Daiichi Sankyo & ArQule Announce Continuation of Phase III Study


ArQule, Inc. and Daiichi Sankyo recently announced that the independent data monitoring committee (DMC) of the METIV-HCC study conducted the planned interim assessment, and it was determined the trial will continue to its final analysis.

METIV-HCC is a biomarker-selected, double-blind, placebo-controlled, pivotal Phase III study evaluating tivantinib (2:1) versus best supportive care in previously systemically-treated patients with MET-high, inoperable HCC, with overall survival as the primary endpoint.

The interim analysis was triggered when at least 60% of the target number of events occurred. The final analysis will take place when 100% 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.

Liver cancer is the sixth most common cancer globally with 782,000 new cases in 2012 and is the second most common cause of cancer-related death with 745,000 deaths in 2012. HCC accounts for about 90% of primary liver cancers. Cirrhosis, chronic hepatitis B and C, and smoking are recognized worldwide as factors increasing the risk of HCC.

Tivantinib is an oral MET inhibitor, currently in Phase II and Phase III 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, such as cetuximab and panitumumab.

In clinical trials to date, treatment with tivantinib has been generally well tolerated and has shown clinical activity in a number of tumors studied. Tivantinib has not yet been approved for any indication in any country. In December 2008, ArQule and Daiichi Sankyo signed a licensing, co-development and co-commercialization agreement for tivantinib in the US, Europe, South America and the rest of the world, excluding Japan, China (including Hong Kong), South Korea, and Taiwan.

In November 2015, ArQule exercised its co-commercialization option for tivantinib in the US. A co-commercialization agreement is expected to be finalized in 2016.

ArQule is a biopharmaceutical company engaged in the research and development of targeted therapeutics to treat cancers and rare diseases. Its mission is to discover, develop, and commercialize novel small molecule drugs in areas of high unmet need that will dramatically extend and improve the lives of patients. For more information, visit www.arqule.com.

Daiichi Sankyo is focused on the discovery and development of novel oncology agents with the goal of delivering first-in-class and best-in-class treatments that address unmet medical needs. The oncology pipeline of Daiichi Sankyo continues to grow and currently includes both small molecules and monoclonal antibodies with novel targets in both solid and hematological cancers. For more information, visit www.daiichisankyo.com.