Results of an open-label phase 1b study of the ERK inhibitor MK-8353 plus the MEK inhibitor selumetinib in patients with advanced or metastatic solid tumors

Role of the funding source

The sponsor was involved in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, and approval of the manuscript; and decision to submit the manuscript for publication.

Ethics approval

The study was compliant with International Council for Harmonisation Good Clinical Practice guidelines and the Declaration of Helsinki. The protocol (MK-8353-014) was approved by an institutional review board or independent ethics committee at each site.

Consent to participate

Written informed consent was obtained from all patients.

Data sharing statement

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: http://engagezone.msd.com/ds_documentation.php) 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.

Conflict of interest

Anastasios Stathis: Consultancy services (institution) to Bayer, Eli Lilly; Advisory (institution): Roche, Janssen; institutional research funding: MSD, AstraZeneca, Roche, AbbVie, Pfizer, Bayer, Novartis, ADC Therapeutics, MEI Therapeutics, Loxo Oncology, Philogen.

Anthony W. Tolcher: ABBVIE, Inc, Aclaris Therapeutics, AGENUS, Inc., ASANA BIOSCIENCES, ASCENTAGE, Axlmmune, Bayer, Blu Print Oncology, Daiichi Sankyo, Inc., GILDE HEALTHCARE PARTNERS, HBM PARTNERS, IDEA Pharma, Immuneering, Immunomet Therapeutics, Inc., Impact Therapeutics US, Inc., Karma Oncology B.V., Kirilys Therapeutics, Inc., Lengo Therapeutics, Inc., Link Immunotherapeutics, Mekanistic Therapeutics, Menarini Ricerche, Mersana, NANOBIOTIX, NervianoMedical Sciences S.r.I. (NMS), Nurix Therapeutics, Ocellaris Pharma, Inc. & Eli Lilly, Partner Therapeutics, Pfizer Inc., Qualigen Therapeutics, PIERRE FABRE, Roche, RYVU THERAPEUTICS, Seattle Genetics, SK Life Science, SOTIO Biotechnology Co., Spirea Limited Inc., Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd, Transcenta Therapeutics Inc., Trillium Therapeutics Inc., Verastem Oncology, VRISE Therapeutics, Inc., Zentails, ADAGENE, Inc., ARO BIOTHERAPEUTICS, BIOINVENT, Boehringer Ingelheim International GmbH, Deka Biosciences, Eleven Bio, ELUCIDA, EMD SERONO/ MERCK KGaA, Hiber Cell, Inc., Ikena Oncology, IMMUNOME, Janssen Global Services, LLC, NBE THERAPEUTICS, Pelican, JAZZ, Pieris Pharma, PYXIS Oncology, Senti Biosciences, Vincerx, ZielBio, Inc., Zymeworks Biopharmaceuticals Inc., MIRATI, Roche.

Judy S.Wang: Consultant fees from BioNTech, Stemline/Menarini, Janssen, Kanaph. Speakers’ Bureau fees from AstraZeneca and Eisai. Research Funding paid to institution only from: Takeda, Medimmune, Genentech, AstraZeneca, El Lilly, Lycera, Pfizer, Checkpoint, Agenus, Jacobio, Evelo, Merck, Jounce, Boehringer Ingelheim, Janssen, Vedanta, H3 Biomedicine, BioNTech, Phoenix Molecular Designs, Bicycle, Qilu Puget Sound, Xencor, Sanofi, Klus, Treadwell, IGM, PureTech, Erasca, Bayer, BioTheryX, Biosplice, NGM, Cullinan, Astellas, BeiGene, Pinoyr, Taiho, Mirati, Hutchinson MediPharma, Stemline, GSK, TopAlliance, Revolution, Relay, StingThera.

Daniel J. Renouf: Consultancy services: Bayer, Roche, Elevation; Research funding: Roche.

Lin-Chi Chen, Tomoko Freshwater, Andrea L. Webber, Tapan Nayak: Employees of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA and stockholders in Merck & Co., Inc., Rahway, NJ, USA.

Leah H. Suttner: Employee of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

Lillian L. Siu: Advisory Role/Consultation (self): Amgen, Arvinas, AstraZeneca, Coherus, Hoopika, InteRNA, Janpix, Marengo, Medicenna, Navire, Oncorus, Relay, Roche, Seattle Genetics, Tessa, Voronoi. Research Support (institution): Amgen, Astellas, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, EMD Serono/Merck KGaA, GlaxoSmithKline, Intensity Therapeutics, Merck, Novartis, Pfizer, Roche/Genentech, Shattucks, Symphogen. Leadership Role (spouse): Treadwell Therapeutics.

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