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
Kerecis Drives the Fish-Skin Conversation at Leading European Wound Conference - EWMA-DEWU 20264.5.2026 21:25:00 EEST | Press release
Kerecis, the company pioneering the use of sustainably sourced intact fish skin in cellular therapy and tissue regeneration, will play a prominent scientific and educational role at the EWMA‑DEWU 2026 Conference, taking place May 6–8 at the Messe & Congress Centrum Bremen in Bremen, Germany. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260504487743/en/ MariCell® Solid This year, The European Wound Management Association's (EWMA) meeting is held in conjunction with the Deutscher Wundkongress (DEWU); combining two major wound-care congresses into a single forum for scientific exchange, education, and clinical discussion. At this year’s conference, Kerecis will highlight growing clinical experience with intact fish‑skin grafts across a broad range of wound indications, supported by two Kerecis‑led scientific symposia, multiple oral and poster presentations, and direct engagement with clinicians at Booth D30, located adjacent
Printing the Future of Medicine: CTIBIOTECH™ Announces $27 Million Investment to Launch U.S. Operations at the SelectUSA Investment Summit4.5.2026 21:00:00 EEST | Press release
CTIBIOTECH™, a pioneering Contract Research, Development, and Manufacturing Organization (CRDMO) and global leader in 3D bioprinting of human tissues, today officially announces the launch of its North American subsidiary, CTIBIOTECH USA™. The official launch took place today at the prestigious SelectUSA Investment Summit in Washington, D.C. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260504107996/en/ From Biopsy to Breakthrough, CTIBIOTECH USA™'s Vision for Precision Medicine Operating from its new United States base in the thriving life sciences “Cellicon Valley” hub of Philadelphia, Pennsylvania, in association with BioLabs for Advanced Therapeutics, CTIBIOTECH USA™ will provide the company's proprietary human cell and tissue bioassays and New Approach Methods (NAMs) directly to North American pharmaceutical, biomedical, and dermatocosmetics markets. By producing and supplying these cutting-edge human bioassays domesti
Kubota Vision Inc. Signs Supply and Licensing Agreement with Laboratoires KÔL for Stargardt Disease Treatment Candidate Under Compassionate Use4.5.2026 18:16:00 EEST | Press release
Kubota Vision Inc. (“Kubota Vision”), a wholly-owned subsidiary of Kubota Pharmaceutical Holdings Co., Ltd. (Minato-ku, Tokyo, Japan) announced signing of a Supply and Licensing Agreement with Laboratoires KÔL (Clermont-Ferrand, France) for the provision of a Stargardt disease (STGD1) treatment candidate under compassionate use authorization. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260414590785/en/ The purpose of this Agreement is for Kubota Vision and KÔL to collaborate on providing “Emixustat” for treatment of Stargardt Disease (STGD1) through compassionate use authorization in France. Kubota Vision will exclusively manufacture and supply Emixustat final products to KÔL and KÔL will have exclusive rights to distribute Emixustat in France under compassionate use access. Ryo Kubota, Chairman, President, and CEO of Kubota Pharmaceutical Holdings, stated, “We are extremely pleased to enter into this Agreement with Labor
Incentive Market Set to Surpass $80B by 2030s — IMA Launches Tools to Help the Industry Keep Pace4.5.2026 17:28:00 EEST | Press release
With combined business spend on loyalty, employee recognition, and channel incentives projected to exceed $80 billion by the 2030s, the incentive industry is entering a period of rapid scale and strategic pressure. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260422729016/en/ In response, the Incentive Marketing Association (IMA) launched a new suite of resources designed to help incentive professionals navigate an environment that’s becoming more specialized, fragmented, and central to business performance. “It’s not just more money coming in—it’s more complexity,” said Vince Chiofolo, President of the Incentive & Engagement Solution Providers (IESP). “Buyers are demanding programs that evolve fast, integrate deeply, and feel personal at scale. These new tools were built for that.” IMA’s Suite of Tools Includes: New Industry Report — Inside the Incentive Buyer’s Mind Drawn from insights of 50+ program owners, the report f
Airship Announces 2026 Elevate Customer Experience Award Winners4.5.2026 16:00:00 EEST | Press release
Airship, the mobile-first customer experience company, today announced the winners of the 2026 Elevate Customer Experience Awards. Global brand leaders from The Economist, Southwest Airlines, and OneFootball were among those honored at the Elevate’26 Customer Experience Summit. The Elevate Awards spotlight global companies that have developed exceptional mobile-first customer experiences for their customers, created innovative campaigns, leveraged AI agents to reach new levels of productivity, and achieved real business results. "Evolving mobile-first consumer behaviors and unprecedented advancements in AI are driving a seismic shift that is reshaping how brands interact with their customers," said Brett Caine, CEO, Airship. "The 2026 Elevate Award winners aren’t just adapting, they’re leading transformative and meaningful customer experiences. These leading organizations are turning everyday interactions into seamless, cross-channel journeys that deliver meaningful business impact and
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
