Array BioPharma Touts Phase III Results for Melanoma Therapy

Shares of Array BioPharma, Inc. are climbing this morning after the company released detailed results for its late-stage combination treatment for metastatic melanoma.

Details of the Phase III COLUMBUS trial, which were completed in 2016, were reported in an article in The Lancet Oncology. Trial data showed that the combination of encorafenib and binimetinib provided a median progression-free survival rate of 14.9 months for patients with BRAF-mutant advanced, unresectable or metastatic melanoma. That was in comparison to the 7.3 months mPFS rate for patients treated with the monotherapy of vemurafenib (Genentech’s Zelboraf).

Array’s encorafenib is a late-stage small molecule BRAF inhibitor and binimetinib is a late-stage small molecule MEK inhibitor. BRAF and MEK are key protein kinases in the MAPK signaling pathway (RAS-RAF-MEK-ERK). The MAPK pathway regulates several key cellular activities including proliferation, differentiation, survival and angiogenesis, according to Array’s data. Inappropriate activation of proteins in this pathway has been shown to occur in many cancers including melanoma and colorectal cancer.

Keith Flaherty, director of the Termeer Center for Targeted Therapy at Massachusetts General Hospital Cancer Center, said a median progression-free survival of nearly 15 months is clinically meaningful for this patient group. Additionally, Flaherty pointed to a previous data point of the trial that showed the combination treatment provided a median overall survival of 33.6 months, compared to 16.9 months with vemurafenib monotherapy.

"This further supplements the published data and shows that the combination of encorafenib and binimetinib may become a promising new therapy for patients with advanced BRAF-mutant metastatic melanoma," Flaherty said in a statement.

Metastatic melanoma is a life-threatening skin cancer. There are about 200,000 new cases of melanoma diagnosed worldwide each year, Array said.

Array’s combination treatment of encorafenib and binimetinib for the treatment of this subset of melanoma patients is currently under review by the U.S. Food and Drug Administration. The FDA is expected to make a decision on the treatment by June 18 under the Prescription Drug User Fee Act. Array has also submitted the combination therapy for approval to the European Medicines Agency, as well as regulatory agencies in Switzerland and Australia. Array has exclusive rights to the combination treatment in the United States and Canada. Ono Pharmaceutical has rights in Japan and South Korea and Pierre Fabre has rights to market the drug in all other countries.

Shares of Array were up nearly 3 percent this morning after the company announced the publication of the data. Array’s common stock hit a morning high of $17.24 as of 10:20 a.m.

In December Array spun off its heart drug research and development group into a new subsidiary called Yarra Therapeutics.  The new company is developing the oral compound Array 797 as a treatment for a rare type of cardiomyopathy.