Astellas reported that zolbetuximab (Vyloy), a CLDN18.2‑targeting monoclonal antibody, did not meet the primary overall survival endpoint in the Gleam Phase II trial for advanced pancreatic cancer. The negative result removes a late‑stage proof point for CLDN18.2 targeting in this indication and will influence Astellas’ development priorities and partner decisions. Zolbetuximab had been evaluated for patients with CLDN18.2‑positive tumors, an emerging precision target. Astellas said it will review the full dataset to understand drivers of the outcome and potential biomarker or subgroup signals. The miss highlights the challenges of treating pancreatic ductal adenocarcinoma and may shift resources toward other oncology programs or combination strategies.