Taiho Pharmaceutical Co., Ltd. and Taiho Oncology, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved LONSURF® (trifluridine/tipiracil) as a single agent or in combination with bevacizumab for the treatment of adult patients with metastatic colorectal cancer (mCRC) previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an antiEGFR therapy. “The FDA approval of this combination provides patients with mCRC an important new treatment option, one that has been shown to extend life compared to LONSURF alone and which I believe will change the treatment landscape for this patient population,” said Marwan Fakih, MD, Professor, Medical Oncology and Therapeutics Research, City of Hope, Duarte, Calif., and lead U.S. investigator for the pivotal Phase 3 SUNLIGHT trial that evaluated this combination. The results from the Phase 3 SUNLIGHT trial demonstrated that the combination of LONSURF plus bevacizumab provided statistically significant and clinically meaningful improvements in overall survival (OS) and progression-free survival (PFS) for patients with mCRC following disease progression or intolerance on two prior chemotherapy regimens compared to LONSURF alone.1 “The treatment of advanced colorectal cancer has been a core focus of our work at Taiho Oncology since our inception and with good reason: approximately 22% of patients2 with colorectal cancer in the U.S. are diagnosed after the cancer has metastasized,” said Timothy Whitten, President and Chief Executive Officer, Taiho Oncology, Inc. “The FDA approval of LONSURF in combination with bevacizumab is another example of how we are continuing to advance care in this disease and provide new hope to patients and their families.” Data from the SUNLIGHT trial were published in the New England Journal of Medicine in May 2023.1 In 2023, the National Comprehensive Cancer Network® (NCCN®) Drugs and Biologics Compendium (NCCN Compendium®) for Colon Cancer and Rectal Cancer was updated to include a Category 2A recommendation for trifluridine/tipiracil as subsequent therapy, either single agent or in combination with bevacizumab (preferred), as a treatment options for patients who have progressed through all available regimens besides regorafenib or trifluridine/tipiracil with or without bevacizumab.2,3 ※ NCCN is a not-for-profit alliance of 33 leading cancer centers devoted to patient care, research, and education. https://www.nccn.org/home/member-institutions “From Taiho Pharmaceutical’s initial discovery of LONSURF to this latest regulatory milestone, we are appreciative of the investigators and patients who helped to contribute to our growing body of knowledge of this important therapeutic through their participation in our clinical development programs,” said Fabio Benedetti, MD, Global Chief Medical Officer for Oncology, Taiho Pharmaceutical Co., Ltd. “And now we look forward to supporting healthcare professionals in the treatment of patients with mCRC who may be candidates for treatment with LONSURF in combination with bevacizumab.” 【About the SUNLIGHT Trial1】 SUNLIGHT is a multinational, randomized, active-controlled, open-label twoarm 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 OS (primary endpoint). 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. 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) 【About Colorectal Cancer】 Colorectal cancer is the third most commonly diagnosed cancer in the U.S.4 In 2023, there will be an estimated 153,020 new cases and 52,550 deaths in the U.S.5 Approximately 22% of U.S. patients are diagnosed after their cancer has metastasized.2 The relative five-year survival rate for patients with metastatic colorectal cancer is 14%.2 【About LONSURF】 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. *LONSURF® Generic name：Trifluridine/ tipiracil Product Name in Japan：LONSURF® combination tablets T15, T20 Indications in Japan: ・Unresectable advanced or recurrent colorectal cancer ・Unresectable advanced or recurrent gastric cancer that has progressed after chemotherapy On July 2023, Servier, who conducted the SUNLIGHT trial with Taiho Oncology, received approval from the European Commission for LONSURF in combination with bevacizumab for the treatment of adults patients with 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 Marketing Authorization covers the 27 countries of the European Union as well as Iceland, Northern Ireland, Liechtenstein and Norway. 【 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 antimetabolic and 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 Holdings 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: https://www.taihooncology.com/us/ 【About Taiho Pharmaceutical Co., Ltd.】 Taiho Pharmaceutical, a subsidiary of Otsuka Holdings Co., Ltd. (www.otsuka.com/en/), is an R&D-driven specialty pharma with a focus on oncology. Taiho Pharmaceutical also has development programs in allergy and immunology, and consumer healthcare products. Our corporate philosophy takes the form of a pledge: “We strive to improve human health and contribute to a society enriched by smiles.” For more information about Taiho Pharmaceutical, please visit: www.taiho.co.jp/en/. 1: Prager GW, Taieb J, Fakih M, et al. Trifluridine–tipiracil and bevacizumab in refractory metastatic colorectal cancer. New England Journal of Medicine. 2023;388(18):1657-1667. Last accessed: July 2023. https://www.nejm.org/doi/10.1056/NEJMoa2214963. 2: Wang J, Li S, Liu Y, Zhang C, Li H, Lai B. Metastatic patterns and survival outcomes in patients with stage IV colon cancer: A population-based analysis. Cancer Med. 2020;9(1):361-373. Last accessed: July 2023. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6943094/#cam42673-bib-0003. 3: National Comprehensive Cancer Network. National Comprehensive Cancer Network® Drugs and Biologics Compendium (NCCN Compendium®) for Colon Cancer (Version 2.2023-April 25, 2023) and Rectal Cancer (Version 3.2023-May 26, 2023). Last accessed July 2023. Available at: http://www.nccn.org/. 4: Siegel RL, Miller KD, Wagle NS, Jemal A. Cancer statistics, 2023. American Cancer Society CA: A Cancer Journal for Clinicians. 2023;73(1):17-48. Last accessed: July 2023. https://doi.org/10.3322/caac.21763. 5: National Cancer Institute Surveillance Epidemiology and End Results Program. Cancer Stat Facts: Colorectal Cancer. SEER. Last accessed July 13, 2023. https://seer.cancer.gov/statfacts/html/colorect.html.

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