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Akeso Launches Global Phase III Trial of Cadonilimab for Gastric Cancer

Akeso has enrolled the first patient in COMPASSION-37, a global Phase III trial testing its PD-1/CTLA-4 bispecific antibody, cadonilimab, against standard nivolumab-based chemotherapy for untreated, advanced gastric or gastroesophageal junction adenocarcinoma. The study aims to determine if dual immune checkpoint blockade improves outcomes for diverse patient populations.

Akeso Launches Global Phase III Trial of Cadonilimab for Gastric Cancer
Photo: Bio & News

The trial represents a significant shift in clinical testing, moving from regional data to a multicenter head-to-head comparison against current international standards. Led by an international team including Dr. Yelena Y. Janjigian of Memorial Sloan Kettering Cancer Center, the study seeks to address a primary challenge in oncology: improving survival rates for patients with low PD-L1 expression, a group that often sees limited benefit from current PD-1 inhibitor therapies.

This development follows the positive results of the COMPASSION-15 study, which demonstrated that cadonilimab significantly reduced the risk of death in Chinese cohorts regardless of PD-L1 status. By expanding this investigation to a global scale, researchers intend to confirm whether this dual-targeting mechanism can provide a broader therapeutic option for the biologically heterogeneous landscape of advanced gastric cancer. Beyond this trial, Akeso is simultaneously exploring the drug's potential in perioperative settings in the United States, marking a comprehensive effort to integrate the bispecific antibody into multiple stages of cancer care.

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