Saad, Fred http://orcid.org/0000-0003-2986-5617
Chi, Kim N.
Shore, Neal D.
Graff, Julie N.
Posadas, Edwin M.
Lattouf, Jean-Baptiste
Espina, Byron M.
Zhu, Eugene
Yu, Alex
Hazra, Anasuya
De Meulder, Marc
Mamidi, Rao N. V. S.
Bradic, Branislav
Francis, Peter
Hayreh, Vinny
Rezazadeh Kalebasty, Arash
Funding for this research was provided by:
Janssen Research and Development
Article History
Received: 31 October 2020
Accepted: 12 February 2021
First Online: 22 March 2021
Compliance with ethical standards
:
: Fred Saad has served as a consultant/advisor for Astellas Pharma, AstraZeneca, Bayer, Janssen, Merck, Myovant, and Sanofi and has received research funding from Astellas Pharma, AstraZeneca, Bayer, Bristol Myers Squibb, Janssen, Merck, Myovant, Pfizer, and Sanofi. Kim N. Chi has served as a consultant/advisor for Amgen, Astellas Pharma, AstraZeneca, Bayer, Constellation Pharmaceuticals, Daiichi Sankyo, ESSA, Janssen, Merck, Point Biopharma Inc., Roche, and Sanofi and has received honoraria from Astellas Pharma, AstraZeneca, Bayer, Janssen, Merck, and Roche. Neal D. Shore reports personal fees from AbbVie, Amgen, AstraZeneca, Bayer, Bristol Myers Squibb, Dendreon, Ferring, Janssen, Merck, Myovant, Pfizer, Sanofi-Genzyme, and Tolmar. Julie N. Graff reports institutional research funding from Astellas, Janssen, Merck, and Sanofi and has received travel grants from Clovis and Merck. Edwin M. Posadas reports honoraria from Pfizer; has served as an expert advisor for Breckenridge Pharmaceuticals; has received travel and accommodations expenses from TRACON Pharma; has served as a consultant for AstraZeneca, Bayer, Janssen, and Novartis; and has received institutional research support from Bristol Myers Squibb, Calithera, IMV, Janssen, Merck, Peleton, and Pfizer. Jean-Baptiste Lattouf has served as a consultant/advisor for Astellas, Bristol Myers Squibb, Merck, and Sanofi and has conducted clinical research for Aragon Pharmaceutical, Astellas, AstraZeneca, Bayer, Bristol Myers Squibb, Janssen, Merck, Myovant, Pfizer, Progenics, and Tokai Pharmaceuticals. Byron M. Espina, Eugene Zhu, Alex Yu, Anasuya Hazra, Marc De Meulder, Rao N. V. S. Mamidi, Branislav Bradic, Peter Francis, and Vinny Hayreh are employees of Janssen Research & Development, LLC, and may hold stock and/or stock options. Arash Rezazadeh Kalebasty has served as a consultant/advisor/review panel member for AstraZeneca, Bayer, Bristol Myers Squibb, EMD Serono, Exelixis, Genentech, Janssen, Merck, Novartis, Pfizer, and Sanofi; has received grant/institutional research support from Astellas Pharma, AstraZeneca, Bavarian Nordic, Bayer, BeyondSpring Pharma, BioClin Therapeutics, Bristol Myers Squibb, Clovis Oncology, Eisai, Epizyme, Exelixis, Genentech, Immunomedics, Janssen, Macrogenics, Novartis, Pfizer, and Seattle Genetics; has participated in speakers’ bureau for Amgen, Astellas Medivation, AstraZeneca, Bayer, Bristol Myers Squibb, Eisai, EMD Serono, Exelixis, Genentech/Roche, Janssen, Merck, Novartis, Pfizer, Sanofi, and Seattle Genetics/Astellas; has received honorarium from AstraZeneca, Bayer, Exelixis, Novartis, and Pfizer; has received travel, accommodation, and expenses from Astellas Medivation, AstraZeneca, Bayer, Eisai, Exelixis, Genentech, Janssen, Novartis, Pfizer, and Prometheus; and reports stock and other ownership interest in ECOM Medical.
: The study protocol and amendments were reviewed and approved by an appropriate institutional review board or independent ethics committee. The study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with Good Clinical Practices and applicable regulatory requirements.
: All patients provided written informed consent to participate in the study.