Daiichi Sankyo announced that the independent data monitoring committee of the METIV-Hepatocellular cancer (HCC) study conducted a planned interim assessment and it was determined the trial will continue to its final analysis.
This pivotal phase 3 study is evaluating whether tivantinib can improve outcomes in previously treated patients with MET-high, inoperable HCC. The interim analysis was triggered when at least 60 percent of the target number of events occurred. The final analysis will take place when 100 percent of the target number of events occurs. The METIV-HCC trial completed patient accrual in December 2015 with more than 300 patients with MET-high HCC enrolled.
About Hepatocellular Carcinoma (HCC)
The liver is the largest organ in the body and is responsible for over 500 functions, including the secretion of glucose, proteins, vitamins, and fats; the production of bile; the processing of hemoglobin; and detoxification of numerous substances.
Hepatocellular carcinoma (HCC) is the most common type of primary liver cancer. According to the Centers for Disease Control and Prevention (CDC), liver cancer is the ninth leading cause of cancer death in the United States and the third leading cause of cancer death worldwide. Factors that increase the risk of developing hepatocellular carcinoma include cirrhosis, long-term, heavy alcohol use, and chronic infection with hepatitis B or C viruses.
About MET and Tivantinib
Tivantinib is an oral MET inhibitor, currently in phase 2 and phase 3 clinical trials. In healthy adult cells, MET can be present in normal levels to support natural cellular function, but in cancer cells, MET can be inappropriately and continuously activated. When abnormally activated, MET plays multiple roles in aspects of human cancer, including cancer cell growth, survival, angiogenesis, invasion, and metastasis. The activation of certain cell signaling pathways, including MET, has also been associated with the development of resistance to anti-EGFR (epidermal growth factor receptor) antibodies including cetuximab and panitumumab.
Reference: Daiichi-Sankyo, Inc. (2016.) Daiiki-Sankyo and Arqule Announce Continuation of METIV-HCC Phase 3 Study of Tivantinib in Second-Line Hepatocellular Carcimona. [Press Release.] Can be accessed at: http://dsi.com/press-releases