Servier and Taiho announce Phase III Trial Data Demonstrates Significant Overall Survival Benefit of LONSURF® (trifluridine and tipiracil) in Patients with Metastatic Gastric Cancer
Servier and Taiho Pharmaceutical Co., Ltd. today announced clinical data from the pivotal Phase III trial (TAGS) for LONSURF® (trifluridine and tipiracil, TAS-102) which showed significant improvement in overall survival (OS) for the treatment of patients with refractory metastatic gastric cancer (HR=0.69 [95% IC 0.56-0.85], p=0.0003). The median overall survival in patients treated with trifluridine/tipiracil and best supportive care (BSC) was 5.7 months as compared to 3.6 months when treated with placebo and BSC, and they had a 31% risk reduction of death. At 12-months, OS rates were 21.2% in the trifluridine/tipiracil group and 13.0% in the placebo group. In addition, the risk for disease progression measured by PFS, a key secondary endpoint, was reduced by 43% (HR: 0.57).
The overall safety profile was consistent with the known safety profile of trifluridine/tipiracil in metastatic colorectal cancer (CRC), with mainly hematological adverse events reported.
“The results presented today from TAGS demonstrate the potential of trifluridine/tipiracil in this group of patients with late-stage metastatic gastric cancer”, 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 at this stage of the disease have very few remaining therapeutic options and it is important that efficacious and manageable treatments are available to expand patient’s survival.”
Ali Zeaiter, Head of Servier Oncology Clinical Development Department added, “We are pleased that trifluridine/tipiracil has shown significant benefit for patients with metastatic gastric cancer who are in need of effective treatments when there are few options remaining. We are committed to improving patients’ outcomes and to providing access to new therapeutic options. We will continue to collaborate with regulatory bodies to progress our mission to make trifluridine/tipiracil accessible to patients and medical professionals.”
Trifluridine/tipiracil is currently indicated in Europe for the treatment of adult patients with metastatic CRC 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.