The European Commission (EC) has approved Astellas Pharma’s Vyloy (zolbetuximab) in combination with chemotherapy for advanced gastric and gastroesophageal junction (GEJ) cancer.
Zolbetuximab is now approved in the European Union (EU) as the first-line of treatment in adult patients with locally advanced unresectable or metastatic HER2-negative gastric or GEJ adenocarcinoma whose tumours are claudin (CLDN) 18.2 positive.
The European Medicines Agency (EMA) has recommended maintaining zolbetuximab’s orphan medicinal product designation due to poor survival rates in gastric and GEJ cancers.
The drug received a positive opinion from EMA’s Committee for Medicinal Products for Human Use (CHMP) in July.
Astellas immuno-oncology development head and senior vice president Moitreyee Chatterjee-Kishore said: “We are delighted to bring zolbetuximab, a first-in-class targeted treatment option, to patients in Europe where gastric and gastroesophageal cancers are the sixth leading cause of cancer-related death.”
Zolbetuximab is said to be the first and only monoclonal antibody specifically targeting gastric tumour cells expressing the CLDN18.2 biomarker.
In August 2024, the claudin 18.2-directed cytolytic antibody was approved in the UK. Prior to that, in March 2024, it was approved by Japan’s Ministry of Health, Labour and Welfare.
Astellas has also submitted applications for zolbetuximab to additional regulatory agencies worldwide, with reviews currently ongoing.
The approval was based on evidence from the Phase 3 SPOTLIGHT and GLOW clinical trials.
According to the results, zolbetuximab significantly improved progression-free survival (PFS) and overall survival (OS) in patients with gastric and GEJ cancers.
In the SPOTLIGHT trial, patients receiving zolbetuximab plus mFOLFOX6 showed greater median PFS compared to placebo plus mFOLFOX6. The median OS was 18.23 months versus 15.54 months in the respective groups.
In the GLOW trial, the median PFS was also more than for zolbetuximab plus CAPOX versus placebo plus CAPOX. The median OS was 14.39 months versus 12.16 months, respectively.
Both trials showed similar rates of serious treatment-emergent adverse events (TEAEs) between the zolbetuximab and control groups.
An expanded Phase 2 trial of zolbetuximab is underway, recruiting patients with metastatic pancreatic adenocarcinoma.
Additionally, Astellas is developing ASP2138, which is currently in a Phase 1/1b study for patients with gastric or GEJ adenocarcinoma and pancreatic adenocarcinoma with CLDN18.2 expression.
