Array Biopharma and Pierre Fabre to present phase 3 Columbus trial at Society for melanoma research annual congress
Array BioPharma (NASDAQ: ARRY) and Pierre Fabre announced today that results from the Phase 3 COLUMBUS trial of binimetinib and encorafenib in BRAF-mutant melanoma will be presented at the 2016 Society for Melanoma Research (SMR) Annual Congress in Boston, Massachusetts on November 9. Findings from COLUMBUS evaluating the combination of encorafenib plus binimetinib (“combination”) in patients with unresectable or metastatic BRAF-mutant melanoma will be presented as an oral, late-breaking abstract. Two new data analyses from the NEMO Phase 3 trial will also be presented, which evaluated binimetinib in patients with NRAS-mutant melanoma.
COLUMBUS TRIAL DATA
Data from the Phase 3 study will be featured as an oral presentation during the late-breaking abstract session on Wednesday, November 9 from 10:00 – 10:15 AM ET:
Abstract 2617508: Results of COLUMBUS Part 1: A Phase 3 Trial of Encorafenib (ENCO) Plus Binimetinib (BINI) Versus Vemurafenib (VEM) or ENCO in BRAF-Mutant Melanoma
Presenter: Keith T. Flaherty, M.D., Director of the Termeer Center for Targeted Therapy, Massachusetts General Hospital and Professor of Medicine, Harvard Medical School, Boston, Massachusetts
As reported in late September, 577 patients were randomized 1:1:1 to receive the combination of encorafenib plus binimetinib, encorafenib alone, or vemurafenib alone. In the analysis of the primary endpoint, the median PFS for patients treated with the combination of encorafenib plus binimetinib ("combination") was 14.9 months versus 7.3 months for patients treated with vemurafenib; HR (0.54), [95% CI 0.41-0.71], p<0.001. 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 with HR (0.75), [95% CI 0.56-1.00], p=0.051, which did not reach statistical significance. 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.
ARRAY BIOPHARMA INVESTOR RECEPTION
Array will be hosting an investor reception immediately following the conclusion of SMR. The event will be held on Wednesday, November 9 from 1 – 3 pm ET in Boston and will include an encore presentation of the COLUMBUS results by Dr. Flaherty. The public is welcome to participate in the presentation through a webcast (live and replay) on the Array BioPharma website.