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Taiho Pharmaceutical to terminate phase 3 trial of orantinib, TACE for hepatocellular carcinoma
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Taiho Pharmaceutical Co., parent company of Taiho Oncology, recently announced its decision to terminate a phase 3 clinical trial of the angiogenesis inhibitor orantinib plus transcatheter arterial chemoembolization for the treatment of patients with unresectable hepatocellular carcinoma.
The ORIENTAL trial – conducted in Japan, South Korea, and Taiwan – was a randomized, double-blind trial of hepatocellular carcinoma patients who were treated with transcatheter arterial chemoembolization (TACE), comparing two treatment groups: orantinib (TACE plus orantinib) vs. placebo (TACE plus placebo).
Intended to validate superiority of the orantinib group in OS, the study enrolled 889 patients from December 2010 to November 2013 , with follow-up scheduled for November 2016.
However, according to the results of an interim analysis from an independent data monitoring committee, orantinib plus TACE did not meet the pre-determined standard related to the primary endpoint of improving OS, and the committee advised that the trial be terminated. Based on this recommendation, Taiho Pharmaceutical made the decision to terminate the trial and communicated this decision to the relevant regulatory authorities as well as the principal researchers.