ROAR (BRAF V600E biliary tract cohort)
In previously treated BRAF V600E-mutated advanced biliary tract cancer, is dabrafenib plus trametinib active?
Trial design and population
Key results
Final basket analysis reported an ORR of 53% in the biliary tract cohort (95% CI 37.7–68.8); median PFS was 9.0 months. This is a molecularly selected, single-arm cohort.
Source-reported outcome visualization
Objective response rate · Best overall response
Bars display source-reported values for the named endpoint; where the endpoint is a median, bars compare medians and do not represent probabilities. No unreported rates are inferred.
Absolute Effect
Single-arm response rate; no comparator-based absolute benefit or NNT can be calculated.
NNT: Not applicable — single-arm cohort. No NNT is derived from median survival/PFS differences.
NNH / harm: Monitor pyrexia, rash, fatigue, cardiac function and ocular toxicity; adverse-event rates vary by cohort and analysis cut-off.
NNT/NNH are only displayed where the endpoint and time horizon support a defensible absolute-risk calculation. Otherwise, the source-reported outcome is visualized.
Safety and treatment burden
Monitor pyrexia, rash, fatigue, cardiac function and ocular toxicity; adverse-event rates vary by cohort and analysis cut-off.
Follow-up, maturity and limitations
Small non-randomized basket cohort; outcomes apply to BRAF V600E-mutated rare cancers, not unselected BTC. Confirm mutation status and local indication.
Clinical interpretation
Current-practice context · reviewed 20 October 2026
This page separates original trial findings from contemporary treatment context. Confirm current disease-specific guidelines, local regulatory status, biomarker requirements, prior treatment exposure and patient-specific contraindications before applying the evidence. Historical comparators may no longer represent current standard practice; subgroup findings and immature endpoints should not be generalized.