Onyx and Bayer HealthCare announced results from the Phase 3 CORRECT trial of regorafenib in patients with metastatic colorectal cancer (mCRC) whose disease had progressed after approved standard therapies.
CORRECT was an international, multicenter, randomized, double-blind, placebo-controlled study that enrolled 760 patients with mCRC whose disease had progressed during or within 3 months following last administration of approved standard therapies. Patients were randomized to receive either regorafenib plus best supportive care (BSC) or placebo plus BSC. Treatment cycles consisted of 160mg of regorafenib (or matching placebo) once daily for three weeks on/one week off plus BSC.
The study met its primary endpoint, showing statistically significant improvement in overall survival (OS) by 29% (HR=0.77, P=0.0052, median OS: 6.4 months vs. 5 months for the placebo group). Per the recommendation from an independent Data Monitoring Committee, the CORRECT study was unblinded in late 2011 following a pre-planned interim analysis that determined that the regorafenib arm showed significant improvement in overall survival; patients on the placebo arm were unblinded and offered treatment with regorafenib.
Regorafenib is an investigational oral multi-kinase inhibitor targeting angiogenic, stromal and oncogenic kinases and is currently being investigated in clinical trials for its potential to treat patients with various tumor types.
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