Astellas Pharma’s claudin 18.2-directed cytolytic antibody has been approved by the European Commission (EC) as part of a first-line combination treatment for a subset of gastric cancer patients.
Vyloy (zolbetuximab) has been authorised for use alongside fluoropyrimidine- and platinum-containing chemotherapy to treat adults 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 18.2 positive.
The European Medicines Agency (EMA) has also recommended that the drug’s designation as an orphan medicinal product be maintained due to the poor survival outcomes associated with gastric and GEJ cancers.
Approximately 136,000 people are diagnosed with gastric cancer every year in Europe and adenocarcinomas, which develop from cells in the innermost lining of the stomach, account for the majority of cases.
The disease usually develops slowly over many years and early-stage symptoms frequently overlap with more common stomach-related conditions, causing most cases to go undetected until an advanced or metastatic stage.
Administered as an infusion every two to three weeks, Vyloy is now the first and only therapy approved in the EU specifically designed to target gastric tumour cells that express the biomarker claudin 18.2.
The approval follows a recent recommendation from the EMA’s human medicines committee and was supported by results from the phase 3 SPOTLIGHT trial, which evaluated first-line Vyloy plus mFOLFOX6 – a combination regimen that includes oxaliplatin, leucovorin and fluorouracil – versus placebo plus mFOLFOX6 in patients with claudin 18.2-positive, HER2-negative, locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma.
A median progression-free survival of 10.61 months was achieved with the Vyloy regimen compared with 8.67 months for placebo plus mFOLFOX6, while median overall survival was 18.23 months versus 15.54 months in the respective treatment groups.
The regulator’s decision was also informed by positive results from the late-stage GLOW study, which assessed Vyloy alongside CAPOX – a combination chemotherapy regimen that includes capecitabine and oxaliplatin – in the same patient population.
Moitreyee Chatterjee-Kishore, senior vice president and head of immuno-oncology development at Astellas, said the company was “delighted” to bring Vyloy to patients in Europe, adding that it is now “entering a new era in precision medicine for these advanced cancers”.