Phase III trial of LGX 818 and MEK 162 (encorafenib + binimetinib) in metastatic melanoma meets primary endpoint- Array BioPharma and Pierre Fabre

Array BioPharma and Pierre Fabre announced top-line results from Part 1 of the Phase III COLUMBUS (Combined LGX 818 Used with MEK 162 in BRAF Mutant Unresectable Skin Cancer) study evaluating LGX 818 (encorafenib), a BRAF inhibitor, and MEK 162 (binimetinib), a MEK inhibitor, in patients with BRAF-mutant advanced, unresectable or metastatic melanoma. The study met its primary endpoint, significantly improving progression free survival (PFS) compared with vemurafenib, a BRAF inhibitor, alone. In the analysis of the primary endpoint, the median PFS for patients treated with the combination of encorafenib plus binimetinib was 14.9 months versus 7.3 months for patients treated with vemurafenib. The combination was generally well-tolerated and reported adverse events were overall consistent with previous combination encorafenib plus binimetinib clinical trial results in BRAF-mutant melanoma patients.

Analysis of a secondary endpoint comparing the PFS of patients treated with combination to patients treated with encorafenib showed a median of 14.9 months versus 9.6 months, which did not reach statistical significance. A complete analysis of these results will be provided to global regulatory authorities as part of planned submissions. In addition, data from Part 2 of the COLUMBUS trial are anticipated in mid 2017 and will also be provided to global health authorities as part of planned regulatory submissions for approval of these product candidates.

Further results from Part 1 of the COLUMBUS trial, including objective response rates, disease control rates, safety endpoints, exploratory analyses such as a Part 1 PFS comparison of encorafenib to vemurafenib and pre-specified subgroup analyses including outcomes in patients who received prior treatment with immunotherapy will be presented at an upcoming medical meeting. Analysis of the secondary endpoint of overall survival (OS) was not planned as part of these initial results.