The FDA ( US Food and Drug Administration ) has granted approval to Encorafenib ( Braftovi ) and Binimetinib ( Mektovi ) combination therapy for the treatment of patients with unresectable or metastatic BRAF V600E or V600K mutation-positive melanoma.
The FDA based its approval on findings from the phase 3 COLUMBUS study, in which researchers randomly assigned 577 patients with BRAF V600-mutant melanoma to receive Encorafenib 450 mg once daily plus Binimetinib 45 mg twice daily, Encorafenib 300 mg once daily, or Vemurafenib 960 mg twice daily.
After a median follow-up of 16.6 months, the median progression-free survival was more than doubled among patients in the combination arm compared with patients treated with Vemurafenib alone ( 14.9 vs 7.3 months; hazard ratio [ HR ], 0.54; 95% CI, 0.41-0.71; P less than 0.0001 ).
The median overall survival was 33.6 months in the Encorafenib plus Binimetinib group versus 16.9 months among patients in the Vemurafenib monotherapy group.
The overall response rates were 63% and 40% among patients who received Encorafenib plus Binimetinib and Vemurafenib alone, respectively, and the median duration of response was 16.6 months compared with 12.3 months, respectively.
The most frequently observed adverse events among those who received combination treatment were fatigue, nausea, diarrhea, vomiting, abdominal pain, and arthralgia.
Approximately 5% of patients discontinued therapy due to treatment-related adverse effects; hemorrhage and headache were the most commonly reported causes. ( Xagena )
Source: FDA, 2018