Taiho Pharma drops orantinib Ph III trial

Japanese drugmaker Taiho Pharmaceutical (TYO: 6470) says it is terminating a Phase III clinical trial (ORIENTAL trial) of the angiogenesis inhibitor TSU-68 (orantinib) in patients with hepatocellular carcinoma due to disappointing results.

This trial was a randomized, double-blind trial of hepatocellular carcinoma patients who were treated by transcatheter arterial chemoembolization (TACE), comparing two arms, TSU-68 arm (TACE plus TSU-68) and placebo arm (TACE plus placebo). The purpose of the study was to demonstrate superiority of TSU-68 arm in overall survival. A total of 889 patients were enrolled from December 2010 to November 2013 and follow-up was scheduled until November 2016. This trial was conducted in Japan, South Korea, and Taiwan.

Fails to meet endpoints

An independent data monitoring committee conducted an interim analysis, the results of which indicated that the pre-determined standard related to the primary endpoint of overall survival was not met, and they therefore recommended that the trial be terminated. Based on this recommendation, Taiho Pharmaceutical made the decision to terminate the trial and communicated to the relevant regulatory authorities as well as all the principal investigators that the trial had been terminated.

Detailed results from this trial will be announced at an appropriate medical conference in the future.