Taiho Oncology has reported positive topline results from the TAS-102 Gastric Study (TAGS) trial, a Phase III study of LONSURF (trifluridine and tipiracil), along with best supportive care (BSC) versus placebo plus BSC to treat patients with previously treated metastatic gastric cancer.
The randomised, double-blind trial met its primary endpoint of prolonged overall survival (OS).
The trial’s secondary endpoint included progression-free survival (PFS), and safety and tolerability, as well as quality of life.
It was performed in Japan, North America, Europe, Russia and Turkey, and other locations.
The trial enrolled 507 adult patients aged 18 years and older who had previously received at least two prior regimens for advanced disease.
Taiho Oncology senior vice-president chief medical officer Martin Birkhofer said: “This is particularly important given that these patients currently have limited approved standard third-line treatment options available to them after first and second line therapies have failed.
“We look forward to including these data in an sNDA submission to the US Food and Drug Administration (FDA) for consideration as a third-line treatment option for appropriate patients with metastatic gastric cancer.”
LONSURF is an oral combination of a nucleoside metabolic inhibitor, trifluridine, and a thymidine phosphorylase inhibitor, tipiracil.
The anticancer drug is currently being used in US for the treatment of patients with metastatic colorectal cancer (mCRC) who have been previously treated with fluoropyrimidine, oxaliplatin and irinotecan-based chemotherapy.
LONSURF is also available for use in European Union (EU), Japan, and other countries.