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Phase 3 Data Show Bayer's Investigational Compound Regorafenib (BAY 73-4506) Met Primary Endpoint Showing Statistically Significant Improvement in Overall Survival in Patients with Metastatic Colorectal Cancer Refractory to Standard Approved Therapi
Date:1/17/2012

as compared to placebo.[i]

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.

Bayer plans to submit regorafenib for marketing authorization in mCRC in 2012.

In 2011, Bayer and Onyx entered into an agreement under which Onyx will receive a royalty on any future global net sales of regorafenib in oncology.

About the CORRECT Study

The CORRECT study was an international, multicenter, randomized, double-blind, placebo-controlled Phase 3 study that enrolled 760 patients with mCRC whose disease had progressed during or within 3 months following last administration of approved standard therapies, which must have included fluoropyrimidine, oxaliplatin, irinotecan, bevacizumab and cetuximab or panitumumab.[i]

Patients who had withdrawn from standard treatment due to unacceptable toxicity warranting discontinuation of treatment and precluding retreatment with the same agent prior to progression of disease were also allowed into the study.

Patients were randomized to receive either regorafenib plus best supportive care (BSC) or placebo plus BSC. Treatment cycles consisted of 160 mg of regorafenib (or matching placebo) once daily for three weeks on / one week off plus BSC.[i]

The study was conducted in North America, Europe, China, Japan and Australia.

About Colorectal Cancer

Colorectal cancer (CRC) is a disease in which malignant (cancer) cells form in the tissues of the colon or rectum. The majority of cancers occurring in the colon and rectum are adenocarcinomas, which account for more than 90 percent of all large bowel tumors.[ii]

CRC is the third most commonly diagnosed cancer and the third leading cau
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SOURCE Onyx Pharmaceuticals, Inc.
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