Competing interests
MST: Advisory role or expert testimony from AbbVie, AstraZeneca, Autolus Therapeutics, Incyte, Kite/Gilead Sciences, Regeneron; financing of scientific research from AstraZeneca, Kite/Gilead Sciences, Regeneron, and F. Hoffmann-La Roche Ltd. BDS: Consulting fees from Adaptive, Amgen, AstraZeneca, Autolus Therapeutics, BeiGene, Bristol Myers Squibb, Century Therapeutics, Deciphera, Gilead Sciences, Jazz Pharmaceuticals, Kite, Lilly, Pepromene Bio, Pfizer, Precision Biosciences, Novartis, and Takeda; research funding from Jazz Pharmaceuticals, Gilead Sciences, Kite, and Servier. EJ: Consulting fees from AbbVie, Adaptive Biotechnologies, Amgen, Ascentage, Astellas Pharma, Autolus Therapeutics, Daiichi-Sankyo, Genentech, Inc., Hikma, Kite, Novartis, Pfizer, Rigel Pharmaceuticals Inc., Takeda, TargetRx, and TERN Pharmaceuticals; research funding from AbbVie, Adaptive Biotechnologies, Amgen, Ascentage, Astex, Autolus Therapeutics, Bristol Myers Squibb, Kite, Novartis, Pfizer, Takeda, TargetRx, and TERN Pharmaceuticals. JHP: Consulting fees from Adaptive Biotechnologies, Affyimmune, Allogene, Amgen, Artiva Biotherapeutics, Autolus Therapeutics, Bright Pharmaceutical Services, Bristol Myers Squibb, Caribou Biosciences, Curocell, Galapagos, Gilead Sciences, Intellia, Kite, Novartis, Pfizer, Servier, Sobi, Synthekine, and Takeda; research funding from Autolus Therapeutics, Fate Therapeutics, Genentech, Inc., InCyte, Servier, Sobi, and Takeda; personal fees from Curocell. PS: Consulting fees from Autolus Therapeutics and Sanofi; honoraria from Bristol Myers Squibb and Sanofi. ACL: Consulting fees from Actinium, Amgen, Kite, Pfizer, Sanofi, and Takeda; research funding from Amgen, Astellas Pharma, Autolus Therapeutics, Gilead Sciences, Pharmacyclics, Sanofi, and Talaris. KSS: Consulting fees from Autolus Therapeutics. MA: Consulting fees from Autolus Therapeutics and Bristol Myers Squibb; research funding from Autolus Therapeutics, Bristol Myers Squibb, and Gilead Sciences; honoraria from AbbVie, Bristol Myers Squibb, and Gilead Sciences; personal fees from CytoDyn. MRB: Consulting fees from Achieve Clinics, Arcellx, Autolus Therapeutics, Bristol Myers Squibb, Chimeric Therapeutics, CRISPR Therapeutics, In8Bio, Iovance Biotherapeutics, Kite, Optum Health, Novartis, and Sana Biotechnology; research funding from Arcellx, Autolus Therapeutics, Bristol Myers Squibb, CRISPR Therapeutics, Gilead Sciences, Lyell, and Novartis; honoraria from AbbVie, ADC Therapeutics, Bristol Myers Squibb, Gilead Sciences, Incyte, Novartis, Sanofi, and Servier; personal fees from Achieve Clinics and In8Bio. DJD: Consulting fees from Amgen, Autolus Therapeutics, Blueprint Medicines, Gilead Sciences, InCyte, Jazz Pharmaceuticals, Novartis, Pfizer, Servier, and Takeda; research funding from AbbVie, Blueprint Medicines, GlycoMimetics, and Novartis; honoraria from Daiichi-Sankyo, and Mt Sinai MPN Consortium. XY: Employment/leadership position and stocks from Medidata Solutions, a Dassault Systèmes company. RD: Employment/leadership position and stocks from Medidata Solutions, a Dassault Systèmes company. KH: Consulting fees from Autolus Therapeutics. RM: Employee of Autolus Therapeutics. WB: Employee of and personal fees from Autolus Therapeutics. JS: Employee of and personal fees from Autolus Therapeutics. CR: Consulting fees from Autolus Therapeutics, Bristol Myers Squibb, Gilead Sciences, and Janssen; honoraria from Autolus Therapeutics, Bristol Myers Squibb, and Gilead Sciences. HMK: Advisory role or expert testimony from AbbVie, Amgen, Ascentage Pharma, Ipsen, Biopharmaceuticals, KAHR Medical, Novartis, Pfizer, Shenzhen Target Rx, Stemline, and Takeda. All authors received nonfinancial support (assistance with manuscript preparation) from Ashfield MedComms, which received funding from Autolus Therapeutics.
Ethics approval and consent to participate
The FELIX study received central ethics approval from the following country-level ethics committee (EC)/institutional review board (IRB): West London & GTAC Research EC (reference number: 19/LO/1949; UK), WIRB-Copernicus Group IRB (reference number: 20200446; US*), and Clinical Research Ethics Committee Hospital Universitari Vall d’Hebron (VHIR) (reference number: 2024-512903-38-00†; Spain). All patients in the FELIX study provided written informed consent. All methods were performed in accordance with the relevant guidelines and regulations. No identifiable images from human research participants appear in this article. The external control arm was derived from data from previously conducted clinical trials accessed through Medidata data-sharing agreements. *While some US sites were able to utilize the central IRB, some sites had their own local IRBs with corresponding approvals. †Original EudraCT reference number was 2019-001937-16.
