Array BioPharma said Wednesday that the investigational drug binimetinib achieved the primary endpoint of a Phase III study in patients with melanoma, sending shares in the drugmaker up as much as 32 percent. Results from the NEMO trial showed that binimetinib prolonged progression-free survival (PFS) in patients with advanced NRAS-mutant melanoma versus dacarbazine. Array chief executive Ron Squarer remarked "we look forward to discussing the data with the FDA and other regulatory agencies in the near future."
In the study, 402 patients with advanced NRAS-mutant melanoma were randomised to treatment with binimetinib or dacarbazine. In addition to the primary endpoint of PFS, secondary endpoints included overall survival. Disease status was radiographically assessed every six weeks, while progression was evaluated via blinded central review.
Specifically, study results showed a median PFS of 2.8 months in the binimetinib arm, versus 1.5 months for dacarbazine-treated patients. Array noted that the therapy was generally well-tolerated, while its adverse events profile was consistent with previously observed findings.
The drugmaker plans to submit binimetinib for regulatory approval for the treatment of patients with NRAS-mutant melanoma in the first half of 2016. Array said it is also evaluating the drug in late-stage studies for the treatment of BRAF-mutant melanoma and low-grade serous ovarian cancer, in addition to several other earlier-stage studies.
