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アレイ・テクノロジーズ

ARRY工業

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kaz*ヒト投与可能で一斉摘発ｗ

No.82017/5/12 9:22

Array gains on Phase III melanoma data

Array BioPharma Inc. (NASDAQ:ARRY) gained $1.41 (20%) to $8.43 on Wednesday after reporting that 45 mg binimetinib (MEK162) plus 300 mg encorafenib (LGX818) significantly improved median progression-free survival (PFS) over encorafenib monotherapy in Part 2 of the Phase III COLUMBUS trial to treat BRAF-mutant melanoma. The company said it is on track to submit an NDA for the combo in June or July. The data were announced after market close on Tuesday.

Last year, data from Part 1 of COLUMBUS showed that 45 mg binimetinib plus 450 mg encorafenib met the primary endpoint of improving median PFS over BRAF inhibitor Zelboraf vemurafenib, and narrowly missed a secondary endpoint of improving median PFS vs. 300 mg encorafenib alone (see BioCentury Extra, Sept. 26, 2016).

Array said encorafenib has improved tolerability when combined with binimetinib, which allowed for the use of a higher dose of encorafenib in the combo arm of Part 1.

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kaz*ヒト投与可能で一斉摘発ｗ
No.92017/5/12 9:23
>>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).
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