Array BioPharma and Pierre Fabre announced top-line data from part 1 of the Phase 3 COLUMBUS study evaluating LGX818 (encorafenib) and MEK162 (binimetinib) in patients with BRAF-mutant advanced, unresectable or metastatic melanoma.
The COLUMBUS (Combined LGX818 Used with MEK162 in BRAF Mutant Unresectable Skin Cancer; n=921) part 1 trial met its primary endpoint, significantly improving progression-free survival (PFS) vs. vemurafenib, aBRAF inhibitor, alone.
The median PFS for patients treated with the combination of encorafenib + binimetinib was 14.9 months vs. 7.3 months for patients treated with vemurafenib (hazard ratio [HR] 0.54, 95% CI: 0.41-0.71; P<0.001). This combination was reported to be generally well tolerated and adverse events were overall consistent with previous combination encorafenib + binimetinib trial results.
The analysis of a secondary endpoint comparing PFS of patients treated with encorafenib + binimetinib vs. encorafenib monotherapy showed a median of 14.9 months vs. 9.6 months (HR 0.75, 95% CI: 0.56-1.00;P=0.051), which did not reach statistical significance.
Additional results from part 1, including objective response rates, disease control rates, safety endpoints, and exploratory analyses will be presented at an upcoming medical meeting. Data from part 2 of the COLUMBUS trial are expected in mid-2017.
LGX818 is a BRAF inhibitor and MEK162 is a MEK inhibitor. MEK and BRAF are protein kinases in the MAPK signaling pathway that regulate key activities such as proliferation, differentiation, survival, and angiogenesis.