NICE has approved encorafenib (Braftovi) with binimetinib (Mektovi) as an option for the treatment of unresectable or metastatic BRAF V600 mutation-positive melanoma in adults.
The decision is based on clinical evidence from the open-label, randomised COLUMBUS trial which compared encorafenib plus binimetinib to vemurafenib in people with unresectable or metastatic BRAF V600-positive melanoma.
At a median follow-up of 11.8 months, median progression-free survival (PFS) for encorafenib with binimetinib was 14.9 months (95% CI 11.0-18.5) compared with 7.3 months (95% CI 5.6-8.2) for vemurafenib (HR 0.54; 95% CI 0.41-0.71).
Median overall survival (OS) was also longer for encorafenib with binimetinib (33.6 months; 95% CI 24.4-39.2) compared with vemurafenib (16.9 months; 95% CI 14.0-24.5), representing a 39% reduction in the risk of death (HR 0.61; 95% CI 0.47-0.79; P<0.0001).
Although there is no trial evidence directly comparing encorafenib with binimetinib to dabrafenib with trametinib, the company carried out network meta-analyses (NMAs) to indirectly estimate PFS, OS, health-related quality of life, and incidence of grade 3 or 4 adverse events. The new combination appeared to be as effective as dabrafenib with trametinib, which was approved in October 2018.
It is estimated that approximately 858 people will be eligible to receive encorafenib with binimetinib in year 1, rising to 972 in year 5.
