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Article History

Received: 29 July 2022

Accepted: 1 November 2022

First Online: 6 January 2023

Declarations

:

: F Lordick reports study funding from Astellas Pharma, Inc.; grants from BMS and MSD (to institution); consulting fees from Amgen, Astellas, AstraZeneca, BMS, Daiichi Sankyo, Eli Lilly, MSD, Roche, and Zymeworks; payments or honoraria from Amgen, Astellas, AstraZeneca, BMS, Eli Lilly, MSD, and Roche; travel support from BMS and Roche; advisory board participation for BioNTech; and leadership or fiduciary role in the European Society for Medical Oncology (unpaid) and the International Gastric Cancer Association (unpaid). P Thuss-Patience reports study funding from Astellas Pharma, Inc. and advisory board participation (outside the submitted work) with Lilly, BMS, MSD, Roche, Astellas Merck Serono, Servier, AstraZeneca, and Pfizer. M Bitzer reports study funding from Astellas Pharma, Inc. U Sahin is a co-founder and ex-shareholder of Ganymed Pharmaceuticals AG; he has also received consultancy fees from Ganymed Pharmaceuticals AG; he is also founder, chief executive officer, and a stockholder of BioNTech Holding, which is developing immunotherapies for cancer and other diseases. In addition, he has received consultancy fees from Astellas Pharma, Inc. and has pending, issued, and licensed patents relevant to the work, which have been acquired by Astellas Pharma, Inc. and for which he receives milestone payments. D Maurus reports study funding from Astellas Pharm, Inc. Ö Türeci is co-founder, chief executive officer, and an ex-shareholder of Ganymed Pharmaceuticals AG; she is also co-founder, chief medical officer and a stockholder of BioNTech Holding, which is developing immunotherapies for cancer and other diseases. In addition, she has received consultancy fees from Astellas Pharma, Inc. and has pending, issued, and licensed patents relevant to the work, which have been acquired by Astellas Pharma, Inc. and for which she receives milestone payments. All authors report management support from OPEN Health for manuscript development.

: The study protocol and informed consent forms were reviewed and approved by the Independent Ethics Committee(s) (IEC) at each participating investigational center. The study was conducted in accordance with the ethical principles of the Declaration of Helsinki, Good Clinical Practice guidelines, and the requirements of public registration of clinical trials.

: Written informed consent was obtained from each patient at the time of enrollment.

: Not applicable.