Miyoshi, Yasuo http://orcid.org/0000-0001-8535-4008
Yoshimura, Yuta
Saito, Kenichi
Muramoto, Kenzo
Sugawara, Michiko
Alexis, Karenza
Nomoto, Kenichi
Nakamura, Seigo
Saeki, Toshiaki
Watanabe, Junichiro
Perez-Garcia, Jose Manuel
Cortes, Javier
Funding for this research was provided by:
Eisai Inc., Woodcliff Lake, NJ, USA
Article History
Received: 17 December 2019
Accepted: 15 February 2020
First Online: 5 March 2020
Compliance with ethical standards
:
: Y. Miyoshi: reports grants from Eisai, Chugai, MSD, Kyowa-Kirin, Eli Lilly, and Taiho; personal fees from Eisai, Chugai, AstraZeneca, Eli Lilly, and Pfizer. Y. Yoshimura: is an employee of Eisai Co., Ltd. K. Saito: is an employee of Eisai Inc. K. Muramoto: is an employee of Eisai Co., Ltd. M. Sugawara: is an employee of Eisai Co., Ltd. K. Alexis: is a former employee of Eisai Inc. K. Nomoto: is an employee of Eisai Inc. S. Nakamura: reports grants from Chugai, Daiichi Sankyo, Eisai, Kyowa-Kirin, Novartis, Pfizer, Taiho, and Takeda; personal fees from AstraZeneca, Bayer, Chugai, Daiichi Sankyo, Eisai, Eli Lilly, Kyowa-Kirin, Nippon Kayaku, Novartis, Pfizer, Taiho, and Takeda. T. Saeki: has received grants from AstraZeneca, Eisai, MSD, Ono Pharmaceutical, Kyowa-Kirin, Daiichi Sankyo, Sawai, Taiho, Chugai, Nihon Medi-Physics, Nippon Kayaku, Novartis, Hamamatsu Photonics, and Fuji Pharma; personal fees from AstraZeneca, Ono Pharmaceutical, Kyowa-Kirin, Taiho, Chugai, Novartis, and Fuji Pharma. J. Watanabe: reports personal fees from Chugai, Daiichi Sankyo, Eisai, Eli Lilly, Novartis, and Pfizer. J.M. Perez-Garcia: reports an advisory role with Roche and Lilly. J. Cortes: reports consulting for Roche, Celgene, Cellestia, AstraZeneca, Biothera Pharmaceutical, Merus, Seattle Genetics, Daiichi Sankyo, Erytech, Athenex, Polyphor, Lilly, Servier, Merck Sharp & Dohme, and GSK; honoraria for Roche, Novartis, Celgene, Eisai, Pfizer, Samsung Bioepis, Lilly, and Merck Sharp & Dohme; research funding to the institution for Roche, Ariad pharmaceuticals, AstraZeneca, Baxalta GMBH/Servier Affaires, Bayer healthcare, Eisai, F. Hoffman-La Roche, Guardant health, Merck Sharp & Dohme, Pfizer, Piqur Therapeutics, Puma C, Queen Mary University of London, and Seagen; stock/patents/intellectual property of MedSIR.
: All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards. Approval was obtained from independent ethics committees (Oxfordshire Research Ethics Committee; reference number 07/Q1606/22) and regulatory authorities in participating countries. EMBRACE was conducted in accordance with the World Medical Association Declaration of Helsinki (WMA General Assembly, Tokyo, 2004) guidelines of the Committee for Proprietary Medicinal Products/International Conference for Harmonisation/Good Clinical Practice (CPMP/ICH/135/95) and local ethical/legal requirements.
: Informed consent was obtained from all individual participants included in the study. This article does not contain any studies with animals performed by any of the authors.