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Article History

Accepted: 14 July 2025

First Online: 13 August 2025

Declarations

:

: Kohei Shitara received personal fees for consulting and advisory roles from ALX Oncology, Amgen, Arcus Biosciences, Astellas, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, Daiichi Sankyo, GlaxoSmithKline K.K., Guardant Health Japan, Healios K.K., Janssen, Merck, Moderna, Novartis, Ono Pharmaceutical, Takeda, and Zymeworks; honoraria from Astellas, AstraZeneca, Bristol Myers Squibb, Janssen, and Ono Pharmaceutical; and research funding (all to institution) from Amgen, Astellas, AstraZeneca, Chugai Pharma, Daiichi Sankyo, Eisai, Merck, Ono Pharmaceutical, PPD-SNBL K.K., PRA Health Sciences, Taiho Pharmaceutical, and Toray, outside the submitted work. Rui-Hua Xu has nothing to report. David Ilson has nothing to report. Sara Lonardi served as consultant/advisor for Amgen, Astellas, AstraZeneca, Bayer, BeiGene, Bristol Myers Squibb, Daiichi Sankyo, GSK, Helion, Incyte, Lilly, Merck Serono, MSD, Nimbus Therapeutics, Rottapharm, Servier, and Takeda; and invited speaker for Amgen, AstraZeneca, Bristol Myers Squibb, GSK, Incyte, Lilly, Merck Serono, MSD, Pierre Fabre, Roche, and Servier. Samuel J. Klempner served as consultant/advisor for Astellas, AstraZeneca, Bristol Myers Squibb, Coherus BioSciences, Daiichi Sankyo, Merck, Mersana Therapeutics, Natera, Novartis, Roche, Sanofi-Aventis, Scandion Oncology, and Servier; and reports prior stock/equity in Nuvalent and Turning Point Therapeutics. Jianning Yang, Akihiro Yamada, Yoko Ueno, Masato Takeuchi, Janet Pavese, Maria Matsangou, and Srinivasu Poondru are employees of Astellas. Tomasz Wojtkowski was an employee of Astellas at the time the study was conducted.

: The research reported in this article was sponsored by Astellas Pharma, Inc.

: Not applicable.

: Not applicable.

: Not applicable.

: Details for how researchers may request access to anonymized participant level data, trial level data and protocols from Astellas sponsored clinical trials can be found at .

: Conceptualization: Jianning Yang and Srinivasu Poondru; methodology: Jianning Yang, Akihiro Yamada, and Srinivasu Poondru; formal analysis and investigation: Jianning Yang, Akihiro Yamada, Kohei Shitara, David Ilson, Sara Lonardi, Samuel J. Klempner, Yoko Ueno, Masato Takeuchi, Janet Pavese, Tomasz Wojtkowski, and Maria Matsangou; writing—original draft preparation: Jianning Yang and Akihiro Yamada; writing—review and editing: Jianning Yang, Akihiro Yamada, Kohei Shitara, Rui-Hua Xu, David Ilson, Sara Lonardi, Samuel J. Klempner, Yoko Ueno, Masato Takeuchi, Janet Pavese, Tomasz Wojtkowski, Maria Matsangou, and Srinivasu Poondru; and supervision: Srinivasu Poondru. All authors participated in the critical review and revision of this manuscript and provided approval of the manuscript for submission.