Clinical Trial

. 2020 Oct;42(10):2852-2862.

doi: 10.1002/hed.26331. Epub 2020 Jun 24.

Two-year follow-up of a randomized phase III clinical trial of nivolumab vs. the investigator's choice of therapy in the Asian population for recurrent or metastatic squamous cell carcinoma of the head and neck (CheckMate 141)

Chia-Jui Yen¹, Naomi Kiyota^{2

3}, Nobuhiro Hanai⁴, Shunji Takahashi⁵, Tomoya Yokota⁶, Shigemichi Iwae⁷, Yasushi Shimizu⁸, Ruey-Long Hong⁹, Masahiro Goto¹⁰, Jin-Hyoung Kang¹¹, Wing Sum Kenneth Li¹², Robert L Ferris¹³, Maura Gillison¹⁴, Toshimitsu Endo¹⁵, Vijayvel Jayaprakash¹⁶, Makoto Tahara¹⁷

Affiliations

¹ Division of Hematology and Oncology, Department of Internal Medicine, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan.
² Department of Medical Oncology and Hematology, Kobe University Hospital, Kobe, Japan.
³ Cancer Center, Kobe University Hospital, Kobe, Japan.
⁴ Department of Head and Neck Surgery, Aichi Cancer Center Hospital, Nagoya, Japan.
⁵ Department of Medical Oncology, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, Japan.
⁶ Division of Gastrointestinal Oncology, Shizuoka Cancer Center, Shizuoka, Japan.
⁷ Department of Head and Neck Surgery, Hyogo Cancer Center, Akashi, Japan.
⁸ Department of Medical Oncology, Hokkaido University Hospital, Sapporo, Japan.
⁹ Department of Oncology, National Taiwan University Hospital, Taipei, Taiwan.
¹⁰ Cancer Chemotherapy Center, Osaka Medical College Hospital, Takatsuki, Japan.
¹¹ Division of Medical Oncology, Department of Internal Medicine, The Catholic University of Korea, Seoul St. Mary's Hospital, Seoul, Republic of Korea.
¹² Department of Clinical Oncology, Queen Elizabeth Hospital, Hong Kong, China.
¹³ UPMC Hillman Cancer Center, University of Pittsburgh Medical Center Cancer Center, Pittsburgh, Pennsylvania, USA.
¹⁴ Department of Thoracic Head and Neck Medical Oncology, Division of Cancer Medicine, MD Anderson Cancer Center, Houston, Texas, USA.
¹⁵ Section 1, Oncology Medical Affairs, ONO Pharmaceutical Co., Ltd, Osaka, Japan.
¹⁶ Oncology Clinical Development, BMS, Bristol-Myers Squibb, Princeton, New Jersey, USA.
¹⁷ Department of Head and Neck Medical Oncology, National Cancer Center Hospital East, Kashiwa, Japan.

PMID: 32583557
PMCID: PMC7540331
DOI: 10.1002/hed.26331

Clinical Trial

Two-year follow-up of a randomized phase III clinical trial of nivolumab vs. the investigator's choice of therapy in the Asian population for recurrent or metastatic squamous cell carcinoma of the head and neck (CheckMate 141)

Chia-Jui Yen et al. Head Neck. 2020 Oct.

. 2020 Oct;42(10):2852-2862.

doi: 10.1002/hed.26331. Epub 2020 Jun 24.

Authors

Affiliations

¹ Division of Hematology and Oncology, Department of Internal Medicine, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan.
² Department of Medical Oncology and Hematology, Kobe University Hospital, Kobe, Japan.
³ Cancer Center, Kobe University Hospital, Kobe, Japan.
⁴ Department of Head and Neck Surgery, Aichi Cancer Center Hospital, Nagoya, Japan.
⁵ Department of Medical Oncology, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, Japan.
⁶ Division of Gastrointestinal Oncology, Shizuoka Cancer Center, Shizuoka, Japan.
⁷ Department of Head and Neck Surgery, Hyogo Cancer Center, Akashi, Japan.
⁸ Department of Medical Oncology, Hokkaido University Hospital, Sapporo, Japan.
⁹ Department of Oncology, National Taiwan University Hospital, Taipei, Taiwan.
¹⁰ Cancer Chemotherapy Center, Osaka Medical College Hospital, Takatsuki, Japan.
¹¹ Division of Medical Oncology, Department of Internal Medicine, The Catholic University of Korea, Seoul St. Mary's Hospital, Seoul, Republic of Korea.
¹² Department of Clinical Oncology, Queen Elizabeth Hospital, Hong Kong, China.
¹³ UPMC Hillman Cancer Center, University of Pittsburgh Medical Center Cancer Center, Pittsburgh, Pennsylvania, USA.
¹⁴ Department of Thoracic Head and Neck Medical Oncology, Division of Cancer Medicine, MD Anderson Cancer Center, Houston, Texas, USA.
¹⁵ Section 1, Oncology Medical Affairs, ONO Pharmaceutical Co., Ltd, Osaka, Japan.
¹⁶ Oncology Clinical Development, BMS, Bristol-Myers Squibb, Princeton, New Jersey, USA.
¹⁷ Department of Head and Neck Medical Oncology, National Cancer Center Hospital East, Kashiwa, Japan.

PMID: 32583557
PMCID: PMC7540331
DOI: 10.1002/hed.26331

Abstract

Background: The present study evaluated the 2-year survival of the Asian population in the CheckMate 141 trial.

Methods: The CheckMate 141 trial included patients with recurrent or metastatic (R/M) squamous cell carcinoma of the head and neck (SCCHN). In the present study, 34 Asian patients (nivolumab group: 23 patients; investigator's choice of therapy [IC] group: 11 patients) were analyzed.

Results: The median overall survival (OS) was 12.1 and 6.2 months for the nivolumab and IC groups, respectively. The estimated 2-year OS rates were 22.7% and 0% for the nivolumab and IC groups, respectively. In the nivolumab group, the patients with any treatment-related adverse events (TRAEs), including skin-related disorders, showed better OS than the patients without any TRAEs.

Conclusions: Nivolumab demonstrated prolonged OS benefits in the Asian population with platinum-refractory R/M SCCHN and a favorable safety profile. TRAEs, including skin-related disorders, may be favorable prognostic factors for nivolumab efficacy.

Clinical trial registration: NCT02105636.

Keywords: Asian population; clinical trial; immunotherapy; nivolumab; squamous cell carcinoma of the head and neck.

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Conflict of interest statement

Dr Yen reports grants from ONO Pharmaceutical and Bristol‐Myers Squibb. Dr Kiyota reports grants from ONO Pharmaceutical, AstraZeneca, Pfizer, and Chugai Pharmaceutical; honoraria from ONO Pharmaceutical, Bristol‐Myers Squibb, Merck Serono, Eisai, and Bayer. Dr Hanai reports grants from ONO Pharmaceutical and Bristol‐Myers Squibb. Dr Takahashi reports grants from ONO Pharmaceutical and Bristol‐Myers Squibb. Dr Yokota reports grants from ONO Pharmaceutical, Bristol‐Myers Squibb, AstraZeneca, Merck Biopharma, MSD, Novartis, Incyte, Eli Lilly, Eisai, and Chugai Pharmaceutical. Dr Iwae reports grants from ONO Pharmaceutical and Bristol‐Myers Squibb. Dr Shimizu reports grants from ONO Pharmaceutical and Bristol‐Myers Squibb. Dr Hong reports grants from ONO Pharmaceutical and Bristol‐Myers Squibb. Dr Goto reports grants from Bristol‐Myers Squibb; and grants, personal fees, and nonfinancial support from ONO Pharmaceutical; and grants, personal fees, and nonfinancial support from Takeda, Chugai, Kyowa Hakko Kirin, Taiho, and Mochida; personal fees and nonfinancial support from Yakult Honsha, Novartis, Bayer Yakuhin; and grants from Nippon Kayaku outside the submitted work. Dr Kang reports grants from ONO Pharmaceutical, AstraZeneca, and Eli Lilly. Dr Li reports grants from ONO Pharmaceutical and Bristol‐Myers Squibb. Dr Ferris reports grants and clinical trial support from AstraZeneca/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. Dr Gillison reports grants from AstraZeneca, Bristol‐Myers Squibb, Kyowa, and Merck and personal fees from Amgen, AstraZeneca, Bristol‐Myers Squibb, Celgene, GlaxoSmithKline, Lilly, and Merck. Dr Tahara reports grants from ONO Pharmaceutical, Bristol‐Myers Squibb, Eisai, Otsuka, Boehringer Ingelheim, AstraZeneca, Pfizer, Novartis, and NanoCarrier and has received personal fees from ONO Pharmaceutical, Bristol‐Myers Squibb, Merck Sharp & Dohme, Bayer, Eisai, Otsuka, AstraZeneca, and Pfizer. T. Endo is an employee of ONO Pharmaceutical. V. Jayaprakash is an employee of Bristol‐Myers Squibb.

Figures

**FIGURE 1**
Overall survival (OS) in the global population, A, and Asian population, B. A, is reproduced with permission from Oral Oncology. ¹¹ Abbreviations: CI, confidence interval; HR, hazard ratio; ITT, intention to treat [Color figure can be viewed at wileyonlinelibrary.com]

**FIGURE 2**
Overall survival (OS), A, and progression‐free survival (PFS), B, in patients with and without treatment‐related adverse events (TRAEs). Abbreviations: CI, confidence interval; HR, hazard ratio [Color figure can be viewed at wileyonlinelibrary.com]

**FIGURE 3**
Overall survival (OS), A, and progression‐free survival, B, in patients with/without skin reactions in the Asian population. Abbreviations: CI, confidence interval; HR, hazard ratio; NR, not reached [Color figure can be viewed at wileyonlinelibrary.com]

See this image and copyright information in PMC

References

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Two-year follow-up of a randomized phase III clinical trial of nivolumab vs. the investigator's choice of therapy in the Asian population for recurrent or metastatic squamous cell carcinoma of the head and neck (CheckMate 141)

Affiliations

Two-year follow-up of a randomized phase III clinical trial of nivolumab vs. the investigator's choice of therapy in the Asian population for recurrent or metastatic squamous cell carcinoma of the head and neck (CheckMate 141)

Authors

Affiliations

Abstract

Conflict of interest statement

Figures

References

Publication types

MeSH terms

Substances

Associated data

LinkOut - more resources

Full Text Sources

Medical