News Releases

May 14, 2015
Taiho Pharmaceutical Co., Ltd.

Results from Global Phase III Trial of TAS-102 (brand name in Japan: "Lonsurf® ") Published in The New England Journal of Medicine

Taiho Pharmaceutical Co., Ltd. (HQ: Tokyo, President and Representative Director: Masayuki Kobayashi) announced today the publication of results from a global Phase III trial (RECOURSE) of TAS-102(nonproprietary names: trifluridine and tipiracil hydrochloride, brand name in Japan: "Lonsurf® combination tablet T15, T20") in the May 14 online issue of The New England Journal of Medicine. TAS-102 is an oral combination anticancer drug intended for use in the treatment of refractory metastatic colorectal cancer (mCRC).

The RECOURSE trial is a pivotal randomized, double blind, placebo controlled trial conducted in 800 mCRC patients, whose disease had progressed after or who were intolerant to standard therapies. This trial met the primary efficacy endpoint of statistically significant improvement in overall survival versus placebo (HR = 0.68, p < 0.001) and demonstrated a safety profile consistent with that observed in earlier clinical trials.

※ N Engl J Med 2015;372:1909-19. DOI: 10.1056/NEJMoa1414325

About TAS-102

TAS-102 is an oral combination investigational anticancer drug of trifluridine (FTD) and tipiracil hydrochloride (TPI). FTD is an antineoplastic nucleoside analog, which is incorporated into DNA, thereby interfering with the function of DNA. The blood concentration of FTD is maintained via TPI, which is an inhibitor of the FTD-degrading enzyme, thymidine phosphorylase. TAS-102 was approved initially in Japan in March 2014 for the indications of "unresectable advanced or recurrent colorectal cancer (only if refractory to standard therapies)," based on the results of the Phase II clinical trial conducted in Japan, and launched in Japan in May 2014 under the brand name "Lonsurf® combination tablet T15, T20". A condition stipulated at the time of approval required that the results of the RECOURSE trial investigating the drug’s efficacy and safety be promptly submitted. After submission of these results, the condition that restricted the drug’s indications to “only if refractory to standard therapies” was removed, and the indications were then revised in March 2015 to “unresectable advanced or recurrent colorectal cancer.” The drug is currently under review by Health Authorities in the United States and Europe.

Information in this news release was current as of the original release date.

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