Taiho Oncology and Servier announced the pivotal Phase 3 (TAGS) trial evaluating LONSURF (trifluridine and tipiracil) plus best supportive care (BSC) versus placebo plus BSC in patients with previously treated metastatic gastric cancer, met its primary endpoint of prolonged overall survival (OS). These results will be presented at an upcoming medical conference and will be submitted to a peer-reviewed journal for publication.
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"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," said Martin J. Birkhofer, M.D., Senior Vice President, Chief Medical Officer, Taiho Oncology. "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 U.S. Food and Drug Administration (FDA) for consideration as a third-line treatment option for appropriate patients with metastatic gastric cancer."
LONSURF is currently indicated in the United States 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.