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Article History

Received: 7 December 2021

Accepted: 4 June 2022

First Online: 16 July 2022

Declarations

:

: This work was supported by Eli Lilly and Company. S. Callies, A. Zimmermann, R. Walgren, and C. Visseren-Grul are full-time employees of Eli Lilly and Company. S. Callies, A. Zimmermann, and R. Walgren are minor stockholders in Eli Lilly and Company. L. Gao owned stock in Eli Lilly and Company at the time of this work. K. Nakagawa has received funding or grants from Takeda, Taiho Pharmaceutical, SymBio Pharmaceuticals, AbbVie, ICON, Kissei Pharmaceutical, Parexel, EPS, Syneos Health, Pfizer, A2 Healthcare, Eisai, CMIC Shift Zero, Kyowa Kirin, Bayer Yakuhin, Otsuka Pharmaceutical, PRA Health Sciences, Covance, Medical Research Support, Sanofi, PPD-SNBL, Japan Clinical Research Operations, Sysmex Corporation, AbbVie, Mochida Pharmaceutical, and GlaxoSmithKline, consulting fees from Astellas Pharmaceuticals, Pfizer, KYORIN, Takeda, Eli Lilly and Company, Ono Pharmaceutical, and speaker’s bereaus from AstraZeneca, Chugai Pharmaceutical, Takeda, Roche Diagnostics, MSD, Eli Lilly and Company, Nippon Kayaku, Astellas Pharma, Bayer Yakuhin, Merck, Nanzando, Daiichi Sankyo, Novartis, Kyowa Kirin, Medical Mobile Communications, Yomiuri Telecasting Corporation, Nikkei Business Publications, Nippon Boehringer Ingelheim, MEDICUS SHUPPAN, Taiho Pharmaceutical, AbbVie, Bristol Myers Squibb, Care Net, Amgen, Medical Review, Yodosha, 3H Clinical Trial Inc., Thermo Fisher Scientific, Hisamitsu Pharmaceutical, Nichi-Iko Pharmaceutical, KYORIN Pharmaceutical, Pfizer, and Ono Pharmaceutical. E. B. Garon received grants from ABL-Bio, AstraZeneca, Bristol Myers Squibb, Dynavax Technologies, Eli Lilly and Company, EMD Serono, Genentech, Iovance Biotherapeutics, Merck, Mirati Therapeutics, Neon, and Novartis, and consulting fees from ABL-Bio, Boehringer-Ingelheim, Bristol Myers Squibb, Dracen Pharmaceuticals, Eli Lilly and Company, EMD Serono, Eisai, GlaxoSmithKline, Merck, Natera, Novartis, Regeneron, Sanofi, Shionogi, and Xilio. M. Reck received consulting fees and honoraria for speaker’s bureaus from Amgen, AstraZeneca, BMS, Boehringer-Ingelheim, Eli Lilly and Company, Merck, MSD, Mirati, Novartis, Pfizer, Roche, and Sanofi. M. Reck has also participated on the data safety monitoring or advisory board from Amgen, AstraZeneca, BMS, Boehringer-Ingelheim, Eli Lilly and Company, Merck, MSD, Mirati, Novartis, Pfizer, Roche, and Sanofi.

: All studies were carried out in accordance with principles for human experimentation as defined in the Declaration of Helsinki and were approved by the human investigational review board/ethics committee of each trial center, as required by International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Guidelines for Good Clinical Practice.

: Informed consent was obtained from each patient after each was informed of the potential risks and benefits, as well as the investigational nature of each trial.