FDA Approves Encorafenib and Binimetinib in Combination for Unresectable or Metastatic Melanoma With BRAF Mutations

Today, the U.S. Food and Drug Administration (FDA) approved encorafenib (Braftovi) and binimetinib (Mektovi) in combination for patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test.

Approval was based on the randomized, active-controlled, open-label, multicenter COLUMBUS trial (ClinicalTrials.gov identifier NCT01909453) in 577 patients with BRAF V600E or V600K mutation–positive unresectable or metastatic melanoma. Patients were randomized (1:1:1) to receive binimetinib at 45 mg twice daily plus encorafenib at 450 mg once daily, encorafenib at 300 mg once daily, or vemurafenib (Zelboraf) at 960 mg twice daily. Treatment continued until disease progression or unacceptable toxicity.

Study Outcomes

The major efficacy measure was progression-free survival using Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1, and assessed by blinded independent central review. The median progression-free survival was 14.9 months for patients receiving binimetinib plus encorafenib and 7.3 months for the vemurafenib-monotherapy arm (hazard ratio = 0.54, 95% confidence interval = 0.41–0.71, < .0001). Overall response rates assessed by central review were 63% and 40%, respectively. Median response duration was 16.6 months vs 12.3 months, respectively.

The most common (≥25%) adverse reactions in patients receiving the combination were fatigue, nausea, diarrhea, vomiting, abdominal pain, and arthralgia. Discontinuation of therapy due to adverse reactions occurred in 5% of patients receiving the combination; the most common reasons were hemorrhage and headache.

The FDA today also granted approval of the THxID BRAF Kit (bioMérieux) as a companion diagnostic for these therapeutics.

The recommended doses are binimetinib at 45 mg orally twice daily and encorafenib at 450 mg orally once daily.

Full prescribing information for encorafenib is available here, and full prescribing information for binimetinib is available here.

 

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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