On March 27, 2017 Kyowa Hakko Kirin Co., Ltd. (Tokyo: 4151, President and CEO: Nobuo Hanai, "Kyowa Hakko Kirin") reported that the top-line results of a Japanese Phase 3 study of ARQ 197 (generic name: tivantinib) did not meet its primary endpoint (Press release, Kyowa Hakko Kirin, MAR 27, 2017, View Source [SID1234518280]).
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JET-HCC is a randomized, double-blind placebo-controlled study in Japan, to evaluate the efficacy and safety of tivantinib in the patients with c-Met diagnostic-high inoperable hepatocellular carcinoma with a history of prior sorafenib therapy.
The primary endpoint is progression-free survival (PFS), and the top-line results did not show a significant difference in PFS, between the tivantinib group and the placebo group. In terms of safety, the results showed that the safety profiles were similar as previously observed, and a novel safety issue was not found.
The details of the study results will be presented at upcoming scientific congresses and/or in scientific journals.
"I sincerely thank all of the patients, their families, and all of the personnel who contributed to completing this Japanese study of tivantinib." said Mitsuo Satoh, Executive Officer, Vice President, Head of R&D Division of Kyowa Hakko Kirin. "The result was disappointing, but Kyowa Hakko Kirin has gained great experiences in oncology fields through this study."
The Kyowa Hakko Kirin Group companies strive to contribute to the health and well-being of people around the world by creating new value through the pursuit of advances in life sciences and technologies.
＜Outline of the study design＞ Target disease Patients with c-Met diagnostic-high inoperable hepatocellular carcinoma with a history of prior sorafenib therapy,
Design Multi-center, randomized, double-blind, placebo-controlled study
Dose One tablet of the study drug (tivantinib 120 mg, or placebo) is daily administered to the subjects of each group twice in a day
Subject Number approximately 190
Primary endpoint Progression-free survival
Study Location Japan
About ARQ197 (tivantinib)
Tivantinib, an oral agent whose molecular target is c-MET, was discovered by ArQule, Inc. (NASDAQ: ARQL). Kyowa Hakko Kirin signed a license agreement with ArQule for the exclusive rights to the development and sales of tivantinib in Japan and some parts of Asia (China, Korea, and Taiwan) on April 27th, 2007. News Release
About c-Met
c-Met is receptor tyrosine kinase. When abnormally activated, the c-Met receptor tyrosine kinase plays multiple roles in aspects of human cancer, including cancer cell growth, survival, angiogenesis, invasion and metastasis.