アレイ・テクノロジーズ【ARRY】の掲示板
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>>9
Binimetinib is a small molecule selective inhibitor of MAP kinase kinase 1 (MAP2K1; MEK1) and MEK2, and encorafenib is a small molecule BRAF inhibitor. In 2015, Array obtained rights to both compounds from Novartis AG (NYSE:NVS; SIX:NOVN), which is funding the trials. Laboratoires Pierre Fabre S.A. (Castres, France) has exclusive, worldwide rights to both products, excluding the U.S., Canada, Japan, Korea and Israel, under a November 2015 deal with Array (see BioCentury Extra, Nov. 16, 2015).
On Wednesday, Array also released results for its third fiscal quarter ending March 31. The company reported a diluted loss per share of $0.21, wider than the Street's loss per share estimate of $0.17. Revenues were $33.3 million, compared to a $37 million consensus.
kaz*ヒト投与可能で一斉摘発ｗ
>>8
In order to assess binimetinib's contribution to the combo, Array reduced the dose of encorafenib to 300 mg in the combination arm of Part 2 to allow for equal comparison across arms.
In Part 2, the 45/300 mg dose combo led to a median PFS of 12.9 months vs. 9.2 months for encorafenib alone (HR=0.77; p=0.029). In Part 1, the 45/450 mg dose combo led to a median PFS of 14.9 months vs. 9.6 months for encorafenib alone (HR=0.75, p=0.051).
The company plans to present detailed results next half at a medical meeting.
Array withdrew an NDA in March for binimetinib monotherapy to treat neuroblastoma Ras viral (v-Ras) oncogene (NRAS)-mutant melanoma after concluding that the clinical benefit shown in the Phase III NEMO trial would not support approval in the indication (see BioCentury Extra, March 20).