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Article History

Received: 22 September 2025

Accepted: 1 November 2025

First Online: 12 November 2025

Declarations

:

: ML, TF, and JAH are employees of MSD, and own stock in Merck & Co., Inc., Rahway, NJ, USA. AB reports grants or contracts from AstraZeneca, Daiichi Sankyo, Eli Lilly, Genentech, Gilead, Menarini, MSD, Novartis, Onkure, and Pfizer and consulting fees from Alyssum, AstraZeneca, Daiichi Sankyo, Eli Lilly, Genentech, Gilead, Menarini, MSD, Novartis, and Pfizer. AC reports grants or contracts from MSD and Pfizer; consulting fees from AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly and Company, MSD, Novartis, Pfizer, Roche/Genentech, Takeda, BeiGene, Summit, Therapeutics, Amgen, Janssen, Regeneron, and Sanofi; payment or honoraria for lectures presentations, speakers bureaus, manuscript writing or educational events from AstraZeneca, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, MSD, Novartis, Pfizer, Roche, Pierre-Fabre, and PharmaMar; and support for attending meetings and/or travel from Boehringer Ingelheim, MSD, Roche, Pfizer, and AstraZeneca. RD reports consulting fees from Roche, Pfizer, Gilead, Lilly, SOBI, Galderma, Sanofi, Novartis, and Bayer; payment or honoraria for lectures presentations, speakers bureaus, manuscript writing or educational events from MSD, Eisai, AstraZeneca, Roche, Pfizer, Gilead, Lilly, SOBI, Galderma, Sanofi, Novartis, and Bayer; and support for attending meetings and/or travel from Bayer and Novartis. RSH reports grants or contracts from AstraZeneca, Eli Lilly and Company, Genentech/Roche, and MSD; consulting fees from AstraZeneca, Amgen, ArriVent, Bristol Myers Squibb, Candel Therapeutics, Inc., Catalym, Checkpoint Therapeutics, Cybrexa Therapeutics, Eli Lilly and Company, Genentech, Gilead, I-Mab Biopharma, Immunocore, Janssen, Mediflix, MSD, NextCure, Novartis, Pfizer, Regeneron, and Roche; support for attending meetings and/or travel from AstraZeneca, Genentech/Roche, and MSD; participation on a Data Safety Monitoring Board or Advisory board for AstraZeneca, Candel Therapeutics, Inc., Checkpoint Therapeutics, Cybrexa Therapeutics, I-Mab Biopharma, Immune-Onc Therapeutics, Inc., Immunocore, and Novartis; a leadership or fiduciary role in other board, society, committee, or advocacy group, paid or unpaid, for the American Association for Cancer Research, International Association for the Study of Lung Cancer, Society for Immunotherapy of Cancer, and Southwest Oncology Group Friends of Cancer Research; stock or stock options in Bolt Biotherapeutics, Checkpoint Therapeutics, and Immunocore Holdings Limited; and is a board member (nonexecutive/independent) for Immunocore Holdings Limited.

: Not applicable

: Not applicable

: Not applicable

: Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA (MSD) is committed to providing qualified scientific researchers access to anonymized data and clinical study reports from the company’s clinical trials for the purpose of conducting legitimate scientific research. MSD is also obligated to protect the rights and privacy of trial participants and, as such, has a procedure in place for evaluating and fulfilling requests for sharing company clinical trial data with qualified external scientific researchers. The MSD data sharing website (available at: ) outlines the process and requirements for submitting a data request. Applications will be promptly assessed for completeness and policy compliance. Feasible requests will be reviewed by a committee of MSD participant matter experts to assess the scientific validity of the request and the qualifications of the requestors. In line with data privacy legislation, submitters of approved requests must enter into a standard data-sharing agreement with MSD before data access is granted. Data will be made available for request after product approval in the US and EU or after product development is discontinued. There are circumstances that may prevent MSD from sharing requested data, including country- or region-specific regulations. If the request is declined, it will be communicated to the investigator. Access to genetic or exploratory biomarker data requires a detailed, hypothesis-driven statistical analysis plan that is collaboratively developed by the requestor and MSD participant matter experts; after approval of the statistical analysis plan and execution of a data-sharing agreement, MSD will either perform the proposed analyses and share the results with the requestor or will construct biomarker covariates and add them to a file with clinical data that is uploaded to an analysis portal so that the requestor can perform the proposed analyses.

: Not applicable

: ML contributed to conceptualization, investigation, methodology, project administration, supervision, visualization, writing—original draft, and writing— review and editing. AB contributed to conceptualization, writing—original draft, and writing— review and editing. AC contributed to resources, validation, writing—original draft, and writing— review and editing. RD contributed to conceptualization, validation, and writing—review and editing. TF contributed to conceptualization, methodology, and writing—review and editing. JAH contributed to conceptualization, formal analysis, investigation, methodology, supervision, writing—original draft, and writing— review and editing. RH contributed to conceptualization, formal analysis, writing—original draft, and writing— review and editing.