The Nordic countries (Denmark, Sweden, Norway, and Finland) are together setting up national clinical precision cancer trials modelled on the very successful DRUP trial in the Netherlands.
On 11-16 November, 2021, a Memorandum of Understanding was signed to this effect by the leaders of the DRUP and the Nordic Precision Medicine Trial Network (ProTarget in Denmark, MEGALit in Sweden, IMPRESS-Norway, and FIN-PROVE in Finland).
A ‘Triple win’
The partners agreed to harmonize study designs, define similar clinical endpoints, and share data. All study cohorts will be opened in parallel in all the Nordic trials and opened cohorts will be shared in a collaborative database including open and closed DRUP-cohorts.
‘This is "a triple win” - for cancer patients, investigators and industry partners’, says Kjetil Tasken from IMPRESS-Norway, ‘as we will generate and gather evidence more rapidly on very rare combinations of diagnosis, mutation and treatment to allow for early implementation of new cancer medicines.
Drug Rediscovery Protocol
The DRUP (Drug Rediscovery Protocol) is a nationwide Dutch study, initiated by the Center for Personalized Cancer Treatment, in which small groups of patients with advanced cancer and no further treatment options, are treated with off-label precision drugs, based on their molecular tumour profile. ‘In the DRUP, we grant patients access to these medicines, and at the same time build up a sound knowledge base,’ says Emile Voest from the Netherlands Cancer Institute and DRUP.
International collaboration crucial for building evidence
Henk Verheul from Radboud university medical center and DRUP: ‘When patient numbers are very small, as is the case in this type of personalized cancer treatment, international collaboration is extremely important for including patients as well as for building evidence. We will now be able to help more patients, and at the same time gain more knowledge about treating cancer patients in a way that takes into account both molecular tumour profile and tumour type.’
Now that the Netherlands and all the Nordic countries have joined forces in clinical research, the overall population base is more than doubled. ‘This is an important start,’ says Kjetil Tasken. ‘By collaborating successfully, we hope to position for bigger European collaboration.’
Whole genome sequencing
The DRUP was launched in 2016 by the Center for Personalized Cancer Treatment, after a large genomics study, based on whole genome sequencing of patients’ tumour DNA, had revealed that in 13% of all cases, DNA mutations were present for which registered medicines were already on the market for other cancer types. - The first results of the DRUP study were published in Nature in 2019. The DRUP is led by three principal investigators from the Netherlands Cancer Institute, Radboud university medical center and Leiden University Medical Center.
Facts (as of 16.11.2021):
DRUP trial (the Netherlands): Opened for inclusion in Q3 2016. Included 1873, 939 started treatment in cohorts (plus 130 patients in Stage 3 studies). 28 drugs, 3 combinations, 2 additional drugs committed.
ProTarget (Denmark): Opened for inclusion 01.09.2020. Included 500+ patients for molecular profiling, 86 prescreened with potential target, 47 included for treatment and opened 34 cohorts. 12 drugs (15 in 2022)
MEGALiT (Sweden): Opened for inclusion 22.10.2020. Included 54 patients for molecular profiling, 1 initiated (7 allocated) for treatment and opened 3 (4) cohorts. 4 drugs.
IMPRESS-Norway (Norway): Opened for inclusion 1.04.2021. Included 100+ patients for molecular profiling, 26 for treatment and opened 23 cohorts. 8 drugs, increasing to 23 by Q1 2022.
FINPROVE (Finland): Opens for inclusion Q1 2022 (or sooner). Study will include 250 for treatment. 12 drugs, increasing to 15 by Q2 2022.