Bayer halts regorafenib trial for colorectal cancer on good Ph III results

USA-based Bayer HealthCare Pharmaceuticals, a subsidiary of Germany’s Bayer AG (BAY: DE), has announced strong results from its Phase III trial evaluating regorafenib (BAY 73-4506) for the treatment of patients with metastatic colorectal cancer (mCRC) whose disease has progressed after approved standard therapies and has, as a result, stopped the study based on data from a pre-planned interim analysis.

The trial met its primary endpoint of statistically-significant improvement in overall survival. The analysis conducted by an independent Data Monitoring Committee (DMC) of the CORRECT (Patients with metastatic co lo r ectal cancer treated with re gorafenib or pla c ebo after failure of standard t herapy) trial recommendation that the study be 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. Data from the study are expected to be presented at a forthcoming scientific meeting.

"These data are significant because they demonstrate that regorafenib increased overall survival in patients with heavily pre-treated metastatic colorectal cancer, an area of high unmet medical need," said Kemal Malik, head of global development and member of the Bayer HealthCare executive committee.