Taiho Pharmaceutical Announces Results of Randomized Phase II Clinical Trial with Novel Antitumor Agent TAS-102
By Taiho Pharmaceutical Co. Ltd., PRNEThursday, July 21, 2011
TOKYO, July 22, 2011 -
- Positive Results of Overall
Survival in Patients with Colorectal Cancer Refractory to Standard
Chemotherapy -
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.
About TAS-102:
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 refractory to
standard chemotherapy and for which there is presently no
established therapy.
About TAS-102 Phase II clinical
trial:
The Phase II trial was conducted with the participation of 172
patients at 20 medical institutions in Japan from August 2009 to
April 2010. 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 the TAS-102 (114 cases) or a placebo (58
cases). The primary endpoint was overall survival. TAS-102 and
placebo were administered at dose of 70mg/m2/day twice daily for
five days followed by two days rest and repeated twice. This was
followed by a 14-day rest period to make a 28-day schedule for one
course. In both cohorts, the 28-day cycle was repeated until the
established criteria for termination were met.
About Taiho Pharmaceutical:
Taiho Pharmaceutical, a subsidiary of Otsuka Holdings Co., Ltd.,
is an R&D-driven specialty pharma focusing on the three fields
of oncology, allergies and immunology, and urology. Its corporate
philosophy takes the form of a pledge: “We strive to improve human
health and contribute to the enrichment of society.” In the field
of oncology in particular, Taiho Pharmaceutical is known as a
leading company in Japan and around the world for developing
evidence-based medicines for the treatment of cancer. In areas
other than oncology, as well, the company creates quality products
that effectively treat medical conditions and can help improve
people’s quality of life. Always putting customers first, Taiho
Pharmaceutical also aims to offer over-the-counter medicinal
products that support people’s efforts to lead fulfilling and
rewarding lives. For more information about Taiho Pharmaceutical,
please visit
About Otsuka Holdings Co., Ltd.:
The Otsuka Group is a global organization of 145 healthcare
companies with nearly 39,000 employees. Otsuka Holdings Co., Ltd.,
is the Group’s holding company. The main operating companies are
Otsuka Pharmaceutical Co., Ltd.; Otsuka Pharmaceutical Factory,
Inc.; Taiho Pharmaceutical Co., Ltd.; Otsuka Warehouse Co., Ltd.;
and Otsuka Chemical Co., Ltd. The Group operates in 23 countries
and regions, conducting diversified businesses in four segments,
all connected by a focus on health: pharmaceuticals,
nutraceuticals, consumer products, and other product areas. The
Group’s corporate philosophy of “Otsuka-people creating new
products for better health worldwide” is supported by the corporate
ethic of “JISSHO (Proof through Execution) and SOZOSEI
(Creativity).” The Otsuka Group thus seeks to foster a culture and
vitality appropriate to an enterprise involved with human health
and to create innovative products that contribute to the health and
wellness of people worldwide. For more information, please visit
the company’s website at
Contact:
Mitsutoshi Utatsu
Public Relations Dep.
Taiho Pharmaceutical Co., Ltd.
Tel: +81-3-3293-2878
e-mail:
* For inquiries, please contact us by e-mail.
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Tags: Japan, July 22, Taiho Pharmaceutical Co. Ltd., Tokyo
