New Cancer Drug Binimetinib Shows Success in Late Stage Trial

On December 16, Array BioPharma announced its new cancer drug, binimetinib, showed success in stage 3 clinical trials.

According to the drug company, binimetinib may be used to treat people with advanced NRAS-mutant melanoma, a particularly deadly form of skin cancer. The trial showed that the drug extended the time it takes for cancer to grow and spread.

In the randomized 402-person trial, those receiving binimetinib had a progression-free survival rate of 2.8 months versus 1.5 months for those in the trial who took the currently used dacarbazine treatment.

According to the Array BioPharma website,

Binimetinib is an oral small-molecule MEK inhibitor invented by Array. MEK is a key protein kinase in the RAS/RAF/MEK/ERK pathway, which regulates several key cellular activities including proliferation, differentiation, migration, survival and angiogenesis. Inappropriate activation of this pathway has been shown to occur in many cancers, in particular through mutations in BRAF, KRAS and NRAS.

Three Phase 3 trials with binimetinib in advanced cancer patients are currently advancing: low-grade serous ovarian cancer (MILO), BRAF-mutant melanoma (COLUMBUS), and NRAS-mutant melanoma (NEMO). NRAS-mutant melanoma represents the first potential indication for binimetinib, with a projected regulatory filing estimated in the first half of 2016. In addition to these registration trials, early-stage studies have been initiated to evaluate binimetinib in numerous solid tumors and hematologic malignancies.

Melanoma is the fifth most common cancer among men and the seventh most common cancer among women in the United States, with 76,000 new cases and over 9,700 deaths from the disease projected in 2014.

Novel therapies that target the RAS/RAF/MEK/ERK pathway have a strong scientific rationale for activity in this disease, as melanoma is often characterized by activating mutations in BRAF (approximately 40% to 60% of patients) and NRAS (15% to 20% of patients). There are presently no approved therapies specifically targeting NRAS-mutant melanoma.