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Article History

Accepted: 30 December 2024

First Online: 14 January 2025

Declarations

:

: This study was funded by Adlai Nortye.

: A.D. has received travel reimbursement from Astra Zeneca, Regeneron, and Exelixis; consulting fees from Merck/EMD Serono; and research funding paid to the institution from Astra Zeneca and Exelixis. L.F.L. has received consulting fees from MSD IT, Merck Serono Spa Healthcare Professional, Merck Healthcare KGaA, GSK, F. Hoffman La Roche Ltd, EMD Serono Research & Development Institute, Inc., Boehringer Ingelheim International GmbH, Simon-Kucher & Partners Strategy & Marketing Consultants, Rgenta Therapeutics, Inc., Alentis Therapeutics AG, and MedImmune Limited; payments or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing, or educational events from Merck Serono Spa, MSD IT, Merck Healthcare KGaA, Adlai Nortye, Bristol Myers Squibb, and ALTIS Omnia Pharma Service Srl. Support for attending meetings and/or travel was provided by TAE Life Science. She has participated on a data safety monitoring board or advisory board for Merck Healthcare KGaA, Merck & Co. Inc., MSD IT, EMD Serono Research & Development Institute, Inc., F. Hoffman-La Roche Ltd, Janssen Research & Development, LLC, Seagen International GmbH, Genmab US, Inc., AstraZeneca UK Limited, Abbvie Srl, Simon-Kucher & Partners Strategy & Marketing Consultants, and Purple Biotech, Ltd. Grants or contracts with research funds donated directly to the institution were received from Adlai Nortye, AstraZeneca, Bristol Myers Squibb, Debiopharm International SA, Eisai, Eli Lilly and Company, Exelixis, Hoffman-La Roche Ltd, Isa Therapeutics, Kura Oncology, Merck Serono, MSD, Merck Sharp & Dohme Corp, Nektar Therapeutics, Novartis, Regeneron, Roche, Sanofi, Syneos, Sun Pharmaceutical, Incyte Biosciences International Sàrl, Gilead Sciences, Inc., Genmab, and Merck Healthcare KGaA. S.F. is a consultant for and has received clinical trial grants from Adlai Nortye, Bristol Myers Squibb, MSD, and Novartis. D.S. is a consultant for ANL, Bristol Myers Squibb, Pfizer, Bicara, Eisai, and Ipsen; received research funding paid to the institution from Bristol Myers Squibb, Incyte, Pfizer, Merck, GSK, and Eisai. A.T. is an employee of Adlai Nortye and holds stock in the company. J.L., S.L., A.T., T.T., K.D., N.H., and L.E.B. are past or present employees of Adlai Nortye.

: The study was conducted in compliance with good clinical practice guidelines, adhering to applicable local regulations and the ethical principles outlined in the Declaration of Helsinki. Approval was obtained from the relevant ethics committees or institutional review boards at each participating center. The study was overseen by a steering committee to ensure adherence to the protocol, with regular safety assessments conducted by an independent data monitoring committee.

: All patients provided written informed consent prior to enrollment.

: All authors have reviewed and approved the final version of this manuscript and consent to its submission and publication.

: The datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.

: The code generated and used in this study is available from the corresponding author upon reasonable request.

: A.D.: conceptualization, software, formal analysis, data curation, writing—original, draft, writing—review and editing, and visualization; J.L.: conceptualization, methodology, validation, formal analysis, resources, writing—review and editing, and project administration; L.F.L.: conceptualization, methodology, and investigation; S.L.: conceptualization and methodology; A.T.: conceptualization, methodology, validation, resources, writing—review and editing, and project administration; T.T.: conceptualization, methodology, resources, and project administration; K.D.: conceptualization, methodology, resources, and project administration; N.H.: conceptualization, methodology, resources, and project administration; L.E.B.: conceptualization, methodology, resources, and project administration; S.F.: conceptualization, methodology, and investigation; and D.S.: conceptualization, methodology, validation, formal analysis, investigation, writing—review and editing, supervision, and project administration.