# COMBI-AD: adjuvant dabrafenib plus trametinib in stage III BRAF-mutated melanoma

Source: https://onco.cc/key-papers/paper-combi-ad-nejm-2017/  
OnCo record `paper-combi-ad-nejm-2017` (Key paper). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Summary

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.

## Fields

- Kind: Key paper
- Last checked: 2026-09-17
- Journal: New England Journal of Medicine
- Year: 2017
- DOI: 10.1056/NEJMoa1708539
- Authors: Long GV, Hauschild A, Santinami M, et al.
- Findings: Three-year relapse-free survival 58 percent vs 39 percent; hazard ratio 0.47.; Five-year relapse-free survival 52 percent vs 36 percent.
- What it means: 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.
- Caveats: Final overall survival analysis pending.; Discontinuation for adverse events in 26 percent.

## Sources

- N Engl J Med 2017: https://doi.org/10.1056/NEJMoa1708539
- PubMed: https://pubmed.ncbi.nlm.nih.gov/28891408/

## Connected records

- cancers: [BRAF V600-mutant melanoma](https://onco.cc/cancers/braf-v600-melanoma/), [Stage III melanoma (after surgery)](https://onco.cc/cancers/stage-iii-melanoma/)
- drugs: [Dabrafenib](https://onco.cc/drugs/dabrafenib/), [Trametinib](https://onco.cc/drugs/trametinib/)
- trials: [COMBI-AD](https://onco.cc/trials/combi-ad/)
- journals: [New England Journal of Medicine](https://onco.cc/journals/nejm/)

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