MHRA Approves Astellas' Vyloy Combo for First-Line Gastric Cancer Treatment

Astellas Pharma's Vyloy (zolbetuximab) has received approval from the Medicines and Healthcare products Regulatory Agency (MHRA) to be used as part of a first-line treatment for certain gastric cancer patients. The monoclonal antibody is approved for use in combination with fluoropyrimidine- and platinum-containing chemotherapy specifically 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 tumors express the claudin 18.2 protein.

In the UK, approximately 6,600 people are diagnosed with gastric cancer each year, with adenocarcinomas—which originate from cells lining the stomach—constituting the majority of cases. Gastric cancer typically develops slowly over several years and seldom causes early symptoms, leading to many cases going undiagnosed until they reach an advanced stage.

Vyloy, administered intravenously every two to three weeks, is now the only treatment licensed to target the claudin 18.2 protein, a protein found in various tissues including gastric, oesophageal, lung, and ovarian tissues. Timir Patel, medical director at Astellas, indicated that the drug “marks a new era in the targeted treatment of gastric cancer, where more treatment options are desperately needed.”

The MHRA's decision was supported by data from the phase 3 SPOTLIGHT trial, which evaluated Vyloy in combination with mFOLFOX6—a chemotherapy regimen including oxaliplatin, leucovorin, and fluorouracil—against a placebo combined with mFOLFOX6. This trial involved patients with claudin 18.2-positive, HER2-negative, locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma. The Vyloy combination showed a significant reduction in the risk of disease progression or death compared to the placebo, reducing the risk by 24.9%.

Additionally, the approval was backed by positive outcomes from the GLOW study, which evaluated Vyloy alongside CAPOX—a chemotherapy regimen comprising capecitabine and oxaliplatin—in the same patient demographic. The CAPOX combination reduced the risk of disease progression or death by 31.3% compared to the placebo plus CAPOX, meeting the primary endpoint of the GLOW study.

Julian Beach, MHRA interim executive director of healthcare quality and access, commented that this new targeted therapy has the potential to extend survival for adults with this particular type of cancer. He also confirmed that the approval of Vyloy met the necessary regulatory standards of quality, efficacy, and safety.

Vyloy's approval signifies a meaningful advancement in the treatment of gastric cancer. By targeting the claudin 18.2 protein, Vyloy provides a new therapeutic option for patients whose cancers are difficult to treat with existing therapies. The successful trial outcomes highlight the potential of Vyloy to improve survival rates and delay disease progression, offering hope to patients facing advanced stages of gastric and GEJ adenocarcinoma.