Tivantinib's Phase III study fails to meet primary endpoint

The METIV-HCC Phase 3 study evaluated tivantinib for treating patients with MET-overexpressing, inoperable HCC.
The METIV-HCC Phase 3 study evaluated tivantinib for treating patients with MET-overexpressing, inoperable HCC. | File photo

ArQule Inc. and Daiichi Sankyo's METIV-HCC Phase 3 study of tivantinib in hepatocellular carcinoma (HCC) failed to meet its primary endpoint of improving overall survival.

“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,” ArQule CEO Paolo Pucci said in a statement.

The METIV-HCC Phase 3 study evaluated tivantinib for treating patients with MET-overexpressing, inoperable HCC intolerant to or previously treated with systemic therapy. The study’s primary endpoint was an increase in overall survival rate, while its secondary endpoints included progression-free survival and safety. The companies presented the results at a scientific forum.

“Despite the negative outcome of this study, we remain committed to applying rigorous science to unmet needs for patients with cancer,” Dr. Antoine Yver, global head of oncology research and development at Daiichi Sankyo, said in a statement. “We would like to take this opportunity to thank all of the investigators, and especially the patients, for their participation in this study.”  

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Daiichi Sankyo, Inc. 2 Hilton Ct Parsippan, NJ 07054