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Article History

Received: 14 April 2025

Accepted: 11 August 2025

First Online: 13 September 2025

Declarations

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: The trial adhered to the International Conference on Harmonisation’s Guidelines on Good Clinical Practice, the Declaration of Helsinki’s ethical principles, and all relevant regulatory requirements. All patients provided written informed consent prior to enrollment.

: Yuko Mishima has received grant or contracts from Bristol Myers Squibb and Eisai; and has received honoraria for lectures, speakers bureaus, manuscript writing, or educational events from Janssen and Takeda. Daigo Hashimoto has received honoraria for lectures from Astellas Pharma Inc., Chugai Pharmaceutical Co., Ltd., Daiichi Sankyo Co., Ltd., Eisai Co., Ltd., Janssen Pharmaceutical K.K., Kyowa Kirin Co., Ltd., Meiji Seika Pharma Co., Ltd., Nippon Kayaku Co., Ltd., Novartis Pharmaceuticals, and Otsuka Pharmaceutical Co., Ltd. Michiko Ichii has received honoraria for lectures, speakers bureaus, manuscript writing, or educational events from Janssen Pharmaceutical. Noriko Fukuhara has received research grants from AbbVie, Chordia Therapeutics, Chugai, Genmab, Incyte, Kyowa Kirin, Loxo Oncology, and Takeda; and has received honoraria from AbbVie, AstraZeneca, Bristol-Myers Squibb, Chugai, CSL Behring, Eisai, Eli Lilly, Genmab, Janssen, Kyowa Kirin, Nippon Shinyaku, Novartis, Ono, Sanofi, Symbio, and Takeda. Toshiki Uchida has received honoraria from AbbVie, Asahi Kasei Pharma, AstraZeneca, Bristol Myers Squibb, Chugai, Eisai, Janssen, Kissei, Kyowa Kirin, Meiji Seika Pharma, Nippon Kayaku, Nippon Shinyaku, Novartis, Otsuka, Sanofi, and Takeda. Koji Kato has received grants or contracts from AbbVie, Astellas, Bristol Myers Squibb, Chugai, Eisai, Genmab, Gilead Sciences, Janssen, Japan Blood Products Organization, Kyowa Kirin, LSI Medience, Meiji, MSD, Novartis, Nippon Shinyaku, Ono, and Takeda; has received consulting fees from AbbVie, Bristol-Myers Squibb, Chugai, Gilead Sciences, Meiji, Novartis, and Takeda; and has received honoraria for lectures, speakers bureaus, manuscript writing, or educational events from AbbVie, Astellas, Bristol-Myers Squibb, Chugai, Eisai, Genmab, Gilead Sciences, Janssen, Japan Blood Products Organization, Kyowa Kirin, Meiji, MSD, Nippon Shinyaku, Novartis, and Otsuka. Ai Omi is an employee of Johnson & Johnson. Yosuke Koroki and Kaname Shiga are employees of Johnson & Johnson; and own stocks of Johnson & Johnson. Dai Maruyama has received research funding from AbbVie, Astellas, AstraZeneca, Bristol-Myers Squibb, Chugai, Eisai, Genmab, Janssen, Kyowa Kirin, Ono, Otsuka, Pfizer, MSD, Novartis, Sanofi, Symbio, Taiho, Takeda, and Zenyaku; has received honoraria from AbbVie, AstraZeneca, Bristol-Myers Squibb, Chugai, Eisai, Genmab, Janssen, Kyowa Kirin, MSD, Mundipharma, Nippon Shinyaku, Novartis, Ono, Sanofi, Symbio, Takeda, and Zenyaku; has participated on a Data Safety Monitoring Board for Ono; and had participated on an Advisory Board for AbbVie, AstraZeneca, Bristol-Myers Squibb, Chugai, Genmab, Janssen, Pfizer, and Sanofi.