Italiano, Antoine
Miller, Wilson H. Jr
Blay, Jean-Yves
Gietema, Jourik A.
Bang, Yung-Jue
Mileshkin, Linda R.
Hirte, Hal W.
Higgins, Brian
Blotner, Steven
Nichols, Gwen L.
Chen, Lin Chi
Petry, Claire
Yang, Qi Joy
Schmitt, Christophe
Jamois, Candice
Siu, Lillian L.
Funding for this research was provided by:
F. Hoffmann-La Roche
Article History
Received: 22 March 2021
Accepted: 15 June 2021
First Online: 28 June 2021
Declarations
:
: This study was conducted at eight participating institutions in accordance with the Declaration of Helsinki and Good Clinical Practice guidelines, after approval by a local human investigations committee and in accordance with an assurance filed with and approved by the Department of Health and Human Services, where appropriate. The study was registered on October 31, 2011, at ClinicalTrials.gov: NCT01462175.
: All patients provided written informed consent.
: All authors have approved the final version of the submitted work and agree to be accountable for all aspects of the report.
: All authors received support from F. Hoffmann-La Roche Ltd during the conduct of the study. Editorial support, provided by an independent medical writer and under the guidance of the authors, was funded by the sponsor. Antoine Italiano reports personal fees for consultancy from AstraZeneca, Novartis, Roche/Genentech, MSD, Bayer, Daiichi-Sankyo, and Astellas (outside the submitted work) and grants (to institution to conduct clinical trials) from AstraZeneca, Novartis, Roche/Genentech, MSD, Merck Serano, Bayer, and Bristol Myers Squibb (outside the submitted work); Wilson H. Miller, Jr. reports personal fees from Merck, Bristol Myers Squibb, Roche/Genentech, Novartis, Amgen, and GlaxoSmithKline (outside the submitted work); Jean-Yves Blay reports research support and honoraria from Roche, Novartis, and Amgen; Jourik A. Gietema reports research grants paid to the institution from Siemens and Abbvie; Yung-Jue Bang reports personal fees for consultancy from AstraZeneca, Novartis, Genentech/Roche, MSD, Merck Serano, Bayer, Bristol Myers Squibb, Eli Lilly, Taiho, Daiich-Sankyo, Astellas, BeiGene, GreenCross, Samyang Biopharm, Hanmi, and Genexine (outside the submitted work), grants (to institution to conduct clinical trials) from AstraZeneca, Novartis, Roche/Genentech, MSD, Merck Serano, Bayer, Bristol Myers Squibb, GlaxoSmithKline, Pfizer, Eli Lilly, Boeringer-Ingelheim, MacroGenics, Boston Biomedical, FivePrime, Curis, Taiho, Takeda, Ono, Daiichi Sankyo, Astellas, BeiGene, Green Cross, CKD Pharma, and Genexine (outside the submitted work); Linda R. Mileshkin has nothing to report; Hal W. Hirte has nothing to report; Brian Higgins reports employment from Roche/Genentech; Steven Blotner reports employment and stocks from Roche/Genentech; Gwen L. Nichols reports employment with Roche/Genentech during conduct of the study; Lin Chi Chen reports employment and equity and stock ownership from Roche/Genentech (during the conduct of the study); Claire Petry reports employment and stock ownership from Roche/Genentech; Qi Joy Yang reports employment with Certara (Canada); Christophe Schmitt reports employment and stock ownership from Roche/Genentech; Candice Jamois reports employment and stock ownership from Roche/Genentech; Lillian L. Siu reports grants and non-financial support from Roche/Genentech (during the conduct of the study), personal fees from Roche/Genentech, Merck, Pfizer, AstraZeneca/Medimmune, Morphosys, Oncorus, Symphogen, Seattle Genetics, GlaxoSmithKline, Voronoi, Arvinas, Relay, Rubius, Janpix, Navire, and Novartis (outside the submitted work), grants (to institution to conduct clinical trials) from Bristol Myers Squibb, Pfizer, Boeringer-Ingelheim, GlaxoSmithKline, AstraZeneca, Merck, Astellas, Bayer, Abbvie, Amgen, Symphogen, Intensity Therapeutics, Mirati, Shattucks, and Avid (outside the submitted work), and that spouse is co-founder of Treadwell Therapeutics and has stock ownership from Agios.