Treatment with binimetinib plus encorafenib improves progression-free survival compared with vemurafenib alone among patients with BRAF-mutant melanoma, according to findings presented at Society for Melanoma Research Annual Congress.1
For part 1 of the international, open-label, phase 3 COLUMBUS trial (ClinicalTrials.gov Identifier: NCT01909453), investigators enrolled 577 patients and randomly assigned them 1:1:1 to receive binimetinib plus encorafenib, encorafenib alone, or vemurafenib alone. In part 2, 344 patients were randomly assigned 3:1 to receive the combination or encorafenib alone.
In the analysis of the primary endpoint, encorafenib plus binimetinib significantly reduced the risk of progression or death by 56% compared with vemurafenib (hazard ratio, 0.54; 95% CI, 0.41-0.71; P < .001). Median progression-free survival for patients who received binimetinib and encorafenib was 14.9 months, vs 7.3 months for patients treated with vemurafenib.
Per blinded independent central review, 63% (95% CI, 56-70) of patients treated with the combination achieved a confirmed objective response, vs 40% (95% CI, 33-48) of those who received vemurafenib alone.
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The most common grade 3 to 4 adverse events with the combination including increased GGT, increased blood creatine phosphokinase, and hypertension. Other adverse events included rash in 23%, pyrexia in 18%, retinal pigment epithelial detachment in 13%, and photosensitivity in 5%.
Quality of life also seemed to be maintained to a greater extent with encorafenib plus binimetinib compared with vemurafenib alone.
- COLUMBUS phase 3 study results in BRAF-mutant melanoma presented at Society for Melanoma Research Annual Congress. Array Biopharma website. http://investor.arraybiopharma.com/phoenix.zhtml?c=123810&p=irol-newsArticle&ID=2221003 Updated November 9, 2016. Accessed November 10, 2016.