Phase III LONSURF study shows progression-free survival in patients with refractory metastatic gastric cancer

Servier and Taiho Oncology, Inc. (U.S.), a subsidiary of Taiho Pharmaceutical Co., Ltd. (Japan), jointly announced today clinical data from the pivotal Phase III TAS-102 Gastric Study (TAGS) evaluating LONSURF^® (trifluridine/tipiracil, TAS-102) versus placebo and best supportive care in patients with heavily pre-treated metastatic gastric cancer who have progressed or are intolerant to previous lines of therapy. The study met its primary endpoint of prolonged overall survival (OS) and secondary endpoint measures of progression-free survival (PFS) consistently supported the OS results, as well as continuing to demonstrate the predictable safety and tolerability profile of trifluridine/tipiracil. Data from TAGS was presented by Dr. Hendrik-Tobias Arkenau, Executive Medical Director of the Sarah Cannon Research Institute UK and an investigator for TAGS, at the ESMO 2018 Congress in Munich, Germany during an oral session (Abstract #LBA25). The study results were simultaneously published in The Lancet Oncology.

Based on the results, Servier filed a new application for an additional indication for gastric cancer to the European Medicines Agency (EMA) for LONSURF.

"Patients with metastatic gastric cancer currently have limited treatment options after first and second line therapies have failed," said Dr. Arkenau. "We are pleased to present new data that demonstrate the overall survival clinical benefit of trifluridine/tipiracil in metastatic gastric and gastroesophageal cancer."

In TAGS patients treated with trifluridine/tipiracil showed a clinically meaningful and statistically significant improvement in OS compared with placebo and a 31 percent risk reduction of death (HR 0.69 one sided p=0.00029), which translated into a prolonged median survival of 2.1 months (5.7 months for trifluridine/tipiracil versus 3.6 months for placebo). In addition, trifluridine/tipiracil demonstrated a statistically significant improvement in PFS and time to deterioration of ECOG performance status versus placebo, as well as a predictable and manageable safety profile consistent with that previously reported in patients with metastatic colorectal cancer.

"We're very excited by the results of TAGS as they show trifluridine/tipiracil has the potential to make a difference to the lives of people living with metastatic gastric cancer who continue to struggle with this devastating disease," said Patrick Therasse, Head of Servier Research and Development Oncology Department.

Trifluridine/tipiracil is currently indicated in 61 countries, including those of the European Union, 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.