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Article History

Received: 26 August 2022

Accepted: 7 December 2022

First Online: 25 July 2024

Declarations

:

: Independent ethics committees, as defined by the US CFR Title 21, Part 56 or equivalent country specific regulations, reviewed and approved the protocol and any amendments. The study was approved by the ethics committees at each institution (Bellberry Limited; Chang Gung Medical Foundation Institutional Review Board; China Medical University Hospital Research Ethics Committee; CEIC Area 5 Hospital Universitario La Paz Paseo de la Castellana; Chaim Sheba Medical Center Tel Hashomer Oncology Institute; CISSS de la Monteregie-Centre-Comite d'Ethique; Comitato Etico 1, Azienda Ospedaliera Universitaria-Policlinico Vittorio Emanuele; Comitato Etico Brianza; Comitato etico centrale-fondazione IRCCS-istituto nazionale dei tumori; Comitato etico-istituto europeo di oncologia; Contrada Amoretta Biomedica Azienda Ospedaliera S.G. Moscati Citta Ospedaliera pal. Uffici; Copernicus Group Independent Review Board; EC of Central Clinical Hospital with polyclinic of the Presidential Administration of the RF; Ege Uni. Tip Fakultesi Arastirma Etik Kurulu; Egeszsegugyi Tudomanyos Tanacs; LEC of Leningrad Regional Clinical Hospital; LEC of Tatarstan Republican Clinical Oncology Dispensary; Meir Medical Center Oncology Institute; National Cheng Kung University Hospital; National Taiwan University Hospital; Oaxaca Site Management Organization S.C.; Rabin Medical Center Helsinki Committee; Rambam Medical Center IRB/IEC; SBI of Stavropol region Pyatigorskiy Oncologic dispensary; Schulman Associates IRB; Soroka Medical Center EC; St Vincents Hospital Research Office; St Vincent's Hospital Sydney Human Research Ethics Committee; Tomsk Scientific Research Institute of Oncology; UBC BCCA Research Ethics Board; Udmurtia Republic Regional Clinical Oncology Dispensary; University of Michigan Medical School Institutional Review Board; US Oncology, Inc. IRB; Western Institutional Review Board; Yorkshire and the Humber Sheffield Research Ethics Committee). All patients provided written informed consent.

: Not applicable.

: MB reports institutional research funding from Amgen, AstraZeneca, BeiGene, Ltd., Boehringer Ingelheim, Bristol-Myers Squibb, Genentech/Roche, Merck Sharpe & Dohme, and Pfizer; and advisory board participation for AstraZeneca, Bristol-Myers Squibb, Merck Sharpe & Dohme, and Roche. RH reports advisory board participation for AstraZeneca, Bristol-Myers Squibb, Eli Lilly, Merck Sharp & Dohme, Novartis, Pfizer, Roche and Seagen; and speaker honoraria from Merck Sharp & Dohme, Novartis and Roche. DU reports honoraria from AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Merck Sharp & Dohme (Israel), Roche, and Takeda; consultancy for Merck Sharp & Dohme (Israel), Roche, and Takeda; and other (travel) for AstraZeneca and Takeda. PC and W–CS have nothing to disclose. CD reports advisory committee participation for Bristol-Myers Squibb and Merck. SG reports personal fees from Blueprint, Roche/Genentech, AstraZeneca, Janssen, Bristol Myers-Squibb, Pfizer, Eli Lilly, Novartis, and Daichii; grants and personal fees from Merck; and a role on the IDMC of a phase III trial sponsored by AstraZeneca. MG reports honoraria from AstraZeneca/MedImmune, Bristol-Myers Squibb, GlaxoSmithKline, MSD Oncology, Roche, and Takeda; consulting or advisory roles with AstraZeneca, Bayer, Blueprint Medicines, Bristol-Myers Squibb, Celgene, Daichii Sankyo, GlaxoSmithKline, Incyte, Inivata, Janssen, Lilly, MSD, Novartis, Pfizer, Regeneron, Roche, Sanofi, Seattle Genetics, Takeda, and Tiziana Life Sciences; Speakers’ Bureau participation with AstraZeneca, Bristol-Myers Squibb, Celgene, Incyte, Lilly, MSD Oncology, Otsuka, Roche, and Takeda; and research funding from Amgen (Inst), AstraZeneca (Inst), AstraZeneca/MedImmune (Inst), Blueprint Medicines (Inst), Bristol-Myers Squibb (Inst), Exelixis (Inst), GlaxoSmithKline (Inst), Incyte (Inst), Ipsen (Inst), Janssen (Inst), Lilly (Inst), MedImmune (Inst), Merck (Inst), MSD (Inst), Novartis (Inst), Pfizer (Inst), Roche/Genentech (Inst), Sanofi (Inst), Spectrum Pharmaceuticals (Inst), and Takeda (Inst); and travel/accommodation/expenses from AstraZeneca, Pfizer, and Roche. LL, MCM, and JD are salaried employees of and own stock in Incyte Corporation. AS and YL are salaried employees of Merck & Co., Inc., Rahway, NJ, USA and own stock in the Company. DRA reports personal fees/honoraria for consultancy and lectures from Roche, AstraZeneca, Bristol-Myers Squibb, Merck Sharp & Dohme, Eli Lilly, Pfizer, and Novartis; travel expenses from Roche, Bristol-Myers Squibb, Merck Sharp & Dohme, and Novartis; and grant support for institutional studies from Bristol-Myers Squibb.