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TOKYO, November 17, 2022 – Astellas Pharma Inc. today announced positive topline results from the Phase 3 SPOTLIGHT clinical trial evaluating the efficacy and safety of zolbetuximab in combination with mFOLFOX6 (a combination regimen that includes oxaliplatin, leucovorin and fluorouracil). Zolbetuximab is an investigational first-in-class monoclonal antibody targeting Claudin 18.2 (CLDN18.2), for the first-line treatment of patients with CLDN18.2-positive, HER2-negative, locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.

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