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

Servier and its partner Taiho Oncology, Inc. (US), a subsidiary of Taiho Pharmaceutical Co., Ltd. (Japan), announced today that detailed results from the analysis of patients with prior gastrectomy enrolled in the Phase III TAS-102 Gastric Study (TAGS) evaluating LONSURF® (trifluridine/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, platinum, and either a taxane and/or irinotecan-containing regimen, and if appropriate, HER2/neu-targeted therapy, were published in the October issue of JAMA Oncology.1

In the preplanned subgroup analysis, 221 of 507 patients with mGC or GEJ adenocarcinoma with prior gastrectomy were enrolled and randomized to receive LONSURF (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 by 6 months vs 3.4 months [95% CI, 0.57 (0.41-0.79)]. 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.

“For patients with metastatic gastric cancer and gastroesophageal junction adenocarcinoma, nearly half will undergo a gastrectomy and often these patients are likely to have more complications compared to those who do not have one. Therefore this data is critical in demonstrating the safety and efficacy for a large sub-population of patients, who in Europe, may have limited treatment options,” said Professor Josep Tabernero, Head of the Medical Oncology Department, Vall d’Hebron University Hospital, Barcelona and Director of the Vall d’Hebron Institute of Oncology (VHIO).

“Patients with metastatic gastric cancer, including gastroesophageal junction adenocarcinoma, have a high unmet medical need when the current standard of care no longer works. We are pleased with the results from this subgroup analysis that strongly suggest the same efficacy and tolerability for LONSURF in this group of patients regardless of previous gastrectomy,” said Patrick Therasse, MD, PhD, Head of Servier Research and Development Oncology.

Data from the subgroup analysis were previously announced at an oral presentation during the 2019 American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO-GI) in San Francisco, US.

In the EU LONSURF is indicated as monotherapy for the treatment of adult patients with metastatic colorectal cancer who have been previously treated with, or are not considered candidates for, available therapies including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, anti-VEGF agents, and anti-EGFR agents. It has recently been accepted by the European Commission as monotherapy for the treatment of adult patients with metastatic gastric cancer including adenocarcinoma of the gastroesophageal junction, who have been previously treated with at least two prior systemic treatment regimens for advanced disease.