Drug Development

Array Bio surges on positive results for first stage of melanoma combo PhIII

Shares of Array Biopharma $ARRY surged 29% Monday morning after the Boulder, CO-based biotech and its partners at Pierre Fabre in France said that the first part of their late-stage study for a combination BRAF/MEK enzyme inhibitor hit its primary endpoint.

Array CEO Ron Squarer

Array CEO Ron Squarer

The combo of encorafenib (LGX818) plus binimetinib beat out a solo BRAF inhibitor, Zelboraf (vemurafenib), with a median progression-free survival rate of 14.9 months vs. 7.3 months in the control arm for BRAF-mutant melanoma patients.

There was a hitch, though, as the pair-up showed a median PFS of 14.9 months versus 9.6 months for encorafenib alone, which was not statistically significant.

Array celebrated another set of upbeat results from its Phase III study of binimetinib, its lead drug, late last year after investigators say they scored promising results for NRAS-mutated melanoma. That success set up Array’s first planned FDA submission.

Novartis had been allied on the drug, but stepped out after their cancer team executed a big asset swap with GlaxoSmithKline, which netted their own MEK inhibitor. The Pierre Fabre stepped in to take their place, paying $30 million upfront, promising milestones and taking a 60/40 split on R&D costs for the combo.

“We look forward to working with global regulatory authorities as they evaluate our planned submission,” noted Array CEO Ron Squarer.

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Sr. Manager, Regulatory Affairs, CMC
CytomX Therapeutics San Francisco, CA
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Catalytic Data Science Charleston, SC
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Flatiron Health New York City or San Francisco

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