News Release


Phase III Clinical Study of S-1 in Patients with Advanced Hepatocellular Carcinoma Did Not Meet Its Primary Endpoint (25/07/2014)

Taiho Pharmaceutical Co., Ltd. (HQ: Tokyo, President and Representative Director: Masayuki Kobayashi) announced today that results of a Phase III clinical study (S-CUBE) conducted in Japan showed that S-1 (Brand name in Japan: TS-1) did not statistically extend overall survival compared to placebo in patients with advanced hepatocellular carcinoma who had failed to sorafenib monotherapy.

Detailed results from this study will be presented at an appropriate upcoming medical conference. The study results do not impact previous approvals of S-1 for other indications.

About S-CUBE
This study was a randomized, placebo-controlled, double-blind Phase III clinical study conducted in Japan in patients with advanced hepatocellular carcinoma whose disease had progressed after treatment with or who were intolerant to sorafenib. It was designed to compare S-1 and placebo in order to expand indications of TS-1 to include hepatocellular carcinoma after standard therapy which is an area of unmet medical needs. The primary objective was superiority of overall survival in the S-1 arm as compared to the placebo arm. A total of 334 patients were enrolled by 58 sites in Japan from October 2009 to August 2013.

About TS-1
A member of the fluoropyrimidine class of chemotherapeutic agents, TS-1 is a combination of three pharmacological compounds: tegafur, an antimetabolite agent that, after absorption, is converted into the anticancer agent fluorouracil (5-FU); gimeracil (5-chloro-2, 4-dihydroxypyridine, or CDHP), which decreases the degradation of 5-FU in the liver; and oteracil potassium (Oxo), which decreases 5-FU phosphorylation in the gastrointestinal tract. Developed as a gastric cancer treatment, TS-1 was first approved in Japan in 1999 and has become a standard of care for the treatment of gastric cancer. TS-1 was subsequently approved in Japan for six additional indications: for the treatment of colorectal, head and neck, non-small cell lung, and inoperable or recurrent breast, pancreatic, and biliary tract cancers. TS-1 is also approved and marketed for patients with gastric cancer in 7 regions and countries* in Asia, and in 19 European countries.* In Taiwan, it is approved and marketed as a treatment of gastric cancer and pancreatic cancer.

* As of July 2014

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