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
INSEAD Establishes Thrive Lab With US$3 Million Funding From Google.org and Google DeepMind30.10.2026 10:00:00 CET | Press release
Launched at INSEAD AI Forum Asia, the new Lab is set to advance global academic research on the impact of AI on human connectivity, meaning and wellbeing in work and life INSEAD, The Business School for the World, today announced it has received US$3 million in funding from Google.org and Google DeepMind. The funding will support the Research Lab for Human and Organisational Thriving (INSEAD Thrive Lab), aimed at accelerating global research on how people and organisations can flourish in an era of continuous technological transformation. Artificial intelligence is emerging as the most consequential technology that profoundly shapes how people learn, work, live and interact with one another. While it presents near limitless possibilities, we need to give careful attention to the potential risks. How can we strengthen our human, social and psychological capital amid relentless technological change? And how must our ecosystems of learning – spanning educational, community, and profession
Sharjah Unveils Uruk: A New Generation of Sustainable Cities Built for the Post-AI Era29.10.2026 19:15:00 CET | Press release
In the presence of His Highness Sheikh Dr. Sultan bin Mohammed Al Qasimi, Supreme Council Member and Ruler of Sharjah, and Her Highness Sheikha Bodour bint Sultan Al Qasimi, President of American University of Sharjah and Chairperson of Sharjah Research, Technology and Innovation Park, a pioneering model for a new generation of cities designed for the post-AI era called “Uruk.” This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261029129346/en/ H.H. Sheikh Dr. Sultan bin Mohammed Al Qasimi, Ruler of Sharjah, during the inauguration of “Uruk” (Photo: AETOSWire) The project was revealed at the opening of the second edition of Sharjah Next, through a strategic partnership between Sharjah Research, Technology and Innovation Park (SPARK), American University of Sharjah (AUS) and SEE Holding, bringing together their capabilities in innovation, scientific research and sustainable urban development. Uruk introduces a new vision for urba
Motive and Vivo Brazil Win 2026 Leading Lights Award for Network API Monetization29.10.2026 17:35:00 CET | Press release
Award recognizes live GSMA Open Gateway deployment replacing SMS OTP with SIM-based silent authentication Motive, a global leader in entitlement, connected device and service management and Vivo Brazil, Brazil’s largest operator and part of the Telefónica Group, have won the 2026 Light Reading Leading Lights Award for Outstanding Use Case: Network API Monetization for the first commercial scale deployment of SIM-based silent authentication in Latin America. SMS OTP remains relevant as an authentication method due to its broad reach, working on virtually any type of mobile device. SIM-based silent authentication takes this experience a step further by eliminating the need to receive and manually enter codes. The result is a simpler, more seamless user journey that reduces friction and can help lower abandonment rates while increasing customer conversion and retention. Using Motive’s CAMARA-compliant Entitlement Server, Vivo can now verify a subscriber’s phone number directly without req
REV Ocean Appoints Paul Baribault as CEO Ahead of 2027 Global Operations29.10.2026 15:45:00 CET | Press release
Global conservation and philanthropic leader to spearhead REV Ocean's next chapter, connecting world-class science with international collaboration and ocean protection REV Ocean has appointed Paul Baribault as Chief Executive Officer as the organization moves towards the international debut of its 195-metre research vessel in Rio de Janeiro in April 2027, alongside the UN Ocean Decade Conference. One of the world's largest privately owned research and exploration vessels, REV represents a major philanthropic investment in ocean science. With nine laboratories, advanced deep-sea exploration vehicles and dedicated collaboration facilities, it is designed to give scientists access to world-class research infrastructure and connect their discoveries with the people and institutions able to drive ocean protection. Baribault joins as REV Ocean moves from a decade of engineering and construction into international operations. His mandate will be to build the international partnerships, fundi
Holder Partners Launches Strategic Communications Practice and Appoints Ali Ponte as Director and Practice Lead29.10.2026 15:15:00 CET | Press release
The new practice connects strategic communications and stakeholder engagement with Holder Partners’ capabilities in investigations, disputes, cybersecurity, due diligence and risk advisory. Holder Partners, a multidisciplinary consulting and advisory firm, today announced the launch of its Strategic Communications practice and the appointment of Ali Ponte as Director and Practice Lead. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261027701219/en/ Ali Ponte, Director and Practice Lead of Holder Partners’ Strategic Communications practice. The practice advises leading companies and institutions, their boards, senior executives and counsel on communications, reputation and stakeholder considerations in complex matters and periods of significant change or opportunity. Each engagement is tailored to the client’s objectives and, where relevant, draws on Holder Partners’ broader advisory capabilities. Its strategic counsel, infor
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