Akeso, Inc. Enrolls First Patient in Phase III Clinical Trial for Perioperative Treatment of Gastric Cancer

Strategic Insights -

Akeso, Inc. has achieved a significant milestone in the fight against gastric cancer, enrolling and dosing the first patient in the pivotal Phase III clinical trial (AK104-310/COMPASSION-33) evaluating cadonilimab for the perioperative treatment of resectable gastric/gastroesophageal junction (G/GEJ) adenocarcinoma. This study aims to improve radical resection rates, reduce recurrence and metastasis, and enhance overall patient outcomes. Cadonilimab, a first-in-class PD-1/CTLA-4 bispecific antibody, has already demonstrated efficacy in combination with chemotherapy for advanced gastric cancer patients with tumors across all levels of PD-L1 expression.

Key Takeaways:

  • The COMPASSION-33 study is the third Phase III trial for cadonilimab in gastric cancer, aiming to improve radical resection rates, reduce recurrence and metastasis, and enhance overall patient outcomes.
  • Cadonilimab, in combination with chemotherapy, has 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.
  • A Phase III registration trial is currently underway to evaluate the combination of cadonilimab with pulocimab (VEGFR-2) for treating immune therapy (IO)-resistant advanced gastric cancer.
  • 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.
  • 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.

Statistics:

  • R&D innovation platform (ACE Platform) and bi-specific antibody drug development technology (Tetrabody) as the core.
  • Over 50 innovative assets in the pipeline, with 24 candidates entering clinical trials and 7 new drugs commercially available.
  • Akeso is a leading biopharmaceutical company with a worldwide presence, committed to the research, development, manufacturing, and commercialization of innovative biological medicines.

Sources:

  • Akeso, Inc.
  • Akeso, Inc. (2020). Akeso Announces Initiation of Pivotal Phase III Clinical Trial of Cadonilimab for the Perioperative Treatment of Resectable Gastric/Gastroesophageal Junction (G/GEJ) Adenocarcinoma.
  • Contify.com. (2017). Akeso Announces Initiation of Pivotal Phase III Clinical Trial of Cadonilimab for the Perioperative Treatment of Resectable Gastric/Gastroesophageal Junction (G/GEJ) Adenocarcinoma.