Chen, Li-Tzong
Satoh, Taroh
Ryu, Min-Hee
Chao, Yee
Kato, Ken
Chung, Hyun Cheol
Chen, Jen-Shi
Muro, Kei
Kang, Won Ki
Yeh, Kun-Huei
Yoshikawa, Takaki
Oh, Sang Cheul
Bai, Li-Yuan
Tamura, Takao
Lee, Keun-Wook
Hamamoto, Yasuo
Kim, Jong Gwang
Chin, Keisho
Oh, Do-Youn
Minashi, Keiko
Cho, Jae Yong
Tsuda, Masahiro
Sameshima, Hiroki
Kang, Yoon-Koo
Boku, Narikazu
Funding for this research was provided by:
Ono Pharmaceutical
Article History
Received: 16 September 2019
Accepted: 10 December 2019
First Online: 20 December 2019
Compliance with ethical standards
:
: L-TC reports personal fees from Ono Pharmaceutical Co., Ltd.,; grants and personal fees from Bristol-Myers Squibb for the work under consideration for publication; grants from the Ministry of Science and Technology (Taiwan), Ministry of Health and Welfare (Taiwan), Pfizer (study funding), OBI (preclinical testing), and Polaris (translational research funding); personal fees from AstraZeneca (honorarium), Eli Lilly (honorarium), Five Prime (honorarium), Ipsen, Shire (honorarium), Ono Pharmaceutical Co., Ltd. (honorarium), and MSD (honorarium); personal fees and non-financial support from PharmaEngine (honorarium and study medication); grants, personal fees, and non-financial support (study medication, funding support, and honorarium) from Novartis, Syncore, and TTY; grants and personal fees (honorarium and translation funding) from Bristol-Myers Squibb; and grants and non-financial support (study medication and funding) from Celgene, outside the submitted work. Dr. Satoh reports grants and personal fees from ONO pharmaceutical CO.,LTD., grants and personal fees from Bristol-Myers-Squib, during the conduct of the study; grants and personal fees from Yakult Honsha, grants and personal fees from Chugai-Pharmaceutical, grants and personal fees from Elli-Lilly, grants and personal fees from Merck-Serono, grants and personal fees from Takeda Pharmaceutical, grants and personal fees from Taiho Pharmaceutical, grants and personal fees from MSD, outside the submitted work. M-HR reports honorarium and advisory board fees from Ono Pharmaceutical Co., Ltd., Bristol-Myers Squibb, MSD, Eli Lilly, Taiho Pharmaceutical, Novartis, and Daehwa Pharmaceutical, outside the submitted work. YC, WKK, S-CO, L-YB, YH, JGK, KC, and JYC report grants from Ono Pharmaceutical Co., Ltd., for the work under consideration for publication. KK reports research funding from Ono Pharmaceutical Co., Ltd., for the work under consideration for publication, and research funding from Merck & Co., Shionogi & Co., Ltd., Ono Pharmaceutical Co., Ltd., MSD, Merck Serono, and BeiGene, outside the submitted work. HCC reports grants from Ono Pharmaceutical Co., Ltd., for the work under consideration for publication; grants (research support) from Eli Lilly, GlaxoSmithKline, MSD, Merck Serono, Bristol-Myers Squibb, Ono Pharmaceutical Co., Ltd., and Taiho Pharmaceutical; personal fees (honoraria) from Merck Serono, Eli Lilly, Foundation Medicine, and Roche; and personal fees (consultation) from Taiho Pharmaceutical, Celltrion, MSD, Eli Lilly, Quintiles, Bristol-Myers Squibb, and Merck Serono, outside the submitted work. J-SC reports grants and personal fees (consultation) from Ono Pharmaceutical Co., Ltd., for the work under consideration for publication. KM reports grants from Ono Pharmaceutical Co., Ltd., for the work under consideration for publication; grants and personal fees from Ono Pharmaceutical Co., Ltd., and Sanofi; grants from MSD, Daiichi Sankyo, Parexel International, Shionogi Pharmaceutical, Sumitomo Dainippon Pharma, Pfizer, Mediscience Planning, Solasia Pharma, and Merck Serono; and personal fees from Eli Lilly, Chugai Pharmaceutical, Takeda Pharmaceutical, Taiho Pharmaceutical, Bristol-Myers Squibb, and Bayer, outside the submitted work. K-HY reports personal fees from Ono Pharmaceutical Co., Ltd. and Bristol-Myers Squibb, for the work under consideration for publication, and personal fees (honoraria) from Boehringer Ingelheim, Takeda Pharmaceutical, MSD, Eli Lilly, and Amgen, outside the submitted work. TY reports grants from Ono Pharmaceutical Co., Ltd., and Bristol-Myers Squibb for the work under consideration for publication; grants and personal fees (honoraria) from Chugai and Taiho Pharmaceutical; personal fees (honoraria) from Bristol-Myers Squibb, Yakult, Nihon Kayaku, Olympus, Daiichi Sankyo, MSD, and Terumo; and personal fees (honoraria and advisory role) from Ono Pharmaceutical Co., Ltd., Eli Lilly (Japan), Johnson and Johnson, and Covidien, outside the submitted work. TT reports grants from Ono Pharmaceutical Co., Ltd., and Bristol-Myers Squibb for the work under consideration for publication; grants from MDS Pharmaceutical, Merck Serono Co., Ltd., and Chugai Pharmaceutical Co, Ltd.; and grants and personal fees from Daiichi Sankyo Ltd., Takeda Pharmaceutical, and Taiho Pharmaceutical, outside the submitted work. K-WL reports grants from Ono Pharmaceutical Co., Ltd., Merck Sharp & Dohme Corp., AstraZeneca/MedImmune, Merck KGaA, Pfizer, Macrogenics, Green Cross Corp, Five Prime Therapeutics, Pharmacyclics, LSK BioPharma, ALX Oncology, Zymeworks, BeiGene, Genexine, ASLAN Pharmaceuticals, and Array BioPharma to his institution for conducting clinical trials, and personal fees (honoraria) from Bristol-Myers Squibb, Eli Lilly, and Genexine, outside the submitted work. D-YO reports grants from AstraZeneca outside the submitted work. KM reports research funding from Ono Pharmaceutical Co., Ltd., for the work under consideration for publication. MT reports grants from Ono Pharmaceutical Co., Ltd., outside the submitted work. HS reports personal fees and employment with Ono Pharmaceutical Co., Ltd., outside the submitted work. Y-KK reports grants from Ono Pharmaceutical Co., Ltd., for the work under consideration for publication, and personal fees from Ono Pharmaceutical Co., Ltd., Bristol-Myers Squibb, Daehwa Pharmaceutical, Blueprint, Merck, and Astellas, outside the submitted work. NB reports grants and personal fees from Ono Pharmaceutical Co., Ltd., and personal fees from Bristol-Myers Squibb for the work under consideration for publication; grants and personal fees from Taiho Pharmaceutical and personal fees from Chugai and Eli Lilly, outside the submitted work.
: All procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the 1964 Declaration of Helsinki and later versions.
: The protocol and its amendments were approved by the independent ethics committee or institutional review board at each study center.
: Written informed consent was provided by all patients before enrollment, and a separate written consent was obtained for collection of tumor tissue for biomarker analysis.