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
Duna, Built by Stripe Veterans, Raises €30 Million CapitalG-led Series A to Solve Business Identity For The Internet5.2.2026 15:00:00 CET | Press release
Duna, the identity fintech founded by two Stripe alumni, today announced a €30 million Series A funding round led by CapitalG, Alphabet’s independent growth fund. Existing investors Index Ventures, Puzzle Ventures and Snowflake Chairman Frank Slootman also participated in the round. The company, based in Germany and the Netherlands, was launched in 2023 by Duco van Lanschot, who was head of Benelux and DACH at Stripe for three years, and David Schreiber, who spent six years at Stripe where he ran the company’s largest global business unit, including the core card payment platform. In May 2025, the company announced a €10.7 million seed round led by Index Ventures. The latest fundraise brings Duna’s total funding to more than €40 million. Duna’s mission is to build global trust infrastructure by providing a digital passport for every business. Over time, this will evolve into a network for shareable identity and one-click onboarding. Today Duna’s AI-native business identity platform ser
AI-Powered Experian Assistant for Model Risk Management Wins 2026 BIG Innovation Award5.2.2026 15:00:00 CET | Press release
Highlights how Experian’s AI capabilities help global financial institutions keep regulatory documentation aligned with rapid model innovations Experian today announced that its recently launched, AI‑powered Experian Assistant for Model Risk Management has been awarded the 2026 BIG Innovation Award in the Innovative Products category. Recognizing trailblazers across industries since 2014, this global award celebrates exceptional innovation and the value it brings to a recipient’s clients, stakeholders and community. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260205042051/en/ Experian's recently launched, AI-powered Experian Assistant for Model Risk Management has been awarded the 2026 BIG Innovation Award in the Innovative Products category. Fully integrated into the Experian Ascend Platform™ and powered by ValidMind technology, Experian Assistant for Model Risk Management helps accelerate model validation, improve audit
LTIMindtree Recognized as a Leader in Everest Group Payments IT Services PEAK Matrix® Assessment 20255.2.2026 14:30:00 CET | Press release
LTIMindtree [NSE: LTIM, BSE: 540005], a leading global technology consulting and digital solutions provider, has been positioned as a Leader in the Everest Group Payments IT Services PEAK Matrix® Assessment 2025. This recognition is for being a strategic transformation partner that combines modernization scale, platform alliances, and innovation across real-time, digital assets, and ensure secure, regulator-ready payment environments. Everest Group highlighted LTIMindtree’s strong market impact and vision and capability in delivering largescale payments across issuers, acquirers, payment processors, card networks, and FinTechs. The assessment comes at a time when enterprises are rapidly modernizing legacy payments platforms to support real-time, cross-border, and ISO 20022 compliant payment environments, while enhancing resiliency, interoperability, and regulatory compliance. LTIMindtree stands out for its product engineering expertise across major payment platforms like Finastra GPP/P
PubNub Achieves SOC 3 Compliance, Reinforcing Commitment to Security, Trust, and Transparency5.2.2026 14:00:00 CET | Press release
PubNub, the real-time communications platform that powers low-latency, event-driven logic across modern application architectures, is pleased to announce that it has achieved SOC 3 compliance. This latest attestation highlights PubNub’s continuous dedication to providing a secure and trusted platform for building and scaling interactive online experiences. The SOC 3 report affirms that PubNub’s systems meet the Trust Services Criteria for security, availability, and confidentiality. Unlike SOC 2 reports, which are restricted to existing customers or partners due to the level of operational detail they include, SOC 3 reports are designed for broad, public distribution. This transparency enables anyone to verify that PubNub adheres to the stringent controls required by the SOC 2 framework, providing proof of robust information security and operational integrity. This achievement adds to PubNub’s extensive compliance portfolio, which includes SOC 2 Type 2, ISO/IEC 27001:2022, HIPAA, and G
Visby Medical Collaborates with Watchmaker Genomics to Enhance Respiratory Pathogen Detection in the At-Home Setting5.2.2026 14:00:00 CET | Press release
Visby Medical, a leading innovator in at-home PCR testing of infectious diseases, has announced a strategic collaboration with Watchmaker Genomics, a supplier of innovative products for molecular analysis, to develop next-generation diagnostic tests for respiratory pathogen detection in the at-home setting. This partnership pairs Visby Medical’s instrument-free PCR testing technology – the first and only of its kind – with Watchmaker’s expertise in engineering enzymes to address application-specific performance gaps. Clinical samples collected from patients for at-home testing are typically unprocessed, making them vulnerable to molecular inhibitors that can reduce signal strength and lower assay sensitivity. The need for rapid results in the at-home setting also places unique performance demands on the assays and the enzymes they rely on. “Recent increases in COVID cases involving new strains and the current flu season highlight the need for tests that are reliable and fast,” explaine
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