Tivantinib is an investigational oral inhibitor of the MET receptor tyrosine kinase, which is currently under phase 3 clinical development for the second-line treatment of hepatocellular carcinoma (HCC), a common type of primary liver cancer.
METIV-HCC is a biomarker-selected, double-blind, placebo-controlled and randomized phase 3 trial, which is assessing tivantinib (2:1) against best supportive care in patients with MET-overexpressing, inoperable HCC intolerant to previously-treated with systemic therapy.
Through the support of validated immunohistochemical assay, the study has analyzed 340 patients with MET-overexpressing HCC. The patients were randomized in the intent-to-treat population for efficacy analysis.
According to ArQule, the primary endpoint of the study is overall survival, while secondary points comprised of progression-free survival and safety.
Excluding Japan, China along with Hong Kong, South Korea and Taiwan, ArQule and Daiichi Sankyo hold a licensing, co-development and co-commercialization agreement for tivantinib in the US, Europe, South America and other parts of the world.
ArQule CEO Paolo Pucci said: "HCC is a disease with high unmet need, especially in the second-line setting, so these results are disappointing for the patients as well as the investigators and the companies.”
Daiichi Sankyo oncology research and development global head and executive vice president Dr Antoine Yver said: "Despite the negative outcome of this study, we remain committed to applying rigorous science to unmet needs for patients with cancer.
"We would like to take this opportunity to thank all of the investigators, and especially the patients, for their participation in this study."