Servier and Taiho Oncology Announce Phase III LONSURF® Study Has Met Primary and Secondary Endpoints Demonstrating Prolonged Overall Survival and Progression-Free Survival in Patients with Refractory Metastatic Gastric Cancer
21.10.2018 12:10:00 EEST | Business Wire | Press release
Servier and Taiho Oncology, Inc. (U.S.), a subsidiary of Taiho Pharmaceutical Co., Ltd. (Japan), jointly announced today clinical data from the pivotal Phase III TAS-102 Gastric Study (TAGS) evaluating LONSURF® (trifluridine/tipiracil, TAS-102) versus placebo and best supportive care in patients with heavily pre-treated metastatic gastric cancer who have progressed or are intolerant to previous lines of therapy. The study met its primary endpoint of prolonged overall survival (OS) and secondary endpoint measures of progression-free survival (PFS) consistently supported the OS results, as well as continuing to demonstrate the predictable safety and tolerability profile of trifluridine/tipiracil. Data from TAGS was presented by Dr. Hendrik-Tobias Arkenau, Executive Medical Director of the Sarah Cannon Research Institute UK and an investigator for TAGS, at the ESMO 2018 Congress in Munich, Germany during an oral session (Abstract #LBA25). The study results were simultaneously published in The Lancet Oncology.
Based on the results, Servier filed a new application for an additional indication for gastric cancer to the European Medicines Agency (EMA) for LONSURF®.
“Patients with metastatic gastric cancer currently have limited treatment options after first and second line therapies have failed,” said Dr. Arkenau. “We are pleased to present new data that demonstrate the overall survival clinical benefit of trifluridine/tipiracil in metastatic gastric and gastroesophageal cancer.”
In TAGS patients treated with trifluridine/tipiracil showed a clinically meaningful and statistically significant improvement in OS compared with placebo and a 31 percent risk reduction of death (HR 0.69 one sided p=0.00029), which translated into a prolonged median survival of 2.1 months (5.7 months for trifluridine/tipiracil versus 3.6 months for placebo). In addition, trifluridine/tipiracil demonstrated a statistically significant improvement in PFS and time to deterioration of ECOG performance status versus placebo, as well as a predictable and manageable safety profile consistent with that previously reported in patients with metastatic colorectal cancer.
“We’re very excited by the results of TAGS as they show trifluridine/tipiracil has the potential to make a difference to the lives of people living with metastatic gastric cancer who continue to struggle with this devastating disease,” said Patrick Therasse, Head of Servier Research and Development Oncology Department.
Trifluridine/tipiracil is currently indicated in 61 countries, including those of the European Union, for the treatment of adult patients with metastatic colorectal cancer 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
The abstract for the trifluridine/tipiracil presentation is available on the ESMO website and the manuscript is published online in The Lancet Oncology.
ENDS
About TAGS
TAGS (
TA
S-102
G
astric
S
tudy)
is a Taiho-sponsored pivotal Phase III, multinational, randomized,
double-blind study evaluating trifluridine/tipiracil, also known as
TAS-102, plus best supportive care (BSC) versus placebo plus BSC in
patients with metastatic gastric cancer, including gastro esophageal
junction cancer, refractory to standard treatments. The primary endpoint
in the TAGS trial is overall survival (OS), and the main secondary
endpoint measures include progression-free survival (PFS), and 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 study was conducted in Japan, the United States, the European Union, Russia, Belarus, Israel, and Turkey.
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
When cancer spreads it is called advanced cancer. Locally advanced cancer is when the cancer has grown outside the organ it started in but hasn’t spread to other parts of the body. When the cancer spreads to other parts of the body this is called metastatic cancer. In the last two decades, the proportion of patients with gastric cancer who present with metastases has risen to over 40%.3
Standard chemotherapy regimens for advanced gastric cancer include fluoropyrimidines, platinum derivatives, and taxanes (with ramucirumab), 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.1
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 CRC.
In June 2015, Servier and Taiho Pharmaceutical entered into an exclusive license agreement for the co-development and commercialization of LONSURF ® .
As of October 2018, LONSURF ® has been approved as a treatment for mCRC in 61 countries and regions worldwide.
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 149 countries
and a turnover of 4.152 billion euros in 2017, Servier employs 21,700
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 twelve molecular entities in clinical development in this area, targeting gastro-intestinal and lung cancers and other solid tumors, as well as various leukemias and lymphomas. This portfolio of innovative cancer treatments is being developed with partners worldwide, and covers different cancer hallmarks and modalities, including cytotoxics, proapoptotics, and targeted therapies, to deliver life-changing medicines to patients.
For more information about Servier, please visit www.servier.com .
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/.
ENDS
1 EMA. Summary of product characteristics: LONSURF. Available at: https://www.ema.europa.eu/documents/product-information/lonsurf-epar-product-information_en.pdf Accessed October 2018.
2 Ferlay J, Soerjomataram I, Dikshit R, et al. Int J Cancer. 2015;136:E359-86.
3 Bernards N, Creemers GJ, Nieuwenhuijzen GA, et al. No improvement in median survival for patients with metastatic gastric cancer despite increased use of chemotherapy. Ann Oncol. 2013;24:3056–60.
4 NICE TA405. Available at: www.nice.org.uk/guidance/TA405 Accessed October 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.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20181021005023/en/
Contact information
Servier
Sonia MARQUES
media@servier.com
Tél.
+33-(0)1-55-72-40-21 / + 33-(0)-7-84-28-76-13
or
Karine
BOUSSEAU
media@servier.com
Tél.
+33-(0)1-55-72-60-37
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Cessna Citation CJ3 Gen3 Achieves First Flight, Advancing Next-Generation Light Jet Toward Certification29.7.2026 19:31:00 EEST | Press release
Textron Aviation Inc., a Textron Inc. (NYSE:TXT) company, recently achieved a key milestone as the Cessna Citation CJ3 Gen3 prototype aircraft completed its first flight, advancing the next-generation light jet toward certification. With this milestone, all three next-generation Citation light jets — the CJ4 Gen3, CJ3 Gen3 and M2 Gen3 — have entered flight testing, demonstrating continued momentum across the Cessna next-generation light jet portfolio. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260729333762/en/ Cessna Citation CJ3 Gen3 achieves first flight, advancing next-generation light jet toward certification. (Photo credit: Textron Aviation) “This achievement continues the forward momentum of the CJ3 Gen3 program and reflects the discipline, innovation and commitment of this team,” said Chris Hearne, senior vice president, Engineering & Programs. “Comprehensive flight testing will now begin for this aircraft with ri
SES Launches Multi-Orbit Satellite Connectivity on LATAM Airbus, Embraer Fleet29.7.2026 18:30:00 EEST | Press release
SES, a leading space solutions company, was selected by LATAM Airlines to provide multi-orbit inflight connectivity service to its growing fleet of Airbus and Embraer aircraft, solidifying SES’s position as the top provider of multi-orbit broadband service in the Americas and around the world. “LATAM’s passengers will soon benefit from reliable, multi-orbit satellite connectivity that will provide the same fast and dependable internet access they enjoy at home no matter where or when they fly. SES’s partnerships with airlines like LATAM highlight how carriers throughout the Americas are leading the way when it comes to the most advanced connectivity. SES is a trusted partner that powers inflight connectivity,” said Mike DeMarco, SES President of Mobility. More than 60 Airbus (A320NEO and A321XLR) and Embraer aircraft (E195-E2) will be equipped with SES services in the coming years. LATAM will be the largest airline in the region to offer service using SES’s new electronically steered a
Carta Rearchitects Private Capital Operations with Plugins for Claude29.7.2026 17:01:00 EEST | Press release
Carta, the connected platform and AI-native ecosystem for private capital, today announces broad availability of its suite of Plugins for Claude following the initial launch in April 2026. With more than 1,500 companies and firms already using the plugins, Carta is changing the way private capital teams — from founders to CFOs — fundamentally operate, bringing fund administration, cap table management, and dealflow analytics directly into the spreadsheets, presentations, and workflows they already use every day. "For the last decade, private capital operation teams have been held back by a hidden tax: the constant, manual handoff of data between disconnected systems," said Henry Ward, Carta CEO. "Carta is eliminating that broken loop entirely by embedding intelligence directly into the tools teams already use. We are not waiting for an AI-native future for private capital — it is running on Carta today." Carta didn't just give Claude a pipe to its data. Carta built its private-capital
VDyne Announces First Patient Treated in TRIVITA US IDE Pivotal Study of the TriNova™ Transcatheter Tricuspid Valve Replacement System29.7.2026 16:00:00 EEST | Press release
VDyne Inc. (“VDyne”), a privately held medical device company developing an innovative transcatheter tricuspid valve replacement (TTVR) system, today announced that the first patient has been enrolled and treated in the TRIVITA US IDE pivotal study of the TriNova™ system. The randomized controlled study will compare TriNova head-to-head with the commercially available Edwards EVOQUE™ TTVR system. The TRIVITA trial (NCT07516444) initiation marks a significant milestone in advancing treatment for tricuspid regurgitation (TR). The prospective, global, multicenter, randomized (1:1) controlled study is designed to evaluate the safety and effectiveness of the TriNova TTVR system in patients with severe or greater tricuspid regurgitation who are suitable for valve replacement. The study will be conducted in the US and Europe with up to 70 sites participating. The first patient was enrolled at the Allina Health Minneapolis Heart Institute at Abbott Northwestern Hospital in Minneapolis, and tre
Grid Dynamics Accelerates Enterprise AI-Native Transformation With Workforce Certification and GAIN Platforms Rollout29.7.2026 16:00:00 EEST | Press release
Grid Dynamics Holdings, Inc. (Nasdaq: GDYN) (“Grid Dynamics”), a leading provider of technology consulting, platform and product engineering, and AI-driven digital transformation services, today announced significant momentum in the adoption of its enterprise agentic AI solutions. Organizations across retail, financial services, manufacturing, CPG, and logistics industries are increasingly deploying Grid Dynamics’ agentic AI-native platforms and Forward Deployed Engineering (FDE)-led services to accelerate software delivery, improve operational efficiency, and transform business processes at scale. Grid Dynamics is widely recognized for its enterprise AI expertise and delivery capabilities across Fortune 1000 organizations. Grid Dynamics has partnership agreements with Anthropic and OpenAI to accelerate the adoption of these platforms within enterprises. By the end of October 2026, Grid Dynamics plans to have 90% of its engineers trained and certified on these platforms. Built to suppo
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom
