News Releases

September 06, 2019
Taiho Pharmaceutical Co., Ltd.

Taiho Pharmaceutical Obtains Approval of Anticancer Agent TAS-102 (brand name in Japan "Lonsurf®") in China for Treatment of Colorectal Cancer

Taiho Pharmaceutical Co., Ltd. today announced that the China National Medical Products Administration (NMPA) has approved the anticancer agent TAS-102 (brand name in Japan “Lonsurf”, trifluridine/tipiracil (FTD/TPI), development code TAS-102) for the treatment of patients with metastatic colorectal cancer (mCRC) who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, in addition, might be treated or not able to be treated by an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy.

This approval is based on the results of the Phase III TERRA study on patients with refractory mCRC in Asia (China, South Korea, and Thailand). The study met the primary efficacy endpoint of statistically prolonging overall survival (OS) in patients with unresectable advanced or recurrent colorectal cancer. The drug appeared to be generally well tolerated and its toxicities were consistent with what has been previously reported.

With this latest approval, Taiho Pharmaceutical expects that Lonsurf will make a broader contribution to patients and medical institutions as a new treatment option for patients with colorectal cancer.

About the TERRA study

The TERRA study was a randomized, double-blind, placebo-controlled Phase III comparison study evaluating the efficacy and safety of orally administered TAS-102 in patients with refractory mCRC. The study enrolled 406 patients who received at least two prior regimens of standard chemotherapies for mCRC and were refractory or intolerant those chemotherapies. The study was conducted in China, South Korea, and Thailand. Patients were randomly assigned to receive either TAS-102 or placebo in order to investigate the efficacy of TAS-102. The primary objective of the TERRA study was improvement in OS versus placebo. The study was conducted under the leadership of principal researchers in China, South Korea, and Thailand. Results from TERRA study were presented at ESMO 2016 Congress and e-published in the Journal of Clinical Oncology in 2017*1.

About Colorectal Cancer

The number of patients with colorectal cancer in China is on the rise. It is the fifth most common cancer cause of death in China after lung cancer, gastric cancer, hepatic cancer, and esophageal cancer. It has been reported that around 250,000 people died of colorectal cancer in China in 2018.*2

About Lonsurf

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 mCRC refractory to prior therapy.

Taiho Pharmaceutical and Servier*2 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 August 2019, Lonsurf has been approved as a treatment for advanced mCRC in 72 countries and regions worldwide. Lonsurf has been approved as a treatment for metastatic gastric cancer in the United States in February 2019, in Japan in August 2019 and in EU in September 2019.

*1 Xu, J., Kim T., Shen L., et al. Results of a Randomized, Double-Blind, Placebo-Controlled, Phase III Trial of Trifluridine/Tipiracil (TAS-102) Monotherapy in Asian Patients With Previously Treated Metastatic Colorectal Cancer: The TERRA Study, Journal of Clinical Oncology, 2018; 36(4): 350-358.

*2 WHO International Agency for Research on Cancer. CANCER TODAY. Colorectal cancer: Estimated number of deaths in 2018, China, both sexes, all age

http://gco.iarc.fr/today/online-analysis-table?v=2018&mode=cancer&mode_population=who&population=900&populations=160&key=asr&sex=0&cancer=39&type=1&statistic=5&prevalence=0&population_group=0&ages_group%5B%5D=0&ages_group%5B%5D=17&nb_items=5&group_cancer=1&include_nmsc=1&include_nmsc_other=1#collapse-group-0-3

(Accessed August 22, 2019)

*3 Servier is an international pharmaceutical company governed by a non-profit foundation, with its headquarters in France (Suresnes).

Information in this news release was current as of the original release date.

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