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Astellas's First-In-Class CLDN18 Antibody Meets Phase III Gastric Endpoints

Competitive Advantage Vs Opdivo?

 
• By Lisa Takagi

Novel candidate acquired from Ganymed in 2016 moves closer to first approval filing anywhere for a CLDN18-targeting antibody, and as a potential competitor for Opdivo in HER2-negative gastric cancer, following positive top-line Phase III results in the first-line combo setting. Results from GLOW trial in combination with CAPOX also awaited.

ZOLBETUXIMAB CAN BECOME A FIRST CANDIDATE TO REACH MARKET AS CLDN18 ANTIBODY
ZOLBETUXIMAB COULD BECOME FIRST ANTI-CLDN18 ANTIBODY TO REACH MARKET • Source: Shutterstock

Astellas Pharma, Inc.'s key oncology candidate zolbetuximab has met its primary and secondary endpoints in the Phase III SPOTLIGHT trial in combination with chemotherapy for gastrointestinal cancers, paving the way for a possible approval filing for the first-in-class, claudin (CLDN) 18.2-targeting antibody.

The drug, granted Fast Track Designation by the US Food and Drug Administration (FDA) in August 2022, was assessed in the SPOTLIGHT study in combination with mFOLFOX6 (a combination of oxaliplatin, leucovorin and fluorouracil), versus placebo and mFOLFOX6, for the first-line treatment of CLDN18

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