Dabrafenib plus trametinib in relapsed or refractory BRAF V600-mutant paediatric high-grade glioma
In children whose BRAF V600-mutant high-grade glioma had relapsed, the combination of dabrafenib and trametinib shrank tumours in more than half and gave responses lasting well over a year, far better than historical chemotherapy.
Overview
Phase 2 study of 41 children and adolescents with relapsed or refractory BRAF V600-mutant high-grade glioma treated with dabrafenib plus trametinib.
Objective response by independent review was 56 percent with a median duration of response of 22.2 months and median progression-free survival of 9.0 months, compared with expected responses of under 20 percent with chemotherapy; toxicity was mostly fever, rash and gastrointestinal.
- Objective response 56 percent; median duration of response 22.2 months.
- Median overall survival 32.8 months.
BRAF V600E testing is mandatory in childhood high-grade glioma and the combination is a standard at relapse and, increasingly, alongside or before radiotherapy in newly diagnosed disease; it supported the tumour-agnostic approval in children.
- Small single-arm cohort.
- Resistance eventually develops in most patients.
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