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Article History

Accepted: 11 May 2025

First Online: 4 June 2025

Declarations

:

: This study was supported by research funding from Bayer AG.

: Lillian L. Siu reports consulting/advisory arrangements with Arvinas, AstraZeneca, Daiichi Sanyko, GlaxoSmithKline, LTZ Therapeutics, Marengo, Medicenna, Merck, Pfizer, Relay Therapeutics, Roche, Tubulis, and Voronoi; stock ownership in Agios (spouse); leadership position in Treadwell Therapeutics (spouse); and institution receives clinical trial support from AbbVie, Amgen, Astellas, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, Daiichi Sankyo, EMD Serono, GlaxoSmithKline, Karyopharm, Merck, Novartis, Pfizer, and Roche/Genentech. David S. Hong reports a consulting/speaker/advisory role with 280Bio (Yingli), AbbVie, Acuta, Adaptimmune, Affini-T, Alkermes, Alpha Insights, Amgen, Astellas, AUM Biosciences, Axiom, Baxter, Bayer, BeiGene, Boxer Capital, BridgeBio, CARSgen, CLCC, COG, COR2ED, EcoR1, EDDC, Erasca, Exelixis, Fate Therapeutics, F. Hoffmann-La Roche, Genentech, Gennao Bio, Gilead, GLG Pharma, groupH, Guidepoint, HCW Precision Oncology, ImmunoGenesis, Incyte, InduPro, Inhibrx, Innovent, Janssen, Jounce Therapeutics, LianBio, Liberum Bio, MEDACorp, Medscape, Novartis, Northwestern, Numab Therapeutics, Oncologia Brasil, ORI Capital, Pfizer, Pharma Intelligence, Precision Oncology and Experimental Therapeutics, prIME Oncology, Projects in Knowledge, Quanta, Rain Therapeutics, Revolution Medicines, Ridgeline, Sanofi/Genzyme, Seagen, Stanford, STCube, Takeda, Tavistock, TD Cowen, T-knife Therapeutics, Trieza Therapeutics, Turning Point Therapeutics, UNC, WebMD, and Ziopharm; research funding (all payments made to institution) from AbbVie, Adaptimmune, Adlai Nortye, Amgen, Astellas, AstraZeneca, Bayer, Biomea Fusion, Bristol Myers Squibb, Daiichi Sankyo, Deciphera, Eisai, Endeavor, Erasca, Fate Therapeutics, F. Hoffmann-La Roche, Genentech, Genmab, ImmunoGenesis, Incyte, Infinity, Kyowa Kirin, Lilly, Merck, Mirati Therapeutics, National Cancer Institute Cancer Therapy Evaluation Program, Navier, Novartis, Numab Therapeutics, Pfizer, Pyramid Biosciences, Quanta, Revolution Medicine, Seagen, STCube, Takeda, TCR2 Therapeutics, Turning Point Therapeutics, and VM Oncology; travel/accommodation/expenses funding from American Association for Cancer Research, American Society of Clinical Oncology, Bayer, CLCC, Genmab, Northwestern, Society for Immunotherapy of Cancer, Telperian, and UNC; and other ownership interests in CrossBridge Bio (advisor), MolecularMatch (advisor), OncoResponse (founder, advisor), and Telperian (founder, advisor). Wolf-Dietrich Döcke is a stockholder in Bayer AG and an inventor on Bayer AG patent applications. Reimo Tetzner is an employee of and stockholder in Bayer AG. Mark Trautwein is an employee of and stockholder in Bayer AG and an inventor on Bayer AG patent applications. Charles Phelps is a stockholder in Amgen, Bayer AG, Janssen, Lilly, and Pfizer. Joerg Willuda is an employee of and stockholder in Bayer AG and an inventor on Bayer AG patent applications. Xiang Qing Yu reports no conflicts of interest. Hendrik Nogai reports no conflicts of interest. Melissa Johnson reports a consulting/advisory role (all payments made to institution) with AbbVie, Alentis Therapeutics, Amgen, Arcus Biosciences, ArriVent BioPharma, AstraZeneca, Biohaven, Boehringer Ingelheim, Bristol Myers Squibb, D3 Bio, Daiichi Sankyo, Fate Therapeutics, Genentech/Roche, Gilead, GlaxoSmithKline, Gritstone Oncology, Hookipa Biotech, Immunocore, Janssen, Jazz, Lilly, Merck, Mirati Therapeutics, ModeX Therapeutics, Normunity, Novartis, Novocure, Pfizer, Pyramid Biosciences, Regeneron, Revolution Medicines, Sanofi-Aventis, Seagen, Synthekine, Takeda, and Zai Lab; and research funding (all payments made to institution) from AbbVie, Adaptimmune, Amgen, Arcus Biosciences, Array BioPharma, ArriVent BioPharma, Artios, AstraZeneca, Bayer, BeiGene, BerGenBio, BioAtla, Black Diamond Therapeutics, Boehringer Ingelheim, Bristol Myers Squibb, Calithera Biosciences, Carisma Therapeutics, City of Hope National Medical Center, Conjupro Biotherapeutics, Corvus, Curis, CytomX, Daiichi Sankyo, Dracen, Elicio Therapeutics, EMD Serono, EQRx, Erasca, Exelixis, Fate Therapeutics, Genentech/Roche, Genmab, Genocea Biosciences, GlaxoSmithKline, Gritstone Oncology, Harpoon Therapeutics, Helsinn Healthcare SA, Hengrui, Hutchison MediPharma, IDEAYA Biosciences, IGM Biosciences, Immuneering Corporation, Immunitas Therapeutics, Immunocore, IMPACT Therapeutics, Incyte, Janssen, Kartos Therapeutics, Lilly, LockBody Therapeutics, Loxo Oncology, Memorial Sloan Kettering Cancer Center, Merck, Merus, Mirati Therapeutics, Mythic Therapeutics, NeoImmuneTech, Neovia Oncology, NextPoint Therapeutics, Novartis, Numab Therapeutics, Nuvalent, OncoC4, Palleon, Pfizer, PMV Pharma, Rain Therapeutics, RasCal Therapeutics, Regeneron, Relay Therapeutics, Revolution Medicines, Ribon Therapeutics, Rubius Therapeutics, Sanofi, Seven and Eight Biopharmaceuticals/Birdie Biopharmaceuticals, Shattuck Labs, Silicon Therapeutics, Summit Therapeutics, Syndax, SystImmune, Taiho Oncology, Takeda, TCR2 Therapeutics, Tempest Therapeutics, Theras, Tizona Therapeutics, Tmunity Therapeutics, Turning Point Therapeutics, Vividion Therapeutics, Vyriad, and Y-mAbs Therapeutics. Boon Cher Goh reports clinical trial funding (all payments made to institution) from Bayer AG, and a leadership or fiduciary role (non-remunerated) on the Drug Advisory Committee, Ministry of Health, Singapore.

: This study was approved by relevant independent ethics committees and institutional review boards at each study center and was compliant with the Declaration of Helsinki and Good Clinical Practice.

: All patients provided written, informed consent.

: Not applicable.

: Availability of the data underlying this publication will be determined according to Bayer’s commitment to the European Federation of Pharmaceutical Industries and Associations/Pharmaceutical Research and Manufacturers of America “Principles for responsible clinical trial data sharing.” This pertains to scope, time point, and process of data access. As such, Bayer commits to sharing, upon request from qualified scientific and medical researchers, patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the USA and EU, as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after 1 January 2014. Interested researchers can use to request access to anonymized patient-level data and supporting documents from clinical studies to conduct further research that can help advance medical science or improve patient care. Information on the Bayer criteria for listing studies and other relevant information is provided in the study sponsor’s section of the portal. Data access will be granted to anonymized patient-level data, protocols, and clinical study reports after approval by an independent scientific review panel. Bayer is not involved in the decisions made by the independent review panel. Bayer will take all necessary measures to ensure that patient privacy is safeguarded.

: Not applicable.

: All authors met the International Committee of Medical Journal Editors authorship criteria. Neither honoraria nor payments were made for authorship. Lillian L. Siu, Wolf-Dietrich Döcke, Reimo Tetzner, Mark Trautwein, Charles Phelps, Joerg Willuda, Xiang Qing Yu, and Hendrik Nogai were responsible for study conception and design. Lillian L. Siu, David S. Hong, Melissa Johnson, and Boon Cher Goh were responsible for data acquisition. All authors participated in data analysis or interpretation, drafted or critically revised the manuscript for intellectual content, gave final approval of the version to be published, and agree to be accountable for all aspects of the work.