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Article History

Received: 17 December 2024

Revised: 27 March 2025

Accepted: 4 April 2025

First Online: 16 April 2025

Competing interests

: AA and DR report employment with Takeda. LS and ShG reports employment with Evidera, which received payment for the statistical analysis during the conduct of the study. IA reports honoraria from Takeda, Amgen, Pfizer, Jazz, Sobi, Kite, Syndax, and Adaptive; consulting/advisory roles at Takeda, Amgen, Pfizer, Jazz, Sobi, Kite, Adaptive, and Syndax; participation in speakers bureau at Pfizer; and research funding from AbbVie and MacroGenics. PM reports consulting/advisory roles at Takeda, Daiichi Sankyo, and Bristol Myers Squibb; participation in speakers bureau at Servier; and research funding from AbbVie, Takeda, Daiichi Sankyo, Novartis, and Servier. PV reports consulting/advisory roles at Abbvie, Amgen, Blueprint Medicines, Cogent Biosciences, Incyte, CTI BioPharma, Corp (now Sobi), Genentech, Geron, GlaxoSmith Kline, Karyopharm, Merck, MorphoSys, Novartis, Pfizer, Stemline, and Takeda. VR reports consulting/advisory roles at Pfizer, Takeda, AbbVie, Astellas, Kite, and Amgen. CP reports consulting/advisory roles at AbbVie, Astellas, Novartis, Bristol Myers Squibb, Menarini Stemline, Blueprint Medicines, Incyte, GlaxoSmithKline, Amgen, Pfizer, and Janssen; and personal fees from Astellas, Novartis, Pfizer, and Amgen. JTL reports consulting/advisory roles at Adaptive Biotechnologies, Kite/Gilead, Pfizer, and Takeda; and support for travel, accommodations, and expenses from Adaptive Biotechnologies. MRB reports institutional research funding from AbbVie, Ascentage Pharma, Astellas, FORMA Therapeutics, Kite/Gilead, Kura Oncology, and Takeda. J-MR reports consulting/advisory roles at Incyte, Pfizer, Bristol Myers Squibb, Novartis, and Takeda; and research funding from Amgen. JM reports personal fees from Bristol Myers Squibb, Takeda, Blueprint Medicine, PharmaEssentia, CTI, GlaxoSmithKline, Incyte, Amgen, and Jazz Pharmaceuticals. JW reports an advisory role at Abbvie. SuG has no conflict of interest to disclose.

: All methods used in this study were performed in accordance with the relevant guidelines and regulations. The PhALLCON trial was conducted in compliance with United States (US) Title 21 Code of Federal Regulations (CFR) Parts 50, 54, 56, and 312; the International Council for Harmonisation (ICH) of Technical Requirements for Pharmaceuticals for Human Use Good Clinical Practice (GCP) Guideline E6; the Declaration of Helsinki; and applicable local regulations. The clinical study protocol and its amendments, as well as the informed consent form (ICF) and Investigator’s Brochure, were reviewed and approved by the Institutional Review Board/Independent Ethics Committee (IRB/IEC) of the participating study centers. This study was conducted in compliance with the informed consent regulations outlined in GCP. All patients completed the initial consent process before enrolling to the study. During this process, the person obtaining consent explained the study objectives and potential risks and benefits to patients using the ICF approved by the IRB/IEC. Patients were given adequate time to ask questions and make a voluntary decision to participate. Each patient signed and dated the ICF before any protocol-specific procedures were performed.