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Study Shows TAS-102 Improves Survival in Refractory Metastatic Colorectal Cancer

Phase III RECOURSE findings to form foundation for FDA submission

The oral combination cancer drug TAS-102 (trifluridine and tipiracil hydrochloride, Taiho Oncology, Inc.), achieved statistically significant improvements in overall survival (OS) and progression-free survival (PFS) in patients with refractory metastatic colorectal cancer (mCRC) whose disease had progressed after or who were intolerant to standard therapies, a study shows.

Detailed findings from the phase III RECOURSE trial of TAS-102 were presented at the European Society for Medical Oncology 16th World Congress on Gastrointestinal Cancer in Barcelona, Spain.

RECOURSE was a global, randomized, double-blind, placebo-controlled comparison trial evaluating the efficacy and safety of orally administered TAS-102 in patients with refractory mCRC. The trial enrolled 800 patients in North America, Japan, Europe, and Australia who had received at least two prior regimens of standard chemotherapies for mCRC and were refractory to or failed those chemotherapies. Patients were randomized (2:1) to receive TAS-102 (35 mg/m2) or placebo, plus best supportive care, twice daily.

The trial met the primary efficacy endpoint of statistically significant improvement in OS versus placebo (hazard ratio [HR], 0.68; P < 0.0001). TAS-102 reduced the risk of mortality by 32% compared with placebo. Median OS was 7.1 months (95% confidence interval [CI], 6.5–7.8) and 5.3 months (95% CI, 4.6–6.0) for TAS-102 and placebo, respectively, and improved with TAS-102 by 1.8 months.

There was also a statistically significant 52% decrease in the risk of disease progression between the two arms (HR, 0.48; P < 0.0001). In addition, the disease control rate of patients treated with TAS-102 was 44.0% versus 16.3% for patients treated with placebo (P < 0.0001). These results were consistent across study regions.

TAS-102 demonstrated a safety profile consistent with that seen in earlier clinical trials. The most commonly reported adverse events included hematological (anemia, neutropenia, and leukopenia) and gastrointestinal (diarrhea, nausea, and vomiting) events. Grade 3 or 4 neutropenia in TAS-102 versus placebo was 37.9% versus 0%, anemia was 18.2% versus 3.0%, and thrombocytopenia was 5.1% versus 0.4%. Febrile neutropenia was 3.8% versus 0%. Grade 3 or 4 diarrhea was 3.0% versus 0.4%, vomiting was 2.1% versus 0.4%, nausea was 1.9% versus 1.1%, fatigue was 3.9% versus 5.7%, and stomatitis was 0.4% versus 0%.

The RECOURSE study data will support U.S. regulatory submissions at the end of 2014.

Colorectal cancer is the third most common cancer worldwide. In 2014, an estimated 136,830 people will be diagnosed with it and 50,310 will die from it in the United States.

TAS-102 is an oral combination anticancer 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.

Source: Taiho Oncology, Inc.; June 28, 2014.

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