Genentech, a member of Swiss pharmaceutical giant Roche Holding AG (RHHBY.PK, ROG.SW, RO.SW), Monday announced that the Phase III coBRIM study met its primary endpoint of progression-free survival.
Genentech plans to submit these data to the FDA for potential approval.
The study demonstrated that the investigational MEK inhibitor cobimetinib, used in combination with Genentech's BRAF inhibitor Zelboraf, helped patients with previously untreated BRAF V600 mutation-positive advanced melanoma live significantly longer without their disease worsening, compared to Zelboraf alone. Adverse events were consistent with those observed in a previous study of the combination.
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.
Sandra Horning, chief medical officer and head of Global Product Development, said, "These encouraging data support the potential combined use of cobimetinib with Zelboraf to block tumor growth longer than Zelboraf alone. We hope this combination therapy will lead to a new option for patients."
The company noted that data from this pivotal study will be presented at an upcoming medical meeting.
For comments and feedback: editorial@rttnews.com