Announcement of Results of Phase II Randomized Clinical Trial of Taiho Pharmaceutical’s Novel Antitumor Agent TAS-102

At the 9th Annual Meeting of the Japanese Society of Medical Oncology held in Yokohama, Taiho Pharmaceutical Co. Ltd, with headquarters in Tokyo and headed by President Toru Usami, declared results of a novel oral nucleoside antitumor agent TAS-102 that is being developed by the company for metastatic colorectal cancer (Abstract no. 10428)

The primary endpoint of overall survival was determined by the Phase II, randomized, double-blind, placebo-controlled study involving 172 patients with refractory metastatic colorectal cancer receiving at least two or more regimens of standard chemotherapy comprising fluoropyrimidine, irinotecan, and oxaliplatin.

Compared with placebo, results demonstrated that TAS-102 significantly improved overall survival (overall survival median: 6.6 months vs 9.0 months) and appreciably decreased mortality risk (HR = 0.56, p = 0.0011). In addition, reports did not indicate any incidences of treatment-related mortality. Neutropenia was the most reported recurrent adverse drug reaction (CTCAE grade 3 or higher). Grade 3 or higher diarrhea, fatigue, nausea, and other adverse reactions were only around 10%.
There exists a highly unmet medical need in patients with metastatic colorectal cancer patients as they have exhausted all proven treatment options; therefore in light of these results, Taiho Pharmaceutical will go ahead with global development of TAS-in order to make this drug available to these patients at the earliest.

About TAS-102

TAS-102: Comprising a mixture of Trifluorothymidine (FTD) that demonstrates antitumor effects through incorporation into DNA as well as 5-chloro-6-(2-iminopyrrolidin-1-yl)-methyl-2,4(1H,3H)-pyrimidinedione hydrochloride (TPI) that inhibits FTD degradation of FTD, TAS-102 is found to be a novel oral nucleoside antitumor agent with a novel mechanism of action.

Phase I trials in Japan commenced in 2005. Refractory to standard chemotherapy, the drug continues to be developed as a treatment for colorectal cancer for which there is no established therapy presently.

About TAS-102 Phase II clinical trial

From August 2009 to April 2010, the Phase II trial involving 172 patients was conducted at 20 medical institutions in Japan. The target for the study is an area for which there is currently no fully established therapy — specifically, patients refractory to standard chemotherapy for metastatic colorectal cancer who have received at least two or more regimens containing a fluoropyrimidine, irinotecan, and oxaliplatin. Patients were randomly assigned to one of the two treatment arms: TAS-102 (114 patients) or placebo (58 patients), and the primary outcome measure was overall survival. Treatment involving 70 mg/m2/day doses of TAS-102 and placebo were administered twice daily for five days and repeated twice after two days of rest. A 14-day rest period after this dosing concluded the 28-day schedule for one course. Until the established criteria for termination were met, the 28-day cycle was repeated in both cohorts.

About Taiho Pharmaceutical

A subsidiary of Otsuka Holdings Co. Ltd, Taiho Pharmaceutical is a specialty pharma with an R&D-driven focus on oncology, allergies and immunology, and urology. The pledge of its corporate philosophy is, “We strive to improve human health and contribute to the enrichment of society.” With special focus on Oncology, Taiho Pharmaceutical is known worldwide as Japan’s leading company for developing evidence-based medicines for treating cancer. The Company also creates quality products, in other areas besides oncology, which effectively treat medical conditions to help improve quality of life. With customers being their center point, Taiho Pharmaceutical aspires to offer over-the-counter medicinal products to help people live fulfilling and rewarding lives.
For more information about Taiho Pharmaceutical, please visit https://www.taiho.co.jp/english/

About Otsuka Holdings Co. Ltd

Entailing a total of 145 healthcare companies with 39,000 employees, the Otsuka Group is a global organization. The Group’s holding company is Otsuka Holdings Co Ltd. Otsuka Pharmaceutical Co Ltd, Otsuka Pharmaceutical Factory Inc, Taiho Pharmaceutical Co Ltd, Otsuka Warehouse Co Ltd, and Otsuka Chemical Co Ltd are the main operating companies. The Group focuses on 4 segments of health: pharmaceuticals, nutraceuticals, consumer products, and other product areas and conducts diversified businesses by operating in 23 countries and regions. The corporate ethic of “JISSHO (Proof through Execution) and SOZOSEI (Creativity)” supports the Group’s corporate philosophy of “Otsuka-people creating new products for better health worldwide.” The aim of the Otsuka Group is to promote a culture and vitality suitable to an endeavor involved with human health and to develop innovative products that contribute to the health and wellbeing of people worldwide.

For more information, please visit the company’s website at https://www.otsuka.com/en/

Contact: Mitsutoshi Utatsu Public Relations Dep.Taiho Pharmaceutical Co., Ltd.Tel: +81-3-3293-2878e-mail: th-102@taiho.co.jp* For inquiries, please contact us by e-mail.
SOURCE Taiho Pharmaceutical Co., Ltd.