The Medicines and Healthcare products Regulatory Agency (MHRA) has licensed Astellas Pharma’s VYLOY (zolbetuximab), an anti-claudin 18.2 (CLDN18.2) monoclonal antibody, in combination with fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of adult patients with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastro-oesophageal junction (GEJ) adenocarcinoma whose tumours are Claudin (CLDN) 18.2 positive.
Zolbetuximab is the only licensed treatment to target the CLDN18.2 protein, a member of the claudin family of proteins, that is expressed in gastric, oesophageal, lung and ovarian tissues. Claudins are a major component of epithelial and endothelial tight junctions, which are involved in holding cells together and controlling the flow of molecules between cells. In healthy tissue CLDN18.2 proteins are largely inaccessible, but studies have shown that CLDN18.2 becomes more exposed and accessible as gastric or GEJ tumors develop, presenting a target for antibody treatment. In two large international trials approximately 42% of gastric and GEJ adenocarcinoma patients were shown to be CLDN18.2 positive (defined as: 2+/3+ IHC staining in ≥75% of tumour cells) and HER2 negative.
The license is based on the results from the Phase 3 SPOTLIGHT and GLOW trials, which, between the two multi-center, double-blind, randomized studies, recruited 1072 patients to clinical trial sites in the U.S., Canada, United Kingdom, Europe, Australia, South America, and Asia, including Japan.
Dr Timir Patel, Astellas Medical Director, said: “Zolbetuximab marks a new era in the targeted treatment of gastric cancer, where more treatment options are desperately needed. This treatment holds the potential to provide patients with more valuable time to spend with their loved ones.”
