Servier Receives Positive CHMP Opinion for LONSURF® (trifluridine/tipiracil) for Refractory Metastatic Colorectal Cancer
Servier today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending LONSURF® (trifluridine/tipiracil), formerly known as TAS-102, for the treatment of adult patients with metastatic colorectal cancer (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.
“The positive CHMP opinion for LONSURF marks our entry into the field of solid tumors, but more importantly, it is an important step forward in the treatment of patients with metastatic colorectal cancer,” said Patrick Therasse MD, PhD, Director & Head of Development, Oncology at Servier. “Patients with mCRC who do not respond to standard therapies currently have limited therapeutic options. The availability of an oral treatment that could help to extend overall survival will be an important advantage for patients.”
The CHMP positive opinion is based on data from the international, double-blind, placebo-controlled Phase III RECOURSE study, which investigated the efficacy and safety of LONSURF with best supportive care (BSC) compared to placebo with BSC in 800 patients with previously treated mCRC. The trial met the primary endpoint of statistically significant improvement in overall survival (OS). Results demonstrated a 32% reduction in risk of death compared to BSC (HR=0.68; 95% CI: 0.58 to 0.81 p<0.001) and an improvement of 1.8 months of median OS (median OS was 7.1 for LONSURF vs 5.3 months for placebo). The most frequently observed side effects (≥ 30%) in patients receiving LONSURF were neutropenia, nausea, fatigue, anemia and leucopenia.1,2
An updated OS analysis in 89% of events, this year presented at ASCO GI, confirmed the clinically meaningful and statistically significant survival benefit of LONSURF with BSC compared to placebo with BSC. This translates into a 31% relative reduction in the risk of death and an improvement of 2 months in the median OS. The median OS was 7.2 months for LONSURF with BSC vs 5.2 months for placebo with BSC (HR=0.69; 95% CI: 0.59 to 0.81; p<0.0001), this translated into 1-year survival rates of 27.1% and 16.6%, respectively.2,3
The CHMP positive opinion will now be reviewed by the European Commission and if marketing authorization is granted, LONSURF will be approved in the 28 member countries of the European Union (EU), as well as Iceland, Lichtenstein and Norway.
In June 2015, Servier entered into an exclusive license agreement with Taiho Pharmaceutical Co., Ltd. for the co-development and commercialization of LONSURF. Under the terms of the agreement, Servier will commercialize LONSURF in Europe and other countries outside of the United States, Canada, Mexico and Asia. Taiho Pharmaceutical retains the right to develop and commercialize LONSURF in the United States, Canada, Mexico, and Asia and to manufacture and supply the product.
About Metastatic Colorectal Cancer
There remains a high unmet need in the treatment of colorectal cancer (CRC), which was the second leading cause of cancer-related deaths in Europe in 2012, responsible for 215,000 deaths.4 Approximately 25% of patients with CRC present with metastases at initial diagnosis and almost 50% of patients with CRC will develop metastases.5 This contributes to the high mortality rates reported for CRC; the 5-year survival rate of patients diagnosed with stage IV mCRC is about 11%.6
LONSURF is currently available in Japan for the treatment of unresectable advanced or recurrent CRC and in the United States for the treatment of patients with mCRC who have been previously treated with fluoropyrimidine -, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy.7,8 LONSURF is an oral combination anticancer drug of trifluridine (FTD) and tipiracil (TPI), whose primary mechanism of action differs from fluoropyrimidines. FTD is an antineoplastic nucleoside analog, which is incorporated directly into DNA, thereby interfering with the function of DNA. The blood concentration of FTD is maintained via TPI, which is an inhibitor of the FTD-degrading enzyme, thymidine phosphorylase.
Servier is an independent research-based pharmaceutical company headquartered in France. With a strong international presence in 148 countries and 92% of its medicines being prescribed outside of France, Servier employs more than 21,200 people worldwide. In 2015, the company recorded a turnover of 3.9 billion euros of which 24% was reinvested in research and development. Currently, there are nine new molecular entities in clinical development for oncology respectively in breast, lung and other solids tumors as well as various leukemias and lymphomas.
This portfolio of innovative cancer treatments is being developed with various partners worldwide, and covers different hallmarks of cancer including cytotoxics, proapoptotic, targeted, immune and cellular therapies.
1 Mayer RJ, et al. Randomized Trial of TAS-102 for Refractory Metastatic Colorectal Cancer. N Engl J Med 2015; 372:1909-19.
2 LONSURF Summary of Product Characteristics
3 TAS-102 versus placebo plus best supportive care in patients with metastatic colorectal cancer refractory to standard therapies: Final survival results of the phase III RECOURSE trial. J Clin Oncol 34, 2016 (suppl 4S; abstr 634) Available at: http://meetinglibrary.asco.org/content/159397-173 Accessed February 2016
4 Ferlay J, Steliarova-Foucher E, Lortet-Tieulent J et al. Cancer incidence and mortality patterns in Europe: estimates for 40 countries in 2012. Eur J Cancer 2013;49: 1374–1403.
5 Metastatic colorectal cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol (2014) 25 (suppl 3): iii1-iii9.
6 American Cancer Society. Colorectal Cancer. Available at: http://www.cancer.org/cancer/colonandrectumcancer/detailedguide/colorectal-cancer-survival-rates Accessed February 2016
7 FDA News Release. FDA approves new oral medication to treat patients with advanced colorectal cancer. 22 September 2015. Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm463650.htm Accessed February 2016
8 Taiho Pharma. Taiho's Lonsurf® (trifluridine and tipiracil hydrochloride) Tablets Approved in Japan for Treatment in Advanced Metastatic Colorectal Cancer. Available at: http://www.taiho.co.jp/english/news/20140324.html Accessed February 2016
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
Pierre Fabre & Array BioPharma Announce a 62% Observed OS at One Year from the Phase 3 BEACON CRC Safety Lead-In of the Combination of Encorafenib, Binimetinib and Cetuximab in BRAF-Mutant CRC at the ESMO GI Congress23.6.2018 11:00 | Pressemelding
Not intended for UK- and US-based media Pierre Fabre and its partner Array BioPharma Inc. today announced updated safety and efficacy results, including OS, from the safety lead-in of the Phase 3 BEACON CRC trial evaluating the triplet combination of encorafenib, a BRAF inhibitor, binimetinib, a MEK inhibitor and cetuximab, an anti-EGFR antibody, in patients with BRAF V600E -mutant metastatic colorectal cancer (CRC). The results showed that, at the time of analysis, the OS data were fully mature through 12.6 months and that the median OS had not yet been reached. The one-year overall survival rate for this cohort was 62%. These data were presented in an oral presentation on Saturday, June 23, at the ESMO 20th World Congress on Gastrointestinal Cancer in Barcelona, Spain. The median progression-free survival (mPFS) for patients treated with the triplet was 8 months [95% CI 5.6-9.3] and is similar between patients receiving one prior line of therapy and patients receiving two prior lines
Compelling Data for LONSURF® (trifluridine/tipiracil) in Metastatic Colorectal Cancer Presented at ESMO’s World Congress on Gastrointestinal Cancer by Servier and Taiho23.6.2018 08:10 | Pressemelding
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
Softomotive and Accelerate RPA Partner to Help Enterprises Achieve Faster Time to Value from RPA22.6.2018 15:13 | Pressemelding
Softomotive, a world–class Robotic Process Automation (RPA) technology provider offering best time to value and affordability for all sizes and types of enterprises, is pleased to announce a strategic partnership with AccelerateRPA, a high calibre professional services provider of trained and certified RPA Consultants within Robotic Process Automation. This partnership means that customers and end users of Softomotive’s software, will have additional knowledgeable and professional guidance available to help achieve significant value quickly from their investment in RPA. Companies who are looking to implement Softomotive’s RPA product suite (WinAutomation and ProcessRobot software) will now have direct access to AccelerateRPA’s highly skilled consultants and Developers. Further, AccelerateRPA has also become a licensed reseller of Softomotive’s products, offering customers a single point of contact for delivering both RPA software and services. Ashley Hudson, Director of AccelerateRPA,
Ascend Performance Materials Announces Price Increase for Intermediate Materials22.6.2018 14:00 | Pressemelding
Ascend Performance Materials announced today a price increase for its intermediate materials. The price increase will take effect globally on July 1, 2018, and includes the following terms: Material Price Increase Terms Hexamethylene diamine (HMD) $0.17/lb. • As contracts allow. • Non-contract business – price determined on an order-by-order basis. Acrylonitrile (AN) $0.20/lb. • As contracts allow. • Non-contract business – price determined on an order-by-order basis. Customers should contact their local sales representative for additional information. About Ascend Performance Materials Ascend Performance Materials is a global premium provider of high-quality plastics, fibers and chemicals and is the world’s largest integrated producer of PA66 resin. Headquartered in Houston, Texas, Ascend has eight global locations, including five fully-integrated manufacturing facilities located in the southeastern United States, all dedicated to the innovation and safe production of nylon 6,6. With
Different Countries, Different Customs: Get Ready for the Motorbike Holidays with Moto-tyres.co.uk22.6.2018 13:41 | Pressemelding
Pack your bags, close the boot and get away on holiday? When you start your holidays on a motorcycle, you usually have to consider a few things more when getting ready for your trip. The right preparation is therefore a must. So that nothing stands in the way of a smooth journey, Moto-tyres.co.uk has put together some tips for your next trip. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180622005345/en/ Different countries, different customs: get ready for the motorbike holidays with Moto-tyres.co.uk (Photo: Business Wire) Whether a weekend trip or extended adventure, it all depends on the right equipment. Functional clothing, protectors and rain protection are a must on long trips. Wearing a suitable motorcycle helmet is a legal requirement almost everywhere. However, there are also very different rules and regulations for motorbike equipment and accessories depending on the destination, and you should familiarise yoursel
Boehringer Ingelheim bolsters biologics research and development with 230 million euro investment in new development center22.6.2018 12:00 | Pressemelding
Today Boehringer Ingelheim announced a 230 million euro investment into a new Biologicals Development Center (BDC) at the company’s Research and Development site in Biberach, Germany during the foundation stone laying for the new center. “The BDC is another key building block supporting the company’s long-term strategy for increasing the pipeline’s share of biologicals. This is particularly driven by two of our core areas, immune oncology and immunology,” says Dr. Fridtjof Traulsen, Corporate Senior Vice President Development at Boehringer Ingelheim. “The share of new biological entities in Boehringer Ingelheim’s research pipeline has been consistently increasing over the past few years and has now reached forty percent.” The BDC will help to maximize synergies by integrating biologicals analytical and process development as well as manufacturing for clinical studies into one seamless unit, while at the same time increasing development capacity. Following a staggered launch beginning i