On July 14, 2014 Roche reported that the Phase III coBRIM study (NCT01689519) met its primary endpoint (Press release Hoffmann-La Roche, JUL 13, 2014, View Source [SID:1234500628]). The study demonstrated that the investigational MEK inhibitor cobimetinib, used in combination with Roche’s BRAF inhibitor Zelboraf, helped patients with previously untreated BRAF V600 mutation-positive advanced melanoma live significantly longer without their disease worsening (progression-free survival; PFS) compared to Zelboraf alone. Adverse events were consistent with those observed in a previous study of the combination.

“Despite great progress in our understanding and therapy in recent years, advanced melanoma remains a difficult and deadly disease that requires more treatment options,” said Sandra Horning, M.D., Chief Medical Officer and Head of Global Product Development. “These encouraging data support the potential combined use of cobimetinib with Zelboraf to block tumour growth longer than Zelboraf alone. We hope this combination therapy will lead to a new option for patients.”

Data from this pivotal study will be presented at an upcoming medical meeting. Additionally, Roche plans to submit these data to the U.S. Food and Drug Administration, European Medicines Agency, and other health authorities around the world for potential approval.

Cobimetinib is designed to selectively block the activity of MEK,2 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 tumours to grow.
About the coBRIM study

CoBRIM is an international, randomised, double-blind, placebo-controlled Phase III study evaluating the safety and efficacy of cobimetinib in combination with Zelboraf, compared to Zelboraf alone, in 495 patients with BRAF V600 mutation-positive unresectable locally advanced or metastatic melanoma, previously untreated for advanced disease.6 The primary endpoint for coBRIM is PFS. Secondary endpoints include overall survival, objective response rate, duration of response and other safety, pharmacokinetic and quality of life measures.

The coBRIM study used the Roche cobas 4800 BRAF Mutation Test to determine eligibility of patients for the study. This test identifies people whose tumours carry the BRAF V600 mutation, and therefore, patients who are most appropriate to receive this combination of treatments.