Astellas Pharma announced positive topline results from the second phase 3 trial of its experimental anti-CLDN18.2 antibody in gastric cancer, providing the foundational data for global regulatory submissions.
The phase 3 GLOW clinical trial evaluated the efficacy and safety of zolbetuximab in combination with CAPOX (a combination chemotherapy regimen that includes capecitabine and oxaliplatin) in patients with CLDN18.2-positive, HER2-negative, locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma. The study met its primary endpoint showing statistical significance in progression-free survival for patients treated with zolbetuximab plus CAPOX compared to placebo plus CAPOX. In addition, the study met a key secondary endpoint — overall survival — showing statistical significance for patients treated with zolbetuximab plus CAPOX compared to placebo plus CAPOX.
This is the second big win for zolbetuximab, which Tokyo-based Astellas picked up back in Oct. 2016 in its $1.4 billion acquisition of German biotech, Ganymed Pharmaceuticals. Last month, Astellas 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).
“We intend to discuss these results with regulatory authorities as we continue to develop zolbetuximab for the first-line treatment of patients with locally advanced unresectable or metastatic gastric and GEJ cancer,” said Ahsan Arozullah, senior VP and head of Development Therapeutic Areas for Astellas.
