Phase 3 TAGS Study Evaluating LONSURF

Phase 3 TAGS Study Evaluating LONSURF

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– Data from pivotal study demonstrate safety and efficacy regardless of prior gastrectomy in previously treated patients with metastatic gastric cancer (mGC) and gastroesophageal junction (GEJ) adenocarcinoma


PRINCETON, N.J., October 14, 2019 – Taiho Oncology, Inc. announced today that detailed results from the analysis of patients with prior gastrectomy enrolled in the Phase 3 TAS-102 Gastric Study (TAGS) evaluating LONSURF® (trifluridine and tipiracil) in adult patients with metastatic gastric or gastroesophageal junction adenocarcinoma previously treated with at least two prior lines of chemotherapy that included a fluoropyrimidine, a platinum, either a taxane or irinotecan, and if appropriate, HER2/neu-targeted therapy, were published in the October 10, 2019 issue of JAMA Oncology.


The U.S. Food and Drug Administration (FDA) approved LONSURF in previously treated mGC and GEJ adenocarcinoma in February 2019, based on data from the global, randomized, double-blind, placebo-controlled TAGS trial, which demonstrated clinically meaningful and statistically significant improvement in overall survival (OS) and progression-free survival (PFS) when compared with placebo in these patients. The safety profile of LONSURF was consistent with studies of the drug in metastatic colorectal cancer (mCRC), and no new safety concerns were reported.


“The outcome of the Phase 3 TAGS trial in this patient population is extremely significant, as nearly half of all patients with metastatic gastric cancer and gastroesophageal junction adenocarcinoma have undergone a previous gastrectomy and are prone to more complications than those without gastrectomy,”[i],[ii],[iii],[iv],[v] said Memorial Sloan Kettering Cancer Center Medical Oncologist David H. Ilson, MD, PhD. “These data provide further evidence of the safety and efficacy of LONSURF and its utility in patients who may have limited treatment options.”


In the preplanned subgroup analysis, 221 of 507 patients with mGC or GEJ adenocarcinoma with prior gastrectomy were enrolled and randomized to receive LONSURF 35 mg/m2 (n=147) or placebo (n=74) on days 1-5 and 8-12 of each 28-day treatment cycle. Results showed that treatment with LONSURF was tolerable and prolonged survival versus placebo regardless of prior gastrectomy. Further, the overall safety profile of the drug, including the incidence of severe AEs in this heavily pretreated patient population, was similar in patients with or without gastrectomy.


“Metastatic gastric cancer and gastroesophageal junction adenocarcinoma are debilitating diseases that generally have a very poor prognosis,” said Taiho Oncology, Inc. Senior Vice President and Chief Medical Officer Martin J. Birkhofer, MD. “Given the unmet treatment need and sense of urgency once earlier rounds of therapy have failed, we are pleased with the results of the subgroup analysis of the TAGS trial, which provide further evidence for the clinical benefit of LONSURF in these vulnerable patients with gastrectomy.”

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