Targeted Combination Treatment for Melanoma now Available

The US Food and Drug Administration (FDA) approved the combination of Bratovi (encorafenib) and Mektovi (binimetinib)for use in patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test.

About Braftovi + Mektovi

(encorafenib) is an oral small molecule BRAF kinase inhibitor and Mektovi (binimetinib) is an oral small molecule MEK inhibitor which target key enzymes in the MAPK signaling pathway. Inappropriate activation of proteins in this pathway has been shown to occur in many cancers including melanoma, colorectal cancer, non-small cell lung cancer, thyroid and others. In the U.S., Braftovi + Mektovi are approved for the treatment of unresectable or metastatic melanoma with a BRAFV600E or BRAFV600K mutation, as detected by an FDA-approved test.

The approval is based on a comparative multicenter clinical trial that was performed in 577 patients with advanced melanoma, known as COLUMBUS, the results of which were published in the Lancet medical journal.1

In the COLUMBUS trial patients with advanced melanoma were treated with either Braftovi + Mektovi, Braftovi, or Zelboraf (vemurafenib) daily and used until evidence of cancer progression.

The overall response rates were 63% and 40% for the combination and for vemurafenib alone, respectively. Median duration of response was 16.6 months vs 12.3 months, respectively.  The median progression-free survival was 14.9 months for patients receiving the combination and 7.3 months for Zelboraf.

On average patients treated with the combination survived 33.6 months compared to 16.9 months for Zelboraf. Combination therapy was generally well tolerated but discontinuation was required because of adverse reactions in 5% of patients receiving the combination; the most common reasons for discontinuation were hemorrhage and headache.



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