Regorafenib is an oral multi-kinase inhibitor of angiogenic, stromal and oncogenic receptor tyrosine kinases (TK) used for the treatment of metastatic colorectal cancer (mCRC).
The double-blind, international, multicenter, placebo-controlled, randomized Correct trial has enrolled 760 patients with mCRC whose disease has progressed after approved standard therapies.
The study met primary endpoint with overall survival.
Bayer HealthCare Executive Committee member and Global Development Head Kemal Malik said these data are significant because they demonstrate that regorafenib increased overall survival in patients with heavily pretreated mCRC.
The company said it will plan to discuss with US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) regarding next steps in filing for approval of regorafenib.