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Jan 18, 2012

Bayer Plans 2012 Filing for Regorafenib Following Positive Phase III mCRC Trial Results

  • Bayer HealthCare and Onyx Pharmaceuticals reported positive data from a Phase III metastatic colorectal cancer (mCRC) study with its investigational cancer drug regorafenib (Bay 73-4506). Bayer says it plans to file for approval of the oral multikinase inhibitor for this indication during 2012.

    The Phase III Correct study involved 760 patients with mCRC whose disease had progressed within three months of the last administration of approved standard therapies, or who had withdrawn from standard treatments due to toxicity. Participants were randomized to receive either regorafenib plus best supportive care (BSC), or placebo plus BSC. The study showed that compared with placebo/BSC therapy, regorafenib/BSC treatment increased overall survival by 29%, led to statistically significant improvements in progression-free survival, and also led to an improvement in disease control rate, from 15.4% to 44.8%.

    The Correct study had previously been unblinded in late-2011 following an interim analysis demonstrating that treatment with the drug led to significant improvements in survival. Patients in the placebo arm were in addition offered the opportunity to switch to regorafenib therapy.

    Onyx passed all regorafenib global development and commercialization rights to Bayer in October 2011, as part of a deal in which the firms’ settled litigation and restructured their oncology partnership. Under terms of the agreement Onyx will receive a royalty on any future global net sales of regorafenib in oncology. In addition, Bayer will contract the Onyx sales force to promote regorafenib, along with Bayer sales representatives, in the U.S. 


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