June 09, 2014
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New mCRC drug combo meets phase 3 endpoint

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Taiho Pharmaceutical Co., parent company of Taiho Oncology, announced recently that its combination drug for refractory metastatic colorectal cancer met its primary endpoint in a phase 3 global RECOURSE trial.

The RECOURSE trial of the combined oral drugs trifluridine and tipiracil hydrochloride (TAS-102) is a global, randomized, double blind, placebo-controlled study of 800 people with refractory mCRC. Each participant had received at least two prior failed treatment attempts using standard chemotherapy and received either TAS-102 or placebo to establish the efficacy and toleration of the drug combination and improve overall survival.

“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,” Fabio M. Benedetti, MD, senior vice president and chief medical officer at Taiho Oncology, said in a press release.

The company is preparing to submit its findings to regulatory agencies in the US and Europe. More study details will be presented at the European Society for Medical Oncology World Congress on Gastrointestinal Cancer, June 25-28, in Barcelona, Spain.