SERVIER
22.10.2021 09:02:09 CEST | Business Wire | Press release
Servier, a global independent pharmaceutical group, announced today that the primary objective (progression free survival) of the Phase III SOLSTICE trial has not been met. SOLSTICE was designed to evaluate the superiority of LONSURF® (trifluridine/tipiracil) + bevacizumab over capecitabine + bevacizumab in 1st line unresectable metastatic colorectal cancer (mCRC) in patients non-eligible for intensive therapy. The trial will continue as planned given that no deleterious effects and no new safety issues have been raised in either study arm.
Data from the primary analysis will be presented at an upcoming medical congress.
“We remain committed to improving outcomes in mCRC and we will continue to follow patients as planned in order to perform the main secondary endpoint analysis on overall survival in 2023,” said Patrick Therasse, M.D., Ph. D., Head of Late Stage and Life Cycle Management, and Deputy Head Oncology and Immuno-Oncology Therapeutic Area, Servier. “The clinical value of LONSURF in its current indications remains unchanged, and the ongoing Phase III SUNLIGHT trial (LONSURF + bevacizumab versus LONSURF in 3rd line mCRC) is proceeding as planned.”
Nearly 1.4 million people are diagnosed with colorectal cancer (CRC) each year worldwide,1 equating to 10% of the global cancer cases.1 In Europe, CRC is the second most common cause of cancer death,2 and metastatic (when the cancer has spread from the primary site to other parts of the body) patients have a 5-year survival rate of just 11%.2 Standard chemotherapy regimens for mCRC include fluoropyrimidines, oxaliplatin, irinotecan or targeted treatments, such as those that target vascular endothelial growth factors (VEGF) or endothelial growth factor receptors (EGFR).
“Metastatic colorectal cancer patients who are not well enough to undergo intensive chemotherapy have limited options, and quality of life is a priority,” said Professor Thierry André, MD, Saint Antoine Hospital, Paris, France, and Lead Investigator for the SOLSTICE study. “We are continuously searching for new ways to give these patients efficient treatment with low toxicities.”
Servier is committed to developing new treatments to support patients in their fight against gastrointestinal cancer.
#ENDS#
About SOLSTICE
SOLSTICE is an open-label, randomized, multicentre Phase III trial in 856 unresectable metastatic colorectal cancer patients who are not candidates for, or do not require, intensive therapy. Patients were randomized 1:1 to receive 1st
line LONSURF + bevacizumab versus capecitabine + bevacizumab. The primary objective is to demonstrate superior progression free survival with LONSURF + bevacizumab over capecitabine + bevacizumab. The first patient was enrolled in March 2019.
For more information on SOLSTICE, please visit www.ClinicalTrials.gov (https://www.clinicaltrials.gov/ct2/show/NCT03869892 ). The ClinicalTrials.gov Identifier is NCT03869892.
About LONSURF
LONSURF
consists of a thymidine-based nucleoside analog, trifluridine, and the thymidine phosphorylase (TP) inhibitor, tipiracil, which increases trifluridine exposure by inhibiting its metabolism by TP. Trifluridine is incorporated into DNA, resulting in DNA dysfunction and inhibition of cell proliferation.
In the EU, LONSURF is indicated as monotherapy for the treatment of 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. LONSURF is also indicated as monotherapy for the treatment of adult patients with metastatic gastric cancer (mGC), including adenocarcinoma of the gastroesophageal junction (mGEJC), who have been previously treated with at least two prior systemic treatment regimens for advanced disease.
As of October 2021, LONSURF has been approved in 96 countries for the treatment of advanced mCRC and in 80 countries for the treatment of advanced mGC/mGEJC.
LONSURF was discovered and developed by Taiho Pharmaceutical Co., Ltd. In June 2015, Taiho Pharmaceutical and Servier entered into an exclusive license agreement for the co-development and commercialization of LONSURF in Europe and other countries outside of the United States, Canada, Mexico, and Asia.
About Servier
Servier is a global pharmaceutical group governed by a Foundation. With a strong international presence in 150 countries and a total revenue of 4.7 billion euros in 2020, Servier employs 22,500 people worldwide. Servier is an independent group that invests over 20% of its brand-name revenue in Research and Development every year. To accelerate therapeutic innovation for the benefit of patients, the Group is committed to open and collaborative innovation with academic partners, pharmaceutical groups, and biotech companies. It also integrates the patient's voice at the heart of its activities, from research to support beyond the pill.
A leader in cardiology, the ambition of the Servier Group is to become a renowned and innovative player in oncology. Its growth is based on a sustained commitment to cardiovascular and metabolic diseases, oncology, neuroscience and immuno-inflammatory diseases. To promote access to healthcare for all, the Servier Group also offers a range of quality generic drugs covering most pathologies. More information: servier.com .
Follow us on Social Media:
LinkedIn
Facebook
Twitter
Instagram
References
1
Digestive Cancers Europe. Prevalence of Colorectal Cancer. Available at: https://digestivecancers.eu/colorectal-cancer/prevalence-of-colorectal-cancer-prevalence/?menu_id=13873
Last accessed: October 2021.
2
World Health Organisation. GLOBOCAN. Cancer today. Estimated age-standardized incidence rates (World) in 2018, all cancers, both sexes, all ages. Available at: https://gco.iarc.fr/today/online-analysis-map?v=2018&mode=population&mode_population=continents&population=900&populations=900&key=asr&sex=0&cancer=39&type=0&statistic=5&prevalence=0&population_group=0&ages_group%5B%5D=0&ages_group%5B%5D=17&nb_items=10&group_cancer=1&include_nmsc=1&include_nmsc_other=1&projection=natural-earth&color_palette=default&map_scale=quantile&map_nb_colors=5&continent=0&rotate=%255B10%252C0%255D
Last accessed: October 2021.
View source version on businesswire.com: https://www.businesswire.com/news/home/20211022005006/en/
Link:
About Business Wire
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
BTG Pactual Timberland Investment Group Raises US$1.24 Billion for Largest Reforestation Fund to Date[1]28.4.2026 17:00:00 CEST | Press release
Milestone positions Latin American reforestation strategy as a leading model for scalable, high-integrity conservation and restoration—combining sustainable commercial reforestation with large-scale ecosystem conservation and restoration to target economic returns, climate and biodiversity gains, and rural community benefits. Conservation International serves as Impact Adviser for social and environmental outcomes. BTG Pactual Timberland Investment Group (BTG Pactual TIG), one of the world’s largest timberland managers, today announced the close of fundraising for its Latin American Reforestation Strategy, reaching US$1.24 billion in commitments. This represents the largest reforestation fund closed to date,1 providing a model for large-scale reforestation and restoration that seeks to deliver durable climate impact, tangible benefits for rural communities, biodiversity outcomes, and sustainable commercial production. Global environmental organization Conservation International serves
Qatar Implements Relief Measures to Support Business Community28.4.2026 16:56:00 CEST | Press release
Qatar has activated a comprehensive package of support measures designed to maintain market stability and reinforce investor confidence amid evolving regional conditions. These measures, delivered through the nation’s foreign direct investment ecosystem, provide immediate financial, regulatory and operational relief to Qatar’s international business community. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260428904909/en/ Infographic highlights key relief measures implemented in Qatar to support the business community (Infographic: AETOSWire) H.E. Sheikh Faisal bin Thani Al Thani, Minister of Commerce and Industry and Chairman of Invest Qatar, stated: “Qatar’s commitment to its business community is unwavering. As regional conditions continue to evolve, we remain fully focused on acting decisively to support companies operating in our market, safeguard business continuity and reinforce confidence. Our approach is grounded i
Dubai’s Medcare Hospital Becomes the World’s First to Treat an Adult Spinal Muscular Atrophy (SMA) Patient Outside the US28.4.2026 15:57:00 CEST | Press release
Medcare Royal Speciality Hospital (MRSH) in Dubai has become the world’s first hospital outside the USA, to offer a newly licensed intrathecal gene therapy - Itvisma, to adult patients with Spinal Muscular Atrophy (SMA). This one-time treatment was recently administered to a 22-year-old Egyptian patient, who was diagnosed at 18 months and confined to a wheelchair for most of his life. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260428038416/en/ Dr. Vivek Mundada with Medcare multidisciplinary medical team (Photo: AETOSWire) Last year, Medcare also became the first healthcare provider globally to administer the newly licensed Itvisma to a four-year-old international SMA patient. SMA is a rare neuromuscular disease that leads to progressive muscle weakness and loss of mobility, impacting movement, breathing, and swallowing. Until now, advancements in gene therapy for SMA were primarily restricted to children under the age o
Perpetual Atomics and QSA Global Fuel the World’s First Americium-Powered Radioisotope Heater Unit Core28.4.2026 15:48:00 CEST | Press release
In a landmark achievement for international space exploration, Perpetual Atomics, QSA Global, Inc. and the University of Leicester have completed the first historical production of an Americium-fuelled Radioisotope Heater Unit (RHU) full scale core containing ceramic form americium-241 pellets in a metal containment structure. This breakthrough builds on the successful americium pelleting work in late 2025 and on two decades of experience in leading the development of americium space nuclear power systems by the Leicester team. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260428027123/en/ QSA Global and Perpetual Atomics Team Born out of ENDURE, a European Space Agency (ESA) project, and part of a transatlantic collaboration, this achievement provides the steppingstones for an industrial pathway to deliver radioisotope power systems for spacecraft enabling these to survive and thrive in the most extreme environments in the
Alipay Launches AI Payment Processing Product to Help Businesses and OPCs Thrive in the Agentic Economy28.4.2026 15:47:00 CEST | Press release
New solution enables businesses to monetize services through AI agents Alipay today launched a new AI payment processing product that enables businesses, large and small, including One Person Companies (OPCs) in the Chinese mainland, to receive payments seamlessly when autonomous AI agents, including OpenClaw-type agents, purchase their services. This new product is being launched as AI agents are increasingly executing tasks on behalf of users, from booking travel and comparing prices, to allocating computing power and buying tokens. The product is available on Alipay’s website (https://aipay.alipay.com/). With Alipay’s AI payment processing product, small and medium-sized businesses do not need to build complex payment or settlement systems. By simply onboarding their monetizable services, businesses can reach more customers and receive payment each time an AI agent purchases their service. Bocha, an AI-powered search tool offering web search support for AI applications including Dee
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