81P - FINPROVE: The Finnish national study to facilitate patient access to targeted anti-cancer drugs – Preliminary data after two years of enrollment

Background

FINPROVE is a national, prospective, investigator-initiated, open-label, non-randomized combined basket and umbrella precision medicine DRUP-like trial. Patients with advanced solid tumors or hematologic malignancies for which standard treatment options no longer exist, and who have acceptable performance status and organ function, are treated in multiple treatment cohorts based on the molecular profile of the tumor.

Methods

The trial started recruitment in January 2022, and by April 2024 data cut-off, 490 patients were screened, and 130 patients have been offered treatment. Currently 16 drugs are included in the study. The treatment recommendation is guided by the molecular tumor board (MTB) based on DNA profiling using the ESCAT criteria.

Results

The most common molecular changes occurred in ERBB2, NF1, CDKN2A/B, and BRAF genes treated within FINPROVE. For the treated patients, the average and median time on treatment was 62 and 96 days, with the longest being 474 days. The median progression-free survival (PFS) was 137 days for ESCAT classes 1-2 combined. Based on these preliminary results, ESCAT criteria classes 1-2 seem to benefit longer from study treatment than the other classes. So far, the safety profile of the study drugs have been as expected and according to the summary of product characteristics (SPC). No new safety signals have been detected. Detailed analysis and updated results will be presented.

Conclusions

We report preliminary molecular screening results, time-on-treatment, PFS and OS in the FINPROVE trial. All cohorts are formed by the molecular profile of the tumor, and drugs are used outside of their current indication. These results demonstrate antitumor activity based on ESCAT criteria classification, with no new safety findings.

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

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. 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. A. Färkkilä: Financial Interests, Personal, Invited Speaker: GSK, AstraZeneca; Financial Interests, Institutional, Research Grant, Research collaboration via agreement between GSK and University of Helsinki. Agreement and project ended in 2023.: GSK. All other authors have declared no conflicts of interest.