Taiho Pharmaceutical Obtains Additional Indication of Gastric Cancer in Japan for Its Anticancer Agent LONSURF

Taiho Pharmaceutical Co., Ltd. today announced that the Japanese Ministry of Health, Labour and Welfare has approved an additional indication of unresectable advanced or recurrent gastric cancer that has progressed after chemotherapy for its anticancer agent LONSURF® combination tablet T15, T20 (trifluridine/tipiracil, TAS-102).

This approval is based on data from global, randomized Phase III study (TAGS) evaluating trifluridine/tipiracil versus placebo in patients with metastatic gastric cancer refractory to standard treatments. In the TAGS trial, the primary endpoint of overall survival (OS) was extended significantly with trifluridine/tipiracil compared to a placebo, and no new safety signals were observed with the study drug.

Taiho Pharmaceutical believes that LONSURF will make a positive contribution as a treatment option for patients with gastric cancer.

TAGS (TAS-102 Gastric Study) is a Taiho-sponsored, global, randomized, double-blind Phase III study evaluating trifluridine/tipiracil (TAS-102) plus best supportive care (BSC) versus placebo plus BSC in patients with metastatic gastric cancer refractory to standard treatments. The primary endpoint in the TAGS trial was OS, and the main secondary endpoint measures included progression-free survival (PFS), safety and tolerability, as well as quality of life. The TAGS trial aimed to enroll 500 adults 18 years and older with metastatic gastric cancer who had previously received at least two prior regimens for advanced disease. The trial enrolled 507 subjects and was conducted in 17 countries and 110 sites around the world.

For more information on the TAGS trial, please visit: https://clinicaltrials.gov/ct2/show/NCT02500043

LONSURF 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. FTD is an antineoplastic nucleoside analogue which is incorporated directly into the DNA, thereby interfering with the function of DNA. The blood concentration of FTD is maintained via TPI, which is an inhibitor of the FTD-degrading enzyme, thymidine phosphorylase.

In Japan, Taiho Pharmaceutical has been marketing LONSURF for the treatment of unresectable advanced or recurrent colorectal cancer since 2014. Since receiving FDA approval in 2015, Taiho Oncology, Inc., a U.S. subsidiary of Taiho Pharmaceutical, has been marketing LONSURF in the United States for metastatic colorectal cancer (mCRC) refractory to prior therapy.

Taiho Pharmaceutical and Servier* have 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 2018, and JEIL Pharmaceutical is preparing to bring the drug to market in South Korea.

As of July 2019, LONSURF has been approved as a treatment for advanced mCRC in 68 countries and regions worldwide. Additionally, LONSURF was approved as a treatment for metastatic gastric cancer in the United States in February 2019. In the European Union, on July 2019 the CHMP has issued a positive opinion for LONSURF as monotherapy for the treatment of adult patients with metastatic gastric cancer. The CHMP's opinion has been sent to the European Commission (EC) for the adoption of the decision.

*Servier is an international pharmaceutical company governed by a non-profit foundation, with its headquarters in France (Suresnes). For more information please visit: www.servier.com

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