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
In the age of AI agents, Splio makes prediction the foundation of CRM and launches its AI-first CRM12.2.2026 09:30:00 CET | Press release
Splio is setting prediction as the new CRM standard and the future interface for AI agentsThe company has evolved Tinyclues AI, initially focused on predictive AI, into an AI enhanced with generative and agentic capabilities, now integrated at the core of its platform Commercial launch of the AI-first CRM powered by Tinyclues AI Launch of the Ask my CRM agent, an intelligent copilot to speed up decision-making and CRM execution based on customer data The company is positioning itself as an AI-first company, already generating 30% of its revenue from AI and aiming for 50% in 2027 Splio announces the launch of its AI-first CRM powered by Tinyclues AI. Now integrated at the core of the platform, predictive AI helps brands orchestrate and personalize their communications at scale across every channel (email, SMS, RCS, WhatsApp...). Splio also unveils "Ask My CRM," its new AI agent designed as an intelligent marketing copilot that, plugged into each brand's customer data, makes customer kno
Stafford Capital Partners Announces New Renewable Energy Investment Strategy with Dedicated Team12.2.2026 09:00:00 CET | Press release
Stafford Capital Partners integrates dedicated renewables team tostrengthen the firm’s strategic infrastructure investing capabilities with a focus on energy transition opportunities. Stafford Capital Partners (“Stafford”), a leading international private markets investment and advisory firm, today announced the launch of a new strategy focused on the renewable energy sector. This initiative leverages the ongoing transformation and rapid growth within the renewables market, targeting the revamping and repowering of existing renewable assets to deliver compelling risk-adjusted returns while accelerating the transition to a low-carbon economy. This new strategic initiative further strengthens Stafford’s position in the global infrastructure investment market, providing institutions with access to a pioneering investment approach to renewable investing. This mirrors the differentiated approach Stafford has taken in developing its secondary market strategies across its real assets platform
KARL LAGERFELD Reunites With Paris Hilton for Spring – Summer 2026 “From Paris with Love” Campaign12.2.2026 08:00:00 CET | Press release
KARL LAGERFELD unveils its Spring–Summer 2026 campaign, From Paris with Love, starring cultural icon Paris Hilton for the second consecutive season. Captured through the lens of long-time brand collaborator Chris Colls at the Maison’s headquarters, 21 Rue Saint-Guillaume in Paris, the global campaign spans the KARL LAGERFELD, KARL LAGERFELD JEANS, and KARL LAGERFELD PARIS collections. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260211077844/en/ KARL LAGERFELD SS26 Campaign Paris Hilton - ©Chris Colls “Shooting the campaign at 21 Rue Saint-Guillaume was incredibly inspiring,” says Paris Hilton. “Stepping into Karl’s world felt personal and true to the DNA of both Karl and the brand. It wasn’t about looking back but being present in a space where his legacy continues to evolve.” Moving through the Maison with ease and confidence, Paris Hilton brings her signature glamour and charisma to KARL LAGERFELD’s universe through pla
AB InBev Reports Full Year and Fourth Quarter 2025 Results12.2.2026 07:01:00 CET | Press release
Underlying EPS increased by 6% with continued margin expansion and free cash flow generation of 11.3 billion USD Anheuser-Busch InBev (Brussel:ABI) (BMV:ANB) (JSE:ANH) (NYSE:BUD): This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260211688662/en/ Figure 14. Terms and debt repayment schedule as of 31 December 2025 (billion USD) Regulated and inside information1 “Beer plays an important role in bringing people together and creating moments of celebration. In 2025, we executed our strategy, made disciplined capital allocation choices and delivered growth within our outlook for the year, even as we navigated a dynamic consumer environment. We exit 2025 with improved momentum and enter 2026 well positioned to engage consumers with our megabrands and an unparalleled lineup of mega platforms. Thank you to our colleagues for their ongoing commitment, hard work and passion for our business.” – Michel Doukeris, CEO, AB InBev Revenue 4Q +
Bardasz Forms Strategic Digital Alliance with GEOLOG to Accelerate Global RTOC Delivery and Digital Well Construction Solutions12.2.2026 07:00:00 CET | Press release
HighlightsBardasz and GEOLOG form an alliance to strengthen delivery of end-to-end RTOC solutions for drilling optimization and NPT mitigation.Alliance combines Bardasz’s leadership in WITSML and ETP transmission, high-speed real-time data aggregation, and Super Store technology with GEOLOG’s global operational scale and local technical workforce.As part of the alliance, GEOLOG has made a minority investment in Bardasz, providing financial flexibility to accelerate Bardasz’s product roadmap and global expansion. Bardasz Group LLC (“Bardasz”), a provider of real-time, decision-ready intelligence for well construction—including drilling, completions, and well interventions—today announced a strategic digital alliance with GEOLOG International B.V. (“GEOLOG”), a global formation evaluation, drilling, and geochemistry services provider supporting subsurface projects in more than 40 countries. The alliance is designed to accelerate Bardasz’s global growth and enhance customer delivery by le
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