A late phase metastatic colorectal cancer trial was stopped after demonstrating a statistically significant improvement in OS.
A phase III trial for an investigational drug for patients with metastatic colorectal cancer was stopped after showing that patients taking the drug experienced a statistically significant improvement in overall survival (OS).
The investigational compound regorafenib (BAY 73-4506) was being studied as part of the CORRECT trial, an international, multicenter, double-blind, placebo-controlled study that enrolled 760 patients with metastatic colorectal cancer whose disease progressed after they had received standard therapies.
Bayer HealthCare and Onyx Pharmaceuticals, partnering companies in the development of regorafenib, announced today that the trial was being stopped because the drug met its primary endpoint, which was improved OS. An independent data-monitoring committee recommended that the study become unblinded and that patients in the placebo arm of the study could start receiving the drug.
Regorafenib, an oral multikinase inhibitor, was given to patients in treatment cycles of 160 mg once daily for 3 weeks. This was followed by 1 week of not taking the drug along with best supportive care. The investigational compound has been shown to block vascular endothelial growth factor (VEGF), a protein that promotes angiogenesis, or the growth of blood vessels. VEGF inhibitors stop the development of new blood vessels and, consequently, the blood flow to the tumors. The compound also inhibits other oncogenic kinases, including RAF and RET, and stromal kinases such as KIT and PDGFR.
“These data are significant because they demonstrate that regorafenib increases overall survival in patients with heavily pretreated mCRC, an area of high unmet medical need,” said Kemal Malik, MD, head of global development and member of the Bayer HealthCare Executive Committee.
According to the National Cancer Institute, an estimated 101,340 new cases of colon cancer and 39,870 new cases of rectal cancer are expected to be diagnosed in the United States in 2011, with a projected 49,380 deaths related to colorectal cancer occurring this year. An estimated 6% of patients with stage IV colorectal cancer, in which the disease has spread to other organs, achieve 5-year survival after treatment.