Roche announced positive data from the coBRIM Phase 3 study with cobimetinib plus Zelboraf (vemurafenib; Genentech) in patients with previously untreated BRAF V600 mutation-positive, advanced melanoma. Cobimetinib is designed to selectively block the activity of MEK by binding to MEK while Zelboraf binds to mutant BRAF to interrupt abnormal signaling that can cause tumors to grow.
CoBRIM is an international, randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of cobimetinib in combination with Zelboraf, compared to Zelboraf alone. In the study, 495 patients with BRAF V600 mutation-positive unresectable locally advanced or metastatic melanoma and previously untreated for advanced disease, were randomized to receive Zelboraf every day on a 28-day cycle plus either cobimetinib or placebo on days 1-21. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent. The primary endpoint was progression-free survival (PFS).
The combined therapy reduced the risk of disease worsening or death by 50% (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.
Roche plans to submit a New Drug Application (NDA) to the Food and Drug Administration (FDA) later this year.
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