Taiho Pharmaceutical Co., Ltd. (HQ: Tokyo, President and Representative Director: Masayuki Kobayashi) announced today its decision to terminate a Phase III clinical trial (ORIENTAL trial) of the angiogenesis inhibitor TSU-68 (orantinib) in patients with hepatocellular carcinoma.
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 trial 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.
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.
Taiho Pharmaceutical remains committed to making further contributions to both cancer patients and physicians engaged in cancer treatment.