Muro, Kei
Shitara, Kohei
Yamaguchi, Kensei
Yoshikawa, Takaki
Satake, Hironaga
Hara, Hiroki
Sugimoto, Naotoshi
Machida, Nozomu
Goto, Masahiro
Kawakami, Hisato
Amagai, Kenji
Omuro, Yasushi
Esaki, Taito
Hironaka, Shuichi
Nishina, Tomohiro
Komatsu, Yoshito
Matsubara, Hisahiro
Shiratori, Shinichi
Han, Shirong
Satoh, Taroh
Ohtsu, Atsushi
Article History
Accepted: 8 February 2023
First Online: 10 April 2023
Declarations
:
: The studies were conducted in accordance with the protocol and its amendments, Good Clinical Practice guidelines, and the Declaration of Helsinki. The study protocols and all amendments were approved by the institutional review board or ethics committee at each institution. All patients provided written informed consent.
: KM has received grants from Sanofi, Astellas, Amgen, Solasia Pharma, Daiichi Sankyo, Parexel International, Taiho Pharmaceutical, MSD K. K., Merck Serono, Pfizer, and Ono; has received honoraria from Eli Lilly, Chugai Pharmaceutical, Takeda, Ono, Taiho Pharmaceutical, Sanofi, Bristol Myers Squibb, and Bayer; and has participated on data safety monitoring board or advisory board for AstraZeneca and Ono. KS has received grants from MSD K. K., Astellas, Lilly, Ono, Dainippon Sumitomo, Daiichi Sankyo, Taiho Pharmaceutical, Chugai Pharmaceutical, MSD K.K., Mediscience, and Eisai; consulting fees from Astellas, Lilly, Bristol Myers Squibb, Takeda, Pfizer, Ono, MSD K.K., Taiho Pharmaceutical, Novartis, AbbVie, GSK, Daiichi Sankyo, Amgen, and Boehringer Ingelheim; and honoraria from Novartis, AbbVie, and Yakult Honsha. KY reports no conflict of interest. TY has received consulting fees from MSD K. K. and honoraria for lectures from MSD K. K., Ono, and Bristol Myers Squibb. HS has received grants from Taiho Pharmaceutical, Chugai Pharmaceutical, and Yakult Honsha; consulting fees from Bristol Myers Squibb; and honoraria from Bristol Myers Squibb, Taiho Pharmaceutical, MSD K.K., Chugai Pharmaceutical, and Yakult Honsha. HH has received funding for medical writing assistance from MSD K.K.; grants from Astellas, AstraZeneca, Bayer, BeiGene, Boehringer Ingelheim, Chugai Pharmaceutical, Daiichi Sankyo, Dainippon Sumitomo, Eisai, Elevar Therapeutics, GSK, Incyte, Merck Biopharma, MSD K. K., Ono, Pfizer, and Taiho Pharmaceutical; consulting fees from Boehringer Ingelheim, Daiichi Sankyo, Dainippon Sumitomo, Lilly, MSD K. K., and Ono; and honoraria from Bayer, Bristol Myers Squibb, Chugai Pharmaceutical, Daiichi Sankyo, Kyowa Hakko Kirin, Lilly, Merck Biopharma, MSD K. K., Ono, Sanofi, Taiho Pharmaceutical, Takeda, and Yakult Honsha. NS’s institution has received funds from MSD K. K., Astellas, Solasia Pharma, Daiichi Sankyo, and Ono. NM has received honoraria from Ono, Taiho Pharmaceutical, Lilly, Daiichi Sankyo, Takeda, Bristol Myers Squibb, and Yakult Honsha. MG reports no conflict of interest. K has received grants from Chugai Pharmaceutical, Taiho Pharmaceutical, and Eisai; honoraria from Bristol Myers Squibb, AstraZeneca, Bayer Yakuhin, Eli Lilly, MSD K. K., Ono, Chugai Pharmaceutical, Daiichi Sankyo, Takeda, and Taiho Pharmaceutical; and consulting fees from Bristol Myers Squibb, Eli Lilly, MSD K. K., Ono, Daiichi Sankyo, and Taiho Pharmaceutical. KA reports no conflict of interest. YO has received grants from MSD K. K., Ono, BeiGene, Astellas, and Daiichi Sankyo. TE has received grants (paid to the institution) from MSD K. K., Novartis, Dainippon Sumitomo, Ono, Daiichi Sankyo, Astellas, Astellas Amgen Biopharma, BeiGene, Pierre Fabre Medicament, Ignyta, Array BioPharma, and Merck Serono and honoraria from MSD K. K., Ono, Daiichi Sankyo, Merck Serono, Eli Lilly, Taiho Pharmaceutical, Chugai Pharmaceutical, Sanofi, Takeda, and Bayer. SH has received grants from Taiho Pharmaceutical, Chugai Pharmaceutical, and Yakult Honsha; consulting fees from Bristol Myers Squibb; and honoraria from Ono, Eli Lilly, Daiichi Sankyo, Bristol Myers Squibb, Taiho Pharmaceutical, Chugai Pharmaceutical, MSD K. K., and Yakult Honsha. TN has received personal fees from Ono, Taiho Pharmaceutical, Takeda, Chugai Pharmaceutical, and Daiichi Sankyo and grants from MSD K. K. YK has received grants from Taiho Pharmaceutical, Chugai Pharmaceutical, Takeda, Bayer Yakuhin, Sanofi-Aventis S. A., Ono, MSD K. K., Yakult Honsha, NanoCarrier, QuintilesIMS, SYSMEX Corp., Mediscience Planning Inc., Dainippon Sumitomo, Kyowa Kirin, Asahi Kasei Pharma, Nippon Zo Pharmaceutical, A2 Healthcare Corp., Daiichi Sankyo, Eisai, Parexel International Corp., Astellas, Incyte, Syneos Health, and IQVIA and personal fees from Taiho Pharmaceutical; Chugai Pharmaceutical; Takeda; Bayer Yakuhin; Sanofi-Aventis S. A.; Ono; Yakult Honsha; Daiichi Sankyo; EA Pharma Co., Ltd.; Eli Lilly Japan K. K.; Nipro Corp.; Bristol Myers Squibb; Moroo; Pfizer; Merck Biopharma; Medical Review Co., Ltd.; Sawai Pharmaceutical; Shiseido; Mitsubishi Tanabe; Nippon Kayaku; Shire Japan K. K.; and Novartis Pharma K. K. HM reports no conflict of interest. SS is an employee of MSD K.K., Tokyo, Japan and a stockholder in Merck & Co., Inc., Rahway, NJ, USA. SH reports no conflict of interest. TS has received grants from MSD K. K., Ono, Yakult Honsha, Chugai Pharmaceutical, Gilead, BeiGene, Eli Lilly, and Taiho Pharmaceutical; honoraria from Ono, Yakult Honsha, Chugai Pharmaceutical, Eli Lilly, and Taiho Pharmaceutical; and consulting fees from Takara-Bio. AO reports no conflict of interest.
: The study funder participated in study design, data interpretation, and the writing of this report. The sponsor maintained the study database.