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Article History

Received: 9 April 2025

Accepted: 30 July 2025

First Online: 1 September 2025

Declarations

:

: DK has received honoraria from Takeda, Chugai, Eli Lilly, Merck Sharp & Dohme (MSD), Ono Pharmaceutical, Seagen, Guardant Health, Eisai, Taiho, Bristol Myers Squibb, Daiichi Sankyo, Pfizer, Merck Biopharma, and Sysmex; and reports grants or funds from Ono Pharmaceutical, MSD, Novartis, Servier, Janssen, IQVIA, Syneos Health, CIMIC, and CMIC Shift Zero. TY has received honoraria from Chugai, Takeda, Merck Biopharma, Bayer Yakuhin, Ono Pharmaceutical, and MSD; consulting fees from Sumitomo Corp; and reports grants or funds from Amgen, Bristol Myers Squibb, Chugai, Daiichi Sankyo, Eisai, FALCO Biosystems, Genomedia, Medical & Biological Laboratories, Merus N.V., Molecular Health GmbH, MSD, Nippon Boehringer Ingelheim, Ono Pharmaceutical, Pfizer Japan, Roche Diagnostics, Sanofi, Sysmex, Taiho, and Takeda. TM has received honoraria from Bayer Yakuhin, Bristol Myers Squibb, Chugai, Daiichi Sankyo, Eli Lilly, Merck Serono, Ono Pharmaceutical, Sanofi, Taiho, Takeda, Yakult Honsha, MSD, Takata, Astellas, and Nippon Kayaku; and reports grants or funds from Amgen, Boehringer Ingelheim, CMIC, Daiichi Sankyo, Eli Lilly Japan, MSD, Novartis, Ono Pharmaceutical, Pfizer, and Syneos Health. YS has received honoraria and grants or funds from Takeda. KY reports honoraria from Chugai, Daiichi Sankyo, Yakult Honsha, Takeda, Merck Serono, Taiho, Eli Lilly, Ono Pharmaceutical, MSD, and Bristol Myers Squibb; and grants or funds from Taiho. HK reports honoraria from Bristol Myers Squibb, Bayer Yakuhin, Eli Lilly Japan K.K., MSD, Ono Pharmaceutical, Chugai, Daiichi Sankyo, Merck Biopharma, Takeda, Yakult Pharmaceutical Industry, Teijin Pharma, Taiho, Otsuka Pharmaceutical, Nippon Kayaku, GlaxoSmithKline, Amgen, Novartis, and Astellas; consulting fees from Daiichi Sankyo, Astellas, and AbbVie; grants or funds from Eisai, Bristol Myers Squibb, Kobayashi Pharmaceutical, Astellas, Taiho; and other potential financial relationship with Medical & Biological Laboratories. TN reports honoraria from Astellas, and Ono Pharmaceutical. YK has received honoraria from Ono Pharmaceutical, Taiho, Chugai, Eli Lilly, Bayer, MSD, Astellas, Yakult, Daiichi Sankyo, and Incyte; and reports grants or funds from Ono Pharmaceutical, Taiho, Chugai, Eli Lilly, Bayer, MSD, Astellas, Yakult, Daiichi Sankyo, Incyte, Eisai, NCCH, Syneos Health, CMIC, and Parexel. TE has received honoraria from Chugai, Taiho, Ono Pharmaceutical, Hisamitsu, Roche Diagnostics, Zeria, MSD, Eli Lilly, and Daiichi Sankyo; and grants or funds from Ono Pharmaceutical, Seagen, Taiho, Jazz Pharmaceuticals, Ignyta, Quintiles, Bristol Myers Squibb, Asahi Kasei Pharma, ALX Oncology, MSD, Nihon Kayaku, Astellas, Amgen, IQVIA, Daiichi Sankyo, Chugai, Syneos Health Clinical, Pfizer, and Amgen. CE reports consulting fees from Amgen, Elevation, GlaxoSmithKline, GE HealthCare, IGM, Merck Biopharma, Natera, Pfizer, Seagen, Taiho, AbbVie, and Takeda; and potential financial relationships paid to Vanderbilt from Janssen, Merck Biopharma, Gritstone, and Hutchinson. SN is employed by and holds stocks/shares with HUTCHMED International Corporation. WS is an employee of and holds stocks/shares with HUTCHMED International Corporation. MK was a previous HUTCHMED International Corporation employee during study conduct and analysis. TS has received honoraria from MSD, AstraZeneca, Ono Pharmaceutical, Bristol Myers Squibb, and Daiichi Sankyo; and reports grants or funds from MSD, AstraZeneca, Ono Pharmaceutical, Bristol Myers Squib, Daiichi Sankyo, Shionogi Pharmaceutical, and Janssen. AT, SU, RP, and ZY have no conflicts to report.

: FRESCO-2 was conducted in accordance with the Declaration of Helsinki and Good Clinical Practice guidelines, including the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, and all applicable laws and regulations. The protocol was approved by the institutional review boards and independent ethics committees at each site. All participating patients provided written informed consent.