The effects and efficacy of Vyloy (zolbetuximab-clzb)

Vyloy (zolbetuximab-clzb) is a new cancer drug for stomach cancer and gastroesophageal junction cancer (GEJ) that targets a protein called Claudin 18.2 on cancer cells, killing them and slowing tumor growth. Vyloy may help increase the length of time before cancer progresses and increase patients' life expectancy, which is sometimes called progression-free survival (PFS) and overall survival (OS). Vyloy is usually given as an intravenous infusion every 2 or 3 weeks.

zolbetuximab-clzb is a tight junction protein 18.2 (CLDN18.2)-directed cytolytic antibody that depletes CLDN18.2-positive cells via antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC). Compared with zolbetuximab-clzb or chemotherapy alone, zolbetuximab-clzb combination chemotherapy had enhanced antitumor activity in a mouse tumor model expressing CLDN18.2. Vyloy is an FDA-approved first-line treatment for gastric (cancer) and GEJ cancers that are claudin (CLDN) 18.2-positive, HER2-negative, have spread (metastasized), or cannot be surgically removed (unresectable). An FDA-approved test must be used to check whether the tumor is claudin (CLDN) 18.2-positive. Vyloy will be used as a combination therapy with fluoropyrimidine-containing and platinum-containing chemotherapy.

Vyloy achieved positive results in the GLOW clinical trial and the SPOTLIGHT clinical trial. In the SPOTLIGHT trial, results showed that the median PFS was 10.6 months in the Vyloy/chemotherapy group compared with 8.7 months in the placebo/chemotherapy group. Median overall survival was 18.2 months in the Vyloy/chemotherapy group and 15.5 months in the placebo/chemotherapy group. The chemotherapy regimen was mFOLFOX6 (a combination chemotherapy regimen including oxaliplatin, leucovorin, and fluorouracil).