USA-based Array BioPharma (Nasdaq: ARRY) and privately-held French drugmaker Pierre Fabre have announced data showing that their combination almost doubles survival in BRAF-positive melanoma compared to the Roche (ROG:SIX) drug Zelboraf (vemurafenib).
The planned analysis of overall survival (OS) from the pivotal Phase III COLUMBUS trial shows that, with treatment with the combination of encorafenib 450mg daily and binimetinib 45mg twice daily, overall survival was 33.6 months, compared to 16.9 months for patients treated with Zelboraf as a monotherapy.
The combination, which is already being reviewed by the US Food and Drug Administration, was generally well-tolerated.
News of the results sent Array’s share price up 15% by Tuesday lunchtime, to $16.23.
Victor Sandor, chief medical officer at Array BioPharma, said: “This encouraging OS 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.”
At the time of the planned analysis, a preliminary analysis of OS in patients treated with 300mg encorafenib alone daily demonstrated a median OS of 23.5 months.
The FDA 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 US regulator 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, as well as the Swiss Medicines Agency and the Australian Therapeutic Goods Administration, is reviewing the Marketing Authorization Applications for encorafenib and binimetinib.