Tivantinib for HCC fails to meet endpoint of progression-free survival

ArQule and its partner Kyowa Hakko Kirin announced top-line results of the JET-HCC phase 3 trial for tivantinib, which did not meet its primary endpoint of progression-free survival, according to a company statement.

The researchers enrolled 190 Japanese patients with c-Met diagnostic-high inoperable hepatocellular carcinoma with a history of prior Nexavar (sorafenib, Bayer) therapy to evaluate the efficacy and safety of tivantinib (ARQ 197), an orally administered, small molecule inhibitor of the c-Met receptor tyrosine kinase and its biological pathway.

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

Tivantinib was previously discontinued for gastric cancer, non–small cell lung cancer, pancreatic cancer, soft tissue sarcoma and germ cell/embryonal neoplasms, according to a press release. HCC was the final indication sought for the drug.

Prior to this announcement, the METIV-HCC phase 3 study for tivantinib failed to meet its primary endpoint of improved overall survival.

Researchers will present complete results from the trial at an upcoming scientific forum.

Reference: www.arqule.com