COMBI-AD: adjuvant dabrafenib plus trametinib in stage III BRAF-mutated melanoma
A year of dabrafenib plus trametinib after surgery for stage III BRAF-mutant melanoma cut the risk of relapse by more than half, giving patients with BRAF mutations a targeted alternative to adjuvant immunotherapy.
Overview
Phase 3 placebo-controlled trial of 870 patients with completely resected stage III BRAF V600E or V600K melanoma randomised to 12 months of dabrafenib plus trametinib or placebo.
Three-year relapse-free survival was 58 versus 39 percent (hazard ratio 0.47) with an early overall survival benefit (hazard ratio 0.57); five-year relapse-free survival was 52 versus 36 percent. Pyrexia and fatigue led to discontinuation in about a quarter.
- Three-year relapse-free survival 58 percent vs 39 percent; hazard ratio 0.47.
- Five-year relapse-free survival 52 percent vs 36 percent.
Adjuvant dabrafenib-trametinib is a standard for resected stage III BRAF-mutant melanoma alongside adjuvant PD-1 blockade; the choice weighs a finite year of oral therapy against immune side effects.
- Final overall survival analysis pending.
- Discontinuation for adverse events in 26 percent.
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