Kuemmel, Sherko
Harper-Wynne, Catherine
Park, Yeon Hee
Franke, Fábio
de Laurentiis, Michelino
Schumacher-Wulf, Eva
Eiger, Daniel
Heeson, Sarah
Cardona, Andrés
Özyilkan, Özgür
Morales-Vàsquez, Flavia
Metcalfe, Ciara
Hafner, Marc
Restuccia, Eleonora
O’Shaughnessy, Joyce
Funding for this research was provided by:
F. Hoffmann-La Roche
Article History
Received: 4 August 2023
Accepted: 25 March 2024
First Online: 24 May 2024
Declarations
:
: This study will be conducted in accordance with the protocol and the principles of the Declaration of Helsinki and Council for International Organizations of Medical Sciences international ethical guidelines, ICH Guideline for Good Clinical Practice, and applicable laws and regulations. All patients are required to provide written informed consent prior to enrollment in the study. Protocol approval was obtained from an independent ethics committee (EC) or institutional review board (IRB) for each participating site (see the for the list of ECs and IRBs).
: Not applicable.
: • SK reports a consulting or advisory role with Agendia, Amgen, AstraZeneca, Celgene, Daiichi Sankyo, Genomic Health, Gilead Sciences, Lilly, MSD Oncology, Novartis, Pfizer, pfm medical, F. Hoffmann-La Roche Ltd/Genentech, Inc., Seagen, SOMATEX, Sonoscape, research funding from F. Hoffmann-La Roche Ltd, and reports travel/accommodation/expenses for Daiichi Sankyo, Gilead Sciences, F. Hoffmann-La Roche Ltd.• CH-W reports honoraria from AstraZeneca, Everything Genetic, Exact Sciences, Gilead Sciences, Lilly, Novartis, Pfizer, F. Hoffmann-La Roche Ltd, Seagen, and research funding from F. Hoffmann-La Roche Ltd.• YHP reports honoraria from AstraZeneca, Lilly, Merck, Novartis, Pfizer, F. Hoffmann-La Roche Ltd, has a consulting or advisory role with AstraZeneca, Boryung, Daiichi Sankyo, Eisai, Gilead Sciences, Lilly, Menarini, MSD, Novartis, Pfizer, F. Hoffmann-La Roche Ltd, and reports research funding from AstraZeneca, Gencurix (institution), Genome Insight (institution), NGeneBio (institution), Pfizer, F. Hoffmann-La Roche Ltd (institution).• FF reports research funding from F. Hoffmann-La Roche Ltd.• MDL reports honoraria from Amgen, AstraZeneca, Gilead Sciences, Ipsen, Lilly, Menarini-Stemline, MSD, Novartis, Pfizer, Pierre Fabre, F. Hoffmann-La Roche Ltd, Sanofi, Seagen, Takeda, a consulting or advisory role with Amgen, AstraZeneca, Gilead Sciences, Ipsen, Lilly, Menarini-Stemline, MSD, Novartis, Pfizer, Pierre Fabre, F. Hoffmann-La Roche Ltd, Sanofi, Seagen, Takeda, a speaker’s bureau with Novartis, Lilly, and research funding from AstraZeneca (institution), Bristol Myers Squibb (institution), Daiichi Sankyo (institution), Eisai (institution), Lilly, Macrogenics (institution), MSD (institution), Novartis (institution), Pfizer (institution), Puma Biotechnology (institution), F. Hoffmann-La Roche Ltd (institution).• ES-W reports research funding from F. Hoffmann-La Roche Ltd.• DE reports employment by, and stocks/shares in, F. Hoffmann-La Roche Ltd.• SH reports employment by Roche Products Limited, stocks/shares in F. Hoffmann-La Roche Ltd, and is a patent holder for PH FDC SC.• AC reports employment by, and stocks/shares in, F. Hoffmann-La Roche Ltd.• ÖÖ reports a consulting role with AstraZeneca, Lilly, MSD, Novartis, Pfizer, F. Hoffmann-La Roche Ltd, a Speakers’ Bureau with AstraZeneca, MSD, F. Hoffmann-La Roche Ltd, research funding/grant from BMS, Lilly, MSD, Pfizer, F. Hoffmann-La Roche Ltd, Servier, and medical writing/editorial support from Lilly.• FM-V reports honoraria from AstraZeneca, Eisai, Gilead Sciences, Lilly, Merck, Novartis, F. Hoffmann-La Roche Ltd, a speakers’ bureau with AstraZeneca, Lilly, research funding from MSD and F. Hoffmann-La Roche Ltd, and travel/accommodation/expenses with AstraZeneca, MSD, F. Hoffmann-La Roche Ltd.• CM reports employment by Genentech, Inc., and stocks/shares in F. Hoffmann-La Roche Ltd.• MH reports employment by Genentech, Inc., and stocks/shares in F. Hoffmann-La Roche Ltd.• ER reports employment by, and stocks/shares in, F. Hoffmann-La Roche Ltd.• JO’S reports honoraria from AbbVie, Agendia, Amgen, Aptitude Health, AstraZeneca, Bayer, Bristol Myers Squibb, Celgene, Daiichi Sankyo, Eisai, G1 Therapeutics, Genentech, Inc., Gilead Sciences, GRAIL, Halozyme, HERON, Immunomedics, Ipsen, Lilly, Merck, Myriad Pharmaceuticals, Nektar, Novartis, Ontada/McKesson, Pfizer, Pharmacyclics, Pierre Fabre, Prime Oncology, Puma Biotechnology, F. Hoffmann-La Roche Ltd, Samsung, Sanofi, Seagen, Syndax, Synthon, Taiho Oncology, Takeda, a consulting or advisory role with AbbVie, Agendia, Amgen, Aptitude Health, AstraZeneca, Bayer, Bristol Myers Squibb, Celgene, Daiichi Sankyo, Eisai, G1 Therapeutics, Genentech, Gilead Sciences, GRAIL, Halozyme, HERON, Immunomedics, Ipsen, Lilly, Merck, Myriad Pharmaceuticals, Nektar, Novartis, Ontada/McKesson, Pfizer, Pharmacyclics, Pierre Fabre, Prime Oncology, Puma Biotechnology, F. Hoffmann-La Roche Ltd, Samsung, Sanofi, Seagen, Syndax, Synthon, Taiho Oncology, Takeda, a Speakers’ Bureau with AstraZeneca, Lilly, Novartis, Pfizer, Seagen, research funding from Seagen (institution) and F. Hoffmann-La Roche Ltd, and travel/accommodation/expenses with AbbVie, Agendia, Amgen, AstraZeneca, Celgene, Eisai, GRAIL, Ipsen, Lilly, Myriad Pharmaceuticals, Novartis, Pfizer, Puma Biotechnology, F. Hoffmann-La Roche Ltd, Sanofi, Seagen.• All authors have received research support for third-party writing assistance for this manuscript, furnished by Brian Law, PhD, of Nucleus Global, an Inizio Company, from F. Hoffmann-La Roche Ltd.