Impressive news was revealed from Roche and Exelixis on June 14, 2014 with successful Phase III study results from their melanoma trial. This comprehensive trial involved Exelixis’s Cobimetinib and Zelboraf, which is marketed by Roche, for treating patients with advanced cases of melanoma. All of the 495 patients had specific mutations of the BRAF gene and many were considered to have unresectable cases of this deadly skin cancer. The surprise for clinical trial investigators came when they found the concomitant use of these two drugs led to a longer progression free survival for patients in comparison to their treatment with Zelboraf alone. These top line results are exciting for the medical and pharmaceutical community as this data clears the way for an upcoming FDA application. The Phase III study, coined coBRIM not only met its primary goal of progression free survival, thanks to the addition of Cobimetinib, but it also proved to be safe and tolerable.
Cobimetinib is a highly selective inhibitor of mitogen-activated protein kinase MEK, and has demonstrated efficacious ability sustain the inhibition of MEK in both mutant RAS and BRAF tumor models. The development of Cobimetinib is currently under Roche and Genentech, with a collaboration agreement with Exelixis. A successful Phase 1b dose escalation study of Cobimetinib, called BRIM7, proved this potent drug was effectual when used adjunctively with the BRAF inhibitor Vemurafenib. The BRIM7 study involved patients with metastatic cases of melanoma who had the BRAFV600 mutation, with the results being presented at the 10th European Association of Dermato-Oncology Congress in May 2014.
Clinical trials are ongoing for Cobimetinib alongside other anti-cancer agents, and many of the patients accepted in these trials are chosen specifically for their genetic mutations. Current studies include combining Cobimetinib with: GDC-0068, an AKT inhibitor; Onartuzumab, a MET targeting antibody; MEHD7945A, a biotherapeutic targeting EGFR and HER3; and GDC-0941, a PI3K inhibitor. This patient population is facing a critical need for new and innovative treatment, and Cobimetinib looks like it may be the agent to meet this need.
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