Encorafenib plus binimetinib significantly improved progression-free survival compared with vemurafenib alone among patients with BRAF-mutant advanced, unresectable, or metastatic melanoma, according to preliminary results of part 1 of the COLUMBUS trial.1

The 2-part, multicenter, open-label, phase 3 COLUMBUS trial (Study Comparing Combination of LGX818 Plus MEK162 Versus Vemurafenib and LGX818 Monotherapy in BRAF Mutant Melanoma; ClinicalTrials.gov Identifier: NCT01909453) randomly assigned 577 patients with BRAF-mutant melanoma 1:1:1 to receive encorafenib plus binimetinib, encorafenib alone, or vemurafenib alone.

Median progression-free survival with the combination was 14.9 months, in contrast with 7.3 months among those treated with vemurafenib, representing a 46% reduction in the risk of disease progression or death with encorafenib plus binimetinib versus vemurafenib.

Median progression-free survival was 14.9 months with the combination of encorafenib and binimetinib, versus 9.6 months with encorafenib alone, though this difference was not statistically significant (P = .051).

RELATED: FDA Modifies Nivolumab Dosage Regimens for RCC, NSCLC, Melanoma

Additional data will be submitted for presentation at an upcoming scientific meeting. Findings from the second part of the study, in which 344 patients were randomly assigned 3:1 to receive encorafenib plus binimetinib or encorafenib alone in different dose combinations than in part 1, are expected to be announced in mid-2017.                           

Reference

  1. Array BioPharma and Pierre Fabre announce COLUMBUS phase 3 study of encorafenib plus binimetinib For BRAF-mutant melanoma met primary endpoint. Array Biopharma website. http://investor.arraybiopharma.com/phoenix.zhtml?c=123810&p=irol-newsArticle&ID=2205821. Updated September 26, 2016. Accessed September 27, 2016.