Kim, Sung-Bae http://orcid.org/0000-0001-5588-8332
Meric-Bernstam, Funda
Kalyan, Aparna
Babich, Aleksei
Liu, Rong
Tanigawa, Takahiko
Sommer, Anette
Osada, Motonobu
Reetz, Frank
Laurent, Dirk
Wittemer-Rump, Sabine
Berlin, Jordan
Article History
First Online: 9 September 2019
Compliance with Ethical Standards
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: This study was funded by Bayer Healthcare. Medical writing support, including assisting authors with the development of the initial draft and incorporation of comments, was provided by Karl Kemp-O’Brien, Ph.D, and editorial support, including referencing, formatting, and proofreading, was provided by Ian Norton, Ph.D and Annabel Ola, MSc, all of Scion, London, UK, supported by Bayer HealthCare according to Good Publication Practice guidelines. The Sponsor was involved in the study design, collection, analysis, and interpretation of data, as well as data checking of information provided in the manuscript. However, ultimate responsibility for opinions, conclusions, and data interpretation lies with the authors.
: A. Sommer, F. Reetz, A. Babich, S. Wittemer-Rump, and R. Liu are shareholders and employees of Bayer AG. T. Tanigawa is an employee of Bayer Yakuhin. M. Osada and D. Laurent were employees of Bayer AG, Berlin, Germany, during the conduct of the study. M. Osada now works at Merck Serono, Tokyo, Japan. D. Laurent now works at Berlin-Chemie, Berlin, Germany. S.-B. Kim reports receiving institutional research funding from Novartis, Sanofi-Genzyme, Kyowa Kirin Inc., and Dongkook Pharma Co Ltd. F. Meric-Bernstam reports receiving commercial research grants from Novartis, AstraZeneca, Taiho, Genentech, Calithera, Debio International Group, Bayer, PUMA, Aileron, Jounce, CytoMx, Effector, Zymeworks, Curis, and Pfizer, and is a consultant/advisory board member for Dialecta, Sumitomo Dainippon, Pieris Pharmaceuticals, Darwin Health, Samsung Bioepis, Aduro, Spectrum, OrigiMed, Debiopharm International, Inflection Biosciences, Xencor, and Genentech. J. Berlin reports consultancy fees and institutional research funding from Genentech, EMD Serono, 5Prime, BeiGene, Karyopharm, and Symphogen, honoraria from Nestlé Health Science, consultancy fees from Celgene, Cornerstone, Exelis, Gritstone Oncology, ERYTECH Pharma, AstraZeneca, Arno Therapeutics, Symphogen, Abbvie, and Eisai, and institutional research funding from Immunomedics, Gilead, Taiho, Loxo, Bayer, Incyte, and Pharmacyclics. A. Kalyan reports advisory boards for BMS, Exelis, Ipsen, and Eisai.
: All patients provided written informed consent. The study was conducted in accordance with the Declaration of Helsinki. The protocol was approved by the institutional review boards (IRBs) of the participating centers: Asan Medical Center IRB (Republic of Korea), Chesapeake IRB, Vanderbilt IRB, Vanderbilt University Human Research Protection Program, and University of Texas, MD Anderson Cancer Center IRB (USA).