Genentech recently submitted a New Drug Application (NDA) for cobimetinib to the FDA for treatment, in combination with vemurafenib (Zelboraf), for people with BRAF V600 mutation-positive advanced melanoma. The submission is based on results of the coBRIM Phase III study, which showed people who received the MEK inhibitor cobimetinib plus vemurafenib lived significantly longer without their disease worsening or death (progression-free survival; PFS) compared to vemurafenib alone.
“In the past several years we have made significant progress in treating advanced melanoma, but it remains a serious and difficult to treat cancer that affects more people each year,” says Sandra Horning, MD, chief medical officer and head of Global Product Development. “We look forward to working with the FDA as they review the NDA and hope the combination of cobimetinib and vemurafenib will soon become a new option for people with BRAF mutation-positive advanced melanoma.”
In the coBRIM study, cobimetinib and vemurafenib reduced the risk of disease worsening or death by half (hazard ratio [HR]=0.51, 95 percent confidence interval [CI] 0.39-0.68; p<0.0001), with a median PFS of 9.9 months for cobimetinib plus vemurafenib compared to 6.2 months with vemurafenib alone. The safety profile was consistent with a previous study of the combination. The most common Grade 3 or higher adverse events in the combination arm included liver lab abnormalities, elevated creatine phosphokinase (CPK, an enzyme released by muscles) and diarrhea. The most common adverse events seen in the combination arm included diarrhea, nausea, rash, photosensitivity and lab abnormalities.
The results were presented at the European Society of Medical Oncology (ESMO) 2014 Congress and published in the New England Journal of Medicine. Roche has already submitted the coBRIM data to the European Medicines Agency.
