Lonsurf prolongs survival in metastatic gastric cancer
A trial designed to compare trifluridine and tipiracil with placebo for treatment of metastatic gastric cancer met its primary endpoint of OS, according to the agents’ manufacturer.
The oral combination of trifluridine, a nucleoside metabolic inhibitor, and tipiracil, a thymidine phosphorylase inhibitor, is marketed under the brand name Lonsurf (Taiho Oncology).
The combination is indicated for the treatment of patients with metastatic colorectal cancer who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy and — if RAS wild-type — an anti-EGFR therapy.
Taiho Oncology released topline data from the phase 3, multinational, double-blind TAGS trial.
The analysis included 507 adults with metastatic gastric cancer who previously received at least two prior regimens for advanced disease.
Researchers randomly assigned patients to best supportive care plus trifluridine and tipiracil, or best supportive care plus placebo.
The trial met its primary endpoint of improved OS.
Full results will be presented at a medical conference and submitted to a medical journal for publication.
“We are delighted by these positive results in the TAGS study, which further underscore the activity of Lonsurf in prolonging survival and as a potential treatment option for patients with metastatic gastric cancer who have failed prior treatments,” Martin J. Birkhofer, MD, senior vice president and chief medical officer of Taiho Oncology, said in a company-issued press release. “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 a supplemental new drug application submission to the U.S. Food and Drug Administration for consideration as a third-line treatment option for appropriate patients with metastatic gastric cancer.”