Lonsurf gastric cancer third-line treatment key phase 3 trials received positive results
Lonsurf gastric cancer third-line treatment key phase 3 trials received positive results
May 10, 2018 Source: Sina Pharmaceutical
Window._bd_share_config={ "common":{ "bdSnsKey":{ },"bdText":"","bdMini":"2","bdMiniList":false,"bdPic":"","bdStyle":" 0","bdSize":"16"},"share":{ }};with(document)0[(getElementsByTagName('head')[0]||body).appendChild(createElement('script')) .src='http://bdimg.share.baidu.com/static/api/js/share.js?v=89860593.js?cdnversion='+~(-new Date()/36e5)];On May 9th, Taiho Oncology and Servier, the US subsidiaries of Japan Dapeng Pharmaceutical Co., Ltd. announced that LONSURF® (trifluridine / tipiracil) combined with best supportive care was used in contrast to placebo + BSC (Best Supportive Care). The key clinical phase 3 study (TAGS) for the treatment of metastatic gastric cancer reached its primary end point for prolonging overall survival. These results will be announced at the upcoming medical conference and will be submitted to peer-reviewed journals for publication.
Dr. Martin J. Birkhofer, Senior Vice President and Chief Medical Officer of Taiho Oncology, said: "We are pleased with these positive results in the TAGS study, which further underscores the benefits of LONSURF in prolonging survival and making the drug a former A potential treatment option for patients with metastatic gastric cancer who have failed treatment. Given the limited standard three-line treatment options available to these patients after first- and second-line treatment failures, the clinical benefit of LONSURF has become particularly important. We look forward to including this data in the US Food and Drug Administration (FDA) as a sNDA application for third-line therapy for patients with metastatic gastric cancer."
The TAGS-Test (TAS-102 Gastric Study) is a multicenter, randomized, double-blind, critical clinical phase 3 study sponsored by Dapeng Pharmaceutical Industries. The enrolled patients were 507 patients with metastatic gastric cancer over 18 years old who were resistant to the previous two treatments. The primary endpoint of the trial was overall survival (OS), and secondary endpoints included progression-free survival (PFS), safety and tolerability, and patient quality of life.
LONSURF is a compound tablet consisting of the nucleoside metabolism inhibitor trifluridine and the thymidine phosphorylase inhibitor tipiracil. It is currently used in the United States for the treatment of fluoropyrimidine, oxaliplatin and irinotecan. A patient with metastatic colorectal cancer who is anti-vascular endothelial growth factor (VEGF) biotherapy, anti-EGFR therapy (RAS wild type). The drug is also available in Europe, Japan and other regions.
In June 2015, Dapeng Pharmaceutical Industry Co., Ltd. and Servier signed an exclusive license agreement for joint development and commercialization of LONSURF. Under the terms of the agreement, Servier is granted the right to jointly develop and commercialize LONSURF in Europe and other countries outside the United States, Canada, Mexico and Asia. Dapeng Pharmaceutical Industries Co., Ltd. reserves the right to develop and commercialize LONSURF in the United States, Canada, Mexico and Asia, and has the right to manufacture and supply the product. (Sina Pharmaceutical Compilation / David)
Article Reference Source: Taiho Oncology Announces Positive Topline Results from Pivotal Phase 3 Trial of LONSURF® (trifluridine/tipiracil) in Metastatic Gastric Cancer
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