SERVIER
12.9.2022 13:04:04 CEST | Business Wire | Press release
Servier, Taiho Oncology, Inc., and Taiho Pharmaceutical Co., Ltd., announced today that the investigational combination of trifluridine/tipiracil plus bevacizumab showed a statistically significant improvement in the primary endpoint of overall survival (OS) compared to trifluridine/tipiracil alone in a Phase III clinical trial of participants with refractory metastatic colorectal cancer (mCRC) following two chemotherapy regimens.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220912005432/en/
Further details about the OS benefit and other results from the primary analysis of the global SUNLIGHT trial will be presented at an upcoming international scientific conference.
“Findings from the SUNLIGHT trial could potentially represent a significant advancement in the treatment of patients with metastatic colorectal cancer who have progressed after two lines of standard chemotherapy,” said Nadia Caussé-Amellal, M.D., Head of Global Development, GI Indications, Oncology and Immuno-Oncology Therapeutic Area, Servier. “Combining trifluridine/tipiracil with bevacizumab demonstrated the potential to extend survival in these patients who have limited therapeutic options.”
Fabio Benedetti, M.D., Global Chief Medical Officer for Oncology at Taiho Pharmaceutical, said: “Trifluridine/tipiracil – discovered by Taiho and developed in our partnership with Servier with the cooperation of many patients and healthcare professionals – has had a significant impact on the management of colorectal cancer for thousands of patients. The results of this study may represent another advancement in the management of this disease, and we now look forward to the further analysis of secondary endpoints.”
Nearly 1.4 million people are diagnosed with colorectal cancer (CRC) each year worldwide,1 equating to 10% of the global cancer cases.1 CRC is the second most common cause of cancer mortality, accounting for 881,000 deaths globally in 2018,2 and patients with metastatic disease have a five-year survival rate of just 11%.3 Standard chemotherapy regimens for mCRC usually include a fluoropyrimidine plus irinotecan and/or oxaliplatin, with a targeted treatment – an antivascular endothelial growth factor or antiepidermal growth factor receptor – frequently added.
“The worldwide incidence of colorectal cancer is forecasted to exceed 3 million cases annually by 2040,4 and the number of deaths is predicted to increase by 69% to approximately 1.6 million per year,5” said Professor Josep Tabernero, M.D., Ph.D., Head of Medical Oncology, Vall d’Hebron University Hospital, Barcelona, Spain, and Primary Investigator for the SUNLIGHT trial. “New treatment options are urgently needed as we seek to reduce the growing global burden of colorectal cancer.”
#ENDS#
About SUNLIGHT
SUNLIGHT is a multinational, open-label, active-controlled, two-arm Phase III trial to investigate the efficacy and safety of trifluridine/tipiracil plus bevacizumab versus trifluridine/tipiracil alone, in patients with refractory mCRC following two chemotherapy regimens. A total of 492 patients were randomly allocated (in a 1:1 ratio) to receive trifluridine/tipiracil plus bevacizumab or trifluridine/tipiracil monotherapy. The primary objective was to demonstrate the superiority of trifluridine/tipiracil plus bevacizumab over trifluridine/tipiracil alone, in terms of OS (primary endpoint). Key secondary objectives were to compare the regimens in terms of progression-free survival (PFS), overall response rate (ORR), disease control rate (DCR) and quality of life (QoL), as well as the safety and tolerability of trifluridine/tipiracil plus bevacizumab in comparison with trifluridine/tipiracil monotherapy.
For more information on SUNLIGHT, please visit: https://clinicaltrials.gov/ct2/show/NCT04737187.
About trifluridine and tipiracil
Trifluridine and tipiracil is an oral nucleoside antitumor agent discovered and developed by Taiho Pharmaceutical Co., Ltd. Trifluridine and tipiracil 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.
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 2021, Servier employs 21,800 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.
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: www.servier.com.
Follow us on social media: LinkedIn, Facebook, Twitter
About Taiho Oncology, Inc.
The mission of Taiho Oncology, Inc. is to improve the lives of patients with cancer, their families and their caregivers. The company specializes in the development of orally administered anti-cancer agents and markets these medicines for a range of tumor types in the U.S. Taiho Oncology’s growing pipeline of selectively targeted anti-cancer agents is led by a world-class clinical development organization. Taiho Oncology is a subsidiary of Taiho Pharmaceutical Co., Ltd. which is part of Otsuka Holding Co., Ltd. Taiho Oncology is headquartered in Princeton, New Jersey and oversees its parent company’s European and Canadian operations, which are located in Zug, Switzerland and Oakville, Ontario, Canada.
For more information, visit www.taihooncology.com.
About Taiho Pharmaceutical Co., Ltd.
Taiho Pharmaceutical Co., Ltd., a subsidiary of Otsuka Holdings Co., Ltd., is an R&D-driven specialty pharma company with a focus on oncology. Taiho Pharmaceutical also has development programs in allergy and immunology, urology and consumer healthcare products. Our corporate philosophy is simple: “We strive to improve human health and contribute to a society enriched by smiles.”
For more information about Taiho Pharmaceutical Co., Ltd., please visit: https://www.taiho.co.jp/en/.
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: September 2022.
2 Tabernero J., Taieb J., Prager G., et al. Trifluridine/tipiracil plus bevacizumab for third-line management of metastatic colorectal cancer: SUNLIGHT study design. Future Oncol. 2021.17(16): 1977–1985.
3 World Health Organization. GLOBOCAN. Cancer Today. Estimated age-standardized mortality rates (World) in 2020, colorectum, both sexes, all ages. Available at: https://gco.iarc.fr/today/online-analysis-map?v=2020&mode=population&mode_population=continents&population=900&populations=900&key=asr&sex=0&cancer=41&type=1&statistic=5&prevalence=0&population_group=0&ages_group%5B%5D=0&ages_group%5B%5D=17&nb_items=10&g. Last accessed: September 2022.
4 Xi Y, Xu P. Global colorectal cancer burden in 2020 and projections to 2040. Transl Oncol. 2021;14(10):101174. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8273208/. Last accessed September 2022.
5 World Health Organization. International Agency for Research on Cancer. Colorectal Cancer Awareness Month 2022. Available at: https://www.iarc.who.int/featured-news/colorectal-cancer-awareness-month-2022/. Last accessed: September 2022.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20220912005432/en/
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
Mevion Introduces the First Proton Therapy System Designed for a LINAC Vault at ESTRO 202611.5.2026 08:00:00 CEST | Press release
The MEVION S250-FIT™ creates a new pathway for European cancer centers to integrate proton therapy into existing radiotherapy programs Proton therapy is entering the LINAC vault. At ESTRO 2026, Mevion Medical Systems will introduce the MEVION S250-FIT Proton Therapy System to the European radiation oncology community, the first proton therapy system designed for installation in a standard radiation therapy vault. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260507172087/en/ The MEVION S250-FIT™ Proton Therapy System Now both U.S. FDA-cleared and CE-marked under Regulation (EU) 2017/745, the S250-FIT creates a new pathway for cancer centers to bring proton therapy into existing LINAC-based treatment environments, aligning advanced proton capability with the infrastructure, workflows, and capital planning of modern radiation oncology. Stanford Medicine: First S250-FIT Installation On April 7, 2026, Stanford Medicine unveiled
Vedanta FY26 Profit Soars by 22% to $2.8 bn; Enters Demerger Phase11.5.2026 02:30:00 CEST | Press release
India-based Vedanta Limited (BSE: 500295 & NSE: VEDL), a global leader in metals, oil & gas, critical minerals, power and technology, announced its results for the fourth quarter and full year ended 31 March 2026. It has delivered its best-ever financial performance, driven by structurally strong businesses and disciplined execution. For the full year, Vedanta’s Profit stood at an all-time high of $2.8 bn, reflecting a 22% YoY increase and a profit of $1 bn in Q4 FY26, up nearly 90% YoY. Vedanta reported its highest-ever annual revenue of about $20 bn, up 15% YoY, with Q4 revenue at $5.6 bn, an increase of nearly 30% YoY. The Company maintained strong cost leadership, contributing to record EBITDA of $6.3 bn for FY26, up by about 30% YoY, with margins expanding to around 40%. Q4 EBITDA stood at $2.0 bn, up by nearly 60% YoY, with a margin of approximately 44%. The balance sheet strengthened further, with Net Debt/EBITDA improving to 0.95x, supported by strong cash generation. Underscor
Andersen Global udvider sin afrikanske platform med tilføjelsen af medlemsfirma i Namibia9.5.2026 02:35:00 CEST | Pressemeddelelse
Andersen Global udbygger sin tilstedeværelse i Afrika med tilføjelsen af Andersen in Namibia, da Windhoek Advisory & Taxation tager Andersen-brandet til sig og styrker sine forudsætninger for at betjene virksomheder med aktiviteter i et af det sydlige Afrikas dynamiske vækstmarkeder. Andersen in Namibia har været et samarbejdsfirma siden 2021 og er en lokalt ejet revisions- og konsulentvirksomhed, der leverer ydelser inden for regnskab, skat og forretningsrådgivning, tilpasset de unikke behov i Namibias erhvervsklima. Med ekspertise inden for minedrift, landbrug, logistik, turisme og finansielle tjenesteydelser – sektorer, der er afgørende for Namibias økonomi – bistår firmaet både indenlandske virksomheder og internationale selskaber, der etablerer sig i regionen. Gennem cloudbaseret teknologi og datadrevet indsigt leverer Andersen i Namibia effektive og skalerbare løsninger, der gør det muligt for virksomheder at optimere deres drift, håndtere skatteforpligtelser på tværs af jurisdik
Andersen Consulting styrker sine kompetencer inden for organisatorisk transformation med Afiniti8.5.2026 20:45:00 CEST | Pressemeddelelse
Andersen Consulting annoncerer en samarbejdsaftale med Afiniti, et globalt konsulentfirma inden for forretningstransformation med hovedkontor i Storbritannien, der hjælper organisationer med at levere og opretholde komplekse forandringsprojekter. Afiniti blev stiftet i 2003 og er et globalt konsulenthus inden for forretningsforandring med base i Storbritannien og USA. De støtter klienter gennem komplekse transformationer på tværs af mennesker, processer, systemer og data, og de skaber mærkbare forandringer gennem kreative konsulentydelser. Virksomheden betjener primært stærkt regulerede, sikkerhedsdrevne og aktivtunge organisationer med store, geografisk spredte arbejdsstyrker inden for sektorer som energi, forsyning, biovidenskab, transport og byggeri. Afiniti samarbejder med velkendte brands om at levere ekspertise fra start til slut på tværs af organisatoriske, digitale og ai-baserede transformationer samt ændringer i kultur og driftsmodeller. Dette gælder især komplekse scenarier s
Verdantis Launches MRO360 “The World's First AI-Native Spare Parts Intelligence Platform”8.5.2026 15:40:00 CEST | Press release
MRO360 is the first milestone in Verdantis's journey to deliver the industry's first fully AI-native Enterprise Asset Management solution. Verdantis today announced the global launch of MRO360, a purpose-built AI platform that transforms how asset-intensive organizations manage their MRO spare parts inventory. Designed for manufacturers, oil and gas operators, mining companies, utilities, and other industrial enterprises, MRO360 deploys nine interconnected AI agents that continuously forecast demand, score parts criticality, manage obsolescence risk, calculate dynamic reorder points, helps intercompany plant transfer thereby realizing the exact dollar value of every optimization opportunity across a spare parts catalog in real time. Unlike traditional EAM and CMMS platforms built on static rules, MRO360's agents adapt continuously as demand patterns, supplier performance, and equipment health evolve. For the first time, a maintenance planner can see which work orders are at supply risk
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