Bayer Pharmaceutical will work in partnership with the US National Surgical Adjuvant Breast and Bowel Project (NSABP) to explore Stivarga (Regorafenib) as an additional therapy in treating colon cancer. NSABP is a leading clinical trial cooperative research group that will determine if Regorafenib is an effective adjuvant treatment for Stage IIIB and IIIC colon cancer after a patient completed the standard adjuvant chemotherapy.
The Stage IIIB and IIIC are given to patient whose tumor has started to invade the walls of the colon, but has not yet metastasized to other adjacent organs.
According to Normal Wolmark, MD, the Chairman of NSABP, they collaborate with Bayer Pharmaceuticals because of an alarming increase of patients diagnosed with colorectal cancer. It is estimated that this year, 2016, over 134,000 of adults in US will be diagnosed with Colorectal Cancer. Two-thirds of these patients or over 95,000 are estimated to be diagnosed with colon cancer.
Wolmark said that despite taking the adjuvant chemotherapy, patients with Stage IIIB and IIIC Colon cancer are still at risk of developing a metastatic disease. This means that the tumor cells have spread from the colon to other adjacent and or distant organs. Thus, NSABP plans to explore Bayer’s Stivagra as potential adjuvant chemotherapy to help patients who are in this early stage of the disease.
About the ARGO Clinical Trial
Bayer and NSABP will conduct the Phase III of ARGO (A Phase III Randomized Placebo-Controlled Study Evaluating ReGOrafenib Following Completion of Standard Chemotherapy for Patients with Stage III Colon Cancer) trial. This clinical trial will be a double-blind, randomized and placebo-controlled study. Bayer will offer consultation services and financial support.
If the findings are favorable, Bayer will use the data as basis for regulatory filing for health care authorities. It will also support the expanded indication of Stivarga in treating early stages of Colon Cancer.
Dario Mirski MD, Bayer’s Head of Medical Affairs and Senior Vice President in America, shared that their collaboration with NSABP shows their commitment to work with research organizations. This investigation will provide full clinical utility of their cancer treatments like Regorafenib. He also added that this collaboration will help patients who are fighting the toughest forms of cancer.
Why NSABP Choose Regorafenib?
Regorafenib or Stivarga is commercialized and marketed in 90 countries worldwide including United States, Japan and European Union. In Japan, Stivarga is used for the treatment of metastatic colorectal cancer (CRC).
The approval of Regorafenib as treatment for Colorectal Cancer was based on the Phase III CORRECT (Colorectal cancer treated with regorafenib or placebo after failure of standard therapy) Trial.
In US, Stivarga is used for treating metastatic colorectal cancer that was previously treated with irinotecan-based chemotherapy, oxaliplatin, and fluoropyrimidine. It is also used for the treatment of patients with metastatic and unresectable gastrointestinal stromal tumor (GIST) who was previously treated with sunitinib malate and imatinib mesylate.
Regorafenib is an effective treatment for metastatic colorectal cancer and it is also indicated for patients with metastatic GIST. This may have prompted the organization to consider the drug to have a promising potential in treating colon cancer.
Giving Hope for Colon Cancer Patients
Colorectal cancer is the third most common cancer in the US. It is also the second leading cause of cancer death for both sexes. It is estimated that 1 out of 20 patients will be diagnosed with colorectal cancer in their lifetime.
With the increasing number of patients at risk of developing colon cancer, there is a need to explore other alternative treatment options. In this way, they will be able to catch the disease at an early stage. This will prevent the further spread of the disease, which means less medical and hospital expense for the patient.