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Article History

Received: 25 June 2025

Revised: 2 December 2025

Accepted: 25 January 2026

First Online: 6 February 2026

Competing interests

: BB has received consulting and speaking fees (Esteve, Eisai, GSK, Pierre Fabre Oncologie and Pfizer), as well as support for travel and accommodation to attend meetings (Pierre Fabre). AP has received speaking fees (Eisai, Bristol Myers Squibb and Pierre Fabre Oncologie). MB has received consulting fees (MSD, Ipsen, Astellas, Janssen, and Merck). DM has received fees for consulting or advisory roles (BMS, Merck, Eisai, MSD Oncology, Pfizer, Ipsen, J&J, Astellas, AstraZeneca, Bayer, Novartis/3 A), as well as support for travel and accommodation to attend meetings (BMS, Johnson & Johnson, Bayer Novartis, Merck). BL has received consulting and speaking fees (Astellas, Pfizer, Ipsen, Bayer, Janssen-Cilag, Astellas, Eisai, BMS), as well as support for travel and accommodation to attend meetings (Ipsen, AstraZeneca, Pfizer, and MSD Oncology, BMS and Novartis). MGG has received consulting and speaking fees (BMS, MSD Oncology, Pfizer, Ipsen, Roche, Bayer/Onyx, Amgen, Sanofi, Janssen-Cilag, Astellas Medivation, AstraZeneca, and Gilead Sciences Inc.), as well as support for travel and accommodation to attend meetings (Bayer, Roche, Ipsen, AstraZeneca, Astellas Pharma, Pfizer, Janssen-Cilag, and MSD Oncology) and research funding (from Pfizer, MSD Oncology, Roche, Ipsen, Janssen-Cilag, AstraZeneca, Merck, and BMS) paid to her institution. PB has received consulting and speaking fees (BMS, Janssen-Cilag, Pfizer, Merck, Novartis/AdaCaP, MSD, IPSEN, Astra Zeneca, Astellas, EISAI, Gilead, BAYER), as well as support for travel and accommodation to attend meetings (AstraZeneca, Bayer, Ipsen, MSD, Merck and Pfizer). CT has received consulting and speaking fees (Pfizer, MSD, Servier, Bayer, Astra-Zeneca). GG has received consulting and speaking fees paid to her institution (BMS, Janssen, Pfizer, Alliance Merck-Pfizer, Novartis, MSD, IPSEN, Astra Zeneca, Astellas, EISAI, AMGEN, BAYER), as well as support for travel and accommodation to attend meetings (AstraZeneca, Bayer, Bristol Myers Squibb, Janssen, Ipsen, MSD, and Pfizer). GG has also received fees related to a data safety monitoring board or advisory board, paid to her institution (Alliance Merck-Pfizer, AstraZeneca, Bayer, Bristol Myers Squibb, Eisai, Ipsen, Janssen, Novartis and Pfizer). WHF has received fees as member of scientific boards (Anaveon, Geneta, IGI, Mestag, OSE immunotherapeutics and Oxford biotherapeutics). CSF has received consulting fees (Mestag). SO has received consulting and speaking fees (Amgen, Astellas, AstraZeneca, BMS, Bayer, Eisai, Ipsen, Janssen, MSD Oncology, Novartis, Pfizer, Roche, Sanofi), as well as support for travel and accommodation to attend meetings (Bayer, Ipsen, Astellas, Janssen, Pfizer, and MSD Oncology) and research funding (Bayer, BMS, AstraZeneca, Ipsen, Janssen and Pfizer) paid to the research team association named ARTIC. YAV has received honoraria (Bristol Myers Squibb, MSD, Merck, Ipsen, Pfizer, Roche and Eisai), as well as support for travel and accommodation to attend meetings (MSD, Merck, Pfizer, Ipsen and EISAI) and research grants (Bristol Myers Squibb and Ipsen). EC is an employee of AstraZeneca. EC has received consulting and speaking fees (BMS, Eisai, AstraZeneca, Pfizer, Janssen, Astellas, MSD, Novartis/Adacap). AJ, CC, DB, DP, EL and CMS declare no conflict of interest.

: The BIONIKK trial protocol and subsequent amendments were approved by the French Health authorities and ethics committee. The trial was conducted in accordance with Good Clinical Practice guidelines. All patients provided written informed consent.

: All authors had full access to the data and control of the final approval and decision to submit the manuscript for publication.