SERVIER
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
Royal Decree Establishes the International Financial Centre of Oman13.1.2026 10:15:00 CET | Press release
His Majesty Sultan Haitham bin Tarik, may God protect and preserve him, has issued a Royal Decree establishing the International Financial Centre of Oman (IFC Oman) and enacting its own dedicated law. The establishment of the International Financial Centre of Oman aligns with the Sultanate of Oman’s strategic directions aimed at diversifying the national economy, strengthening Oman’s position as a global hub for financial services, attracting capital, and supporting innovation. The creation of the Centre also reflects Oman’s commitment to building a trusted and effective ecosystem for delivering advanced financial services that meet the needs of investors and global institutions. Under the Law of the International Financial Centre of Oman, issued by Royal Decree No. (8/2026), the Centre shall have administrative, financial, and legislative independence. It will develop a regulatory, legal, and judicial framework aligned with international standards and based on English Common Law. The
Forrester: AI-Led Job Disruption Will Escalate, While Fears Of A Job Apocalypse Are Overstated13.1.2026 10:00:00 CET | Press release
Only 6% Of Jobs In The US Will Be Automated By 2030 Forrester (Nasdaq: FORR) forecasts that automation and AI will have a real but modest impact on jobs through 2030. While AI could account for 6% of total US job losses, equating to 10.4 million roles, widespread AI-driven job replacement remains unlikely, as labor productivity would need to accelerate significantly for AI to replace human talent at scale. Rather than eliminating roles, Forrester forecasts that AI will augment 20% of jobs over the next five years, making it essential for businesses to invest in employee training and upskilling. According to the new report, The Forrester AI Job Impact Forecast, US, 2025–2030, over-automating roles due to the hype surrounding AI can lead to costly pullbacks, damaged reputations, and weakened employee experiences. Forrester’s 2026 future-of-work predictions further reveal that over half of layoffs attributed to AI will be quietly reversed as companies realize the operational challenges of
AI EdgeLabs Adds Advanced Risk and Compliance Center with Linux Audit Capabilities to Its AI Runtime Platform13.1.2026 10:00:00 CET | Press release
AI EdgeLabs, the pioneer in autonomous AI runtime platform, today announced the launch of Compliance Center and Linux Audit. Purpose-built for organizations facing NIS2, CRA, and global critical-infrastructure mandates, the new capabilities replace manual reporting and scan-based compliance with continuous visibility, automated control coverage, and real-time posture insights. Key capabilities include: A single Risk Score representing their current posture Real-time compliance visibility for CRA and NIS2 Prioritized assets based on impact and criticality Extended support for firmware, custom OS, and RTOS Linux audit and configuration hardening insights Automated, framework-specific checklists Incident Reporting and Automated Response “As NIS2 and the Cyber Resilience Act come into force, companies need continuous proof of compliance, not manual mapping or siloed visibility,” said Inna Ushakova, CEO of AI EdgeLabs. “This release provides real-time compliance posture, instant detection o
KAYTUS Introduces One-Stop End-to-End Liquid-Cooled Datacenter Solution Targeting AI Market13.1.2026 09:02:00 CET | Press release
- Enhances competitiveness with 30% reduction in cooling energy consumption - Supports high-density, high-efficiency, and eco-friendly data center construction through 4D differentiation strategy KAYTUS, a leading provider of end-to-end AI and liquid cooling solutions, has introduced its One-Stop End-to-End Liquid-Cooled Data Center Solution in response to the surging demand for AI adoption and energy efficiency. The solution is designed with the concepts of modularization, prefabrication, and safety, supporting up to 15 kW per node and 130 kW per cabinet, with a PUE below 1.1. It provides an end-to-end liquid cooling solution covering design, development, deployment, and operation, addressing the complexity and high entry barriers of large-scale liquid-cooled deployment while supporting eco-friendly data center operations aligned with the government’s carbon neutrality initiatives. Rapid Growth of Domestic AI Market Highlights Urgent Need for Energy Efficiency The AI industry is rapid
The Blind Sailor Takes the Stage at WEF: "HIRO’s CHOICE" Project to Set Sail13.1.2026 05:00:00 CET | Press release
A Solo, Non-Stop Crossing of the Pacific Ocean “Blind Sailor Single-Handed Pacific Crossing Project 2027” is a world-first initiative in which Mitsuhiro Iwamoto, a completely blind Japanese yachtsman (blind sailor) based in San Diego, will attempt a solo, non-stop trans-Pacific crossing in the spring of 2027. Sailing a 28-foot yacht single-handedly, he aims to cross the Pacific Ocean from San Diego on the U.S. West Coast to Amakusa, Kumamoto Prefecture, Japan, without making port. Iwamoto will speak about this project at the World Economic Forum Annual Meeting 2026, to be held in January 2026. Project URL: https://hiros-choice.com/ This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260108087321/en/ Hiro Iwamoto / Global Keynote Speaker, First Totally Blind Sailor to Cross the Pacific The message he most wishes to convey at the WEF is the power of choice. He lost his sight at the age of sixteen—a moment when he nearly gave up on
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