Array Snags FDA Approval for BRAF-Mutant Metastatic Melanoma Combination Treatment

Array BioPharma, Inc. secured approval for its combination treatment for BRAF-mutant metastatic melanoma. The new treatment, Braftovi + Mektovi, is already available to order through select specialty pharmacies in the U.S. market.

The combination treatment was approved off of Phase III results that showed median progression-free survival rate of 14.9 months in comparison to the 7.3 months for patients treated with the monotherapy of vemurafenib. However, earlier this year, Colorado-based Array released updated Phase III results that showed median overall survival (mOS) of 33.6 months for patients compared to 16.9 months mOS for patients treated with vemurafenib (Genentech’s Zelboraf) as a monotherapy.

Last week ahead of the regulatory approval, Array Chief Executive Officer Ron Squarer told BioSpace that approval of the melanoma treatment is important to the patient population due to the low survival rates of metastatic melanoma.

“We are thrilled with the approval of BRAFTOVI + MEKTOVI, which help fill a critical unmet need for patients with advanced BRAF-mutant melanoma, a serious and deadly type of skin cancer,” Squarer said Wednesday following the approval from the Food and Drug Administration (FDA). “As presented at ASCO, Braftovi + Mektovi is the first targeted treatment to demonstrate over 30 months median overall survival in a Phase III trial. These products represent a new standard of care for BRAF-mutant melanoma patients and we sincerely thank the patients and dedicated researchers who participated in our clinical program.”

At ASCO Array released updated survival results from its Phase III trial that included the mOs data. The updated results showed the combination treatment reduced the risk of death when compared to treatment with vemurafenib alone. Two-year overall survival with the Array therapy was 58 percent.

Braftovi is an oral small molecule BRAF kinase inhibitor and Mektovi is an oral small molecule MEK inhibitor which targets key enzymes in the MAPK signaling pathway (RAS-RAF-MEK-ERK). Inappropriate activation of proteins in this pathway has been shown to occur in many cancers including melanoma, colorectal cancer, non-small cell lung cancer, thyroid and others. Array’s combination treatment targets about half of the patients who have metastatic melanoma, as Squarer notes that the majority of those patients have the BRAF mutation.

Keith T. Flaherty, director of the Termeer Center for Targeted Therapy at Massachusetts General Hospital Cancer Center, said the approval of the Array treatment provided physicians and patients a treatment option that has not been available.

Now, physicians and patients have the option to consider treatment with Braftovi + Mektovi, which has been shown to delay disease progression, improve overall survival and is generally well-tolerated,” Flaherty said in a statement.

Valerie Guild, co-founder and president of the AIM at Melanoma Foundation also chimed in on the FDA’s decision. Guild said the approval of Array’s treatment “arms BRAF-mutant late-stage melanoma patients with an important new targeted treatment in their fight against this devastating disease."

Array has exclusive rights to the newly approved Braftovi + Mektovi in the U.S. and Canada Ono Pharmaceutical has exclusive rights to commercialize the medicine in Japan and South Korea and Pierre Fabre exclusive rights to commercialize both products in all other countries, including Europe, Asia and Latin America.