Genentech, a member of the Roche Group, submitted a New Drug Application (NDA) to the U.S Food and Drug Administration (FDA) for the use of cobimetinib in combination with Zelboraf (vemurafenib) in the treatment of patients with BRAF V600 mutation-positive advanced melanoma.
The company presented the results of CoBRIM, an international, randomized, double-blind, placebo-controlled Phase III study that tested the safety and efficacy of 60 mg once daily of cobimetinib in combination with 960 mg twice daily of Zelboraf, compared to 960 mg twice daily of Zelboraf alone.
In the trial, 495 patients with BRAF V600 mutation-positive unresectable locally advanced or metastatic melanoma were randomized to receive Zelboraf daily on a 28-day cycle plus either cobimetinib or placebo on days 1-21. Results showed that patients who received cobimetinib in combination with Zelboraf had a higher rate of progression-free survival (PFS) compared to those patients who received Zelboraf alone. Furthermore, the median PFS for cobimetinib plus Zelboraf was of 9.9 months, compared to only 6.2 months for Zelboraf alone.
The combination therapy was found to reduced the risk of disease worsening or death by half. In terms of Grade 3 adverse events, people receiving the combined treatment had liver lab abnormalities, elevated creatine phosphokinase and diarrhea.
In a recent press release, Sandra Horning, M.D., chief medical officer and head of Global Product Development said “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. 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.”
CoBRIM results were presented during the 2014 Congress of the European Society of Medical Oncology and were recently published in the New England Journal of Medicine. Data from this trial has already been submitted by Roche to the European Medicines Agency.