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Trifluridine/Tipiracil (TAS-102) Improves Survival in Colorectal Cancer Patients
Positive phase III results have been reported for an investigational combination anticancer drug, TAS-102 (trifluridine/tipiracil hydrochloride, Taiho Pharmaceutical Co.), in patients with refractory metastatic colorectal cancer (mCRC).
The study met its primary endpoint of demonstrating improvement in overall survival (OS) in patients with refractory mCRC whose disease had progressed after approved standard therapies.
TAS-102 is an oral combination drug consisting of trifluridine and tipiracil hydrochloride. Trifluridine is an antineoplastic nucleoside analog that is incorporated directly into DNA, thereby interfering with the function of DNA. The blood concentration of trifluridine is maintained by tipiracil, which is an inhibitor of the rifluridine-degrading enzyme thymidine phosphorylase.
Results from this study will be presented June 28 at the European Society for Medical Oncology (ESMO) 16th World Congress on Gastrointestinal Cancer, to be held in Barcelona, Spain. In addition, a new drug application (NDA) for TAS-102 is being prepared for submission to the FDA.
The RECOURSE study was a global, randomized, double-blind, placebo-controlled phase III trial evaluating the efficacy and safety of orally administered TAS-102 compared with placebo in patients with refractory mCRC. The trial enrolled 800 patients who had received at least two regimens of standard chemotherapies for mCRC and who were refractory to, or failed on, those therapies. The trial’s primary objective was improvement in OS versus placebo. The study was conducted in North America, Europe, Australia, and Japan.
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 U.S.
Source: Taiho Pharmaceutical Co.; May 12, 2014.