ルリジン・チピラシル塩酸塩、開発コード：「TAS-102」)について、「治癒切除不能な進行・再発の胃がん」の適応追加申請を行ったと発表した。標準治療に不応となった既治療の切除不能胃がん患者において本剤とプラセボを比較したフェーズ３ (TAGS試験) の結果に基づいて申請したもので、同試験の主要評価項目の全生存期間を有意に延長したとしている。現行の適応症は「治癒切除不能な進行・再発の結腸・直腸がん」。
Taiho Pharmaceutical Applies for Additional Indication of Gastric Cancer in Japan for its Anticancer agent LONSURF® Taiho Pharmaceutical Co., Ltd. August 17, 2018Taiho Pharmaceutical Co., Ltd. announced today that it applied to the Japanese Ministry of Health, Labour and Welfare for an additional indication for unresectable advanced or recurrent gastric cancer for its anticancer agent LONSURF combination tablet T15, T20 (trifluridine and tipiracil).This application is based on the results of a Phase III TAS-102 Gastric Study (TAGS) trial that compared trifluridine/tipiracil plus best supportive care (BSC) versus placebo plus BSC, in patients with previously treated metastatic gastric cancer refractory to standard therapies. In the TAGS trial, the primary endpoint of overall survival (OS) was extended significantly with trifluridine/tipiracil compared to placebo, and no new safety signals were observed with the study drug.Taiho Pharmaceutical anticipates that, if approved, LONSURF will provide a new oral treatment option for patients with gastric cancer.
About Gastric Cancer In Japan, gastric cancer is the most common cancer by site, with 131,893 people newly diagnosed per year (2013)*1 and 45,531 people losing their lives to it in 2016*2. Gastric cancer is the fifth most common cancer worldwide and the third most common cause of cancer-related deaths (after lung and liver cancer), with an estimated 723,000 deaths annually*3. In recent years, the outcome for gastric cancer has improved remarkably, and survival has increased dramatically over the past 10 years. As gastric cancer progresses, treatment options become limited as numerous complications can restrict the usable drugs and preclude intensive chemotherapy. Accordingly, new therapeutic drugs which prolong survival and relieve symptoms in late-stage treatment of metastatic gastric cancer are considered valuable in the treatment of the disease.
About TAGS The TAGS (TAS-102 Gastric Study) trial is a Taiho-sponsored pivotal Phase III multinational, randomized, double-blind study evaluating LONSURF (trifluridine and tipiracil), 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 overall survival (OS), and secondary endpoint measures included progression-free survival (PFS), and safety and tolerability, as well as quality of life. The TAGS trial enrolled 507 adults 18 years and older with metastatic gastric cancer who had previously received at least two prior regimens for advanced disease. Amongst other locations, the TAGS trial was conducted in Japan, North America, Europe, Russia and Turkey.
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 metastatic 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, Jeil Pharmaceutical and TTY Biopharm, which are Taiho Pharmaceutical's business partners in South Korea and Taiwan, respectively, are preparing to bring the drug to market. As of July 2018, LONSURF has been approved as a treatment for advanced mCRC in 51 countries and regions worldwide.*1: 2013 national estimates of cancer incidence based on cancer registries in Japan *2: 2016 Vital Statistics in Japan by the Ministry of Health, Labour and Welfare *3: Ferlay J, Soerjomataram I, Dikshit R, et al. Int J Cancer. 2015;136:E359-86
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