WHIPPANY, N.J., June 1, 2016 /PRNewswire .Bayer and the U.S. National Surgical Adjuvant Breast and Bowel Project (NSABP), a leading clinical trials cooperative group, are collaborating on a new Phase III study to investigate Stivarga® (regorafenib) tablets as an additional adjuvant therapy in colon cancer. The ARGO trial will investigate regorafenib as a single agent for the adjuvant treatment of Stage IIIB and IIIC colon cancer following completion of standard adjuvant chemotherapy. In this stage, the tumor has started to invade the wall of the colon, but not yet spread to other distant organs.
"In 2016, more than 134,000 adults in the United States will be diagnosed with colorectal cancer. Two-thirds of these cases, or more than 95,000, will be cancers of the colon," said Norman Wolmark, M.D., Chairman of the NSABP. "Despite receiving adjuvant chemotherapy, patients with stage IIIB and IIIC colon cancer are at risk of developing metastatic disease, meaning that the disease has spread from the colon to distant organs. We are keen to explore if regorafenib could help patients at earlier stages of the disease."
The Phase III study ARGO, a randomized, double-blind, placebo-controlled study, will be conducted by NSABP, with Bayer offering consultation as well as financial support. If positive, Bayer may use the results as the basis for regulatory filings to health care authorities to support an expanded indication for the use of Stivarga in this earlier stage of disease.
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