AsianScientist (Aug. 9, 2011) – Kyowa Hakko Kirin Co. Ltd. announced today that it will commence an international Phase III clinical study evaluating the combination of ARQ 197 (tivantinib) and erlotinib in patients with advanced or metastatic non-small cell lung cancer in Asia (Japan, Korea, and Taiwan).
ARQ 197 is an orally administered low molecular weight compound discovered by Massachusetts-based ArQule Inc., which selectively inhibits c-Met (receptor tyrosine kinase), a hepatocyte growth factor receptor over-expressed in solid cancers. c-Met expression is reported to be correlated with the malignancy of cancer.
Kyowa Hakko Kirin signed a license agreement with ArQule for the exclusive rights to the development and sales of ARQ 197 in Japan and some parts of Asia (China, Korea, and Taiwan) on April 27, 2007.
Erlotinib is an orally administered drug that selectively inhibits tyrosine kinase in epidermal growth factor receptors. It is indicated for non-small cell lung cancer and marketed under the brand name Tarceva®.
This study is a randomized, double-blind trial comparing overall survival of patients treated with ARQ 197 and erlotinib to overall survival of patients treated with placebo and erlotinib. The target number of patients to be enrolled in this study is 460.
In addition to the Phase III trial, Kyowa Hakko Kirin is conducting a Phase II international study with ARQ 197 in patients with previously treated advanced/recurrent gastric cancer in Asia (Japan and Korea).
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Source: Kyowa Kirin.
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