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
Brenus Pharma Presented New Preclinical and Early Clinical Data in Colorectal Cancer During AACR Immuno-Oncology Conference 202619.2.2026 08:50:00 CET | Press release
Brenus Pharma, a clinical-stage biotechnology company pioneering in vivo “off-the-shelf” immunotherapies, announced the selection of an abstract for a poster presentation at the American Association for Cancer Research Immuno-Oncology (AACRIO) annual conference (February 18-21, 2026), in Los Angeles. The poster showcases new preclinical data and early clinical insights from the company's lead candidate, STC-1010, supporting it as a promising therapeutic option for MSS, immune-cold colorectal cancer (CRC)—a major unmet clinical need. In a syngeneic CT26 model, murine STC-1010 significantly inhibits tumor growth and extends survival by 40%. New mechanistic datas reveal expansion of CD4⁺ and CD8⁺ T cells in draining lymph nodes alongside a significant humoral response compared to control, demonstrating coordinated cellular and humoral immune activation in vivo. Other findings show that dendritic cells efficiently capture STC-1010, leading to their activation as demonstrated by transcripto
ENHERTU® Type II Variation Application Validated in the EU as Post-Neoadjuvant Treatment for Patients with HER2 Positive Early Breast Cancer19.2.2026 08:30:00 CET | Press release
Based on DESTINY-Breast05 phase 3 trial results, which showed ENHERTU reduced the risk of invasive disease recurrence or death by 53% compared to T-DM1 If approved, Daiichi Sankyo and AstraZeneca’s ENHERTU has the potential to become a new standard of care in this early breast cancer setting The European Medicines Agency (EMA) has validated the Type II Variation marketing authorization application for ENHERTU® (trastuzumab deruxtecan) as a monotherapy for adult patients with HER2 positive (immunohistochemistry [IHC] 3+ or in-situ hybridization [ISH]+) breast cancer who have residual invasive disease after neoadjuvant HER2 targeted treatment. ENHERTU is a specifically engineered HER2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568) and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca (LSE/STO/NYSE: AZN). The validation confirms the completion of the application and commences the scientific review process by the EMA’s Committ
NHOA Energy Advances Delivery of the 51 MWh Broni Battery for Neoen in Italy19.2.2026 08:00:00 CET | Press release
The project confirms NHOA Energy’s long-term commitment to the Italian market NHOA Energy, global provider of utility-scale energy storage systems, is advancing the construction of the Broni Battery, a 10 MW/51 MWh project located in Broni (Pavia), Italy, executed for Neoen, one of the world’s leading independent producers of renewable energy. Civil works at the site are currently underway and advancing on schedule, with commissioning activities planned to start in late spring 2026. Once operational, the Broni Battery will provide essential flexibility services to the Italian electricity system, supporting grid stability and reliability as renewable energy penetration continues to increase. The project represents Neoen’s first battery storage asset in Italy and marks a strategic step in the company’s expansion, as it continues to grow its battery storage portfolio in key markets worldwide to support power system flexibility. The Broni Battery further strengthens NHOA Energy’s long-term
Compass Pathways Announces Pricing of $150 Million Public Offering19.2.2026 02:18:00 CET | Press release
Compass Pathways plc (Nasdaq: CMPS), a biotechnology company dedicated to accelerating patient access to evidence-based innovation, announced today the pricing of its public offering of 17,500,000 American Depositary Shares (“ADSs”) at a public offering price of $8.00 per ADS, each representing one ordinary share, and in lieu of ADSs, to certain institutional investors, pre-funded warrants to purchase up to 1,250,000 ADSs at a public offering price of $7.9999 per pre-funded warrant. In addition, Compass Pathways has granted the underwriters a 30-day option to purchase up to an additional 2,812,500 ADSs at the public offering price, less the underwriting discounts and commissions. All of the securities are to be sold by Compass Pathways. The offering is expected to close on or about February 20, 2026, subject to the satisfaction of customary closing conditions. The gross proceeds to Compass Pathways from the offering, before deducting underwriting discounts and commissions and other est
Andersen Consulting udvider sine kompetencer inden for ledelsesrekruttering med Lansdowne Executive Search18.2.2026 17:08:00 CET | Pressemeddelelse
Andersen Consulting styrker sin humancapital-praksis gennem en samarbejdsaftale med Lansdowne Executive Search, der er en Dublin-baseret virksomhed med speciale i lederrekruttering, midlertidige ledelser og bestyrelsesudnævnelser. Lansdowne Executive Search er en irisk-ejet virksomhed, der blev grundlagt i 2015, og som tilbyder C-level-ledelsesekruttering, deltidsledere og bestyrelsesplaceringer. Som en partnerdrevet boutique-virksomhed er Lansdowne kendt for, at seniorledelsen er tæt involveret i alle kundeprojekter. Virksomheden hjælper kunder med at navigere i komplekse ledelsesovergange og vækststrategier på tværs af en bred vifte af sektorer, herunder finans, byggeindustrien, nonprofit, landbrug, videregående uddannelse, den offentlige sektor samt teknologi, medier og telekommunikation. "God ledelse er afhænger af situationen, og det kræver forståelse af langt mere end blot et CV," sagde Tom Keane, der er partner hos Lansdowne Executive Search. "Samarbejdet med Andersen Consulting
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