Pertuzumab, trastuzumab, and chemotherapy in HER2-positive gastric/gastroesophageal junction cancer: end-of-study analysis of the JACOB phase III randomized clinical trial.

"Declarations Conflict of interestAll authors reported receiving research support in the form of third-party medical writing assistance for this manuscript, provided by F. Hoffmann-La Roche Ltd. Josep Tabernero reported receiving consulting fees from Array BioPharma, AstraZeneca, Avvinity Therapeutics, Bayer, Boehringer Ingelheim, Chugai, Daiichi Sankyo, F. Hoffmann-La Roche Ltd, Genentech, Inc., HalioDX SAS, Hutchison MediPharma International, Ikena Oncology, Inspirna, IQVIA, Lilly, Menarini, Merck Serono, Merus, MSD, Mirati Therapeutics, Neophore, Novartis, Ona Biotechnology, Orion Biotechnology, Peptomyc, Pfizer, Pierre Fabre, Samsung Bioepis, Sanofi, Seattle Genetics, Scandion Oncology, Servier, Sotio Biotech, Taiho Pharmaceutical, Tessa Therapeutics, and TheraMyc (paid to self), and honoraria for educational events from Imedex, Medscape Education, MJH Life Sciences, PeerView Institute for Medical Education, and Physicians’ Education Resource (paid to self). Paulo M. Hoff reported receiving research grant/funding from F. Hoffmann-La Roche Ltd and is the President of the Brazilian Oncology Society (SBOC). Lin Shen reported receiving research grant/funding from Beihai Kangcheng Medical Technology, Baiji Shenzhou (Beijing) Biotechnology Co., Beijing Xiantong Biomedical Technology, Jacobio Pharmaceuticals, Qilu Pharmaceutical, Yaojie Ankang (Nanjing) Technology Co., and Zai Lab (paid to institution), consulting fees from Boehringer Ingelheim, Haichuang Pharmaceutical, Harbour Biomed, Merck, Mingji Biopharmaceutical, and MSD (paid to self), honoraria for speakers bureaus from CSTONE Pharmaceuticals, Jiangsu Hengrui Medicine, Hutchison Whampoa, and Zai Lab (paid to self), and has participated on advisory boards for AstraZeneca, BMS, CSTONE Pharmaceuticals, Daiichi Sankyo, F. Hoffmann-La Roche, Rongchang Pharmaceuticals, Sanofi, and Zai Lab. Atsushi Ohtsu reported receiving research grant/funding from F. Hoffmann-La Roche Ltd and BMS (paid to self), and honoraria for lectures from Chugai (paid to self). Manish A. Shah reported receiving research grants/funding from BMS, Merck, and Oncolys BioPharma (paid to institution). Asna Siddiqui and Sarah Heeson are employees of Roche Products Ltd and own shares in F. Hoffmann-La Roche Ltd. Astrid Kiermaier is an employee of and owns shares in F. Hoffmann-La Roche Ltd. Harrison Macharia is an employee of F. Hoffmann-La Roche Ltd. Eleonora Restuccia is an employee of and owns shares in F. Hoffmann-La Roche Ltd/Genentech Inc. Yoon-Koo Kang reported receiving consulting fees from ALX Oncology, Amgen, Blueprint, BMS, Daehwa Pharmaceutical, F. Hoffmann-La Roche, MacroGenics, MSD, Novartis, Surface Oncology, and Zymeworks (paid to self). Human rights statement and informed consentJACOB was performed in accordance with the principles of the Declaration of Helsinki and the International Conference on Harmonisation E6 guideline for Good Clinical Practice, or the laws and regulations of the country in which the research was conducted, whichever afforded greater protection to the individual. Approval for the protocol, any amendments, informed consent forms, information provided to patients, and relevant supporting information was obtained from institutional review boards and/or ethics committees at participating sites. All patients provided written informed consent. Conflict of interest All authors reported receiving research support in the form of third-party medical writing assistance for this manuscript, provided by F. Hoffmann-La Roche Ltd. Josep Tabernero reported receiving consulting fees from Array BioPharma, AstraZeneca, Avvinity Therapeutics, Bayer, Boehringer Ingelheim, Chugai, Daiichi Sankyo, F. Hoffmann-La Roche Ltd, Genentech, Inc., HalioDX SAS, Hutchison MediPharma International, Ikena Oncology, Inspirna, IQVIA, Lilly, Menarini, Merck Serono, Merus, MSD, Mirati Therapeutics, Neophore, Novartis, Ona Biotechnology, Orion Biotechnology, Peptomyc, Pfizer, Pierre Fabre, Samsung Bioepis, Sanofi, Seattle Genetics, Scandion Oncology, Servier, Sotio Biotech, Taiho Pharmaceutical, Tessa Therapeutics, and TheraMyc (paid to self), and honoraria for educational events from Imedex, Medscape Education, MJH Life Sciences, PeerView Institute for Medical Education, and Physicians’ Education Resource (paid to self). Paulo M. Hoff reported receiving research grant/funding from F. Hoffmann-La Roche Ltd and is the President of the Brazilian Oncology Society (SBOC). Lin Shen reported receiving research grant/funding from Beihai Kangcheng Medical Technology, Baiji Shenzhou (Beijing) Biotechnology Co., Beijing Xiantong Biomedical Technology, Jacobio Pharmaceuticals, Qilu Pharmaceutical, Yaojie Ankang (Nanjing) Technology Co., and Zai Lab (paid to institution), consulting fees from Boehringer Ingelheim, Haichuang Pharmaceutical, Harbour Biomed, Merck, Mingji Biopharmaceutical, and MSD (paid to self), honoraria for speakers bureaus from CSTONE Pharmaceuticals, Jiangsu Hengrui Medicine, Hutchison Whampoa, and Zai Lab (paid to self), and has participated on advisory boards for AstraZeneca, BMS, CSTONE Pharmaceuticals, Daiichi Sankyo, F. Hoffmann-La Roche, Rongchang Pharmaceuticals, Sanofi, and Zai Lab. Atsushi Ohtsu reported receiving research grant/funding from F. Hoffmann-La Roche Ltd and BMS (paid to self), and honoraria for lectures from Chugai (paid to self). Manish A. Shah reported receiving research grants/funding from BMS, Merck, and Oncolys BioPharma (paid to institution). Asna Siddiqui and Sarah Heeson are employees of Roche Products Ltd and own shares in F. Hoffmann-La Roche Ltd. Astrid Kiermaier is an employee of and owns shares in F. Hoffmann-La Roche Ltd. Harrison Macharia is an employee of F. Hoffmann-La Roche Ltd. Eleonora Restuccia is an employee of and owns shares in F. Hoffmann-La Roche Ltd/Genentech Inc. Yoon-Koo Kang reported receiving consulting fees from ALX Oncology, Amgen, Blueprint, BMS, Daehwa Pharmaceutical, F. Hoffmann-La Roche, MacroGenics, MSD, Novartis, Surface Oncology, and Zymeworks (paid to self)."

"Funding This study was sponsored by F. Hoffmann-La Roche Ltd. The sponsor, F. Hoffmann-La Roche Ltd, contributed to the design of this study. Data collected by the investigators were analyzed by statisticians at F. Hoffmann-La Roche Ltd. Authors employed by the study sponsor contributed to the conduct of the study, collection, management, analysis, and interpretation of the data, and preparation, review, and approval of the manuscript, as well as the decision to submit the manuscript for publication."

"Trial registration NCT01774786; https://clinicaltrials.gov/ct2/show/NCT01774786 ."