News about ONC201 access in the UK

By 19 December 2023News

Some of you will know that Chimerix, a US based company is currently running clinical studies for patients with histone mutated glioma (H3K27M mutations) using their agents ONC201 and ONC206. The Phase 3 ACTION study is recruiting in the UK for newly diagnosed patients and is open in 10 sites across the UK see https://www.clinicaltrials.gov/study/NCT05580562.

We are very keen to include as many UK patients as possible in this study so we get an early answer about the effectiveness of this agent. Please contact your nearest recruiting centre to discuss study entry.

Many of you may also know that some patients with histone mutated tumours have been accessing a version of ONC201/ONC206 via a private German clinic. This unregulated supply has now been stopped. Chimerix are taking steps to ensure that patients who have been taking these agents can continue to access them through an expanded access programme. This is already available in the US and should be available in the UK in January 2024. This will be available through the NHS free of charge and oncology clinicians will be able to refer for access. Patients who think they may be eligible for access should enquire via their oncologist who should contact Chimerix.