Ryoo, Baek-Yeol http://orcid.org/0000-0002-9052-833X
Cheng, Ann-Li http://orcid.org/0000-0002-9152-6512
Ren, Zhenggang
Kim, Tae-You
Pan, Hongming
Rau, Kun-Ming
Choi, Hye Jin http://orcid.org/0000-0001-5917-1400
Park, Joong-Won
Kim, Jee Hyun
Yen, Chia Jui
Lim, Ho Yeong
Zhou, Dongli
Straub, Josef
Scheele, Juergen
Berghoff, Karin
Qin, Shukui
Funding for this research was provided by:
Merck KGaA
Merck KGaA, Darmstadt, Germany
Article History
Received: 2 October 2020
Revised: 10 March 2021
Accepted: 25 March 2021
First Online: 10 May 2021
Ethics approval and consent to participate
: All patients provided written informed consent for participation in the study. The study was conducted in accordance with the Declaration of Helsinki. This study has been reviewed and approved by the respective Institutional Review Boards/Independent Ethics Committees according to national and international regulations (Supplementary Table InternalRef removed).
: Not applicable.
: Data are held by the sponsor Merck KGaA (Darmstadt, Germany), to whom any request for additional data should be addressed.
: Ann-Lii Cheng has provided consulting for AstraZeneca, Bristol-Myers Squibb, Eisai, Merck KGaA, Novartis, Ono Pharmaceutical, Exelixis, IPSEN Innovation, Bayer Healthcare, Merck Sharp Dohme, Roche/Genentech, BeiGene, CSR Pharma Group, F. Hoffmann-La Roche and IQVIA; attended speakers’ bureau for Bayer Yakuhin Ltd., Novartis, Eisai, Ono Pharmaceutical and Amgen Taiwan; received travel grants from Bayer Yakuhin Ltd, Roche/Genentech and IQVIA. Joong-Won Park participated in consultant and advisory boards for AstraZeneca, Ipsen, Bristol-Myers Squibb, Roche and Bayer, and attended speaker’s bureau for Bayer, Ipsen and Eisai. Ho Yeong Lim attended advisory boards for Bayer, Eisai, Ono Pharmaceuticals, Bristol-Myers Squibb, Merck KGaA, Ipsen, AstraZeneca, and attended speaker’s bureau for Bayer. Baek-Yeol Ryoo, Zhenggang Ren, Tae-You Kim, Hongming Pan, Kun-Ming Rau, Hye Jin Choi, Jee Hyun Kim, Chia Jui Yen and Shukui Qin have nothing to declare. Juergen Scheele was an employee of Merck KGaA, Darmstadt, Germany, at the time the work was conducted. Karin Berghoff, Josef Straub and Dongli Zhou are employees of Merck KGaA, Darmstadt, Germany and also hold stocks with the company.
: The sponsor, Merck KGaA, Darmstadt, Germany, provided the study drug and worked with investigators on the trial design and plan, collection and analyses of data, and interpretation of results. Data sets were reviewed by the authors, and all authors participated fully in developing and reviewing the paper for publication. Funding for a professional medical writer with access to the data was provided by the sponsor for initial drafts of the paper. All authors had full access to all the data in the study and had final responsibility for the decision to submit for publication. Medical writing assistance was provided by Helen Swainston (Bioscript Science, Macclesfield, UK), Jack Eaton (Syneos Health, UK) and Mark Dyson, DPhil (Berlin, Germany), and was funded by Merck KGaA, Darmstadt, Germany.