Taiho Oncology, Inc. has received FDA approval for Lonsurf (trifluridine/tipiracil) for the treatment of adult patients with metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma previously treated with at least two prior lines of chemotherapy.
The approval is based on results from a global, randomized, phase 3 TAGS trial (NCT02500043) evaluating trifluridine/tipiracil plus best supportive care (BSC) versus placebo plus BSC in patients with previously treated advanced gastric cancer or GEJ adenocarcinoma following progression or intolerance to previous lines of standard therapy. TAGS met its primary and secondary endpoints of prolonged overall survival with trifluridine/tipiracil versus placebo, and progression-free survival, safety and tolerability, and quality of life.
Gastric cancer is the fifteenth most common cancer in the U.S. In 2018, there were an estimated 26,240 new cases and 10,800 deaths. There are limited treatment options following the failure of first- and second-line therapies. Metastatic gastric cancer is associated with a five-year survival rate of about 5%.
Trifluridine/tipiracil is a thymidine-based nucleoside analog, trifluridine, and the thymidine phosphorylase (TP) inhibitor, tipiracil, which increases trifluridine exposure by inhibiting its metabolism by TP. Trifluridine is incorporated into DNA, which results in DNA dysfunction and the restraining of cell proliferation.
In patients with metastatic gastric cancer or GEJ, the most common adverse reactions were nausea, decreased appetite, vomiting, infections, and diarrhea.
Source: Taiho Oncology, February 25, 2019