Array walks back its FDA pitch on binimetinib, derailing plans for commercial launch

Ron Squarer, CEO

Array BioPharma has some explaining to do. Fifteen months after the Boulder, CO-based biotech said that it had the data needed for its first approval of binimetinib for NRAS-positive melanoma, execs are walking back the application and its plans for a launch.

In a statement out Sunday evening, Array $ARRY said that after getting feedback from the FDA, execs  “concluded that the clinical benefit demonstrated in the Phase 3 NEMO clinical trial would not be found sufficient to support approval of the NRAS-mutant melanoma NDA.”

Shares of Array dropped 26% in pre-market trading Monday.

Michael Schmidt at Leerink was not pleased. He noted:

While NRAS+ melanoma was only a small value driver for the company, we think this comes as a surprise to investors and is a clear setback for the company and mgmt.’s regulatory and commercial strategy. Recall, management planned to build a commercial infrastructure and visibility with customers this year around the launch in NRAS+ melanoma, which would also be in preparation for the planned launch in 2018 of binimetinib/encorafenib in more competitive BRAF+ melanoma, which is ARRY’s main value driver.

It was a much different story back in late 2015 when CEO Ron Squarer said that their MEK blocker hit the primary endpoint on progression-free survival, with the drug arm registering 2.8 months compared to 1.5 months for a group on dacarbazine. It didn’t look like much, but Array said it was plenty to take to the FDA.

In the summer of 2016, though, the biotech also conceded that the drug had not significantly improved overall survival.

Array has had plenty of ups and downs with the drug. Novartis had partnered with the company, but punted the program when they executed a big asset swap with GlaxoSmithKline. Pierre Fabry then took their spot, but Array held on to US commercial rights.

Array is planning to file binimetinib for BRAF-mutant melanoma in a few months.

Last fall the biotech reported that a 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.

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