - 2019/9
N2 - Objectives: Many patients with squamous cell carcinoma of the head and neck (SCCHN) are ≥65 years old; comorbidities and other age-related factors may affect their ability to tolerate traditional chemotherapy. Nivolumab is the only immunotherapy to significantly improve overall survival (OS) versus investigator's choice (IC) of single-agent chemotherapy at primary analysis in a phase 3 trial (CheckMate 141) in patients with recurrent/metastatic SCCHN post-platinum therapy. In this post hoc analysis, we report efficacy and safety by age. Patients and methods: Eligible patients were randomized 2:1 to nivolumab 3 mg/kg every 2 weeks (n = 240) or IC (methotrexate, docetaxel, or cetuximab n = 121). The primary endpoint of the trial was OS. For this analysis, outcomes were analyzed by age < 65 and ≥65 years. The data cut-off date was September 2017 (minimum follow-up 24.2 months). Results: At baseline, 68 patients (28.3%) receiving nivolumab and 45 patients (37.2%) receiving IC were ≥65 years. Baseline characteristics were generally similar across age groups. OS and tumor response benefits with nivolumab versus IC were maintained regardless of age. The 30-month OS rates of 11.2% (<65 years) and 13.0% (≥65 years) with nivolumab were more than tripled versus corresponding IC rates of 1.4% and 3.3%, respectively. The nivolumab arm had a lower rate of treatment-related adverse events versus IC regardless of age, consistent with the overall patient population. Conclusion: In CheckMate 141, nivolumab resulted in a higher survival versus IC in patients <65 and ≥65 years, with a manageable safety profile in both age groups. ClinicalTrials.gov: NCT02105636.
AB - Objectives: Many patients with squamous cell carcinoma of the head and neck (SCCHN) are ≥65 years old; comorbidities and other age-related factors may affect their ability to tolerate traditional chemotherapy. Nivolumab is the only immunotherapy to significantly improve overall survival (OS) versus investigator's choice (IC) of single-agent chemotherapy at primary analysis in a phase 3 trial (CheckMate 141) in patients with recurrent/metastatic SCCHN post-platinum therapy. In this post hoc analysis, we report efficacy and safety by age. Patients and methods: Eligible patients were randomized 2:1 to nivolumab 3 mg/kg every 2 weeks (n = 240) or IC (methotrexate, docetaxel, or cetuximab n = 121). The primary endpoint of the trial was OS. For this analysis, outcomes were analyzed by age < 65 and ≥65 years. The data cut-off date was September 2017 (minimum follow-up 24.2 months). Results: At baseline, 68 patients (28.3%) receiving nivolumab and 45 patients (37.2%) receiving IC were ≥65 years. Baseline characteristics were generally similar across age groups. OS and tumor response benefits with nivolumab versus IC were maintained regardless of age. The 30-month OS rates of 11.2% (<65 years) and 13.0% (≥65 years) with nivolumab were more than tripled versus corresponding IC rates of 1.4% and 3.3%, respectively. The nivolumab arm had a lower rate of treatment-related adverse events versus IC regardless of age, consistent with the overall patient population. Conclusion: In CheckMate 141, nivolumab resulted in a higher survival versus IC in patients <65 and ≥65 years, with a manageable safety profile in both age groups. ClinicalTrials.gov: NCT02105636.
KW - Age
KW - Biomarkers
KW - Nivolumab
KW - Phase 3 clinical trial
KW - Squamous cell carcinoma of the head and neck
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UR - http://www.scopus.com/inward/citedby.url?scp=85068230265&partnerID=8YFLogxK
U2 - 10.1016/j.oraloncology.2019.06.017
DO - 10.1016/j.oraloncology.2019.06.017
M3 - Article
C2 - 31422216
AN - SCOPUS:85068230265
SN - 1368-8375
VL - 96
SP - 7
EP - 14
JO - Oral Oncology
JF - Oral Oncology
ER -