Array is anxiously awaiting the FDA to approve its combination treatment for BRAF-mutant metastatic melanoma. If approved, Chief Executive Officer Ron Squarer believes it will not only be an important milestone for the company, but also for the patients.
Array BioPharma is anxiously awaiting the U.S. Food and Drug Administration (FDA) to approve its combination treatment for BRAF-mutant metastatic melanoma. If approved, Chief Executive Officer Ron Squarer believes it will not only be an important milestone for the company, but also for the patients.
Metastatic melanoma is the most serious and life-threatening type of skin cancer and is associated with low survival rates. Array’s late-stage combination of encorafenib and binimetinib is looking to change that. Updated Phase III results, which were not included in the company’s New Drug Application to the FDA, 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. When initially reported, the COLUMBUS trial 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. Squarer said that MPFS rate of nearly 15 months was impressive and that the medication was generally well tolerated.
“This is clinically meaningful for patients with advanced BRAF-mutant advanced melanoma,” he said.
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.
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.
“Even with recent treatment advances, many patients with BRAF-mutant melanoma still face significant challenges managing their disease, and there remains a substantial need for well-tolerated treatments that delay disease progression and improve overall survival,” Squarer told BioSpace in an email. “Results of the Company’s pivotal Phase III COLUMBUS trial demonstrated that the median progression-free survival for patients treated with the combination of encorafenib and binimetinib was nearly 15 months, which is more than double that of the vemurafenib monotherapy control arm.”
If the FDA gives the green light to Array, the approval of the combination treatment would help fill a critical unmet need for patients with BRAF-mutant advanced melanoma, Squarer added. The FDA PDUFA date is set for June 30, but approval or rejection could come any time before that.
Earlier this month Array released updated survival results from its Phase III trial that included the mOs data. Additionally, 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, the company said ahead of the American Society of Clinical Oncology meeting in Chicago.
If given the go-ahead nod from the FDA, Squarer said Array will work to bring the product to patients as quickly as possible. The company will work with payers, advocacy organizations, healthcare providers and patients to “help ensure access to encorafenib and binimetinib to patients who need it,” he said. Squarer added that no price point has yet been set. He said the company is considering benchmarks for the market. Squarer noted that the company is working with payers, advocacy organizations and healthcare providers to help ensure patient access to encorafenib and binimetinib.
While Array waits for a decision, Squarer said the company has its entire customer-facing organization in place including more than 60 employees across sales, market access and medical affairs.
“We’re thrilled with the talent that we’ve been able to attract based on the profile of the drugs that we look forward to commercialize in this year,” Squarer said.
In addition to its potential treatment for BRAF-mutant metastatic melanoma, Array also has a Phase III therapy for patients with BRAF-mutant colorectal cancer. The company will provide updated results from the 30-patient safety lead-in in an oral presentation at the ESMO (European Society for Medical Oncology) 20th World Congress on Gastrointestinal Cancer later this week.
