Compelling Data for LONSURF® (trifluridine/tipiracil) in Metastatic Colorectal Cancer Presented at ESMO’s World Congress on Gastrointestinal Cancer by Servier and Taiho
Servier and Taiho Pharmaceutical Co., Ltd. today announced that the TASCO-1 trial demonstrated promising results for LONSURF® (trifluridine/tipiracil) in combination with bevacizumab in patients with previously untreated metastatic colorectal cancer (mCRC) who are not suitable for intensive treatment, with a median progression-free survival (PFS) of 9.2 months (ranging from 7.6 to 11.5 months). A second non-comparative arm in the trial, evaluated the outcome of patients treated with the current standard of care of capecitabine in combination with bevacizumab. The median PFS of this arm was 7.8 months (ranging from 5.5 to 10.1 months).
“Colorectal cancer is the third most common cancer in the world. While there has been some progress in treatment, there are still few options for patients with metastatic disease who are not suitable for intensive treatment,” said Professor Eric Van Cutsem, Head of Digestive Oncology at the University of Leuven, Belgium. “These compelling results suggest that trifluridine/tipiracil, in combination with bevacizumab, can improve progression-free survival in advanced disease, offering a new option to metastatic colorectal cancer patients. These results are an important first step and will need to be investigated further in a global Phase III study.”
Servier has announced the results of a large interim analysis of the Phase IIIb early access study PRECONNECT which is assessing trifluridine/tipiracil in 462 patients with mCRC who have been previously treated with standard therapy. The study showed median progression-free survival of 2.8 months, consistent to that seen in the Phase III RECOURSE trial, which was used as the basis for the European Commission approval of trifluridine/tipiracil in 2016. A similar disease control rate (36.8%) and time to ECOG deterioration (8.7 months) compared to RECOURSE were also shown.
“The incidence of colorectal cancers is growing globally and for those diagnosed with metastatic disease the five-year survival is just 11%,” said Ali Zeaiter, Head of Servier Oncology clinical development department. “For patients with metastatic disease not candidates for intensive therapy or for those who have been pre-treated with chemotherapy and targeted therapies, there are limited options that can extend their survival. We are committed to improving outcomes for people living with cancer, and both TASCO-1 and PRECONNECT studies demonstrate the potential of LONSURF® to provide a substantial benefit to patients with metastatic colorectal cancer.”
TASCO-1 is an international, randomized, non-comparative Phase II trial designed to evaluate efficacy of trifluridine/tipiracil in combination with bevacizumab and the current standard of care (capecitabine and bevacizumab) for patients with untreated metastatic colorectal cancer, who are not suitable for intensive therapy.
In addition to the primary endpoint of PFS, secondary endpoints of the trial included overall survival and disease control rate. The combination of trifluridine/tipiracil and bevacizumab was manageable, with the most frequently observed toxicities being gastrointestinal and hematologic. There was a 3.9% serious febrile neutropenia event rate reported in both arms of the trial.
Servier and Taiho Pharmaceutical are committed to exploring all possible combinations of LONSURF® in the treatment of metastatic colorectal cancer, with a number of ongoing clinical trials.
PRECONNECT is an ongoing international, multicentre, Phase IIIb study designed to further assess safety and efficacy of trifluridine/tipiracil in daily practice by giving eligible adult metastatic colorectal cancer patients access to trifluridine/tipiracil. The study aims to treat 1,000 patients in 20 countries; as of 29th May 2018 the study had recruited 794 patients across 14 countries.
The PRECONNECT trial gives early access to trifluridine/tipiracil for adult patients with mCRC 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. PRECONNECT will also assess the quality of life of patients; preliminary data are anticipated in 2019.
About colorectal cancer
Colorectal cancer is the third most common cancer worldwide with approximately 1.4 million new diagnoses in 2012.1 Each year there are over 690,000 deaths making it the fourth biggest cancer killer worldwide (after lung, liver and gastric cancer).2 Those with metastatic disease (where the cancer has spread from the primary site) the average five-year survival is approximately 11%.3 Standard chemotherapy regimens for advanced metastatic colorectal cancer include fluoropyrimidines, oxaliplatin, irinotecan or targeted treatments, such as those that target vascular endothelial growth factors (VEGF) or endothelial growth factor receptors (EGFR).
About LONSURF ® (trifluridine/tipiracil)
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.4
LONSURF® is recommended by the National Institute for Health and Care Excellence (NICE),5 NCCN6,7 and ESMO Guidelines8 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®.
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. 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 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: www.servier.com
Find us on Social Media:
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 visit: https://www.taiho.co.jp/en/
1 World Health Organisation. Globocan (2012), colorectal cancer. Available at: http://globocan.iarc.fr/Pages/fact_sheets_cancer.aspx?cancer=colorectal Last accessed June 2018
2 Cancer Research UK. Worldwide cancer statistics. Available at: http://www.cancerresearchuk.org/health-professional/cancer-statistics/worldwide-cancer/mortality#heading-One Last accessed June 2018
3 American Cancer Society. Survival Rates for Colorectal Cancer, by Stage. Available at: https://www.cancer.org/cancer/colon-rectal-cancer/detection-diagnosis-staging/survival-rates.html Last accessed June 2018
4 European Medicines Agency. EPAR Lonsurf. Available from: http://www.ema.europa.eu/ema/. Last accessed June 2018.
5 NICE TA405. Available at: www.nice.org.uk/guidance/TA405.
6 National Comprehensive Cancer Network (NCCN). NCCN Guidelines Insights: Colon Cancer, Version 2.2018.
7 National Comprehensive Cancer Network (NCCN). NCCN Guidelines for Patients: Rectal Cancer, Version 1.2017.
8 ESMO consensus guidelines for the management of patients with metastatic colorectal cancer: Van Cutsem E et al. Ann Oncol. 2016;27:1386-422.
Om Business Wire
(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
IFF to Release Fourth Quarter and Full Year 2018 Results February 1322.1.2019 21:15 | Pressemelding
Regulatory News: International Flavors & Fragrances Inc. (NYSE:IFF) (Euronext Paris: IFF) (TASE: IFF), a leading innovator of scent, taste, and nutrition, announced that it will release its fourth quarter and full year 2018 earnings results following the market close on Wednesday, February 13, 2019. The management team will host a live webcast on Thursday, February 14, 2019 at 10:00 a.m. ET to discuss results and outlook with the investor community. Investors may access the live webcast and accompanying slide presentation on the Company's website at ir.iff.com. For those unable to listen to the live webcast, a recorded version will be made available for replay. Meet IFF International Flavors & Fragrances Inc. (NYSE:IFF) (Euronext Paris: IFF) (TASE: IFF) is a leading innovator of scent, taste, and nutrition, with over 110 manufacturing facilities, 100 R&D centers, and 33,000 customers globally. At the heart of our company, we are fueled by a sense of discovery, constantly asking “what i
Gilead Sciences to Release Fourth Quarter and Full Year 2018 Financial Results on Monday, February 4, 201922.1.2019 21:05 | Pressemelding
Gilead Sciences, Inc. (Nasdaq: GILD) announced today that its fourth quarter and full year 2018 financial results will be released on Monday, February 4, after the market closes. At 4:30 p.m. Eastern Time, Gilead’s management will host a conference call to discuss the company’s financial results for the fourth quarter and full year 2018 and provide a business update. The live webcast of the call can be accessed at the company’s Investors page at http://investors.gilead.com/. Please connect to the company’s website at least 15 minutes prior to the start of the call to ensure adequate time for any software download that may be required to listen to the webcast. Alternatively, please call 877-359-9508 (U.S.) or 224-357-2393 (international) and dial the conference ID 3826138 to access the call. Telephone replay will be available approximately two hours after the call through 8:00 p.m. Eastern Time, February 6, 2019. To access the replay, please call 855-859-2056 (U.S.) or 404-537-3406 (int
Oxford Nanopore Prevails in Patent Ruling against Pacific Biosciences22.1.2019 17:04 | Pressemelding
Today the European Patent Office revoked Pacific Biosciences patent EP3045542 with claims to a single molecule sequencing process wherein two strands of DNA are linked by a connecting nucleic acid. The validity of the patent had been challenged by Oxford Nanopore. The EPO ruled that the claims to a single molecule sequencing process were unsupported in the application and that the application only supported a template-directed synthesis sequencing method. As Pacific Biosciences were unwilling to accept this change, the patent was revoked. The decision by the EPO is consistent with a recent decision by the International Trade Commission (ITC) to limit the claims of a related Pacific Biosciences US patent to template-directed synthesis. View source version on businesswire.com: https://www.businesswire.com/news/home/20190122005733/en/ Contact information Oxford Nanopore Zoe McDougall firstname.lastname@example.org Website: https://nanoporetech.com/
Värde Partners Names New Partners, Additional Deputy CIO22.1.2019 17:00 | Pressemelding
Värde Partners is pleased to announce the appointment of Elena Lieskovska and Haseeb Malik to Partner, and the promotion of Brad Bauer to Deputy Chief Investment Officer. “It gives me great pleasure to announce the promotions of three individuals who have been instrumental in the success of our firm through their investing expertise, leadership and integrity,” said George Hicks, Co-Founder and CEO of Värde Partners. “Brad, Elena and Haseeb have all made significant contributions to Värde’s culture, global presence, and, most importantly, delivering returns to our investors.” Based in London, Elena is Head of European Financial Services, responsible for Värde’s private equity investments in specialty finance companies and related businesses in Europe. She joined the firm in 2008 and over the past decade has helped establish the firm as a leader in the consumer finance space, building large credit platforms. Haseeb is Head of Asia Corporate and Traded Credit. Based in Singapore since the
Citi Announces Inaugural Green Bond Issuance22.1.2019 17:00 | Pressemelding
Citi today announced the issuance of the firm’s first green bond, further enhancing its commitment to environmental and climate finance. The bond will fund renewable energy, sustainable transportation, water quality and conservation, energy efficiency and green building projects financed as part of Citi’s $100 billion Environmental Finance Goal. In the deal, which priced on 22nd January 2019, Citi issued €1 billion 3-year fixed rate notes. The transaction marks the first green bond offering from Citigroup Inc. “We are proud to start the year with the launch of our inaugural green bond,” said Jamie Forese, President of Citigroup and Head of the Institutional Clients Group. “This transaction represents an important next step in expanding Citi’s commitment to sustainable growth. This bond also further enhances our green bond expertise, strengthens our partnerships with clients around the world and responds to increasing investor interest in sustainable finance.” In 2015, Citi announced a
NGINX Has Modernized Full API Lifecycle Management22.1.2019 15:44 | Pressemelding
NGINX, Inc., the company based on the popular open source project and offering a suite of technologies designed to develop and deliver modern applications, today announced general availability of its API Management Module. The API Management Module for NGINX Controller is part of the NGINX Application Platform, a modular and integrated set of technologies to help organizations create applications with performance, reliability, security, and scale. The NGINX API management solution enables infrastructure and operations (I&O) teams to define and publish APIs, manage traffic to and secure backend applications, monitor performance issues, and analyze API usage. NGINX API Management Module is built on an innovative architecture that provides three unique benefits: Proven – NGINX combines new control-plane functionality with the raw power and efficiency of NGINX Plus, the industry’s most deployed API gateway. NGINX software powers more than 350 million websites and, according to our 2018 use