Tivantinib (ARQ 197)

Overview

Tivantinib is an investigational oral inhibitor of the MET receptor tyrosine kinase. Tivantinib has been jointly developed by ArQule and Daiichi Sankyo in the Americas, Europe, Australia and rest of the world, excluding Japan, China (including Hong Kong), South Korea and Taiwan, where development has been conducted by ArQule and Kyowa-Hakko Kirin.

Our most advanced trial with tivantinib, METIV-HCC, was a pivotal Phase 3 randomized, double-blind, controlled study of tivantinib as single agent therapy in previously treated patients with MET diagnostic-high, inoperable HCC conducted by Daiichi Sankyo and us. The primary endpoint was overall survival (OS) in the intent-to-treat (ITT) population, and the secondary endpoint was progression-free survival (PFS) in the same population. On February 17, 2017, we and Daiichi Sankyo announced that the METIV-HCC trial did not meet its primary endpoint of improving OS.

A second Phase 3 clinical trial with tivantinib known as JET-HCC was conducted in Japan. JET-HCC was a pivotal, randomized, double-blind, controlled study of tivantinib as single-agent therapy in previously treated patients with MET diagnostic-high, inoperable HCC conducted by Kyowa Hakko Kirin. The primary endpoint was PFS in the ITT population. Kyowa Hakko Kirin has enrolled approximately 190 patients in the study. On March 27, 2017, we and Kyowa Hakko Kirin announced that the JET-HCC trial did not met its primary endpoint of PFS.

Mechanism of Action

Overexpression of the MET pathway is associated with poor outcomes in many cancers, including HCC, non-small cell lung cancer (NSCLC) and others.

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 for unknown reasons. When abnormally activated, MET plays multiple roles in aspects of human cancer, including cancer cell growth, survival, angiogenesis, invasion and metastasis.

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