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ArQule liver cancer med fails another Phase 3 trial

March 28, 2017

ArQule, Inc. (Nasdaq: ARQL) today reported that its partner, Kyowa Hakko Kirin, announced top-line results of the JET-HCC Phase 3 trial of tivantinib in Japan, and that the trial did not meet its primary endpoint of progression free survival (PFS).

JET-HCC is a randomized, double-blind placebo-controlled study that enrolled approximately 190 Japanese patients with c-Met diagnostic-high inoperable hepatocellular carcinoma (HCC) with a history of prior sorafenib therapy, to evaluate the efficacy and safety of tivantinib.

The primary endpoint of the trial is PFS, and the top-line results did not show a significant difference in PFS between the tivantinib group and the placebo group. There were no new safety issues observed in the trial.

The details of the study results will be presented in an upcoming scientific forum.

“I would like to thank our partner, Kyowa Hakko Kirin, and all the participants in their study,” said Paolo Pucci, Chief Executive Officer of ArQule. “The results are disappointing as there is a need for a second-line HCC therapy in Japan.”

About Hepatocellular Carcinoma (HCC)

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 2012.1 HCC accounts for about 90 percent of primary liver cancers.2Cirrhosis, chronic hepatitis B and C and smoking are recognized worldwide as factors increasing the risk of HCC.2

About Tivantinib (ARQ 197)

Tivantinib (ARQ 197) is an orally administered, small molecule inhibitor of the c-Met receptor tyrosine kinase (“MET”) and its biological pathway. Kyowa Hakko Kirin and ArQule entered into a license agreement for exclusive rights to the development and sale of tivantinib in Japan and certain parts of Asia (China, Korea, and Taiwan) on April 12, 2007.

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