Wednesday February 7, 2018 0 comments
BOULDER -- Array BioPharma Inc. (Nasdaq: ARRY) and France-based Pierre Fabre announced results of a study of overall survival in patients with BRAF-mutant melanoma, indicating that treatment with a combination of encorafenib and binimetinib reduced the risk of death compared to treatment with vemurafenib.
Median overall survival was 33.6 months for patients treated with the drug combination, compared to 16.9 months for patients treated with vemurafenib as a monotherapy.
"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 T. Flaherty, director of the Termeer Center for Targeted Therapy, Massachusetts General Hospital Cancer Center and Professor of Medicine, Harvard Medical School.
"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."
"We are excited to report these overall survival results from the COLUMBUS trial," said Victor Sandor, Array BioPharma chief medical officer.
"This encouraging overall survival finding further validates previously reported median progression-free survival and overall response rate results, and taken together with the attractive tolerability profile, these data suggest that the combination of encorafenib with binimetinib has the potential to become a promising new treatment option for these patients."
As previously reported, the combination of encorafenib and binimetinib was generally well-tolerated. Full safety results of COLUMBUS Part 1 were presented at the 2016 Society for Melanoma Research Annual Congress.
The U.S. Food and Drug Administration is currently reviewing the New Drug Applications to support use of the combination of encorafenib and binimetinib for the treatment of patients with BRAF-mutant advanced, unresectable or metastatic melanoma.
The FDA set a target action date under the Prescription Drug User Fee Act (PDUFA) of June 30, 2018 for both applications.
In addition, the European Medicines Agency (EMA), as well as the Swiss Medicines Agency (Swissmedic) and the Australian Therapeutic Goods Administration (TGA), is reviewing the Marketing Authorization Applications for encorafenib and binimetinib.