Astellas Pharma, a pharmaceutical company creating medicines to address unmet medical needs, has announced that Vyloy (zolbetuximab), in combination with fluoropyrimidine- and platinum-containing chemotherapy, has been accepted by the Scottish Medicines Consortium (SMC) as a first-line treatment for 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 (CLDN) 18.2 positive.
Gastric cancer is the fifth most commonly diagnosed cancer globally; early symptoms of gastric and GEJ cancers often overlap with other stomach-related conditions, leading to these cancers being diagnosed at advanced or metastatic stages. The five-year survival rate for patients with metastatic gastric cancer is 7%. Around 386 patients in Scotland annually have advanced or metastatic gastric cancer that has spread or is inoperable, highlighting a significant unmet medical need.
Approximately 38% of patients with locally advanced unresectable or metastatic gastric and GEJ adenocarcinomas are likely to be CLDN18.2 positive.
The SMC’s decision to accept Vyloy is based on data from the phase 3 SPOTLIGHT and GLOW trials. Both trials found an increased length of progression-free survival in patients treated with the Vyloy-chemotherapy combination, compared to patients treated with placebo and chemotherapy alone. Vyloy also demonstrated a favourable safety profile, with a similar incidence of serious treatment-emergent adverse events in the Vyloy and control arms of the studies.
Vyloy attaches to CLDN18.2, a protein that keeps stomach lining cells attached and that can become exposed when these cells become cancerous. By attaching to cancerous cells, Vyloy allows the immune system to attack and kill them.
Dr Timir Patel, medical director of Astellas, said: “Zolbetuximab is an innovative approach to treating advanced gastric cancer. This recommendation by the SMC highlights the importance of personalised approaches in cancer care and underscores the potential of zolbetuximab to improve patient outcomes.”
