Lin, Chia-Chi
Doi, Toshihiko
Muro, Kei
Hou, Ming-Mo
Esaki, Taito
Hara, Hiroki
Chung, Hyun Cheol
Helwig, Christoph
Dussault, Isabelle
Osada, Motonobu
Kondo, Shunsuke http://orcid.org/0000-0001-9565-117X
Funding for this research was provided by:
Merck KGaA
GlaxoSmithKline
Article History
Accepted: 19 March 2021
First Online: 11 April 2021
Declarations
:
: This trial was funded by Merck KGaA, Darmstadt, Germany, and is part of an alliance between Merck KGaA and GlaxoSmithKline. Merck KGaA provided the study drug and worked with investigators on the trial design and plan, collection and analysis of data, and interpretation of results. Funding for a professional medical writer with access to the data was provided by Merck KGaA and GlaxoSmithKline.
: C.-C. Lin reports honoraria from Eli Lilly, Novartis, and Roche; has consulted for Blueprint Medicines, Boehringer Ingelheim, Bristol Myers Squibb, Daiichi Sankyo, Eli Lilly, and Novartis; and received travel grants from BeiGene and Eli Lilly. T. Doi has consulted for Taiho, Merck Sharp & Dohme, Amgen, Sumitomo Dainippon Pharma, Rakuten Medical, Daiichi Sankyo, Takeda, Bayer, Novartis, Boehringer Ingelheim, AbbVie, and Janssen Pharma; has received research grants from Bristol Myers Squibb, Taiho, Merck Sharp & Dohme, Novartis, Merck Biopharma Co., Ltd., Japan—an affiliate of Merck KGaA, Darmstadt, Germany—Lilly, AbbVie, Boehringer Ingelheim, Eisai, Kyowa Hakko Kirin, IQVIA, Pfizer, Sumitomo Dainippon Pharma, and Daiichi Sankyo; and reports honoraria from Bristol Myers Squibb, Astellas, AbbVie, Ono Pharmaceutical, Oncolys BioPharma, and Taiho. K. Muro has consulted for Ono Pharmaceutical, Amgen, and Solasia Pharma; has received research grants from Parexel International, Merck Biopharma Co., Ltd., Japan—an affiliate of Merck KGaA, Darmstadt, Germany—Merck Sharp & Dohme, Daiichi Sankyo, Sanofi, Sumitomo Dainippon Pharma, Shionogi, Pfizer, Mediscience Planning, and Solasia Pharma; and reports honoraria from Eli Lilly, Chugai, Takeda, Ono Pharmaceutical, Taiho, Sanofi, Bristol Myers Squibb, and Bayer. T. Esaki received research grants from Merck Sharp & Dohme, Novartis, Sumitomo Dainippon Pharma, Ono Pharmaceutical, Daiichi Sankyo, Astellas, Amgen, BeiGene, Pierre Fabre Medicament, Ignyta, Array BioPharma, Bayer, Taiho, and Lilly; and reports honoraria from Chugai, Taiho, Merck Sharp & Dohme, Eli Lilly, Daiichi Sankyo, Nihon Kayaku, Sanofi, Ono Pharmaceutical, Takeda, Bayer, Merck Biopharma Co., Ltd., Japan—an affiliate of Merck KGaA, Darmstadt, Germany—Bristol Myers Squibb, and Eisai. H. Hara has consulted for Lilly, Merck Sharp & Dohme, and Ono Pharmaceutical; received research grants from Astellas, AstraZeneca, BeiGene, Boehringer Ingelheim, Chugai, Daiichi Sankyo, Sumitomo Dainippon Pharma, Eisai, Incyte, LSK BioPharma, Merck Biopharma Co., Ltd., Japan—an affiliate of Merck KGaA, Darmstadt, Germany—Merck Sharp & Dohme, Ono Pharmaceutical, Pfizer, and Taiho; and reports honoraria from Bayer, Bristol Myers Squibb, Chugai, Daiichi Sankyo, Kyowa Hakko Kirin, Lilly, Merck Biopharma Co., Ltd., Japan—an affiliate of Merck KGaA, Darmstadt, Germany—Merck Sharp & Dohme, Ono Pharmaceutical, Sanofi, Taiho, Takeda, and Yakult. C. Helwig is an employee of and has ownership interest in Merck KGaA, Darmstadt, Germany. I. Dussault is an employee of EMD Serono Research & Development Institute, Inc., Billerica, MA, USA—an affiliate of Merck KGaA, Darmstadt, Germany—and has ownership interest in EMD Serono Research & Development Institute, Inc., and Amgen. M. Osada is an employee of Merck Biopharma Co., Ltd., Japan—an affiliate of Merck KGaA, Darmstadt, Germany. S. Kondo has received research funding from ASLAN Pharmaceuticals, AstraZeneca, Bayer, Eli Lilly, Merck Sharp & Dohme, and Pfizer. The remaining authors declare no competing interests.
: The protocol for this study was approved by all relevant regulatory authorities and ethics committees at participating institutions, and the study was conducted in accordance with the International Conference on Harmonisation Topic E6 Good Clinical Practice and the Declaration of Helsinki. Each patient provided written informed consent before study enrollment.
: All authors gave final approval of the version to be published.
: For all new products or new indications approved in both the European Union and the United States after January 1, 2014, Merck KGaA, Darmstadt, Germany will share patient-level and study-level data after deidentification, as well as redacted study protocols and clinical study reports from clinical trials in patients. Any requests for these data by qualified scientific and medical researchers for legitimate research purposes will be subject to Merck KGaA’s Data Sharing Policy. All requests should be submitted in writing to Merck KGaA's data sharing portal (ExternalRef removed). When Merck KGaA has a co-research, co-development, or co-marketing or co-promotion agreement, or when the product has been out-licensed, the responsibility for disclosure might be dependent on the agreement between parties. Under these circumstances, Merck KGaA will endeavor to gain agreement to share data in response to requests.
: CH, ID, and MO contributed to study conception and design; CCL, TD, KM, M-MH, TE, HH, HCC, and SK contributed to data acquisition. All authors contributed to data interpretation and drafting of the manuscript. All authors reviewed and approved the final manuscript and approved the final manuscript for publication.