Phase III TERRA study of Lonsurf (trifluridine and tipiracil hydrochloride) meets primary endpoint in colorectal cancer- Taiho Pharmaceutical

Taiho Pharmaceutical Co has announced results from its Phase III TERRA study on its oral combination anticancer drug TAS-102 or Lonsurf (trifluridine and tipiracil hydrochloride) in Asian (China, South Korea and Thailand) patients with refractory metastatic colorectal cancer (mCRC). The TERRA study is a randomized, double-blind, placebo-controlled Phase III comparison study evaluating the efficacy and safety of orally administered TAS-102 in patients with refractory mCRC. The study enrolled 406 patients who received at least two prior regimens of standard chemotherapies for mCRC and were refractory to, or failed, those chemotherapies.

The TERRA study met its primary endpoint of demonstrating improvement in overall survival in patients with refractory mCRC whose disease had progressed after approved standard therapies. In this study, TAS-102 appeared to be generally well tolerated and its toxicities were consistent with what was previously reported. More detailed results from this study will be presented at a future international academic conference.

Comment: Lonsurf is currently available in Japan for the treatment of unresectable advanced or recurrent CRC and in the United States for the treatment of patients with mCRC who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy. This drug was CHMP recommended in February 2016.