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
Entrepreneurs Invited to Apply for 2027 SPIE Startup Challenge11.8.2026 21:40:00 EEST | Press release
Entrepreneurs around the world are invited to apply for a chance to pitch their optics or photonics technologies or products to a panel of expert judges at the 17th annual SPIE Startup Challenge. SPIE, the international society of optics and photonics, holds the competition at Photonics West every January, with multiple teams walking away with cash prizes. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260811090450/en/ Coalesenz won first prize for their hand-held, point-of-care coagulation analyzer at the SPIE Startup Challenge at Photonics West in January 2026. More than a simple pitch competition, the SPIE Startup Challenge is an entry point into the community of high-tech business development of new products in healthcare and deep tech, with an audience of experienced photonics innovators and investors. Cash prizes of $10,000, $5,000, and $2,500 are provided by Startup Challenge Founding Partner Jenoptik. Also given is t
The Aga Khan Museum Welcomes Prince Aly Muhammad Aga Khan and Saira Bhojani to its Board of Directors11.8.2026 18:30:00 EEST | Press release
The Aga Khan Museum is pleased to announce the appointment of Prince Aly Muhammad Aga Khan and Saira Bhojani to its Board of Directors. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260811597825/en/ Prince Aly Muhammad Aga Khan, board member, Aga Khan Museum Prince Aly Muhammad Aga Khan joins the Board with a deep commitment to arts and culture. He brings an international outlook shaped by working with the Aga Khan Foundation and Aga Khan Music Programme. Committed to advancing pluralism and cultural dialogue, Prince Aly brings a fresh perspective that will help guide the Museum as it continues to evolve, engage new audiences, and expand its impact both in Canada and internationally. Prince Aly is the son of His Late Highness Prince Karim Aga Khan IV and brother of His Highness Prince Rahim Aga Khan V. Joining him on the Board is Saira Bhojani, Partner at Torys LLP and one of Canada's leading tax lawyers. Ms. Bhojani is wid
Mouser Explores the Future of Quantum Computing and Its Potential to Transform Engineering11.8.2026 17:48:00 EEST | Press release
Mouser Electronics, Inc., the authorized global distributor with the newest electronic components and industrial automation products, today announced the latest installment of its Empowering Innovation Together (EIT) technology series, A Quantum Leap in Computer Processing. This installment explores the emerging field of quantum computing and examines how the principles of quantum mechanics could unlock new computational capabilities for solving problems that remain difficult for conventional computing architectures. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260811222432/en/ Explore how quantum computing could help engineers address problems too complex for traditional systems. Unlike traditional computers, quantum computers leverage quantum-mechanical phenomena, such as superposition, entanglement, and interference, to perform calculations in fundamentally different ways. While today's quantum systems still face challe
Andersen Global Expands Legal Capabilities with Beech Incorporated11.8.2026 16:30:00 EEST | Press release
Andersen Global enters into a Collaboration Agreement with Beech Incorporated, a legal firm based in South Africa, broadening its legal capabilities in the region. Beech Incorporated provides legal and regulatory services to the mining, renewable energy, infrastructure, oil and gas sectors, specializing in mergers and acquisitions, commercial, project financing, health, safety and environmental, employment, and compliance matters. The firm’s multidisciplinary team advises clients across the full project lifecycle—from development and financing to operations and stakeholder engagement—and is recognized as a leading legal firm by publications including Chambers and Partners and The Legal 500. “Our approach is built on understanding the industries we serve at a practical level and providing practical, actionable advice to clients operating in complex regulatory environments,” said Warren Beech, CEO of Beech Incorporated. “By working alongside the member and collaborating firms of Andersen
Rehlko Expands Power Plus™ Connected-Services Capabilities, Enhancing Value Across Installed Base11.8.2026 16:15:00 EEST | Press release
Rehlko, a global industrial energy resilience platform providing custom-engineered, integrated power solutions for mission-critical infrastructure worldwide, today announced the expanded capabilities of Rehlko Power Plus™ industrial remote monitoring. The cloud-based platform is designed to help customers reduce downtime, improve backup power reliability, and proactively manage critical power assets through real-time monitoring, alerts, diagnostics, and reporting. Rehlko Power Plus represents a meaningful expansion of Rehlko’s aftermarket capabilities and reinforces the company's strategy to deepen customer engagement across the asset lifecycle while growing its higher-value aftermarket business. As backup power systems become increasingly critical to business continuity, organizations need more than periodic inspections and reactive maintenance. Rehlko Power Plusenables customers and distributors to continuously monitor generators and automatic transfer switches, receive real-time ale
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
