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

Jaa

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

Tietoja julkaisijasta

For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.

Tilaa tiedotteet sähköpostiisi

Haluatko tietää asioista ensimmäisten joukossa? Kun tilaat mediatiedotteemme, saat ne sähköpostiisi välittömästi julkaisuhetkellä. Tilauksen voit halutessasi perua milloin tahansa.

Lue lisää julkaisijalta Business Wire

AbuDhabi Dubai STOB Series 22 Investment Enters into Favorable Tender Offer Agreement with MINDOL HOLDINGS21.9.2018 04:00Tiedote

AbuDhabi Dubai STOB Series 22 Investment Limited Partnership, hereafter AbuDhabi22, and MINDOL HOLDINGS LIMITED, hereafter MINDOL, listed on the Hong Kong-based Coinsuper exchange (https://www.coinsuper.com) have reached an agreement where AbuDhabi22 will acquire the minimum 33.3 percent holding for the MINDOL cryptocurrency (MIN, https://mindol.net) to be issued by MINDOL, via a tender offer (TOB). Implementation of the TOB will serve to strengthen the strategic partnership with MINDOL. Both companies expect that the AbuDhabi22 bid will greatly exceed any bids made via ordinary exchange channels. With a bid offering at a stable price, the TOB method was chosen for its strategic worth. The MINDOL business vision for 2019 sets a target for its cryptocurrency, from among the more than 2,000 types of cryptocurrencies currently available, to have a top-30 market capitalization. As a business that focuses on "the fusion of subculture and blockchain," they will develop an online game that ta

Afton Chemical’s S$380 Million Phase II Expansion of Its Jurong Island Plant is Now Complete20.9.2018 23:30Tiedote

Afton Chemical Corporation, a global leader in the lubricant and fuel additive market, today announced the completion of the Phase II expansion of its Chemical Additive Manufacturing Facility in Jurong Island, Singapore. This milestone was marked by a special visit from Singapore’s Minister for Trade & Industry Mr. Chan Chun Sing, who also made a speech and toured the facility. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180920005903/en/ Afton Chemical Corporation – Singapore Chemical Additive Manufacturing Facility Phase II Expansion (Photo: Business Wire) As a wholly owned subsidiary of NewMarket Corporation (NYSE: NEU), Afton has been a leading player in the lubricant and fuel additive marketplace for over 90 years. The company was founded on a Passion for Solutions® and has maintained a focus on customizing commercial and industrial solutions that meet customer needs. Afton begun its Singapore manufacturing operations

IFF Announces Pricing of €1,100,000,000 Senior Notes Offering20.9.2018 23:15Tiedote

Regulatory News: International Flavors & Fragrances Inc. (NYSE:IFF) (Euronext Paris: IFF), a leading innovator of sensorial experiences that move the world, today announced that it has priced its public offering of €300,000,000 aggregate principal amount of its 0.500% senior notes due 2021 and €800,000,000 aggregate principal amount of its 1.800% senior notes due 2026. IFF intends to use the net proceeds from the offering to pay a portion of the consideration for the previously announced merger with Frutarom Industries Ltd. and to pay related fees and expenses. IFF anticipates that the offering will close on September 25, 2018, subject to customary closing conditions. The offering is not contingent upon the consummation of the merger. If the closing of the merger has not occurred on or prior to February 7, 2019, or, if prior to such date, the merger agreement with Frutarom is terminated, IFF will be required to redeem all of the notes on the special mandatory redemption date at a redem

Pierre Fabre Receives EU Approval for BRAFTOVI® (encorafenib) + MEKTOVI® (binimetinib) in Adult Patients with Advanced BRAF-Mutant Melanoma20.9.2018 20:21Tiedote

Pierre Fabre today announced that the European Commission (EC) has granted marketing authorisation for the combination of BRAFTOVI® (encorafenib) and MEKTOVI® (binimetinib) for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation, as detected by a validated test.1,2 The EC decision is applicable to all 28 European Union (EU) member states plus Liechtenstein, Iceland and Norway. "We are extremely pleased that European patients with advanced BRAF-mutant melanoma will now have the combination of BRAFTOVI and MEKTOVI as a new treatment option”, said Frédéric Duchesne, President & CEO of the Pierre Fabre Pharmaceuticals Division. “All of us at Pierre Fabre are driven to make a real difference for patients. Bringing more than 30 years of oncology experience and our heritage in dermatology to our partnership with Array BioPharma, we have been able to harness our expertise in order to help men and women living with this devastating disease. Today’s

Clothesource Report Shows Retail Sales Aren’t Falling or Moving Online: Management’s Let Itself Get Misguided20.9.2018 20:19Tiedote

According to a new Clothesource report, “The Emperors’ Clothes” retail sales aren’t falling, and they’re not leaving physical stores. Both the UK’s Office of National Statistics and the US Bureau of the Census report higher retail sales than ever – with sales in physical stores still growing every year. Retailers just need to rely on their own customer understanding, recapture their self-confidence, and rediscover their traditional frugality. Among recent front-page stories have been Sears in the US hinting it’s about to go under and profits at Britain’s John Lewis falling 99%. But the well run clothing retailers are prospering. Primark goes from strength to strength: the biggest clothing specialists on either side of the Atlantic (Inditex and TJX) have just upped their sales and profit forecasts. So it’s not about consumer purchasing: The main problem lies with management, says Clothesource CEO Mike Flanagan in a new report “The Emperors’ Clothes”. They’ve lost touch with their custom

BCW Names Latin America Market Leaders20.9.2018 19:23Tiedote

BCW (Burson Cohn & Wolfe), a leading global communications agency, today announced the appointment of market leaders in Latin America who will be responsible for business growth, client satisfaction and talent development. All market leaders report to Francisco Carvalho, President, Latin America, BCW. “BCW has a dominant presence in Latin America, thanks to Burson-Marsteller’s 40-year-history and expansive footprint across the region and Cohn & Wolfe’s strength in Brazil and Mexico,” said Carvalho. “This team has unmatched market knowledge, strong client relationships and deep commitment to talent, all of which is critical for our continued success in the region. Those strengths, together with our industry-leading expertise in delivering digitally driven integrated communications programs, make BCW a powerful partner for our clients.” All of BCW’s Latin America market leaders have been drawn from the legacy Burson-Marsteller organization and had been leading their respective markets, e

Uutishuoneessa voit lukea tiedotteitamme ja muuta julkaisemaamme materiaalia. Löydät sieltä niin yhteyshenkilöidemme tiedot kuin vapaasti julkaistavissa olevia kuvia ja videoita. Uutishuoneessa voit nähdä myös sosiaalisen median sisältöjä. Kaikki STT Infossa julkaistu materiaali on vapaasti median käytettävissä.

Tutustu uutishuoneeseemme