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Tivantinib fails to improve OS in hepatocellular carcinoma
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A phase 3 study of tivantinib as second-line treatment for hepatocellular carcinoma failed to meet its primary endpoint of improved OS, according to the drug’s manufacturers.
METIV-HCC — a biomarker-selected, double blind, placebo-controlled, randomized study — compared tivantinib (ARQ197; ArQule, Daiichi Sankyo), an investigational inhibitor of the MET receptor tyrosine kinase, with best supportive care in 340 patients with MET–overexpressing, inoperable hepatocellular carcinoma (HCC) who were intolerant to or previously treated with systemic therapy.
OS served as the primary endpoint. Secondary endpoints included PFS and safety.
“HCC is a disease with high unmet need, especially in the second-line setting,” Paolo Pucci, CEO of ArQule, said in a press release. “These results are disappointing for the patients as well as the investigators and the companies.”
Complete results from the trial will be presented at an upcoming scientific forum.
“Despite the negative outcome of this study, we remain committed to applying rigorous science to unmet needs for patients with cancer,” Antoine Yver, MD, MSc, executive vice president and global head of oncology research and development at Daiichi Sankyo, said in the release. “We would like to take this opportunity to thank all of the investigators, and especially the patients, for their participation in this study.”