Oncology Update: regorafenib improves survival in metastatic colorectal cancer (mCRC)

According to a press release issued by Onyx Pharmaceuticals, Inc. on October 25, 2011 a Phase 3 trial with regorafenib in metastatic colorectal cancer (mCRC) patients  being conducted by Bayer HealthCare Pharmaceuticals met its primary endpoint of improved overall survival.   Apparently, this trial’s independent Data Monitoring Committee conducted a pre-planned interim analysis and recommended that the study be unblinded and patients in the placebo arm be offered treatment with regorafenib.  While no data has been made publicly available at this time, given  the positive nature of the announcement we have expedited our review of this multikinase inhibitor.  We are currently reviewing the published pre-clinical and early stage clinical trial data, as well as mCRC clinical epidemiology to provide clients with analytical support for organization specific reimbursement and list/don’t list formulary decisions.