COLUMBUS — Encorafenib Plus Binimetinib Versus Vemurafenib in BRAF V600-Mutant Advanced Melanoma (COLUMBUS)

Phase 3 · 2018 · Melanoma

Design

Randomized, open-label trial of encorafenib plus binimetinib vs vemurafenib (with an encorafenib-monotherapy arm).

Population

Advanced or metastatic BRAF V600E/K-mutant melanoma, treatment-naive or after first-line immunotherapy.

Primary Endpoint

progression-free survival (PFS)

Key Result

Median PFS 14.9 vs 7.3 mo vs vemurafenib (HR 0.54); median OS 33.6 vs 16.9 mo (HR 0.61).

Guideline Impact

FDA-approved 2018; NCCN category 1 encorafenib + binimetinib for BRAF V600-mutant melanoma