Bayer HealthCare Pharmaceuticals, announced the results from its Phase III trial evaluating its investigational compound regorafenib (see structure below, BAY 73-4506) for the treatment of patients with metastatic colorectal cancer (mCRC) whose disease has progressed after approved standard therapies: The trial met its primary endpoint of statistically significant improvement in overall survival.
This is the result of a pre-planned interim analysis conducted by an independent Data Monitoring Committee (DMC) of the CORRECT (Patients with metastatic colorectal cancer treated with regorafenib or placebo after failure of standard t herapy) trial. Per the recommendation of the DMC, the study has been unblinded and patients in the placebo arm will be offered treatment with regorafenib. In this trial, the safety and tolerability of regorafenib were generally as expected.
"These data are significant because they demonstrate that regorafenib increased overall survival in patients with heavily pretreated metastatic colorectal cancer, an area of high unmet medical need," said Kemal Malik .....
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