China-based Akeso Biopharma (HKG: 9926) has announced the enrollment of the first subject in a pivotal Phase III study for its innovative bispecific antibody (BsAb), cadonilimab (AK104). The study will assess cadonilimab in combination with chemotherapy for first-line treatment of unresectable locally advanced or metastatic gastric cancer/gastroesophageal junction adenocarcinoma (GC/GEJC).
Study Details
This marks the world’s first clinical study for a PD-1/CTLA-4 BsAb combined with chemotherapy in first-line gastric cancer. The trial is set to enroll 610 subjects, with the primary endpoint being the comparison of overall survival (OS) achieved using the cadonilimab regimen versus placebo combined with XELOX in the intention-to-treat (ITT) population. Interim analysis is expected at the end of 2023.
Previous Approvals and Ongoing Research
Cadonilimab was first conditionally approved in China in June 2022 for the treatment of patients with recurrent or metastatic cervical cancer who previously failed platinum-based chemotherapy. As a global first-in-class PD-1/CTLA-4 BsAb, cadonilimab is also subject to ongoing studies for various indications, including GC/GEJ and hepatocellular carcinoma.
Significance of the Study
The initiation of this Phase III trial highlights Akeso Biopharma’s commitment to advancing innovative cancer treatments. The study aims to provide valuable data on the efficacy and safety of cadonilimab in gastric cancer, potentially expanding its application and improving treatment outcomes for patients.-Fineline Info & Tech
