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FDA approves Braftovi-Mektovi combination for BRAF-mutated melanoma
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The FDA approved the combination of encorafenib and binimetinib for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or BRAF V600K mutation.
The FDA based this approval of encorafenib (Braftovi, Array BioPharma) — a BRAF inhibitor — and binimetinib (Mektovi, Array BioPharma), a MEK inhibitor, on the phase 3 COLUMBUS trial.
The analysis included 577 patients with BRAF V600E or BRAF V600K mutation-positive unresectable or metastatic melanoma. Investigators randomly assigned patients 1:1:1 to binimetinib 45 mg twice daily plus encorafenib 450 mg once daily, encorafenib 300 mg once daily or vemurafenib (Zelboraf, Genentech/Roche) 960 mg twice daily.
The median PFS was 14.9 months for patients who received binimetinib plus encorafenib compared with 7.3 months for vemurafenib monotherapy (HR = 0.54; 95% CI, 0.41-0.71). Overall response rate was 63% per central review in the combination arm compared with 40% with vemurafenib alone. Median duration of response appeared prolonged in the combination arm compared with vemurafenib alone (16.6 months vs. 12.3 months).
“The PFS of just under 15 months [with encorafenib and binimetinib] ... suggests that this [novel combination] really is a regimen that has the roughly comparable early effect in terms of response and disease control but that the maintenance of that effect over time appears to be superior,” Keith T. Flaherty, MD, medical oncologist at Massachusetts General Hospital Cancer Center, told HemOnc Today.
As HemOnc Today previously reported, researchers presented PFS and updated OS results for this combination at ASCO Annual Meeting.
“The study also showed that [the combination] was well tolerated with adverse events that were similar to other BRAF/MEK combinations, except that certain characteristic toxicities associated with some of these other combinations — such as pyrexia and photosensitivity — occurred at much lower rates,” Victor Sandor, MD, chief medical officer of Array Biopharma, told HemOnc Today. “We’re very excited about this approval because we believe this represents an important new therapy for patients with BRAF-mutant melanoma.”
The most common adverse reactions observed with the combination included fatigue, nausea, diarrhea, vomiting, abdominal pain and arthralgia. Five percent of patients discontinued therapy due to adverse reactions, the most common being hemorrhage and headache.
The FDA also approved the THxID BRAF Kit (bioMérieux) as a companion diagnostic for these therapeutics.