Taiho Pharmaceutical Co. Ltd. and its division Taiho Oncology, Inc. announced results from its global Phase 3 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.

 

“We are very pleased by the results from the Phase 3 RECOURSE trial in refractory mCRC, which support TAS-102 as a potential new treatment option for this patient population,” said Fabio Benedetti, senior vice president and chief medical officer at Taiho Oncology. “The Taiho Oncology team is preparing for the submission of the NDA and MAA of TAS-102 in the United States and the European Union, respectively. We would like to thank our clinical investigators and healthcare professionals, as well as the patients and caregivers, for their participation in this important trial.”

 

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 3 RECOURSE trial will be presented in the oral presentation session during the ESMO 16th World Congress on Gastrointestinal Cancer 2014 that will be held in Barcelona, Spain.

 

Date: May 12, 2014

Source: Taiho Pharmaceutical