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Article History

Received: 27 October 2024

Accepted: 30 January 2025

First Online: 29 April 2025

Declarations

:

: The protocol was approved by the ethics committee of the Ministry of Health of Russian Federation and by the participating clinical sites’ ethics committees. The study was conducted in accordance with the 1964 Declaration of Helsinki and the Good Clinical Practice Guidelines of the International Conference on Harmonization. All patients provided written informed consent.

: Not applicable.

: AT – speaker: Novartis, Pfizer, R-Pharm, consultancy/advisory board: Novartis; OV: no competing interests to declare; EL has received fees for lecturing and expert opinion from Novartis, Pfizer, Sotex, Pharmstandard and Fusion Pharma; ES: no competing interests to declare; OS: no competing interests to declare; EC – speaker: Novartis, Pfizer, R-Pharm, consultancy: Ascentage Pharma; DS: no competing interests to declare; IN: no competing interests to declare; AP: speaker: Novartis, Alexpharm; AB: no competing interests to declare; NS: no competing interests to declare; Vasily Shuvaev received fees for lecturing and expert opinion from Novartis, Pfizer, Amgen, and AbbVie; IM: no competing interests to declare; FN was employed by Fusion Pharma; Veronika Shulgina: was employed by Fusion Pharma; AH: Honoraria and research funding (Novartis, Incyte); research funding (Bristol Myers Squibb, Pfizer, MSD); OO: Amgen, Incyte, Celgene, Roche, Fusion Pharma, Novartis: honoraria. Amgen, Incyte, and Celgene: research funding; JC: Consultancy (Pfizer, Takeda, Nerviano, Sun Pharma, Novartis, Biopath Holdings, Tigel); research funding (Ascentage, Novartis, Sun Pharma, Tern Pharma, Abbvie); membership on an entity’s board of directors or advisory committees (BioPath Holdings); RPG is a consultant to Antengene Biotech LLC, Ascentage Pharma Group and NexImmune Inc.; Medical Director, FFF Enterprises Inc.; A speaker for Janssen Pharma and Hengrui Pharma; Board of Directors: Russian Foundation for Cancer Research Support; and Scientific Advisory Boards, Nanexa AB and StemRad Ltd.; GC is employed by Fusion Pharma.