June 6, 2016

Array BioPharma plans cancer-drug regulatory filing this month following Phase 3 results

BOULDER — Officials for Array BioPharma  (Nasdaq: ARRY) on Monday afternoon said they plan to file for regulatory approval with the U.S. Food and Drug Administration later this month for the use of binimetinib in the treatment of NRAS-mutant melanoma.

Array announced full results of its Phase 3 NEMO trial, which showed median progression-free survival in patients receiving binimetinib of 2.8 months versus 1.5 months with chemotherapy drug dacarbazine.

The company had unveiled preliminary results of the trial showing similar numbers in December, causing Boulder-based Array’s share price to shoot up 35 percent.

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Array shares had enjoyed an early spike Monday after the company announced over the weekend a partnership with Pierre Fabre and Merck to jointly initiate a Phase 3 clinical trial looking at the use of Array drugs binimetinib and encorafenib in conjunction with Merck offering Erbitux in the treatment of BRAF-mutant colorectal cancer. But shares tapered off following the NEMO trial announcement.

Array shares closed at $3.84, up 5 cents from Friday’s close.

The NEMO trial showed an overall response rate of 15 percent in patients receiving binimetinib versus a 7 percent rate in those receiving dacarbazine. Disease control rate was 58 percent for binimetinib patients versus 25 percent for dacarbazine. The median overall survival showed no statistically significant difference for binimetinib versus dacarbazine but was estimated at 11 months for the former and 10.1 months for the latter.

“The NEMO trial results demonstrate the potential of binimetinib to help slow disease progression in this patient population, an often overlooked subset without treatment options beyond immunotherapy,” Array chief medical officer Victor Sandor said in a release from the company.

In the colorectal cancer trial, Array will act as global sponsor of the study. Pierre Fabre, which last year licensed commercial rights to binimetinib and encorafenib in Europe and other global markets, will fund 40 percent of the trial, dubbed the BEACON CRC trial. Merck owns Erbitux outside the United States and Canada and will supply the drug to all trial sites outside of the U.S. and Canada.

The announcement of the BEACON BRC trial came in conjunction with positive results from a phase 2 trial looking at binimetinib in the treatment of colorectal cancer.

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