Business Wire

Compelling Data for LONSURF® (trifluridine/tipiracil) in Metastatic Colorectal Cancer Presented at ESMO’s World Congress on Gastrointestinal Cancer by Servier and Taiho

Share

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.”

ENDS

About TASCO-1

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.

About PRECONNECT

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®.

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. 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.

To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.

Contact information

Press:
Servier
Sonia MARQUES
media@servier.com
Tél. +33 (0)1 55 72 40 21 / + 33 (0) 7 84 28 76 13
or
Karine BOUSSEAU
media@servier.com
Tél. +33 (0)1 55 72 60 37

About Business Wire

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

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

Aizon Launches New AI-powered eBR Light Solution to Enhance Manufacturing Productivity in Collaboration with Euroapi18.9.2024 19:00:00 EEST | Press release

Aizon, an Artificial Intelligence (AI) SaaS provider dedicated to transforming pharmaceutical manufacturing operations, is launching a new product called Aizon Execute, an innovative eBR (Electronic Batch Record) software product, developed in collaboration with Euroapi, a leading global API manufacturer. This collaboration was born out of the need to digitize operations towards more data-driven manufacturing - focusing on the essential user needs while avoiding the heavy lift currently associated with going paperless in manufacturing. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240918037613/en/ Aizon Execute is a modern, user-centric, lightweight product designed to adapt to small-scale productions and highly flexible plants like chemical API CDMOs - and has the potential to become the true backbone of digital transformation journeys. Aizon Execute light eBR is designed to facilitate the rapid transition from paper-based

Headline Closes $865 Million to Invest in Growth-Stage Tech Companies18.9.2024 18:53:00 EEST | Press release

Headline today announced Headline Global Growth IV with $865M1 of capital committed to the strategy to support companies at their Growth inflection points, Series B and beyond. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240918812241/en/ Headline's Global Growth Equity Team (Photo: Business Wire) The Global Growth strategy has three distinct advantages: a diverse and experienced team, extensive geographic coverage, and advanced in-house built technology for sourcing (Searchlight) and analytics (DeepDive). Led by seasoned Growth investor Shalini Rao, the Growth team is committed to identifying and nurturing "Paradiesvögel"—tenacious technology founders poised for global success. Recent team additions to Headline Global Growth include Nancy Xiao, Trevor Neff, Reda Bensaid, Jake Horwitz and Austin Hack, all of whom will work out of Headline’s San Francisco and European offices. Global Growth IV represents the evolution of gr

New Garmin G5000 Avionics Upgrade Now Available for Cessna Citation XLS Aircraft at Textron Aviation Service Centers18.9.2024 18:00:00 EEST | Press release

Textron Aviation today announced customers can now upgrade their Cessna Citation XLS+ and Citation XLS Gen2 aircraft with the Garmin G5000 integrated flight deck following Garmin’s receipt of FAA supplemental type certification (STC) for the avionics upgrade. Customers can have the upgrade installed at selected domestic Textron Aviation Service Centers to add significant technological advances and new capabilities to their aircraft. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240918046690/en/ New Garmin G5000 avionics upgrade now available for Cessna Citation XLS aircraft at Textron Aviation Service Centers. (Photo: Garmin, Textron Aviation) Beechcraft, Cessna and Hawker customers receive factory-direct support, maintenance and modifications by Textron Aviation Inc., a Textron Inc. (NYSE: TXT) company, through a global network of service and part centers, mobile service units and 24/7 1CALL AOG support. “The G5000 avionic

ProAmpac Brings Fiberization and Sustainable Packaging Innovation to FACHPACK 202418.9.2024 17:45:00 EEST | Press release

ProAmpac, a leader in flexible packaging and material science, will showcase its latest sustainable packaging solutions at FACHPACK 2024 from September 24-26 in Nuremberg, Germany. At stand 5-126, ProAmpac will present advanced offerings such as ProActive Recyclable® FibreSculpt, ProActive Intelligence® Moisture Protect MP-1000, and the ProActive Recyclable® RP-1050, alongside its RAP Packaging line of fiber-based food-to-go solutions. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240918028305/en/ FibreSculpt (Photo: Business Wire) “We invite attendees to explore ProAmpac’s innovative solutions driving the fiberization of packaging,” said Alex Baumgartner, president of ProAmpac’s European division. “From our MP-1000 technology, which transforms moisture control in powdered beverages and nutraceuticals, to our fiber-based food-to-go packaging, these advancements meet the growing demand for sustainable, high-performance packa

Takeda Commits Over $32 Million in Five New Global Corporate Social Responsibility Partnerships to Further Drive Health Impact in 93 Countries18.9.2024 17:00:00 EEST | Press release

Takeda (TOKYO:4502/NYSE: TAK) today committed JPY4.6 billion (Approx. USD 32 million) to five new Global Corporate Social Responsibility (CSR) partners as part of the company’s ongoing commitment to improving health systems resiliency in low and middle-income countries around the world. This commitment demonstrates Takeda’s focus on tackling systemic disparities and supporting local leadership in strengthening health infrastructure, empowering health workforce, and increasing local knowledge and capacity to improve equitable and sustainable healthcare access and delivery. By 2030, these new collaborations are anticipated to extend Takeda’s impact to 27 million people across 93 countries, raising the total contributions from Takeda’s Global CSR Program to over JPY 28.8 billion (Approx. USD 199.1 million) across 34 significant partnerships since it began in 2016. The five new partners were selected by more than 22,000 Takeda employees across 80 countries and regions through a company-wid

In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.

Visit our pressroom
HiddenA line styled icon from Orion Icon Library.Eye