How well does Vyloy(zolbetuximab) work?

Zolbetuximab has shown significant therapeutic potential in the treatment of CLDN18.2-positive advanced or metastatic gastric cancer. This article aims to summarize and analyze the therapeutic effects of zolbetuximab, with a view to providing references for its clinical application.

Therapeutic Effects of Zolbetuximab

1. Trial Design

This was a multicenter, randomized, double-blind, phase 3 trial. The trial investigated the efficacy and safety of zolbetuximab plus mFOLFOX6 (modified leucovorin or levoleucovorin, fluorouracil, and oxaliplatin regimen) versus placebo plus mFOLFOX6 in patients with CLDN18.2-positive, HER2-negative, locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma.

2. Trial Result Settings

Patients were enrolled from 215 centers across 20 countries/regions. Patients were randomly assigned (1:1) via an interactive response technology and stratified by region, number of metastatic organs, and previous gastrectomy. Patients received a loading dose of zolbetuximab (800 mg/m²), followed by 600 mg/m² every 3 weeks plus mFOLFOX6 (every 2 weeks), or placebo plus mFOLFOX6. The primary endpoint was the assessment of progression-free survival (PFS) in all randomly assigned patients by an independent review committee.

3. Trial Results

In patients with CLDN18.2-positive, HER2-negative, locally advanced unresectable or metastatic gastric adenocarcinoma or gastroesophageal junction adenocarcinoma, treatment with zolbetuximab combined with mFOLFOX6 significantly prolonged progression-free survival and overall survival compared with placebo combined with mFOLFOX6. Zolbetuximab combined with mFOLFOX6 may represent a new first-line treatment option for these patients.