Taiho Pharmaceutical, a subsidiary of Otsuka Holdings Co., Ltd., is an R&D-driven specialty pharma focusing on the three fields of oncology, allergies and immunology, and urology, announced results from its global phase III RECOURSE trial on its oral combination anticancer drug TAS-102 (nonproprietary names: trifluridine and tipiracil hydrochloride) in refractory metastatic colorectal cancer (mCRC). The RECOURSE trial met its primary endpoint of demonstrating improvement in overall survival (OS) in patients with refractory mCRC whose disease had progressed after approved standard therapies. In this trial, TAS-102 appeared to be generally well tolerated and the toxicities were consistent with what was previously reported.

More detailed results from the global phase III RECOURSE trial will be presented on June 28 in the oral presentation session during the ESMO 16th World Congress on Gastrointestinal Cancer 2014 that will be held in Barcelona, Spain (Speaker: Dr. Takayuki Yoshino, the National Cancer Center Hospital East, Japan).

The Taiho team is preparing for the NDA and MAA of TAS-102 in the United States and the European Union, respectively.

The RECOURSE trial is a global, randomized, double-blind, placebo-controlled Phase III comparison trial evaluating the efficacy and safety of orally administered TAS-102 in patients with refractory mCRC. The trial enrolled 800 patients who received at least two prior regimens of standard chemotherapies for mCRC and were refractory to, or failed, those chemotherapies. The trial was conducted in Japan, North America, Europe and Australia. Patients were randomly assigned to receive either TAS-102 or placebo in order to investigate the efficacy of TAS-102. The primary objective of the RECOURSE trial was improvement in overall survival (OS) versus placebo. The principal researchers are Dr. Atsushi Ohtsu, Director of the Exploratory Oncology Research & Clinical Trial Center of the National Cancer Center Hospital East (Japan), Dr. Robert J. Mayer of the Dana-Farber Cancer Institute (USA) and Dr. Eric Van Cutsem of the University Hospital Gasthuisberg (Belgium).

Colorectal cancer is the third most common cancer worldwide. In 2014, it is estimated that 136,830 patients (71,830 men and 65,000 women) will be diagnosed with, and 50,310 patients will die from, cancer of the colon or rectum in the United States.i Colorectal cancer was the second most common cancer in Europe in 2012. In addition, it was estimated that 447,000 patients (242,000 men and 205,000 women) were diagnosed with and 215,000 patients died of colorectal cancer in Europe during 2012.

TAS-102 is an oral combination drug of trifluridine (FTD) and tipiracil hydrochloride (TPI). FTD is an antineoplastic nucleoside analog, which is incorporated directly 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.