Vyloy

Vyloy is indicated for the first-line treatment of adult patients with locally advanced unresectable or metastatic HER2-negative gastric or gastro-oesophageal junction (GEJ) adenocarcinoma whose tumors are Claudin (CLDN) 18.2 positive. CLDN18.2 positivity is defined as ≥ 75% of tumor cells demonstrating moderate to strong membranous CLDN18 staining. The recommended loading dose for Vyloy is 800 mg/m², with maintenance doses of 600 mg/m² every 3 weeks or 400 mg/m² every 2 weeks.

In efficacy trials, the median Progression-Free Survival (PFS) was 8.21 months, compared to 6.80 months for the placebo + CAPOX arm. The PFS rate at 12 months was 34.86%, versus 19.13% for placebo + CAPOX. The median Overall Survival (OS) was 14.39 months, compared to 12.16 months for the placebo + CAPOX arm. The OS rate at 12 months was 57.54%, versus 50.79% for placebo + CAPOX.

Regarding safety, 37.3% of patients receiving zolbetuximab + mFOLFOX6 or CAPOX experienced adverse events leading to permanent discontinuation. Grade ≥3 adverse events occurred in 80.1% of patients receiving zolbetuximab + mFOLFOX6 or CAPOX, compared to 74.0% in the placebo + mFOLFOX6 or CAPOX arm. Serious adverse events were reported in 46.0% of patients receiving zolbetuximab + mFOLFOX6 or CAPOX.