News Releases

Taiho Pharmaceutical Co., Ltd. (hereafter “Taiho”) announced today that its partner, Servier (France) has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) , recommending the use of trifluridine/tipiracil (LONSURF^®) in combination with bevacizumab, for the treatment of adult patients with metastatic colorectal cancer (mCRC) who have received two prior anti-cancer treatment regimens, including fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapies, anti-VEGF agents, and/or anti-EGFR agents.

The CHMP’s positive opinion on LONSURF in combination with bevacizumab, in patients with refractory mCRC is based on clinical data from the SUNLIGHT trial, and will be referred to the European Commission (EC) for the final decision. This decision will be applicable to all 27 EU member states plus Iceland, Norway, Northern Ireland and Liechtenstein.

Taiho remains committed in delivering new treatment options to patients and health care professionals around the world.

Colorectal cancer (CRC) is the third most common cancer worldwide,^1,2 with over 1.9million people newly diagnosed with the disease in 2020,² equating to 10% of the global cancer cases.¹ Approximately 70% of CRC patients will eventually develop metastatic relapse³, and median overall survival in refractory mCRC is between 4-8 months.⁴ CRC is the second most common cause of cancer mortality, accounting for 930,000 deaths globally in 2020.² The worldwide incidence of colorectal cancer is expected to exceed 3 million cases annually by 2040,⁵ and the number of deaths is predicted to increase by more than 70% to 1.6 million per year.⁵

LONSURF is an oral nucleoside antitumor agent discovered and developed by Taiho Pharmaceutical Co., Ltd. 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 2015, Taiho and Servier entered into an exclusive license agreement for the co-development and commercialization of LONSURF. Under the terms of the agreement, Servier has been developing and commercializing LONSURF in Europe and other countries outside of the United States, Canada, Mexico and Japan/Asia. LONSURF is approved by the EC 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; as well as metastatic gastric cancer including adenocarcinoma of the gastroesophageal junction, who have been previously treated with at least two prior systemic treatment regimens for advanced disease.⁶

SUNLIGHT is a multinational, randomized, active-controlled, open-label two-arm Phase 3 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 assess trifluridine/tipiracil plus bevacizumab versus trifluridine/tipiracil alone, in terms of overall survival (OS). Key secondary endpoints were 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 used in combination with bevacizumab in comparison with trifluridine/tipiracil monotherapy.

The SUNLIGHT trial was conducted by Servier and Taiho Oncology, Inc. For more information on SUNLIGHT, please visit: https://clinicaltrials.gov/ct2/show/NCT04737187

SUNLIGHT：An open-label, randomised, phase III study comparing trifluridine/tipiracil in combination with bevacizumab to trifluridine/tipiracil monotherapy in patients with refractory metastatic colorectal cancer. (SUNLIGHT Study)

Founded to serve health, Servier is a global pharmaceutical group governed by a non-profit foundation that aspires to have a meaningful social impact, both for patients and for a sustainable world. As a world leader in cardiology, the Group’s ambition is to become a renowned, focused and innovative player in oncology by targeting hard-to-treat cancers. Servier is also involved in neuroscience and immune-inflammatory diseases to increase the pace of therapeutic innovation. To promote access to quality care for all, Servier offer a range of quality generic medicines covering most pathologies.

In all these areas, the Group include the patient voice at each stage of the life cycle of a medicine.

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: June 2023

2:World Health Organization. International Agency for Research on Cancer. Colon factsheet. Available at: https://gco.iarc.fr/today/data/factsheets/cancers/8-Colon-fact-sheet.pdf Last accessed: June 2023

3:Wang J., Li S., Liu Y., et al. Metastatic patterns and survival outcomes in patients with stage IV colon cancer: A population‐based analysis. Cancer Med. 2020. 9(1): 361–373

4:Tabernero J., Taieb J., et al. Trifluridine/tipiracil plus Bevacizumab for third-line management of metastatic colorectal cancer: SUNLIGHT study design. Future Oncol. 2021.17(16): 1977–1985. Available at: https://www.futuremedicine.com/doi/full/10.2217/fon-2020-1238. Last accessed: June 2023

5:World Health Organization. International Agency for Research on Cancer. Global burden of colorectal cancer in 2020 and 2040: incidence and mortality estimates from GLOBOCAN. Available at: https://www.iarc.who.int/news-events/global-burden-of-colorectal-cancer-in-2020-and-2040-incidence-and-mortality-estimates-from-globocan/#:~:text=The%20authors%20predict%20that%20by,an%20increase%20of%2073%25. Last accessed: June 2023

6:EMA. LONSURF: Summary of Product Characteristics. Available at : https://www.ema.europa.eu/en/documents/product-information/lonsurf-epar-product-information_en.pdf Last accessed: June 2023