Zhu, Andrew X. http://orcid.org/0000-0003-4873-5033
Finn, Richard S.
Kang, Yoon-Koo
Yen, Chia-Jui
Galle, Peter R.
Llovet, Josep M.
Assenat, Eric
Brandi, Giovanni
Motomura, Kenta
Ohno, Izumi
Daniele, Bruno
Vogel, Arndt
Yamashita, Tatsuya http://orcid.org/0000-0002-3602-8086
Hsu, Chih-Hung
Gerken, Guido
Bilbruck, John
Hsu, Yanzhi
Liang, Kun
Widau, Ryan C.
Wang, Chunxiao
Abada, Paolo
Kudo, Masatoshi
Funding for this research was provided by:
Eli Lilly and Company
Article History
Received: 31 July 2020
Revised: 11 December 2020
Accepted: 7 January 2021
First Online: 3 February 2021
Ethics approval and consent to participate
: REACH and REACH-2 complied with the Declaration of Helsinki, the International Conference on Harmonization Guidelines for Good Clinical Practice and applicable local regulations. Ethics committees at all participating centres approved the protocol, and all patients provided written informed consent. Institutional Review Board (IRB) details for Dr. Zhu’s site were: Dana-Farber Cancer Institute (DFCI) IRB, 450 Brookline Avenue, OS229, Boston, MA, USA 02215. The DFCI IRB protocol number for the study is 15-287. Details of clinical protocols and complete list of investigators for REACH and REACH-2 have been reported previously.<sup>17,23</sup>
: Eli Lilly and Company provides access to all individual participant data collected during the trial, after anonymisation, with the exception of pharmacokinetic or genetic data. Data are available to request 6 months after the indication studied has been approved in the United States and EU and after primary publication acceptance, whichever is later. No expiration date of data requests is currently set once data are made available. Access is provided after a proposal has been approved by an independent review committee identified for this purpose and after receipt of a signed data-sharing agreement. Data and documents, including the study protocol, statistical analysis plan, clinical study report, blank or annotated case report forms, will be provided in a secure data-sharing environment. For details on submitting a request, see the instructions provided at ExternalRef removed.
: A.X.Z. reports that his institution received research support from Eli Lilly and Company. R.S.F. reports consultant/advisory roles with AstraZeneca, Bayer, Bristol-Myers Squibb, C-Stone, Eisai, Eli Lilly, Exelixis, F. Hoffmann-La Roche, Genentech, Merck, Novartis and Pfizer. Y.-K.K. reports consultant/advisory roles with Bristol-Myers Squibb, DAE HWA Pharmaceutical, Lilly/ImClone, Merck Serono, Ono Pharmaceutical, Roche/Genentech and Taiho Pharmaceutical; and research funding from DAE HWA Pharmaceutical and LSK Biopharma. C.-J.Y. has no relationships to disclose. P.R.G. has been on advisory boards and received lecture fees from Bayer, Bristol-Myers Squibb, MSD, Merck, Sirtex, AstraZeneca, Sillajen, Eli Lilly and Company, Ipsen, Roche and Novartis. J.M.L. received grants and personal fees from Bayer, Eisai Inc., Bristol-Myers Squibb, Ipsen, Blueprint and Incyte, as well as personal fees from Eli Lilly and Company, Celsion Corporation, Exelixis, Merck, Clycotest, Navigant, Leerink Swann LLC, Midatech Ltd, Fortress Biotech Inc., Spring Bank Pharmaceuticals and Nucleix, outside the submitted work. E.A. has received honoraria from Bayer, Novartis and Sirtex Medical, and reports consultant/advisory roles with Ipsen and Sanofi. G.B. has no relationships to disclose. K.M. has received honoraria from Eisai. I.O. has had a consulting/advisory role with Merck Serono, and has been on the Speakers’ Bureau for Taiho Pharmaceutical. B.D. has received honoraria from Bayer, Eisai, Eli Lilly and Company, Ipsen and MSD, and reports consultant/advisory roles with AstraZeneca, Bayer, Eisai, Ipsen, MSD, Roche and Sanofi. A.V. reports consultant/advisory roles with Eli Lilly and Company, Bayer, MSD, Roche, Novartis, AstraZeneca and Beigene. T.Y. has been on the Speakers’ Bureau for Bayer, Eisai and Eli Lilly and Company. C.-H.H. reports consultant/advisory roles with Bristol-Myers Squibb, Ono, Merck/Serono and Roche/Genentech, and research funding from MSD. G.G. has no relationships to disclose. J.B. is an employee of Envision Pharma Group. Y.H., K.L., R.W., C.W., and P.A. are employees of Eli Lilly and Company and own stock from Eli Lilly and Company. M.K. has had a consulting/advisory role with Bayer, Bristol-Myers Squibb, Eisai Co., Ltd, MSD and Ono Pharmaceutical, has received honoraria from Bayer, EA Pharma Co., Ltd, Eisai Co., Ltd and MSD, and has received research funding from AbbVie Inc., Astellas Pharma Inc., Bristol-Myers Squibb, Chugai Pharmaceutical Co., Ltd, Daiichi Sankyo Co., Ltd, EA Pharma Co., Ltd, Eisai Co., Ltd, Gilead Sciences, Inc., Medico’s Hirata Inc., Otsuka Pharmaceutical Co., Ltd, Taiho Pharmaceutical and Takeda Pharmaceutical Company Limited.
: This study was sponsored by Eli Lilly and Company. Medical writing assistance was provided by John Bilbruck of ProScribe—Envision Pharma Group and was funded by Eli Lilly and Company.