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Article History

Received: 8 July 2025

Revised: 25 November 2025

Accepted: 12 December 2025

First Online: 27 December 2025

Competing interests

: GP: Consulting/advisory role for Janssen and Sanofi. Honoraria from Bristol Myers Squibb and Sanofi. MC: Speaker’s bureau for Amgen, Janssen, and Sanofi. FeS: no competing interests. VH: Honoraria from AbbVie, Amgen, Bristol Myers Squibb/Celgene, Janssen, Sanofi, and Takeda; Support for attending meetings and/or travel from Amgen, Bristol Myers Squibb/Celgene, Janssen, and Sanofi; Participation on a Data Safety Monitoring Board or Advisory Board for Amgen, Bristol Myers Squibb/Celgene, and Janssen. MD: Honoraria from participation in advisory boards and satellite symposia for Amgen, BeiGene, Bristol Myers Squibb, GlaxoSmithKline, Janssen, Menarini-Stemline, Regeneron, Sanofi, and Takeda. SD: Honoraria for advisory boards and satellite symposia Amgen, AOP Pharma, Bristol Myers Squibb, GlaxoSmithKline, Johnson & Johnson, Sanofi. JM: Consulting fees from Amgen, Bristol Myers Squibb, Celgene, GlaxoSmithKline, Janssen, and Sanofi. Honoraria for lectures, presentations, and speaker bureaus from Amgen, Bristol Myers Squibb, Celgene, GlaxoSmithKline, Janssen, Pfizer, and Sanofi. Participation on a Data Safety Monitoring Board or advisory board for Amgen, Bristol Myers Squibb, Celgene, GlaxoSmithKline, Janssen, and Sanofi. IŠ: Consulting fees from Amgen, Bristol Myers Squibb, GlaxoSmithKline, Janssen-Cilag, Sanofi, and Takeda. Honoraria for lectures, presentations, and speaker bureaus from Amgen, Bristol Myers Squibb, Janssen-Cilag, Sanofi, and Takeda. Support for attending meetings and/or travel from Janssen-Cilag, Sanofi, and Takeda. Participation on a Data Safety Monitoring Board or advisory board for Amgen, Janssen-Cilag, Sanofi, and Takeda. LP, HM, GE: no competing interests. KS: Research funding from AbbVie, Beigene, Bristol Myers Squibb, Chugai, GlaxoSmithKline, Incyte, Janssen, Kyowa Kirin, Mitsubishi Tanabe, Novartis, ONO, Otsuka, Pfizer, Sanofi; Honoraria from Bristol Myers Squibb, Janssen, Pfizer, and Sanofi. JY: Research funding from AbbVie, Amgen, AstraZeneca, BrightPath Bio, Bristol Myers Squibb, Celaid Therapeutics, Chugai, Daiichi Sankyo, Genmab, Incyte, Janssen, Mitsubishi Tanabe, MSD, Novartis, Sanofi, Sumitomo Pharma, and Takeda. RH: Grants or contracts from Amgen, Bristol Myers Squibb, Celgene, Janssen, Novartis, and Takeda. Consulting fees from AbbVie, Amgen, Bristol Myers Squibb, Celgene, Janssen, Novartis, PharmaMar, and Takeda. Honoraria for lectures, presentations, and speaker bureaus: Amgen, Bristol Myers Squibb, Celgene, Janssen, PharmaMar, and Takeda. Support for attending meetings and/or travel from Amgen, Celgene, Janssen, and Takeda. Participation on a Data Safety Monitoring Board or advisory board for Amgen, Bristol Myers Squibb, GlaxoSmithKline, Janssen, Oncopeptides, Sanofi, and Takeda. CS, DY, PC, EC, and FS: employed by Sanofi; may hold stock and/or stock options in the company. KB and VK: employed by Excelya on behalf of Sanofi; may hold stock and/or stock options in the company. HQ: Research funding from Bristol Myers Squibb, GlaxoSmithKline, Karyopharm, and Sanofi; Consulting/advisory role for Antengene, Beigene, Bristol Myers Squibb, GlaxoSmithKline, Janssen Cilag, Karyopharm, Regeneron, and Sanofi.

: The study was approved by the local health authorities and the Institutional Review Board or Independent Ethics Committee at each study center. The study was conducted following the Declaration of Helsinki and the International Council for Harmonisation (ICH) Guidelines for Good Clinical Practice. All patients provided written informed consent.