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Phase III 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 Thera
Date:1/17/2012

WAYNE, N.J., Jan. 17, 2012 /PRNewswire/ -- Bayer HealthCare today announced latest data on its investigational compound regorafenib (BAY 73-4506) from the Phase III CORRECT (Colorectal cancer treated with regorafenib or placebo after failure of standard therapy) trial. 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.(1) 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.(1)

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 as compared to placebo.(1)

Per the recommendation from an independent Data Monitoring Committee, the
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SOURCE Bayer HealthCare
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