Astellas’ zolbetuximab fails pancreatic cancer study endpoint

Astellas Pharma’s Phase II GLEAM study, evaluating zolbetuximab in combination with gemcitabine and nab-paclitaxel for Claudin (CLDN)18.2-positive metastatic pancreatic cancer, did not demonstrate a statistically significant improvement in overall survival compared to chemotherapy alone. This means the primary endpoint of the study was not met. The safety profile of the zolbetuximab combination therapy was consistent with the known safety profiles of the individual drugs.

Astellas plans to complete detailed data analysis of the GLEAM study, including secondary endpoints and subgroup analyses, and will collaborate with the principal investigators for results publication. The company remains committed to enriching its pipeline to provide new treatment options for patients with advanced pancreatic cancer.

The company stated that the impact of this announcement on Astellas Pharma's full-year consolidated earnings for the fiscal year ending March 2026 is expected to be minor. The GLEAM study, NCT03816163, was a global, multi-center, non-blinded, randomized trial that enrolled 393 patients across 136 medical institutions.