publication date: Oct. 30, 2014

Cobimetinib-Zelboraf Therapy Increases OS In BRAF V600 Mutation-Positive Disease

 

A phase III trial showed that people with previously untreated BRAF V600 mutation-positive advanced melanoma who received the MEK inhibitor cobimetinib plus Zelboraf (vemurafenib) lived significantly longer without their disease worsening or death compared to Zelboraf alone.

The combined therapy reduced the risk of disease worsening or death by half (HR=0.51, 95% CI 0.39-0.68; p<0.0001), with a median PFS of 9.9 months for cobimetinib plus Zelboraf compared to 6.2 months with Zelboraf alone.

Cobimetinib is designed to selectively block the activity of MEK, one of a series of proteins inside cells that make up a signaling pathway that helps regulate cell division and survival. Cobimetinib binds to MEK while Zelboraf binds to mutant BRAF, another protein on the pathway, to interrupt abnormal signaling that can cause tumors to grow.

Results from the trial, named coBRIM, were statistically significant across multiple secondary endpoints. The median PFS by independent review committee was 11.3 months for the combination arm compared to 6.0 months for the control arm (HR=0.60, 95% CI 0.45-0.79; p=0.0003). The objective response rate was higher in the combination compared to the control arm (68 vs. 45 percent; p<0.0001).

Overall survival data are not yet mature. The data were presented at ESMO 2014 Congress, and were published in the New England Journal of Medicine.

CoBRIM is an international, randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of 60 mg once daily of cobimetinib in combination with … Continue reading CCL Oct – Melanoma

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