Astellas reports glowing data from phase 3 gastric cancer trial

2023-03-22

临床3期临床结果并购上市批准抗体药物偶联物

Tokyo-based Astellas Pharma shared positive results this week from its phase 3 glow trial investigating a potential first-line treatment for gastric cancer, zolbetuximab, in combination with chemotherapy.

The GLOW trial examined Astellas' Claudin 18.2 targeted monoclonal antibody 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 adenocarcinoma HER2-negative, locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma. The study enrolled 507 patients at 166 study locations in the U.S., Canada, United Kingdom, Europe, South America and Asia.

The drug was found to significantly improve progression-free survival in comparison to CAPOX with placebo in a study. The risk of progression or death was also lowered by 31.3% with zolbetuximab plus CAPOX. The combination treatment was also found to significantly prolong overall survival, a key secondary endpoint, reducing the risk of death by 22.9%.

Zolbetuximab works by binding on the CLDN18.2 found on the surface of cancer cells. According to preclinical data, the interaction induces cell cancer by activating the immune system pathways necessary.

The drug is Astellas’s most valuable R&D asset, according to Evaluate Pharma's sellside consensus with 2028 sales forecasted at $522 million. Astellas initially picked it up back in Oct. 2016 in its $1.4 billion acquisition of German biotech, Ganymed Pharmaceuticals.

Last November, 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).

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