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Cancer research

Akeso Announces Enrollment in Pivotal Phase III Clinical Trial for Cadonilimab in Perioperative Treatment of Gastric Cancer

Strategic Insights

— 2 min read

Akeso, Inc. has announced the enrollment and dosing of the first patient in the pivotal Phase III clinical trial evaluating cadonilimab, a first-in-class PD-1/CTLA-4 bispecific antibody, in combination with chemotherapy for the perioperative treatment of resectable gastric/gastroesophageal junction adenocarcinoma. This trial represents the third Phase III study for cadonilimab in gastric cancer and aims to improve the radical resection rate, reduce the risk of recurrence and metastasis, and enhance overall patient outcomes.

Key Takeaways:

  • The COMPASSION-33 study is the third Phase III trial for cadonilimab in gastric cancer, evaluating its efficacy in combination with chemotherapy for the perioperative treatment of resectable gastric/gastroesophageal junction adenocarcinoma.
  • The trial aims to improve the radical resection rate, reduce the risk of recurrence and metastasis, and enhance overall patient outcomes in patients with advanced gastric cancer.
  • Cadonilimab, in combination with chemotherapy, has already been approved for the first-line treatment of advanced gastric cancer in China, showing efficacy for patients with tumors across all levels of PD-L1 expression.
  • The study broadens cadonilimab's clinical application from unresectable advanced gastric cancer to resectable advanced gastric cancer, potentially expanding the number of gastric cancer patients that can benefit from its synergistic and simultaneous targeting of PD-1 and CTLA-4 checkpoints.
  • Preliminary data suggest that cadonilimab may offer superior efficacy and a more favorable safety profile compared to existing PD-1 therapies for the perioperative treatment of G/GEJ adenocarcinoma.
  • The study aims to provide a new, effective second-line treatment option for patients with IO resistance, further demonstrating cadonilimab's potential to address critical unmet need in this difficult to treat cancer patient populations.

Statistics:

  • There are currently no approved perioperative immunotherapy regimens in the world, highlighting a significant unmet need in the treatment of gastric cancer.
  • Cadonilimab has already demonstrated superior efficacy compared to other treatment options in a Phase III trial for the first-line treatment of advanced G/GEJ adenocarcinoma.
  • Preliminary data suggest that cadonilimab may offer clinically meaningful survival benefit even in patients with low or negative PD-L1 expression, with a significant reduction in the risk of death compared to other approved PD-1 treatments.
  • The trial represents a significant step forward in the development of a novel immunotherapy regimen for the perioperative treatment of gastric cancer, with the potential to improve patient outcomes and expand treatment options for this difficult to treat cancer population.

Sources:

  • NewsRx LLC, "Akeso Announces Enrollment in Pivotal Phase III Clinical Trial for Cadonilimab in Perioperative Treatment of Gastric Cancer," NewsRx, 2025.

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