FDA Approves The Combination of Encorafenib (Braftovi) and Binimetinib (Mektovi) for BRAF-mutant Melanoma

2018-07-25

At June 27, 2018, the U.S. FDA approved the BRAF inhibitor Encorafenib and the MEK inhibitor Binimetinib in combination for patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test. In the randomized, open-label phase 3 COLUMBUS trial, 577 melanoma patients were randomly assigned to the Encorafenib plus Binimetinib group (n=192), the Encorafenib group (n=194), or the Vemurafenib group (n=191). The median PFS was 14.9 months (95% CI 11.0-18.5) in the Encorafenib plus Binimetinib group and 7.3 months (5.6-8.2) in the Vemurafenib group (HR 0.54, 95% CI 0.41-0.71; p<0.0001). Median OS was 33.6 months (95% CI, 24.4-39.2) in the combination group and 16.9 months (95% CI, 14.0-24.5) in the Vemurafenib group (HR 0.61, 95% CI 0.47-0.79; p<0.0001). The ORR was 63% (56-70%) vs. 40% (33-48%) with combination versus single-agent Vemurafenib. Combination of Encorafenib and Binimetinib could represent a new treatment option for patients with BRAFV600-mutant melanoma.

Source: Dummer R, et al. Lancet Oncol. 2018 May;19(5):603-615.