Business Wire

Phase III Study Evaluating the Efficacy and Safety of Lonsurf (trifluridine/tipiracil) in Patients with Metastatic Gastric Cancer Refractory to Standard Therapies (The TAGS Trial) Meets Primary Endpoint

Del

Servier and Taiho Pharmaceutical Co., Ltd. announced today that the pivotal Phase III trial (TAGS) evaluating Lonsurf® (trifluridine/tipiracil) plus best supportive care (BSC) versus Placebo plus BSC in patients with advanced metastatic gastric cancer (mGC) met its primary objective to improve overall survival (OS).

These results will be submitted for presentation at an upcoming international medical conference and will be submitted to a peer-reviewed journal for publication.

About TAGS

The TAGS trial is a global, randomized, double-blind, placebo-controlled trial evaluating Lonsurf® versus Placebo in patients with pretreated metastatic gastric cancer (mGC).

The TAGS trial enrolled 507 patients who had received at least two prior regimens for mGC and who were refractory to, or unable to, tolerate further chemotherapy. Patients were randomized to receive Lonsurf® plus Best Supportive Care or placebo plus BSC in order to investigate the efficacy and safety. The primary endpoint is overall survival (OS) and secondary endpoint measures include progression free survival (PFS), safety and tolerability, as well as quality of life.

For more information on the TAGS trial, please visit https://clinicaltrials.gov/ct2/show/NCT02500043

The ClinicalTrials.gov Identifier is NCT02500043.

About Metastatic Gastric Cancer

Gastric cancer is the fifth most common cancer worldwide and the third most common cause of cancer-related death (after lung and liver cancer), with an estimate of 723,000 deaths annually1. Approximately 50% of patients with gastric cancer have advanced disease at the time of diagnosis2. Standard chemotherapy regimens for advanced gastric cancer include fluoropyrimidines, platinum derivatives, taxanes, 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

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.3

Lonsurf® is recommended by the National Institute for Health and Care Excellence (NICE).4 NCCN2 and ESMO Guidelines5 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 Lonsurf®.

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.

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 visit: www.servier.com/en/ and www.servier-oncology.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/

More information is available at: https://servier.com/en/

1. 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.fr

2. National Comprehensive Cancer Network (NCCN). Clinical Practice Guidelines in Oncology. Gastric cancer. V.1.2018.

3. European Medicines Agency. EPAR Lonsurf. Available from: http://www.ema.europa.eu/ema/

4. NICE TA405. Available at: www.nice.org.uk/guidance/TA405

5. ESMO consensus guidelines for the management of patients with metastatic colorectal cancer: Van Cutsem E et al. Ann Oncol. 2016;27:1386-422

Contact information

Servier Media Relations
Sonia MARQUES:
media@servier.com
Tel.: +33(0)155724021 /+33(0)784287613
or
Karine BOUSSEAU:
media@servier.com
Tel.: +33(0)155726037

Om 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.

Følg saker fra Business Wire

Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.

Siste saker fra Business Wire

Zephyr Endobronchial Valves Improve Breathing, Quality of Life and Activity for Severe Emphysema Patients in US Pivotal Trial22.5.2018 17:19Pressemelding

Pulmonx® Corp. today announced positive one-year results from the U.S. LIBERATE pivotal trial of the Zephyr® Endobronchial Valve, a minimally-invasive treatment for severe emphysema, an advanced form of chronic obstructive pulmonary disease (COPD). This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180522006139/en/ Zephyr Endobronchial Valves (Photo: Business Wire) “The LIBERATE Study definitively proves that Zephyr Valves offer clinically meaningful improvements in three important areas for patients – the ability to breathe better, be more active, and enjoy an improved quality of life,” said the study’s lead investigator, Gerard Criner, MD, FACP, FACCP, Chair and Professor of Thoracic Medicine and Surgery, Lewis Katz School of Medicine at Temple University. He continued, “All primary and secondary endpoints were met, with Zephyr Valve treatment showing significant improvement for patients across multiple measures of breathing a

Seoul Semiconductor Announces the Availability of a Series of AC LED Modules22.5.2018 16:03Pressemelding

Seoul Semiconductor, a leading global innovator of LED products and technology, announces a comprehensive series of AC LED modules that use the company’s patented Acrich AC LED technology. The modules are offered in designs from 200 to 10,000 lumens in round, rectangular and linear formats. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180522006054/en/ Seoul Semiconductor Announces the Availability of a Series of AC LED Modules (Photo: Business Wire) These AC modules integrate Seoul Semiconductor’s patented Acrich AC driver technology with the company’s advanced LEDs, enabling the design of compact light fixtures with superior lighting performance, making these modules ideal for a wide range of lighting applications. “Lighting designers who are looking to significantly reduce the size, weight, and volume of their luminaire designs can select one of our standard round, rectangular, or linear AC module designs to develop a co

Medicortex Finland Announces Agreement with Pro-Lab22.5.2018 13:58Pressemelding

Medicortex Finland Oy announces that it has entered into an agreement with a Canadian company Pro-Lab Diagnostics Inc. Pro-Lab will be responsible for the regulatory process and registration of the ProbTBI™ brain injury detection kit in Canada and UK. Following a brain injury, the diagnostic test will detect in urine and saliva a unique brain injury biomarker which has been discovered and characterized by Medicortex. The agreement gives Pro-Lab exclusive rights for sales in the UK and Canada from which Medicortex will receive royalties. The agreement between the parties is confidential and no other details about the content of the agreement are disclosed. Pro-Lab will be responsible for the clinical validation of the kit prior to the commercial launch in the territories. In addition to the licensing agreement, the parties intend to initiate a development collaboration, the details of which are being discussed currently. “We are very proud that Pro-Lab Diagnostics has chosen to cooperat

ResMed Studies Show Remote Monitoring and Automated Resupply Improve Adherence to PAP Therapy22.5.2018 12:55Pressemelding

Remote patient monitoring and resupply programs have been shown to improve patient adherence to positive airway pressure (PAP) therapy, according to two separate studies presented by ResMed (NYSE: RMD, ASX: RMD) this week at the ATS 2018 International Conference. Remote monitoring boosts compliance In the first study, medXcloud, a ResMed-assembled group of healthcare key opinion leaders, examined de-identified data of more than 2.6 million U.S. PAP users from ResMed’s world-leading remote monitoring network, AirView. Using this big data approach, researchers observed excellent adherence among patients initiating PAP therapy: 75 percent achieved the CMS compliance threshold.* This rate compares very favorably with that of non-cloud-connected PAP therapy and other chronic medical therapies – both around 50 percent. Plus, the large sample suggests that the findings are generalizable and likely to reflect real-world clinical care. Resupply program boosts long-term compliance In a separate

FLIR Launches Radar and Thermal Products for Border Patrol and the Dismounted Warfighter22.5.2018 12:00Pressemelding

FLIR Systems, Inc. (NASDAQ: FLIR) today announced the availability of three products for use by global militaries and government agencies including border patrol agents. These products include two FLIR Ranger® mid-range panel radars, one with airborne drone and ground target detection, and the Recon® V UltraLite thermal monocular. The products, unveiled at the Special Operations Forces Industry Conference (SOFIC) 2018 in Tampa, Florida, are part of FLIR’s Soldier Solutions family and demonstrate the company’s commitment to deliver the most advanced equipment to armed services personnel. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180522005421/en/ FLIR Ranger R8SS-3D drone-detecting radar can detect over 500 threats and their exact locations simultaneously (Photo: Business Wire) The FLIR Ranger R8SS-3D and R8SS radars, part of FLIR Ranger family of radars, offer mid-range detection capability for both fixed-based installat

Phil Brakewell Set to Lead WilsonHCG's Executive Search Efforts Across EMEA; Forbes Ranks WilsonHCG Among Best Executive Recruiting Firms22.5.2018 12:00Pressemelding

WilsonHCG, global leader and premium provider of innovative talent solutions, further expands its Executive Search division with the appointment of Director Phil Brakewell. Phil, who brings more than 14 years of talent acquisition leadership experience and most recently served as Head of Executive Search for ResourceBank, will be responsible for leading WilsonHCG’s efforts in the EMEA region. Prior to joining ResourceBank, Phil held consultant and resourcing leadership positions at Hitchenor Wakeford and The Caudwell Group – where he was responsible for developing the business internationally and drove innovative search solutions on behalf of a diverse range of clients. “WilsonHCG’s reputation speaks for itself,” said Phil. “WilsonHCG tailors its key service offerings – including Executive Search – to suit individual client needs, and I am thrilled to be part of such a dedicated, innovative team. The new Director position, covering EMEA, demonstrates our commitment to both Executive Se