SERVIER

Servier and Taiho Oncology, Inc. (U.S.), a subsidiary of Taiho Pharmaceutical Co., Ltd. (Japan), jointly announced today that the safety and efficacy data in the gastrectomy patient subgroup of the global Phase III trial TAGS evaluating LONSURF^® (trifluridine/tipiracil, TAS-102) in patients with metastatic gastric cancer (mGC) are consistent with the overall study results published in The Lancet Oncology . These data were highlighted in an oral presentation at the ASCO 2019 Gastrointestinal Cancers Symposium (ASCO-GI) on Thursday 17 January.

In TAGS, 221 (44%) of the 507 randomized mGC patients had undergone prior gastrectomy (147 LONSURF, 74 placebo), which is reflective of the real-world patient population diagnosed with mGC. The results confirmed that trifluridine/tipiracil prolonged survival versus placebo regardless of prior gastrectomy. The overall results of TAGS demonstrated that patients treated with oral trifluridine/tipiracil showed a clinically meaningful and statistically significant improvement in overall survival (OS) compared with placebo and a 31 percent risk reduction of death (HR 0.69 one sided p=0.00029), which translated into a prolonged median survival of 2.1 months (5.7 months for trifluridine/tipiracil versus 3.6 months for placebo).

Additional data investigating trifluridine/tipiracil in metastatic colorectal cancer (mCRC) patients will be presented during a poster session on Saturday 19 January:

• Health-related quality of life in the early-access phase IIIb study of trifluridine/tipiracil in pretreated metastatic colorectal cancer (mCRC): Results from PRECONNECT study (abstract 638)
• Validation of cost-effectiveness of trifluridine/tipiracil versus best supportive care and regorafenib for previously treated metastatic colorectal cancer in the UK using phase IIIb PRECONNECT early access clinical trial data in the real world setting (abstract 639)
• QoL from TASCO1: Health related quality of life of trifluridine/tipiracil-bevacizumab and capecitabine-bevacizumab as first-line treatments in metastatic colorectal cancer patients not eligible for intensive chemotherapy: results from the TASCO1 phase II study (abstract 676)
• Trifluridine/tipiracil and regorafenib in patients with metastatic colorectal cancer (mCRC): A single institution retrospective study (abstract 592)
• Exploratory analysis of the effect of trifluridine/tipiracil in patients treated in RECOURSE by prognostic factors (abstract 677)

Trifluridine/tipiracil is indicated in European Union 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.¹ Applications for an additional indication in mGC for LONSURF are currently under review by health authorities in Japan, the United States and the European Union.

About TAGS

TAGS (TA S-102 G astric S tudy) is a Taiho-sponsored pivotal Phase III, multinational, randomized, double-blind study evaluating trifluridine/tipiracil, also known as TAS-102, plus best supportive care (BSC) versus placebo plus BSC in patients with metastatic gastric cancer, including gastroesophageal junction cancer, refractory to standard treatments. The primary endpoint in the TAGS trial is OS, and the main secondary endpoint measures include progression-free survival (PFS), and safety and tolerability, as well as quality of life.

TAGS enrolled 507 adult patients with metastatic gastric cancer who had previously received at least two prior regimens for advanced disease. The study was conducted in Belarus, the European Union, Israel, Japan, Russia, Turkey and the United States.

For more information on TAGS, please visit www.ClinicalTrials.gov (https://clinicaltrials.gov/ct2/show/NCT02500043 ). The ClinicalTrials.gov Identifier is NCT02500043.

About Metastatic Gastric Cancer

Gastric cancer, also known as stomach cancer, is a disease in which malignant cells form in the lining of the stomach. It is the fifth most common cancer worldwide and the third most common cause of cancer-related death (after lung and liver cancer), with an estimated 723,000 deaths annually.²

When cancer spreads it is called advanced cancer. Locally advanced cancer is when the cancer has grown outside the organ it started in but hasn’t spread to other parts of the body. When the cancer spreads to other parts of the body, this is called metastatic cancer. In the last two decades, the proportion of patients with gastric cancer who present with metastases has risen to over 40%.³

Standard chemotherapy regimens for advanced gastric cancer include fluoropyrimidines, platinum derivatives, and taxanes (with ramucirumab), or irinotecan. The addition of trastuzumab to chemotherapy is standard of care for patients with HER2-neu-positive advanced gastric cancer. However, after failure of first- and second-line therapies, standard third-line treatments are limited.

About Metastatic Colorectal Cancer

Colorectal cancer is the third most common cancer worldwide with approximately 1.4 million new diagnoses in 2012.⁴ Each year there are over 690,000 deaths making it the fourth biggest cancer killer worldwide (after lung, liver and gastric cancer).⁵ Those with metastatic disease (where the cancer has spread from the primary site) the average five-year survival is approximately 11%.⁶ Standard chemotherapy regimens for advanced metastatic colorectal cancer include fluoropyrimidines, oxaliplatin, irinotecan or targeted treatments, such as those that target vascular endothelial growth factors (VEGF) or endothelial growth factor receptors (EGFR).

Over the last decade, clinical outcomes for patients with mCRC have improved considerably due to the advent of novel treatment agents, predictive biomarkers, and a more strategic approach to the delivery of systemic therapies. Currently, the median overall survival for patients with mCRC being treated both in phase III trials and in large observational series or registries is 30 months – more than double that of 20 years ago.^7,8,9

About LONSURF

LONSURF (trifluridine/tipiracil) is an oral anticancer drug, which utilizes the combination of trifluridine (FTD) and tipiracil (TPI), whose dual mechanism of action is designed to maintain clinical activity and differs from conventional fluoropyrimidines. Trifluridine is an antineoplastic nucleoside analogue, which is incorporated directly into the DNA, thereby interfering with the function of DNA. The blood concentration of trifluridine is maintained via tipiracil, which is an inhibitor of the trifluridine-degrading enzyme, thymidine phosphorylase.

In Japan, Taiho Pharmaceutical Co., Ltd. has been marketing LONSURF for the treatment of unresectable advanced or recurrent colorectal cancer since 2014. In the United States, beginning in 2015, Taiho Oncology, Inc., a U.S. subsidiary of Taiho Pharmaceutical, began marketing the drug for the treatment of patients with mCRC who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy. In June 2015, Taiho Pharmaceutical and Servier entered into an exclusive license agreement for the co-development and commercialization of LONSURF in Europe and other countries outside of the United States, Canada, Mexico and Asia. In parts of Asia outside of Japan, Taiho Pharmaceutical’s business partner TTY Biopharm launched LONSURF in Taiwan in July 2018, and Jeil Pharmaceutical is preparing to bring the drug to market in South Korea.

As of December 2018, LONSURF has been approved as a treatment for advanced mCRC in 62 countries and regions worldwide.

About Servier

Servier is an international pharmaceutical company governed by a non-profit foundation, with its headquarters in France (Suresnes). With a strong international presence in 149 countries and a turnover of 4.152 billion euros in 2017, Servier employs 21,700 people worldwide. Entirely independent, the Group reinvests 25% of its turnover (excluding generic drugs) in research and development and uses all its profits for development. Corporate growth is driven by Servier’s constant search for innovation in five areas of excellence: cardiovascular, immune-inflammatory and neuropsychiatric diseases, cancer and diabetes, as well as by its activities in high-quality generic drugs. Servier also offers eHealth solutions beyond drug development.

Becoming a key player in oncology is part of Servier’s long-term strategy. Currently, there are twelve molecular entities in clinical development in this area, targeting gastro-intestinal and lung cancers and other solid tumors, as well as various leukemias and lymphomas. This portfolio of innovative cancer treatments is being developed with partners worldwide, and covers different cancer hallmarks and modalities, including cytotoxics, proapoptotics, and targeted therapies, to deliver life-changing medicines to patients.

More information: www.servier.com

About Taiho Pharmaceutical Co., Ltd. (Japan)

Taiho Pharmaceutical, a subsidiary of Otsuka Holdings Co., Ltd., is an R&D-driven specialty pharma focusing on the three fields of oncology, allergy and immunology, and urology. Its corporate philosophy takes the form of a pledge: “We strive to improve human health and contribute to a society enriched by smiles.” In the field of oncology in particular, Taiho Pharmaceutical is known as a leading company in Japan for developing innovative medicines for the treatment of cancer, a reputation that is rapidly expanding through their extensive global R&D efforts. In areas other than oncology, as well, the company creates and markets quality products that effectively treat medical conditions and can help improve people's quality of life. Always putting customers first, Taiho Pharmaceutical also aims to offer consumer healthcare products that support people's efforts to lead fulfilling and rewarding lives.

For more information about Taiho Pharmaceutical, please visit: https://www.taiho.co.jp/en/ .

¹ EMA. Summary of product information (LONSURF). Available at: https://www.ema.europa.eu/documents/product-information/lonsurf-epar-product-information_en.pdf Last accessed January 2019.
² Ferlay J, Soerjomataram I, Dikshit R, et al. Int J Cancer. 2015;136:E359-86.
³ Bernards N, Creemers GJ, Nieuwenhuijzen GA, et al. No improvement in median survival for patients with metastatic gastric cancer despite increased use of chemotherapy. Ann Oncol. 2013;24:3056–60.
⁴ World Health Organisation. Globocan (2012), colorectal cancer. Available at: http://globocan.iarc.fr/Pages/fact_sheets_cancer.aspx?cancer=colorectal Last accessed January 2019.
⁵ Cancer Research UK. Worldwide cancer statistics. Available at: http://www.cancerresearchuk.org/health-professional/cancer-statistics/worldwide-cancer/mortality#heading-One Last accessed January 2019.
⁶ American Cancer Society. Survival Rates for Colorectal Cancer, by Stage. Available at: https://www.cancer.org/cancer/colon-rectal-cancer/detection-diagnosis-staging/survival-rates.html Last accessed January 2019.
⁷ Brenner H, Kloor M, Pox CP. Colorectal cancer. Lancet (London, England). 2014;383(9927):1490-1502.
⁸ Price TJ, Segelov E, Burge M, et al. Current opinion on optimal systemic treatment for metastatic colorectal cancer: outcome of the ACTG/AGITG expert meeting ECCO 2013. Expert review of anticancer therapy. 2014;14(12):1477-1493.
⁹ Van Cutsem E, Cervantes A, Adam R, et al. ESMO consensus guidelines for the management of patients with metastatic colorectal cancer. Annals of Oncology: official journal of the European Society for Medical Oncology. 2016;27(8):1386-1422.

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