228TiP - FINPROVE: The Finnish national study to facilitate patient access to targeted anti-cancer drugs

Background

FINPROVE is the first national protocol to enhance precision oncology in Finland. The pronounced societal impacts are evident via building the national network and establishment of the molecular testing framework. Together with systematic biobank sampling, the data generated in the trial will generate an important resource not only to scientists but also for Finnish authorities for generating data on approval, reimbursement, and pricing process of potential new drugs. The study significantly facilitates access to approved targeted therapies, leading to potentially increased quality of life and outcomes directly benefitting cancer patients in Finland. Importantly, the discovery of new biomarkers will significantly enhance precision oncology applications and improve the treatment of advanced cancer patients.

Trial design

Eligible patients in FINPROVE have advanced malignancies for which standard treatment options no longer exist and who have acceptable performance status and organ function. A tumor DNA, RNA and/or protein expression analysis is required, and the results must identify at least one potentially actionable molecular variant as defined in the protocol. Molecular profiling will be utilized to determine an appropriate drug or drugs from among those available in the protocol. Drug selection will be guided by a list of potential profiles, the molecular tumor board (MTB) according to the ESCAT criteria. Data for standard efficacy outcomes including tumor response, progression-free and overall survival as well as duration of treatment is collected for all patients. In addition, treatment related toxicity will be collected according to CTCAE 5.0. Study is being conducted with drugs approved by any competent authority (EMA, FDA or PMDA). Currently there are 16 drugs in the study. The study will enroll up to 250 patients over a 5-year period. Further, collaboration with other European DRUP trials will enable faster data collection and validation between DRUP centers. We are part of PCM4EU and PRIME-ROSE consortiums and have obtained EU funding for data aggregation, enabling validation of the research findings in independent matching patient cohorts.

Clinical trial identification

EudraCT 2021-000689-14; NCT05159245.

Editorial acknowledgement

Legal entity responsible for the study

Helsinki University Hospital.

Funding

Roche Oy, Novartis Oy, Bayer Oy, Lilly Oy, Janssen-Cilag Oy are providing sixteen drugs as part of the clinical study. Pfizer Oy supporting the Molecular Tumor Board development. Cancer Foundation Finland has financially supported FINPROVE trial. Eschner Foundation has financially supported patient prescreening in Turku University Hospital.

Disclosure

E. Alanne: Financial Interests, Personal, Invited Speaker: Roche, Bayer; Financial Interests, Personal, Advisory Board: Novartis, AbbVie; Financial Interests, Personal, Other, Producing training material: Roche; Financial Interests, Personal, Other, Salary from Roche from participation in data collection and analyzing.: Roche; Non-Financial Interests, Member of Board of Directors: Finnish Lymphoma Group. S.M.E. Iivanainen: Financial Interests, Personal, Advisory Board: MSD, BMS, Novartis, Roche; Financial Interests, Personal, Invited Speaker: Siemens Healthineers, AstraZeneca, Eisai; Financial Interests, Institutional, Local PI: BMS, Faron; Financial Interests, Institutional, Research Grant: AstraZeneca, Roche; Financial Interests, Institutional, Other, Sub-investigator: MSD, GSK; Financial Interests, Personal and Institutional, Steering Committee Member, The Origama study: Roche; Financial Interests, Institutional, Coordinating PI: Roche; Other, Study Steering committee member: Hoffman-La Roche; Other, Consultant: Elekta. K. Jalkanen: Financial Interests, Personal, Advisory Board: MSD, Ipsen, Roche, BMS, Pfizer, Lilly, Novartis, Bayer; Financial Interests, Personal, Stocks/Shares: Faron Pharmaceuticals; Financial Interests, Institutional, Local PI, Conduct of sponsored clinical trial: Novartis; Financial Interests, Institutional, Local PI, Sponsored clinical trial: Exelixis; Financial Interests, Institutional, Local PI, Several clinical trials: BMS, MSD, Roche; Financial Interests, Institutional, Local PI, clinical trials: Incyte; Financial Interests, Institutional, Local PI, Conduct of clinical trials: Pfizer; Financial Interests, Institutional, Local PI, Conduct of clinical trial: Bayer. All other authors have declared no conflicts of interest.