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The Dutch national trial that gives patients whose tumour carries a targetable change an already-approved drug outside its licence, inside a trial, so that what happens is recorded and the drugs that work can be paid for.
DRUP is a prospective, non-randomised, adaptive phase 2 trial run nationally on behalf of the Center for Personalized Cancer Treatment and led by the Netherlands Cancer Institute (registry acronym M15DRU). It started in August 2016 and the registry lists it as recruiting, with an estimated enrolment of 1,550 and primary completion estimated for September 2027. Patients with advanced cancer who have exhausted standard treatment and whose tumour test shows a potentially actionable variant are matched by a molecular tumour board to one of the commercially available targeted drugs or immunotherapies that collaborating companies contribute, and treated in cohorts defined by drug, tumour type and variant; a fresh biopsy is taken before treatment for whole-genome sequencing. The registry lists Amgen, AstraZeneca, Bayer, Bristol-Myers Squibb, Novartis, Roche, Merck Sharp & Dohme, Boehringer Ingelheim, Ipsen, Eisai, Pfizer, Clovis, Eli Lilly, Janssen, GlaxoSmithKline, Incyte, the Dutch Cancer Society and Stelvio for Life as collaborators.
The first report, in Nature in 2019, found clinical benefit (response, or stable disease beyond 16 weeks) in 34 per cent of 215 treated patients and a 63 per cent benefit rate in a cohort with microsatellite-unstable tumours given nivolumab.
It showed that a country can let patients use an approved drug off-label without each case vanishing into an anecdote: every treatment is a trial cohort, and a cohort that works can make the case for paying for that use.
This is the cohort behind the Hartwig Medical Database, which the foundation describes as the largest of its kind, offered free of charge to researchers. It showed whole-genome sequencing of metastases done at national scale, and found a variant that could point to a treatment in most of the patients sequenced.
Shares Oncode Institute, Emile Voest, Netherlands Cancer Institute (NKI-AvL).
Shares The Drug Rediscovery Protocol: approved cancer drugs used outside their licence, inside a national trial, Netherlands Cancer Institute (NKI-AvL).
Shares Oncode Institute, Netherlands Cancer Institute (NKI-AvL).
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