BioCentury
ARTICLE | Clinical News

Array planning melanoma combo NDA submission on Phase III data

May 12, 2017 7:55 PM UTC

Array BioPharma Inc. (NASDAQ:ARRY) reported top-line data showing that twice-daily 45 mg oral binimetinib (MEK162) plus once-daily 300 mg oral encorafenib (LGX818) significantly improved median progression-free survival (PFS) vs. encorafenib monotherapy in Part 2 of the open-label, international Phase III COLUMBUS trial in 921 patients with BRAF V600 mutation-positive locally advanced, unresectable or metastatic melanoma (12.9 vs. 9.2 months, HR=0.77, 95% CI: 0.61, 0.97, p=0.029). The company said it is on track to submit an NDA to FDA for the combo in June or July.

Last year, data from Part 1 of COLUMBUS showed that twice-daily 45 mg binimetinib plus once-daily 450 mg encorafenib met the primary endpoint of improving median PFS vs. BRAF inhibitor Zelboraf vemurafenib (14.9 vs. 7.3 months, HR=0.54, 95% CI: 0.41, 0.71, p<0.001), and narrowly missed a secondary endpoint of improving median PFS vs. once-daily 300 mg encorafenib alone (14.9 vs. 9.6 months, HR=0.75, 95% CI: 0.56, 1, p=0.051) (see BioCentury, Oct. 3, 2016). Part 1 of the trial enrolled 577 patients and Part 2 of the trial enrolled 344 patients...