Bayer Begins Cancer Drug Regorafenib Phase III Trial
Bayer Healthcare announced it has initiated the Phase III trial of its cancer drug regorafenib (Stivarga) tablets for colorectal cancer (CRC). Bayer is now enrolling CRC patients with resected liver metastases for the study.
The COAST (Patients with Stage IV COlorectal Cancer treated with Adjuvant Regorafenib Versus Placebo after Curative Treatment of Liver Metastases in A Randomized, Double-blind, Placebo-controlled Phase-III Study) clinical trial will evaluate regorafenib as an adjunct treatment to colorectal cancer following resection of liver metastases with curative purposes. The COAST study will measure disease-free survival (DFS) and overall survival (OS) in patients who will take oral regorafenib in an adjuvant setting. Approximately 750 patients will be randomized in a 1:1 ratio to take either 160 mg of regorafenib or placebo. Safety and tolerability levels of the treatment groups will be continuously observed.
Dr. Jörg Möller, member of the Bayer HealthCare Executive Committee and Head of Global Development, said, “The COAST trial is another step forward in Bayer’s ongoing commitment to explore the full clinical potential of regorafenib for colorectal cancer patients across different stages of this disease… Many patients with advanced colorectal cancer that has metastasized to the liver experience disease recurrence despite curative surgery and are in need of new treatment options.” CRC is the third most common cancer around the world. More than one million cases occur every year globally.
Regorafenib was developed by Bayer and marketed under the brand name Stivarga. The compound is an oral multi-kinase inhibitor which targets mechanisms involved in tumor growth and progression such as angiogenesis, oncogenesis, and tumor microenvironments. The drug demonstrated inhibition of several angiogenic VEGF receptor tyrosine kinases critical in tumor neoangiogenesis in preclinical studies. Aside from VEGFR 1-3, Stivarga also inhibits different oncogenic and tumor microenvironment kinases which include TIE-2, RAF-1, BRAF, BRAFV600, KIT, RET, PDGFR, and FGFR. These kinases influence tumor growth both individually and collectively. They also impact stromal microenvironment formation and disease progression in patients.
Bayer said the COAST study for regorafenib will be conducted in North America, Europe, Asia, Brazil, Israel, and Australia.