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).
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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.
- 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.