Document is current

Article History

Received: 26 October 2021

Accepted: 14 March 2022

First Online: 21 May 2022

Declarations

:

: V. Moreno: consulting fees from: Bayer, Pieris, BMS, Janssen. Traveling support from: Regeneron/Sanofi, BMS, Bayer. Speaker´s Bureau: Nanobiotix, BMS, Bayer. Educational Grant: Medscape/Bayer. E. Calvo: Advisory: Adcendo, Alkermes, Amunix, Anaveon, Amcure, AstraZeneca, BMS, Janssen, MonTa, MSD, Nanobiotix, Nouscom, Novartis, OncoDNA, PharmaMar, Roche/Genentech, Sanofi, Servier, SyneosHealth, TargImmune, T-knife; Research grants: Achilles, BeiGene (IDMC steering committee), EORTC IDMC (non-financial interest), MedSIR (steering committee); Scientific Board: Adcendo, Chugai Pharmaceuticals, PsiOxus Therapeutics; Employee: HM Hospitals Group and START Program of Early Phase Clinical Drug Development in Oncology; Medical Oncologist, Clinical Investigator; Director, Clinical Research Ownership: START corporation; Oncoart Associated; International Cancer Consultants; Non-profit Foundation INTHEOS (Investigational Therapeutics in Oncological Sciences): founder and president. M. R. Middleton: Dr. Middleton reports grants from Roche and AstraZeneca; grants and personal fees from GSK, personal fees and other from Novartis, Immunocore, Bristol-Myers Squibb, other from Millenium, Pfizer, Regeneron, personal fees, non-financial support, and other from Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA; personal fees and other from BiolineRx, personal fees and non-financial support from Replimune, personal fees from Kineta and Silicon Therapeutics, and personal fees from Silicon Therapeutics outside the submitted work. F. Barlesi: personal fees from AstraZeneca, Bayer, Bristol-Myers Squibb, Boehringer–Ingelheim, Eli Lilly Oncology, F. Hoffmann–La Roche Ltd, Novartis, Merck, MSD, Pierre Fabre, Pfizer, and Takeda. C. Gaudy-Marqueste: Honoraria for lectures by Bristol-Myers Squibb; travel support from MSD, BMS, Pierre Fabre. A. Italiano: grants to institution from Bayer, AstraZeneca, Bristol-Myers Squibb, MSD, Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA, Roche, Springworks, Epizyme; and consulting fees from AstraZeneca, Bayer, Roche, Daiichi-Sankyo. E. Romano: travel support from MSD for participation in a scientific meeting outside the topic of the submitted work. A. Marabelle: institutional research funding from MSD; grant from Fondation MSD Avenir outside the topic of the manuscript; and honoraria and travel expenses for participation in a scientific advisory board from MSD outside the topic of the submitted work. E. Chartash: employee of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA and stockholder in Merck & Co., Inc., Rahway, NJ, USA. K. Dobrenkov: employee of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA and stockholder in Merck & Co., Inc., Rahway, NJ, USA. H. Zhou: employee of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. E.C. Connors: employee of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA and stockholder in Merck & Co., Inc., Rahway, NJ, USA. Y. Zhang: employee of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA and stockholder in Merck & Co., Inc., Rahway, NJ, USA. M. Wermke: Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA for funding of study and professional medical writing; research funding to institution from Roche; consulting fees from Novartis, Pfizer, Boehringer-Ingelheim, Gemoab, Roche, Takeda, Lilly, MSD, AstraZeneca, Amgen, Bristol-Myers Squibb, Immatics; honoraria from Novartis and Roche; travel support from Roche, Bristol-Myers Squibb, Amgen, Pfizer; and participation on data safety monitoring board or advisory board for ISA Therapeutics.

: Procedures were approved by an institutional review/ethics committee at each site. Patients provided written informed consent.

: 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 subject 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 subject 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.