Rapid label expansion based on public-private collaboration in IMPRESS-Norway.
Authors: Aslaug Helland, Kjetil Tasken, Egil Støre Blix, Per Eystein Lonning, Bjorn T. Gjertsen, Randi Hovland, Ulla Randen, Bjornar Gilje, Jon Amund Kyte, Åsmund Flobak, Hege Russnes, Gro Live Fagereng, Sigbjørn Smeland
Journal: Journal of Clinical Oncology (2024)

e13529 Background: Access to new cancer drugs requires knowledge of biomarkers. As a consequence, there is an increasing access gap to new treatments between different cancer subgroups. Several precision medicine trials aim to address this gap through drug repurposing (1-3). IMPRESS-Norway is a national precision cancer medicine trial providing treatment to patients with advanced-stage disease after standard therapy. Patients with biomarkers are identified through the national infrastructure for precision diagnostics, InPreD, a part of the national healthcare services for stratification into biomarker-driven clinical trials. IMPRESS-Norway opened for inclusion on April 1st, 2021. Currently InPreD identifies biomarker in 31% of patients, and 50 % of patients included in treatment cohorts in IMPRESS-Norway are diagnosed with a rare cancer (4). The IMPRESS-Norway has, together with the public-private partnership CONNECT (Norwegian Cancer Precision Medicine Implementation Consortium), developed a roadmap for expanding access through ordinary reimbursement decisions. Methods: New drugs can efficiently be incorporated into the IMPRESS-Norway drug portfolio and tested across all relevant indications through a three-stage process. In stage 1 and 2, a total of 24 patients are recruited into a drug/diagnosis/biomarker-specific cohort, with drug provided by the company and a per-patient fee. If ≥ 5 patients exhibit clinical benefit (stable disease or better at week 16), the drug may undergo further testing in stage 3 (expansion cohorts). The company provides drugs during the first 16 weeks of treatment and with public reimbursement after week 16 for all patients experiencing clinical benefit. Results: Positive reimbursement decisions in Norway can be made based on knowledge of effect from single armed studies (5). Norwegian payers can therefore make reimbursement decisions based on results from the expansion cohort. Similar systems are set-up in the Netherlands (6). Several drugs are currently concluding stage 2 in IMPRESS-Norway. The first expansion cohort in IMPRESS-Norway (jointly with other DRUP-like trials in the EU Cancer Mission project PRIME-ROSE), exploring the effect of olaparib in patients with biallelic BRCA1/2 inactivation in non-approved diagnosis, is based on the DRUP-trial, exemplifying the European collaboration in these trials. Conclusions: Public-private collaboration facilitates rapid identification of eligible patients, irrespective of cancer subgroup, providing potential for new indications. IMPRESS-Norway presents a feasible strategy for rapid label expansion. 1. DLvan der Velden et al, Nature 2019; 574:127-31. 2. PM Mangat et al, JCO Prec Oncol 2018; 10. 3. Å Helland et al, J Trans Oncol 2022; 20. 4. Puco K et al., 2024 in press. 5. GL Fagereng et al, Front Pharmacol 2014; doi:10.3389. 6. SBW Doorn-Khosrovani et al. Ann Oncol 2019; 30: 663-5. Clinical trial information: NCT04817956 .