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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