Array's melanoma drug clears Phase III with an FDA filing in sight

Array CEO Ron Squarer

Array BioPharma's ($ARRY) new treatment for skin cancer extended survival in a Phase III trial, meeting its main goal and clearing the way for an FDA submission next year, the company said.

The drug, binimetinib, blocks the MEK enzyme to halt the proliferation of cancer cells, designed for the roughly 20% of melanoma patients with a mutation in the NRAS gene. In a Phase III study on 402 patients comparing binimetinib to the chemotherapy dacarbazine, Array's candidate clocked median progression-free survival of 2.8 months compared with 1.5 months for the old drug, the company said. The difference was statistically significant and met the trial's primary endpoint, according to Array.

Array is releasing only top-line results for now, holding off on disclosing how binimetinib scored on its secondary goals until a medical meeting next year. But the data put Array on track to submit binimetinib for FDA approval in melanoma in the first half of 2016, management said, giving the company a shot at the first of many planned approvals for its lead drug.

The results sent Array's shares up about 25% in pre-market trading on Wednesday.

The Boulder, CO-headquartered Array regained the rights to binimetinib last year after ex-partner Novartis ($NVS) picked up a MEK inhibitor of its own in a sweeping, $16 billion asset swap with GlaxoSmithKline ($GSK). But the terms of the breakup kept Novartis on the hook for development costs tied to the drug, allowing Array to advance binimetinib on its former patron's dime while looking for a new deal.

Last month, Array signed an agreement with Pierre Fabre covering binimetinib and encorafenib, another therapy abandoned by Novartis. Under that deal, Array is hanging onto commercial rights in the U.S., Canada, Japan, South Korea and Israel, handing over the rest of the world to Pierre Fabre in exchange for up to $455 million tied to milestones.

- read the statement