NEW YORK – The European Medicines Agency has accepted Astellas Pharma's marketing authorization application for the monoclonal antibody zolbetuximab as a first-line treatment for patients with locally advanced, unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma that is HER2 negative but CLDN18.2 positive.
Astellas submitted data from the Phase III SPOTLIGHT and GLOW trials, in which investigators compared the activity of zolbetuximab paired with different chemotherapies to chemo alone. Researchers reported a median progression-free survival benefit of 8.2 months on the zolbetuximab-chemotherapy combination versus 6.8 months with just chemo. After one year on treatment, 35 percent of patients who received zolbetuximab-chemo were alive without their cancer progressing versus 19 percent in the comparator arm; two-year progression-free survival rates were 14 percent versus 7 percent, respectively.
In these studies, 38 percent of screened patients were CLDN18.2-positive, defined as moderate-to-strong staining via immunohistochemistry testing for CLDN18 on at least 75 percent of tumor cells.
The EMA's Committee for Medicinal Products for Human Use will review this data and make a recommendation to the European Commission, which will decide whether to make zolbetuximab available to gastric cancer patients in Europe by next year. There were around 136,000 newly diagnosed gastric cancer patients in Europe in 2020 accounting for around 3 percent of all cancer cases. The five-year survival rate for patients across all stages of gastric cancer in Europe is 26 percent.
"Patients with gastric cancer in Europe face extremely low five-year survival rates regardless of their disease stage, and innovative therapies that extend survival are needed," Moitreyee Chatterjee-Kishore, Astellas' senior VP and head of immuno-oncology development, said in a statement. "The EMA's acceptance of the zolbetuximab MAA continues a cascade of regulatory milestones for Astellas that are aimed at bringing a new option to patients with advanced gastric and GEJ cancer."
Astellas is also seeking approval for zolbetuximab in this same setting in the US and in Japan.