Taiho Pharmaceutical Announces Results of Randomized Phase II Clinical Trial with Novel Antitumor Agent TAS-102
TOKYO, July 22, 2011 /PRNewswire/ -- Taiho Pharmaceutical Co., Ltd. (HQ: Tokyo, President: Toru Usami) announced on July 22 the results of a randomized, Phase II clinical trial for the novel oral nucleoside antitumor agent TAS-102 under development by the company for metastatic colorectal cancer, at the 9th Annual Meeting of the Japanese Society of Medical Oncology held in Yokohama. (Abstract no. 10428)
The trial was a randomized, double-blind, placebo-controlled study with a primary outcome measure of overall survival involving 172 patients with refractory metastatic colorectal cancer who had received standard chemotherapy at least two or more regimens containing a fluoropyrimidine, irinotecan, and oxaliplatin. The results indicated that the TAS-102 significantly improved overall survival compared with the placebo (overall survival median: 9.0 months vs. 6.6 months) and significantly reduced the risk of mortality (HR=0.56, p=0.0011). Also, no instances of treatment-related mortality were reported. The most frequently reported adverse drug reaction with a CTCAE grade 3 or higher was neutropenia. Grade 3 or higher diarrhea, fatigue, nausea, and other adverse reactions were no more than 10%.
In light of these results, Taiho Pharmaceutical will proceed with global development of TAS-102 so that this drug can be offered as soon as possible to metastatic colorectal cancer patients who have exhausted proven treatment options and there remains a high unmet medical need.
TAS-102 is a novel oral nucleoside antitumor agent with a novel mechanism of action, composed of a mixture of Trifluorothymidine (FTD), which demonstrates antitumor effects through incorporation into DNA, and 5-chloro-6-(2-iminopyrrolidin-1-yl)-methyl-2,4(1H,3H)-pyrimidinedione hydrochloride (TPI), which inhibits the degradation of FTD. Phase I trials began in Japan in 2005, and the drug continues to be developed as a treatment for colorectal cancer refra