Array’s encorafenib/binimetinib beats Roche’s Zelboraf in phase 3

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Array had to yank its NDA for binimetinib in NRAS-mutant melanoma last year, but the candidate is showing promise as part of a combo treatment for BRAF-mutant melanoma. (Image: Nadine Doerlé)

Last year, Array Biopharma pulled the NDA for its melanoma drug binimetinib when the FDA said its phase 3 data wouldn’t make the grade. Now, the Colorado-based biotech is logging a win as a combination including binimetinib nearly doubled survival in melanoma patients compared to Roche’s Zelboraf.

The combo treatment, creatively dubbed COMBO450, pairs binimetinib, an MEK inhibitor with the BRAF inhibitor encorafenib. Both molecules target enzymes in the MAPK signaling pathway, which has been implicated in a number of cancers.

The Columbus trial compared the safety and efficacy of the combination treatment against encorafenib alone, as well as Zelboraf, in patients with BRAF-mutant melanoma. Patients treated with encorafenib/binimetinib had a median overall survival of 33.6 months, nearly double that of patients treated with Zelboraf, at 16.9 months.

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While Array had to withdraw its binimetinib application for a different form of the cancer—NRAS-mutant melanoma—this did not affect its other programs. The biotech carried on with other trials of binimetinib and the encorafenib/binimetinib is under FDA review for BRAF-mutant advanced, unresectable or metastatic melanoma. The agency will return a decision by June 30.

"Many patients with BRAF-mutant melanoma still face significant challenges managing their disease, and there remains a substantial need for well-tolerated treatments that delay disease progression and improve overall survival," said Keith Flaherty, M.D., director of the Termeer Center for Targeted Therapy at Massachusetts General Hospital Cancer Center, in a statement.

“This data suggests that the combination of encorafenib and binimetinib may have the potential to become a meaningful new therapy for patients with advanced BRAF-mutant melanoma,” Flaherty said.