Detailed data from Phase III trial of TAS 102 in mCRC-Taiho Pharma

Taiho Pharmaceutical has announced detailed findings from its global Phase III RECOURSE trial of TAS 102 (trifluridine and tipiracil hydrochloride), for patients with refractory metastatic Colorectal Cancer (mCRC). TAS 102 achieved statistically significant improvements in overall survival (OS) and progression-free survival (PFS) in patients with mCRC whose disease had progressed after or who were intolerant to standard therapies. The trial met the primary efficacy endpoint of statistically significant improvement in overall survival versus placebo.

TAS 102 reduced the risk of mortality by 32% when compared to placebo. Median overall survival was 7.1 months and 5.3 months for TAS 102 and placebo, respectively, and was improved in favor of TAS 102 by 1.8 months. There was also a statistically significant 52% decrease in the risk of disease progression between the two arms. TAS 102 demonstrated a safety profile consistent with that observed in earlier clinical trials. The most commonly reported adverse events included hematological (anemia, neutropenia, and leukopenia) and gastrointestinal (diarrhea, nausea, and vomiting) events. Data were presented during an at the European Society for Medical Oncology (ESMO) 16th World Congress on Gastrointestinal Cancer.