What is Vyloy (zolbetuximab-clzb)?

Vyloy (zolbetuximab-clzb) is a cytolytic antibody directed against claudin 18.2 for the combination treatment of patients with HER2-negative gastric cancer or gastroesophageal junction cancer whose tumors are CLDN18.2-positive. Gastric cancer is a type of stomach cancer, and gastroesophageal junction (GEJ) adenocarcinoma is a type of cancer that starts at the junction of the esophagus and stomach. CLDN18.2 is a transmembrane protein on the surface of gastric epithelial cancer cells. Vyloy induces cancer cell death by binding to CLDN18.2 and activating two different immune system pathways: antibody-dependent cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC).

The U.S. Food and Drug Administration (FDA)approval ofVyloy is based on the results of the Phase 3 SPOTLIGHT (Vyloy plus mFOLFOX6 compared with placebo plus mFOLFOX6) and GLOW (Vyloy plus CAPOX compared with placebo plus CAPOX) clinical trials. Both trials met the primary endpoint (progression-free survival) and the key secondary endpoint (overall survival) in patients treated with Vyloy plus chemotherapy compared with placebo plus chemotherapy.

Vyloy is typically used with fluoropyrimidine- and platinum-containing chemotherapy regimens, administered by intravenous infusion, -mFOLFOX6 is a combination chemotherapy regimen that includes oxaliplatin, aldohydrofolate, and fluorouracil, and CAPOX is a combination chemotherapy regimen that includes capecitabine and oxaliplatin. Common adverse reactions include nausea, vomiting, fatigue, decreased appetite, diarrhea, peripheral sensory neuropathy, abdominal pain, constipation, weight loss, allergic reactions, and pyrexia. Warnings and precautions related to Vyloy include serious allergic reactions and severe nausea and vomiting. Patients should be premedicated with antiemetic medication before each infusion.