On 22 February 2019, the FDA approved the fixed combination tablets of the nucleoside metabolic inhibitor trifluridine plus the thymidine phosphorylase inhibitor tipiracil (Lonsurf®, Taiho Pharmaceutical) for the treatment of adult metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma patients pretreated with two or more prior lines of chemotherapy including a fluoropyrimidine, a platinum, and either a taxane or irinotecan plus (when appropriate) HER2/neu-targeted therapy.¹FDA website

TAGS

The international, randomised, double-blind, placebo-controlled TAGS (NCT02500043) trial randomised 507 metastatic gastric or GEJ adenocarcinoma patients 2:1 to receive trifluridine/tipiracil (N=337) plus best supportive care (BSC) or matching placebo (n=170) plus BSC. All patients had received at least two prior lines of chemotherapy. Treatment was until disease progression or unacceptable toxicity.

The progression-free survival (PFS) benefitted patient randomised to the active arm vs patients on placebo. The hazard ratio (HR) for PFS was 0.56 (95% CI: 0.46-0.68; P<0.0001). The median overall survival in patients treated with trifluridine/tipiracil measured 5.7 months (4.8-6.2) vs 3.6 months (3.1-4.1) in the placebo-arm (HR=0.69; 95% CI: 0.56-0.85; P=0.0006).

Safety

Common adverse reactions and laboratory abnormalities in ≥10% of patients treated with trifluridine/tipiracil and at with a higher rate when compared to patients receiving placebo included neutropenia, anaemia, nausea, decreased appetite, thrombocytopenia, vomiting, and diarrhoea.

Full prescribing information LONSURF.