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news.Bayer's investigational compound Regorafenib (BAY 73-4506) has met all the endpoints in the Phase 3 Colorectal cancer treated with regorafenib or placebo after failure of standard therapy (CORRECT) trial.
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Regorafenib is an investigational oral multi-kinase inhibitor targeting angiogenic, stromal and oncogenic kinases and is currently being evaluated in clinical trials for its potential to treat patients with various tumor types.
The international multicenter randomized double-blind placebo-controlled CORRECT study enrolled 760 patients with metastatic colorectal cancer (mCRC) whose disease had progressed during or within 3 months following last administration of approved standard therapie.
In the trial, patients were randomized to receive either regorafenib plus best supportive care (BSC) or placebo plus BSC.
The study demonstrated that the drug met its primary endpoint, showing 29% improvement in overall survival (OS), and also met secondary endpoints showing improvement in progression-free survival (PFS) and disease control rate in mCRC patients treated with Regorafenib.
Bayer plans to submit Regorafenib for marketing authorization in mCRC this year.
In 2011, Bayer and Onyx signed an agreement, under which Onyx will receive a royalty on any future global net sales of Regorafenib in oncology.