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Article History

Received: 12 December 2025

Accepted: 23 April 2026

First Online: 17 September 2026

Declarations

Ethics approval and consent to participate: Study 114 was conducted in accordance with the Principles of the World Medical Association Declaration of Helsinki, all applicable Japanese Good Clinical Practices and regulations, and the Pharmaceutical and Medical Device Act for studies conducted in Japan. Prior to enrollment, patients signed informed consent forms. Ethical approval and written informed consent were granted and approved by the applicable local institutional review board.

Consent for publication: Not applicable

Competing interests: H. Ishiguro reports receiving research funding and funding for participating in a speaker’s bureau from Eisai, and served as a principal investigator for Eisai. Y. Miyoshi reports receiving research funding and honoraria from AstraZeneca, Chugai, Daiichi-Sankyo, Eisai, Eli Lilly, Kyowa-Kirin, MSD, Pfizer, and Taiho, and consulting fees from Daiichi-Sankyo. H. Yasojima has no conflicts of interest to disclose. J. Watanabe reports receiving research funding and funding for serving as an invited speaker and on an advisory board from Eisai. T. Takano reports receiving funding for serving as an invited speaker from Chugai, Daiichi-Sankyo, and Eli Lilly, for serving on an advisory board from Daiichi-Sankyo, Eisai, and Gilead, and for serving as a principal investigator from AstraZeneca, Chugai, Daiichi-Sankyo, Eli Lilly, Eisai, Gilead, and MSD. A. Shimomura reports receiving research funding from Eisai. E. Tokunaga reports receiving research funding and funding for serving on a speaker’s bureau from Eisai, and has served as a principal investigator for Eisai. T. Mukohara reports receiving research funding from Eisai, Daiichi-Sankyo, Sysmex, MSD, Pfizer, Sanofi, and Chugai Pharmaceuticals. Y. Naoi reports receiving research funding and funding for serving as a speaker from Eisai. D. Matsuoka, S. Okumura, Y. Otake, T. Suzuki, T. Takase, T. Semba, and Z. Zhao are employees of Eisai Co., Ltd. K. Yonemori reports receiving research funding from AstraZeneca, Boehringer Ingelheim, Chugai, Daiichi-Sankyo, Eisai, Eli Lilly, Genmab, Haihe, Kyowa Hakko Kirin, Merck Sharp & Dohme LLC, Nihon Kayaku, Novartis, Ono, Pfizer, Sanofi, Seattle Genetics, Taiho, and Takeda, consulting fees from AstraZeneca, Chugai, Eisai, Genmab, Novartis, OncXerna, Sanofi, and Takeda, and lectures fees from Pfizer, Eisai, Astellas, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, Chugai, Daiichi-Sankyo, Eli Lilly, FujiFilm Pharma, MSD, Ono, PDR Pharma, Sanofi, and Takeda.