Data from TAGS presented at ESMO 20th World
Congress on Gastrointestinal Cancer 2018
Servier and Taiho Pharmaceutical Co., Ltd. today announced
clinical data from the pivotal Phase III trial (TAGS) for LONSURF®
(trifluridine and tipiracil, TAS-102) which showed significant
improvement in overall survival (OS) for the treatment of patients
with refractory metastatic gastric cancer (HR=0.69 [95% IC
0.56-0.85], p=0.0003). The median overall survival in patients
treated with trifluridine/tipiracil and best supportive care (BSC)
was 5.7 months as compared to 3.6 months when treated with placebo
and BSC, and they had a 31% risk reduction of death. At 12-months,
OS rates were 21.2% in the trifluridine/tipiracil group and 13.0%
in the placebo group. In addition, the risk for disease progression
measured by PFS, a key secondary endpoint, was reduced by 43% (HR:
0.57).
The overall safety profile was consistent with the known safety
profile of trifluridine/tipiracil in metastatic colorectal cancer
(CRC), with mainly hematological adverse events reported.
“The results presented today from TAGS demonstrate the potential
of trifluridine/tipiracil in this group of patients with late-stage
metastatic gastric cancer”, said Professor Josep Tabernero. Head of
the Medical Oncology Department, Vall d’Hebron University Hospital,
Barcelona and Director of the Vall d’Hebron Institute of Oncology
(VHIO). “Patients at this stage of the disease have very few
remaining therapeutic options and it is important that efficacious
and manageable treatments are available to expand patient’s
survival.”
Ali Zeaiter, Head of Servier Oncology Clinical Development
Department added, “We are pleased that trifluridine/tipiracil has
shown significant benefit for patients with metastatic gastric
cancer who are in need of effective treatments when there are few
options remaining. We are committed to improving patients’ outcomes
and to providing access to new therapeutic options. We will
continue to collaborate with regulatory bodies to progress our
mission to make trifluridine/tipiracil accessible to patients and
medical professionals.”
Trifluridine/tipiracil is currently indicated in Europe for the
treatment of adult patients with metastatic CRC who have been
previously treated with, or are not considered candidates for,
available therapies including fluoropyrimidine-, oxaliplatin- and
irinotecan-based chemotherapies, anti-VEGF agents, and anti-EGFR
agents.1
About TAGS
TAGS (TAS-102 Gastric Study) is a Taiho-sponsored pivotal Phase
III multinational, randomized, double-blind study evaluating
trifluridine and tipiracil, plus best supportive care (BSC) versus
placebo plus BSC in patients with metastatic gastric cancer
refractory to standard treatments. The primary endpoint in TAGS is
overall survival (OS), and secondary endpoint measures include
progression-free survival (PFS), safety and tolerability, as well
as quality of life.
TAGS enrolled 507 adult patients with metastatic gastric cancer
who had previously received at least two prior regimens for
advanced disease. The trial was conducted in Europe, Russia,
Turkey, Japan, and North America.
For more information on TAGS, please visit
www.ClinicalTrials.gov
(https://clinicaltrials.gov/ct2/show/NCT02500043). The ClinicalTrials.gov Identifier is
NCT02500043.
About Metastatic Gastric Cancer
Gastric cancer, also known as stomach cancer, is a disease in
which malignant cells form in the lining of the stomach. It is the
fifth most common cancer worldwide and the third most common cause
of cancer-related death (after lung and liver cancer), with an
estimated 723,000 deaths annually.2 Approximately 50 percent of
patients with gastric cancer have advanced disease at the time of
diagnosis.3
Standard chemotherapy regimens for advanced gastric cancer
include fluoropyrimidines, platinum derivatives, and taxanes, or
irinotecan. The addition of trastuzumab to chemotherapy is standard
of care for patients with HER2-neu-positive advanced gastric
cancer. However, after failure of first- and second-line therapies,
standard third line treatments are limited.
About LONSURF® (trifluridine and tipiracil,
TAS-102)
LONSURF® is an oral anticancer drug, comprising a combination of
trifluridine (FTD) and tipiracil (TPI), whose dual mechanism of
action is designed to maintain clinical activity. LONSURF® is
registered in Japan, USA, European Union and in many other
countries. In the European Union, LONSURF® is indicated for the
treatment of adult patients with metastatic colorectal cancer (CRC)
who have been previously treated with, or are not considered
candidates for, available therapies including fluoropyrimidine-,
oxaliplatin- and irinotecan- based chemotherapies, anti-VEGF
agents, and anti-EGFR agents.i
LONSURF® is recommended by the National Institute for Health and
Care Excellence (NICE),4 NCCN5,6 and ESMO Guidelines7 for the
treatment of adult patients with metastatic colorectal cancer.
In June 2015, Servier and Taiho Pharmaceutical entered into an
exclusive license agreement for the co-development and
commercialization of LONSUF®.
About Servier
Servier is an international pharmaceutical company governed by a
non-profit foundation, with its headquarters in France (Suresnes).
With a strong international presence in 148 countries and a
turnover of 4.152 billion euros in 2017, Servier employs 21,600
people worldwide. Entirely independent, the Group reinvests 25% of
its turnover (excluding generic drugs) in research and development
and uses all its profits for development. Corporate growth is
driven by Servier’s constant search for innovation in five areas of
excellence: cardiovascular, immune-inflammatory and
neuropsychiatric diseases, cancer and diabetes, as well as by its
activities in high-quality generic drugs. Servier also offers
eHealth solutions beyond drug development.
Becoming a key player in oncology is part of Servier’s long-term
strategy. Currently, there are nine molecular entities in clinical
development in this area, targeting gastric and lung cancers and
other solid tumors, as well as different types of leukemia and
lymphomas. This portfolio of innovative cancer treatments is being
developed with partners worldwide, and covers different cancer
hallmarks and modalities, including cytotoxics, proapoptotics,
immune, cellular and targeted therapies, to deliver life-changing
medicines to patients.
More information: www.servier.com
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About Taiho Pharmaceutical Co., Ltd. (Japan)
Taiho Pharmaceutical, a subsidiary of Otsuka Holdings Co., Ltd.
(https://www.otsuka.com/en/), is an R&D-driven specialty pharma
focusing on the three fields of oncology, allergy and immunology,
and urology. Its corporate philosophy takes the form of a pledge:
“We strive to improve human health and contribute to a society
enriched by smiles.” In the field of oncology, in particular, Taiho
Pharmaceutical is known as a leading company in Japan for
developing innovative medicines for the treatment of cancer, a
reputation that is rapidly expanding through their extensive global
R&D efforts. In areas other than oncology, as well, the company
creates and markets 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
consumer healthcare products that support people's efforts to lead
fulfilling and rewarding lives.
For more information about Taiho Pharmaceutical, please visit:
https://www.taiho.co.jp/en/.
1 European Medicines Agency. Lonsurf. Available at:
http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/003897/human_med_001975.jsp&mid=WC0b01ac058001d124
Last accessed May 2018.2 Ferlay J, Soerjomataram I, Ervik M,
Dikshit R, Eser S, Mathers C, Rebelo M, Parkin DM, Forman D, Bray,
F. GLOBOCAN 2012 v1.0, Cancer Incidence and Mortality Worldwide:
IARC CancerBase No. 11 [Internet]. Lyon, France: International
Agency for Research on Cancer; 2013. Available from:
http://globocan.iarc.fr3 National Comprehensive Cancer Network
(NCCN). Clinical Practice Guidelines in Oncology. Gastric cancer.
V.1.2018.4 NICE TA405. Available at: www.nice.org.uk/guidance/TA405
Last accessed May 2018.5 National Comprehensive Cancer Network
(NCCN). NCCN Guidelines Insights: Colon Cancer, Version 2.2018.6
National Comprehensive Cancer Network (NCCN). NCCN Guidelines for
Patients: Rectal Cancer, Version 1.2017.7 ESMO consensus guidelines
for the management of patients with metastatic colorectal cancer:
Van Cutsem E et al. Ann Oncol. 2016;27:1386-422.
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