We have previously reported that the Regional Health Organizations have approved the opening of the first expansion cohort in IMPRESS-Norway (read more here). Recently, AstraZeneca and IMPRESS-Norway have also entered into an agreement which ensures support for the opening of the first expansion hospital. All the necessary approvals are now in place and the expansion cohort is now open for inclusion.
“We are very pleased to announce that the first expansion cohort in IMPRESS-Norway is open for inclusion. This is an important milestone that shows that we in Norway are serious about implementing precision medicine and are willing to try new models for cooperation and approval”
Professor Kjetil Taskén, Head of the center for precision medicine in cancer, OUC-CCC
Testing a PARP inhibitor on new patient groups
In the expansion cohort, patients with bi-allelic BRCA1/2 inactivation can be included for treatment with the PARP inhibitor Olaparib (Lynparza). The expansion cohort is opened in collaboration with DRUP and is based on the results from the first 24 patients (stage 1 and stage 2) who were treated in DRUP (van der Wijngaart H., et al. Clin Cancer Res. 2021 Nov 15;27(22):6106-6114. The article is published here). An important improvement in the expansion cohort is the definition of the molecular profile (biomarker). For the first 24 patients, DRUP had a broader biomarker definition, but the analyzes of the first 24 patients showed that it was patients with bi-allelic BRCA1/2 inactivation who had the best effect from the treatment.
Public-private collaboration on expansion cohort
IMPRESS-Norway is based on the model of the DRUP study in the Netherlands, where drugs are tested on new types of cancer with specific gene changes. In the model, the drug is first tested on 8 patients, and if one or more of the patients have effect, the medicine is tested on a further 16 patients. If five or more of the total of 24 first patients have an effect, the drug can be tested further in an expansion cohort. In an expansion cohort, the pharmaceutical company gives the medicine to patients free of charge for the first 16 weeks of treatment, and then the public takes over the cost of the medicine for those patients who have an effect.
The expansion cohort will be opened in collaboration with DRUP and hopefully the other Nordic countries. Collaboration is important as we expect to find relatively few patients with this biomarker profile in Norway, but by combining data from several countries we will be able to obtain data from many patients and thus obtain better knowledge of the effect.