Business Wire

LONSURF® (trifluridine/tipiracil) Receives Positive Opinion from CHMP in the EU for Patients with Previously Treated Metastatic Gastric Cancer

Share

Servier and its partner Taiho Pharmaceutical Co., Ltd announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for LONSURF (trifluridine/tipiracil) as monotherapy for the treatment of adult patients with metastatic gastric cancer including adenocarcinoma of the gastroesophageal junction, who have been previously treated with at least two prior systemic treatment regimens for advanced disease. The CHMP’s opinion will now be sent to the European Commission (EC) for the adoption of the decision.

Gastric cancer in Europe affects approximately 130,000 people a year,1 and it is estimated that 40% of those patients will have metastatic disease.2 For those with advanced or metastatic disease the treatment options are limited and are often palliative.

“The positive opinion from the CHMP for LONSURF is very welcomed; patients with metastatic gastric cancer have few therapeutic options remaining, so it is of the upmost importance new therapies are made available. The Phase III trial TAGS demonstrated that LONSURF was effective and tolerable for these patients and gave patients valuable months of life,” 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).

The marketing authorization application was supported by data from the global Phase III trial TAGS ( TA S-102 G astric S tudy) which was a randomized, double-blind study evaluating LONSURF, plus best supportive care (BSC) versus placebo plus BSC in patients with metastatic gastric cancer refractory to standard treatments. LONSURF demonstrated significant improvement in overall survival (OS) (HR=0.69 [95% CI 0.56-0.85], p=0.00029) compared to placebo plus BSC. The median OS in patients treated with LONSURF and BSC was 5.7 months compared to 3.6 months when treated with placebo and BSC, and there was a 31% risk reduction of death. The overall safety profile was consistent with the known safety profile of LONSURF in metastatic colorectal cancer (CRC), with mainly hematological adverse events reported.

“Today’s announcement is one step closer to ensuring patients with metastatic gastric cancer have another treatment option, bringing an incremental survival benefit over the standard of care,” said Patrick Therasse, Head of Servier Research and Development Oncology. “Gastric cancer is difficult to treat and each step forward is a major event.”

Currently in the EU, LONSURF is indicated 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.3

#ENDS#

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 colorectal cancer), with an estimated 780,000 deaths annually.4 

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%.2

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, there are neither approved nor standard third-line treatments in the EU.

About LONSURF3

LONSURF consists of a thymidine-based nucleoside analog, trifluridine, and the thymidine phosphorylase (TP) inhibitor, tipiracil, which increases trifluridine exposure by inhibiting its metabolism by TP. Trifluridine is incorporated into DNA, resulting in DNA dysfunction and inhibition of cell proliferation.

In the EU, 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.

As of July 2019, LONSURF has been approved as a treatment for advanced mCRC in 68 countries and regions. In February 2019, LONSURF has been approved as a treatment for mGC/mGEJC in the United States.

LONSURF was discovered and developed by Taiho Pharmaceutical. In June 2015, Taiho Pharmaceutical and Servier entered into an exclusive license agreement for the co-development and commercialization of LONSURF in Europe and other countries outside of the United States, Canada, Mexico and Asia.

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 4.2 billion euros in 2018, Servier employs 22,000 people worldwide. Entirely independent, the Group reinvests 25% of its turnover (excluding generics) 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 neurodegenerative 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 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 targeted therapies, to deliver life-changing medicines to patients.

More information: www.servier.com

Follow us on Social Media:

LinkedIn
Facebook
Twitter


1 World Health Organisation. Globocan. World cancer statistics. Available at: https://gco.iarc.fr/today/data/factsheets/populations/900-world-fact-sheets.pdf Last accessed July 2019.

2 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.

3 European Medicines Agency. LONSURF summary of product characteristics. Available at: https://www.ema.europa.eu/en/documents/product-information/lonsurf-epar-product-information_en.pdf Last accessed July 2019.

4 World Health Organisation. Globocan (2018), gastric cancer. Available at: https://gco.iarc.fr/today/data/factsheets/cancers/7-Stomach-fact-sheet.pdf. Last accessed July 2019.

Contact information

Servier Media Relations
Sonia MARQUES: media@servier.com
Tel.: +33 (0)1 55 72 40 21 / + 33 (0)7 84 28 76 13

Jean-Clément VERGEAU: media@servier.com
Tel.: +33 (0)1 55 72 46 16 / +33 (0)6 79 56 75 96

Karine BOUSSEAU: media@servier.com
Tel. +33 (0)1 55 72 60 37 / + 33 (0) 6 49 92 16 05


About Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

(c) 2018 Business Wire, Inc., All rights reserved.

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

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

Softomotive Named a Strong Performer Among Robotic Process Automation Vendors by Independent Research Firm23.10.2019 16:18:00 CESTPress release

Softomotive announced today it has been positioned as a Strong Performer in The Forrester Wave™: Robotic Process Automation, Q4 2019 report. According to the Forrester report, Softomotive received the highest possible score in three categories, including the Innovation/market approach/access to capital, product roadmap and differentiation, and Enterprise RPA customers criteria. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20191023005637/en/ Softomotive Named a Strong Performer in The Forrester Wave™: Robotic Process Automation, Q4 2019 report. According to the Forrester report (Graphic: Business Wire) Softomotive believes that this report arrives at a time of huge growth in the category, with companies focused on not only adopting RPA technology, but being concerned about how to scale and empower their workforce. This shift has driven a 2x increase in customer count year over year for Softomotive as it expands its global rea

Citi, OPIC and Ford Foundation Launch Scaling Enterprise, a $100MM Financing Partnership to Support Social Enterprises23.10.2019 16:00:00 CESTPress release

Citi Inclusive Finance, the Overseas Private Investment Corporation (OPIC) and the Ford Foundation today introduced Scaling Enterprise, a $100 million loan guarantee facility, which will enable Citi to provide early-stage financing in local currency to companies that expand access to products and services for low-income communities in emerging markets. The announcement was made at the 2019 SOCAP Conference. Loans and working capital in local currency and at affordable rates can enable early-stage social impact companies to achieve scale, greater efficiencies and lower costs. Scaling Enterprise will facilitate vital growth financing to eligible companies that are expanding access to finance, agriculture, energy, affordable housing, water and sanitation to low-income households in emerging markets. Marking the first two transactions under Scaling Enterprise, the partners have committed $5 million in financing to INI Farms to help smallholder banana and pomegranate farmers in India access

Velodyne Announces ADAS Collaboration with Hyundai Mobis23.10.2019 12:00:00 CESTPress release

Velodyne Lidar, Inc. today announced an agreement with Hyundai Mobis to launch a new lidar-based advanced driver assistance system (ADAS) that integrates Velodyne lidar technology and Hyundai Mobis cognitive software. The Velodyne Velarray™-based system is designed specifically for ADAS in consumer vehicles. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20191023005425/en/ Velodyne Lidar announced an agreement with Hyundai Mobis to launch a new lidar-based ADAS system that integrates Velodyne lidar technology and Hyundai Mobis cognitive software. (Photo: Velodyne Lidar). "Hyundai Mobis is delighted to cooperate with Velodyne Lidar, one of the industry's most innovative lidar sensor providers, to launch a lidar system that is essential in high level autonomous driving," said Ko Youngsuk, Head of the Hyundai Mobis Strategy Planning division. "The Velarray, utilizing Velodyne’s industry-leading sensing technology, meets the deman

GSMA and Sónar Release First Details of xside23.10.2019 11:00:00 CESTPress release

The GSMA’s successful Four Years From Now (4YFN) start-up platform and Sónar, the international festival devoted to advanced music, creativity and technology, today announced further details of their hotly anticipated co-curated event, xside. Taking place within the 4YFN venue, from 24-26 February 2020 at Fira Montjuïc, in parallel to 4YFN and MWC Barcelona 2020, xside is a new gathering including conference, networking and music to explore the role technology, design and innovation play in the future of creativity, cultures and business. As the creative heart of 4YFN and MWC Barcelona, xside is designed to create links between Sónar’s audience of creative communities, and the technological and entrepreneurial attendees of the world’s largest mobile event. It is the first integrated convergence event of its kind on this scale, co-created by leading event brands of music, creativity, technology, design and entrepreneurship. xside will welcome over 25,000 attendees across three days and

SES and Thales Reach Record Speed and Enhanced Coverage via Integrated GEO/MEO Network, Raise Bar for Inflight Connectivity23.10.2019 06:55:00 CESTPress release

SES and Thales have taken inflight connectivity to a new level, successfully demonstrating uninterrupted access to high-throughput broadband applications for the first time over a platform supporting multi-orbit interoperability, switching seamlessly between SES’s geostationary (GEO) and O3b medium earth orbit (MEO) satellite beams. The demo flight from Melbourne, Florida to the Atlantic coast of Nicaragua saw dozens of switches successfully completed between GEO and MEO beams, and between multiple MEO satellites within a beam, using the Hughes JUPITER(TM) Aeronautical system high performance airborne modem system, SES and Thales announced today. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20191022006244/en/ SES and Thales Reach Record Speed and Enhanced Coverage via Integrated GEO/MEO Network, Raise Bar for Inflight Connectivity (Photo: Business Wire) Engineers aboard the test flight were able to simultaneously use a broad

REE Cooperates with Hino Motors to Showcase New FlatFormer Concept Vehicle at the 46th Tokyo Motor Show23.10.2019 06:30:00 CESTPress release

Tokyo Motor Show – Today, REE announced its cooperation with Hino Motors, a leading provider of commercial vehicles, and showcased its technology within Hino’s new FlatFormer modular concept model, a super-flexible chassis that optimizes electric mobility solutions, at the 46th Tokyo Motor Show. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20191022006241/en/ (Photo: Business Wire) REE’s corner module technology plays an important role to the FlatFormer concept design. FlatFormer leverages REE’s unique technology, which allows the entire drive components to reside within the wheel housing, thus creating a fully flat chassis. With the contribution of REE’s novel electric solution, Hino’s light duty FlatFormer chassis delivers optimized space, flexibility and energy efficiency to customers. [SO2] It supports a diverse range of plug-and-play body configurations that optimize internal vehicle space and provide room for additional