A Roche Group member, Genentech announced Sunday that the company submitted a New Drug Application to the U.S. Food and Drug Administration to use cobimetinib for treating BRAF V600 mutation-positive advanced melanoma alongside vemurafenib (Zelboraf).
Genentech made the submission in light of results from a coBRIM Phase II study showing people given MEK inhibitor cobimetinib and Zelboraf dramatically lived longer with their condition worsening compared to just taking Zelboraf alone.
Aside from being published in the New England Journal of Medicine, the study was also presented at the 2014 European Society of Medical Oncology Congress. Roche submitted the results of the coBRIM study as well to the European Medicines Agency.
The coBRIM study showed that the combination of cobimetinib and Zelboraf cut risks of advanced melanoma getting worse or leading to death by as much as half, with a median PFS of 9.9 months compared to the 6.2 months that Zelboref alone registered. The combination's safety profile was also in line with previous studies of the interaction between cobimetinib and Zelboraf.
The most common adverse side effects observed in the cobimetinib-Zelboraf combination were lab abnormalities, photosensitivity, rashes, nausea and diarrhea. For side effects Grade 3 and higher, higher levels of creatine phosphokinase, diarrhea and liver lab abnormalities were common.
"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," said Sandra Horning, M.D., Global Product Development head and chief medical officer for Genentech, adding the company looks forward to working closely with the FDA as the NDA is reviewed and hopes the cobimetinib-Zelboraf combo becomes a new option for those with BRAF mutation-positive advanced melanoma.
Melanoma is not very common but it is one of the deadlier, more aggressive forms of skin cancer. Early detection can typically cure disease but those who have advanced forms of the cancer are not as lucky. In fact, according to the American Cancer Society, over 76,100 new cases of the cancer will be diagnosed in the United States this year while 9,700 deaths will be caused by the cancer.
Significant strides have been made in treating metastatic melanoma, giving patients a number of options to consider. However, the cancer continues to be a serious issue, with unmet needs high and the number of cases steadily growing each year for the last 30 years.
