Astellas' zolbetuximab meets primary endpoint in Phase III

Japanese drug major Astellas Pharma (TYO: 4503) today announced positive top-line results from the Phase III 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.

Originated at Ganymed Pharmaceuticals, zolbetuximab (IMAB362) came into Astellas’ hands in 2016, when it acquired the German company for $1.4 billion. The drug was discovered by Uğur Şahin and Özlem Türeci, who became known as the couple behind one of the world’s first Covid-19 vaccines, even before they founded BioNTech (Nasdaq: BNYX).