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Article History

Received: 4 February 2026

Accepted: 21 June 2026

First Online: 11 August 2026

Declarations

Conflict of interest: Makoto Nishio reports receiving speaker fees from AbbVie, AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Chugai Pharmaceuticals, Daiichi Sankyo, Eli Lilly Japan K.K., Janssen, Merck Biopharma, MSD, Nippon Kayaku, Novartis Pharma K.K., Ono Pharmaceutical, Pfizer Japan, Taiho Pharmaceuticals, and Takeda Pharmaceuticals. Hidetoshi Hayashi reports receiving honoraria from AbbVie, Amgen, AstraZeneca K.K. Bristol Myers Squibb, Chugai Pharmaceuticals, CMIC, Daiichi Sankyo, Eisai Inc., Eli Lilly Japan K.K., EPS Corporation, MSD K.K., Ono Pharmaceuticals, and Takeda Pharmaceuticals; research funding from A2 Healthcare Corp, AbbVie, Amgen, Astellas Pharma, AstraZeneca K.K., Bristol Myers Squibb, Chugai Pharmaceuticals, Daiichi Sankyo, GlaxoSmithKline K.K., ICON Clinical Research GK, IQVIA Services JAPAN K.K., Janssen Pharmaceutical K.K., MSD K.K., Nippon Boehringer Ingelheim, Pfizer R&D Japan G.K., PPD-SNBL K.K., PRA Health Sciences Inc., Sanofi K.K., SYNEOS HEALTH CLINICAL K.K., Sysmex Corporation, Taiho Pharmaceuticals, and WJOG (West Japan Oncology Group); manuscript fees from Guardant Health Japan Corp. and Ono Pharmaceuticals; scholarship donations from Chugai Pharmaceuticals and Eisai Co. Ltd. Yasushi Goto reports receiving honoraria from AbbVie GK, Amgen K.K., AstraZeneca K.K., Asuka Corporation, Bristol-Myers Squibb K.K., Chugai Pharmaceutical Co., Ltd., Daiichi Sankyo Co., Ltd., Eisai Co., Ltd., Eli Lilly Japan K.K., Igaku Academy YTL Co., Ltd., Janssen Pharmaceutical K.K., Johnson & Johnson, Kagaku Hyoronsha Publishing Co., Ltd., Medical Review Co., Ltd., MSD K.K., Nippon Boehringer Ingelheim Co., Ltd., Nippon Kayaku Co., Ltd., Novartis Pharma K.K., Ono Pharmaceutical Co., Ltd., Pfizer Japan Inc., Sandoz K.K., Taiho Pharmaceutical Co., Ltd., Takeda Pharmaceutical Company Limited; research funding and manuscript fees from AstraZeneca K.K. Satoshi Ikeda reports receiving honoraria from Amgen, AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Chugai Pharmaceuticals, Daiichi Sankyo, Eli Lilly, MSD, Novartis, Pfizer, Regeneron, Taiho Pharmaceuticals, and Takeda; research funding from AstraZeneca and Chugai. Toshihide Yokoyama reports receiving honoraria from AstraZeneca, Bristol Myers Squibb, Chugai, Eli Lilly, Janssen, MSD, Ono, Pfizer, and Takeda; research funding from AstraZeneca, Bristol Myers Squibb, Chugai, Daiichi Sankyo, Eli Lilly, Janssen, MSD, Parexel Internation, Pfizer, and Takeda. Hiroshi Tanaka reports receiving research funding to institution and honoraria from AstraZeneca, Bristol Myers Squibb, Chugai, MSD, and Ono. Yuichi Tambo reports receiving honoraria from AstraZeneca, Bristol Myers Squibb, Chugai, Daiichi Sankyo, Kyowa Kirin, MSD, Pfizer, Taiho, and Takeda; research funding from AstraZeneca, Beigene, Bristol Myers Squibb, Daiichi Sankyo, Gilead, MSD, Ono, and Regeneron; grant from JSPS Kakenhi. Katsuyuki Hotta reports receiving honoraria from Amgen, AstraZeneca, Boehringer-Ingelheim, Bristol Myers Squibb, Chugai, Janssen, Lilly, Merck, MSD, Nippon Kayaku, Ono, Taiho, and Takeda; research funding from AbbVie, AstraZeneca, Bristol Myers Squibb, Janssen, Lilly, MSD, and Ono. Haruko Daga reports receiving honoraria from AstraZeneca. Marina Tschaika and Takekazu Aoyama report employment and stock ownership in Bristol Myers Squibb. Nan Hu is an employee of Bristol Myers Squibb. Tatsuro Fukuhara, Ken Masubuchi, and Hideaki Mizutani have no conflicts of interest to disclose.

Ethical approval: The institutional review board or independent ethics committee at each center approved these trials, and they were conducted in accordance with the Declaration of Helsinki and the International Conference on Harmonisation Good Clinical Practice guidelines. All patients provided written informed consent. The trial protocols have been published previously (Hellmann MD, et al. N Engl J Med 2018;378:2093–2104; Paz-Ares, L, et al. Lancet Onc , 2021;22:198–211).