Akeso, Inc. announced positive results from an interim analysis of AK104-302 study, a randomized, double-blind, multicenter, phase III clinical study evaluating PD-1/CTLA-4 bispecific antibody, cadonilimab (???®) in combination with capecitabine plus oxaliplatin (XELOX) compared to placebo plus XELOX in for first-line treatment of unresectable locally advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma (GC/GEJC). The trial achieved its primary endpoint by demonstrating a statistically significant overall survival (OS) improvement. The Independent Data Monitoring Committee (IDMC) recommended the early submission of a supplemental new drug application (sNDA) for cadonilimab in this indication based on the interim analysis.

The interim analysis showed that cadonilimab plus chemotherapy significantly improved OS in the all-comer patients irrespective of PD-L1 status, compared to placebo plus chemotherapy, meeting the pre-defined efficacy criteria. The safety profile remained consistent with previous results, with no new safety signals identified. These data will be presented in future international academic conferences/journals.

Interim Analysis Highlight: Cadonilimab combined with chemotherapy significantly reduces the risk of death in all-comer patients, including whose with PD-L1 CPS=5 and PD-L1 CPS<5. The hazard ratios (HRs) for OS in patients with different PD-L1 status were superior to other disclosed PD-1 plus chemotherapy combination treatment; The combination of cadonilimab and chemotherapy also demonstrated superior OS in patients with PD-L1 CPS<5 as well as PD-L1 negative, maintaining the excellent performance seen in the phase II study.