The gist: A combination of the drugs cobimetinib and vemurafenib (aka Zelboraf) might soon become a new treatment option for U.S. patients with advanced melanoma whose tumors have a V600 mutation in the BRAF gene. The drug company Genentech submitted a New Drug Application to the U.S. Food and Drug Administration (FDA) asking for FDA approval of the combo. In a clinical trial, Genentech researchers found that patients who take cobimetinib along with vemurafenib do better than patients who take vemurafenib alone. Both drugs are targeted therapies.
“Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced the company has submitted a New Drug Application (NDA) for cobimetinib to the U.S. Food and Drug Administration (FDA) for treatment, in combination with Zelboraf® (vemurafenib), 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 Zelboraf lived significantly longer without their disease worsening or death (progression-free survival; PFS) compared to Zelboraf 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,’ said Sandra Horning, M.D., 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 Zelboraf will soon become a new option for people with BRAF mutation-positive advanced melanoma.’
“In the coBRIM study, cobimetinib and Zelboraf 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 Zelboraf compared to 6.2 months with Zelboraf 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 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.”