The disease rarely shows any early symptoms and is therefore often not detected until it has progressed to an advanced stage.
The Medicines and Healthcare products Regulatory Agency (MHRA) has approved Astellas Pharma’s Vyloy (zolbetuximab) as part of a first-line combination treatment for a subset of patients with gastric cancer.
The monoclonal antibody is approved for use in combination with chemotherapy to treat adult patients with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors are claudin-18.2 positive.
Adenocarcinoma, which develops in cells of the innermost lining of the stomach, accounts for most cases of stomach cancer in the UK, with around 6,600 cases diagnosed each year.
The disease rarely shows early symptoms and tends to progress slowly over years, so in most cases it goes undetected until it is at an advanced stage.
Vyloy is currently the only approved treatment targeting the claudin 18.2 protein, which is expressed in gastric, esophageal, lung and ovarian tissues and is administered intravenously every two to three weeks.
The approval is based on positive results from the late-stage GLOW study, which evaluated the agent in conjunction with CAPOX, a combination chemotherapy regimen that includes capecitabine and oxaliplatin, in the same patient population.
Treatment with Vyloy significantly reduced the risk of disease progression or death compared with placebo, reducing the risk by 24.9%.
Compared with placebo plus CAPOX, the combination reduced the risk of progression or death by 31.3%, meeting GLOW’s primary endpoint.
