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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

SOUTH SAN FRANCISCO, Calif., Jan. 17, 2012 /PRNewswire/ -- Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX) today announced results from the Bayer HealthCare Phase 3 CORRECT (Colorectal cancer treated with regorafenib or placebo after failure of standard therapy) trial of Bayer's investigational compound regorafenib (BAY 73-4506). 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. 5.0 months for the placebo group) in patients with metastatic colorectal cancer (mCRC) whose disease had progressed after approved standard therapies.[i] This late-breaking abstract, with these updated data, will be presented by Axel Grothey, MD, Professor of Oncology, Mayo Clinic and co-principal investigator of the CORRECT study, in an oral abstract session (LBA No. 385, January 21, 2012 from 2:30 p.m. – 4:00 p.m. PT, Level 3 Ballroom, Moscone Center West) at the 2012 Gastrointestinal Cancers Symposium of the American Society of Clinical Oncology (ASCO-GI), in San Francisco, CA.

Additionally, findings from the secondary endpoints of the CORRECT study showed statistically significant improvement in progression-free survival (PFS) (HR=0.49, p<0.000001, median PFS: 1.9 months vs. 1.7 months) and an improvement in disease control rate (44.8% vs. 15.3%) in patients treated with regorafenib compared to those treated with placebo. The difference in objective response rate between the two arms (1.0% vs. 0.4%) did not reach statistical significance.[i]

The most common drug-related treatment-emergent adverse events included fatigue (47.4% vs. 28.1%), hand-foot skin reaction (46.6% vs. 7.5%), diarrhea (33.8% vs. 8.3%), anorexia (30.4% vs. 15.4%), hypertension (27.8% vs. 5.9%), oral mucositis (27.2% vs. 3.6%) and rash/desquamation (26.0% vs. 4.0%) for patients receiving regorafenib
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SOURCE Onyx Pharmaceuticals, Inc.
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