Astellas’ Pancreatic Cancer Study Misses Endpoint

Astellas Pharma says its Phase 2 GLEAM study evaluating zolbetuximab in combination with standard chemotherapy for metastatic pancreatic cancer failed to meet its primary endpoint of improving overall survival. The randomized, open-label trial compared zolbetuximab plus gemcitabine and nab-paclitaxel with chemotherapy alone in patients with CLDN18.2-positive metastatic pancreatic adenocarcinoma. At final analysis, the addition of zolbetuximab did not extend survival compared with standard treatment, the company says, adding that the safety profile of the combination regimen was consistent with the known safety of the individual agents. The company plans a full evaluation of the trial data, including analyses of secondary endpoints and subgroups, before publishing results.

Zolbetuximab, a monoclonal antibody that targets CLDN18.2, is currently approved for CLDN18.2-positive, HER2-negative gastric or gastroesophageal junction cancers.