ArQule Inc. (ARQL) said its liver-cancer drug tivantinib (ARQ 197) to treat hepatocellular carcinoma failed to meet the primary endpoint in a Phase 3 trial.

In the late-stage oncology study, ARQ 197 did not show any considerable improvement in overall survival (OS). OS is the duration of time from either the date of diagnosis or the start of treatment for a disease, such as cancer, that patients diagnosed with the disease are still alive.

The drug was evaluated for safety and efficacy as a second-line treatment for patients with MET-overexpressing hepatocellular carcinoma (HCC). The drug has secured Orphan Drug Designation from the U.S. Food And Drug Administration (FDA) for treating the given indication of HCC.

"Despite the negative outcome of this study, we remain committed to applying rigorous science to unmet needs for patients with cancer," said Antoine Yver, MD, MSc, Executive Vice President and Global Head, Oncology Research and Development, Daiichi Sankyo. The companies plan to announce the detailed results of the study at an upcoming scientific forum.

ArQule has a licensing, co-development, and co-commercialization agreement with its Japanese partner Daiichi Sankyo, that covers the U.S., Europe, South America, and the rest of the world. ArQule has Kyowa Hakko Kirin as its co-development partner in Japan, China (including Hong Kong), South Korea, and Taiwan. (See also, Kite Inks $250M Cancer Deal With Daiichi.)

HCC, also called malignant hepatoma, is the most common form of liver cancer and accounts for around 90% of all liver cancer cases. The condition emanates as a result of a viral infection like hepatitis B or C, or NASH. (See also, Gilead To Focus on NASH and HIV Drugs In 2017.)

Following the results of the Phase 3 study, ArQule stock tanked more than 18%, and closed at $1.20 per share on Friday. (See also, Top Cancer Drugs with High Future Sales Potential.)

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