LONSURF® (trifluridine/tipiracil) Receives Positive Opinion from CHMP in the EU for Patients with Previously Treated Metastatic Gastric Cancer

Servier and its partner Taiho Pharmaceutical Co., Ltd announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for LONSURF (trifluridine/tipiracil) as monotherapy for the treatment of adult patients with 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. The CHMP’s opinion will now be sent to the European Commission (EC) for the adoption of the decision.

Gastric cancer in Europe affects approximately 130,000 people a year,¹ and it is estimated that 40% of those patients will have metastatic disease.² For those with advanced or metastatic disease the treatment options are limited and are often palliative.

“The positive opinion from the CHMP for LONSURF is very welcomed; patients with metastatic gastric cancer have few therapeutic options remaining, so it is of the upmost importance new therapies are made available. The Phase III trial TAGS demonstrated that LONSURF was effective and tolerable for these patients and gave patients valuable months of life,” said Professor Josep Tabernero, Head of the Medical Oncology Department, Vall d’Hebron University Hospital, Barcelona and Director of the Vall d’Hebron Institute of Oncology (VHIO).

The marketing authorization application was supported by data from the global Phase III trial TAGS ( TA S-102 G astric S tudy) which was a randomized, double-blind study evaluating LONSURF, plus best supportive care (BSC) versus placebo plus BSC in patients with metastatic gastric cancer refractory to standard treatments. LONSURF demonstrated significant improvement in overall survival (OS) (HR=0.69 [95% CI 0.56-0.85], p=0.00029) compared to placebo plus BSC. The median OS in patients treated with LONSURF and BSC was 5.7 months compared to 3.6 months when treated with placebo and BSC, and there was a 31% risk reduction of death. The overall safety profile was consistent with the known safety profile of LONSURF in metastatic colorectal cancer (CRC), with mainly hematological adverse events reported.

“Today’s announcement is one step closer to ensuring patients with metastatic gastric cancer have another treatment option, bringing an incremental survival benefit over the standard of care,” said Patrick Therasse, Head of Servier Research and Development Oncology. “Gastric cancer is difficult to treat and each step forward is a major event.”

Currently in the EU, LONSURF is indicated for the treatment of adult patients with metastatic colorectal cancer 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.³

#ENDS#

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 colorectal cancer), with an estimated 780,000 deaths annually.⁴

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%.²

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, there are neither approved nor standard third-line treatments in the EU.

About LONSURF³

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 the EU, LONSURF is indicated for the treatment of adult patients with metastatic colorectal cancer (CRC) 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 of July 2019, LONSURF has been approved as a treatment for advanced mCRC in 68 countries and regions. In February 2019, LONSURF has been approved as a treatment for mGC/mGEJC in the United States.

LONSURF was discovered and developed by Taiho Pharmaceutical. 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.

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 4.2 billion euros in 2018, Servier employs 22,000 people worldwide. Entirely independent, the Group reinvests 25% of its turnover (excluding generics) 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 neurodegenerative 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 different types of leukemia and lymphomas. This portfolio of innovative cancer treatments is being developed with partners worldwide, and covers different cancer hallmarks and modalities, including cytotoxics, proapoptotics, immune targeted therapies, to deliver life-changing medicines to patients.

More information: www.servier.com

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¹ World Health Organisation. Globocan. World cancer statistics. Available at: https://gco.iarc.fr/today/data/factsheets/populations/900-world-fact-sheets.pdf Last accessed July 2019.

² 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.

³ European Medicines Agency. LONSURF summary of product characteristics. Available at: https://www.ema.europa.eu/en/documents/product-information/lonsurf-epar-product-information_en.pdf Last accessed July 2019.

⁴ World Health Organisation. Globocan (2018), gastric cancer. Available at: https://gco.iarc.fr/today/data/factsheets/cancers/7-Stomach-fact-sheet.pdf. Last accessed July 2019.

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