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Bayer Initiates Phase III Trial Of StivargaA® (regorafenib) Tablets In Patients With Colorectal Cancer After Resection Of Liver Metastases

WHIPPANY, N.J., Feb. 20, 2014 /PRNewswire/ -- Bayer HealthCare today announced that the company has begun to enroll patients in the COAST trial studying Stivarga ® (regorafenib) tablets in colorectal cancer (CRC) patients with resected liver metastases. The randomized, double-blind, placebo-controlled Phase III trial is designed to determine the effects of Stivarga as adjuvant treatment following surgical removal of liver metastases. 1

"Patients with more advanced colorectal cancer often develop liver metastases – meaning the disease has spread to the liver," said Joseph Germino, Vice President of Medical Affairs, Oncology, Bayer HealthCare. "The COAST trial will investigate treatment with Stivarga in these patients following surgery to remove liver tumors and completion of chemotherapy."

Stivarga is approved by the U.S. Food and Drug Administration (FDA) to treat two different tumor types. In September 2012, Stivarga was first approved for the treatment of patients with metastatic colorectal cancer (mCRC) who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if KRAS wild type, an anti-EGFR therapy. In February 2013, the FDA also approved Stivarga to treat patients with locally advanced, unresectable or metastatic gastrointestinal stromal tumor (GIST) who have been previously treated with imatinib mesylate and sunitinib malate. 2

About Colorectal CancerColorectal cancer is the third most commonly diagnosed cancer and the third leading cause of cancer death in the United States, in both men and women. It is estimated that almost 143,000 people will be diagnosed with CRC in 2013, and nearly 51,000 people will die from the disease. 3 Approximately 50% of colon cancer patients will be diagnosed with liver metastases, either at the time of diagnosis or due to recurrent disease. 4

About the COAST StudyThe COAST [Patients with Stage IV CO lorectal Cancer treated with A djuvant Regorafenib Versus Placebo after Curative Treatment of Liver Metastases in a Randomized, Double-blind, Placebo-controlled Phase-III ST udy] clinical trial is studying Stivarga in patients with colorectal cancer after surgical removal of liver metastases and completion of all planned chemotherapy. The primary endpoint of the study is Disease Free Survival (DFS) as assessed by the investigator. DFS is defined as the time (in days) from date of randomization to date of first observed disease recurrence or death. The trial will enroll approximately 750 patients who will be randomized in a 1:1 ratio to receive either Stivarga or placebo. Patients will receive 160 mg Stivarga or placebo. Both treatments will be followed by a low-fat meal for 3 weeks of treatment followed by 1 week without treatment. Safety and tolerability of the treatment groups will be continuously monitored. 1

The study will be conducted in North America, Brazil, Europe, Asia, Israel and Australia. For further information about the study, please visit www.clinicaltrials.gov.

About Stivarga (regorafenib)In the United States, Stivarga is indicated for the treatment of patients with mCRC who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if KRAS wild type, an anti-EGFR therapy. It is also indicated for the treatment of patients with locally advanced, unresectable or metastatic GIST who have been previously treated with imatinib mesylate and sunitinib malate. 2

Stivarga is an inhibitor of multiple kinases involved in normal cellular functions and in pathologic processes such as oncogenesis, tumor angiogenesis and maintenance of the tumor microenvironment. 2

Stivarga is a compound developed by Bayer. In 2011, Bayer entered into an agreement with Onyx Pharmaceuticals, Inc., an Amgen subsidiary (NASDAQ: AMGN), under which Onyx receives a royalty on all global net sales of Stivarga in oncology.

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