The board of directors of Akeso, Inc. announced that AK104-302, a Phase III clinical trial of Kai Tan Ni (cadonilimab, PD-1/CTLA-4), a novel global first-in-class PD- 1/CTLA-4 bi-specific immuno-therapy drug independently developed by the Company, in combination with XELOX chemotherapy (oxaliplatin and capecitabine) as first line treatment for unresectable locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma (GC/GEJC) reached primary endpoint at interim analysis. The independent data monitoring committee (IDMC) recommended to file a supplemental new drug application (sNDA) of cadonilimab based on the interim analysis results of this trial. This trial (AK104-302) is a randomized, double-blind, multi-center Phase III clinical trial with primary endpoint of overall survival (OS).

Based on the interim analysis of IDMC, cadonilimab in combination with chemotherapy demonstrated statistically significant and clinically meaningful improvements in the primary endpoint of OS compared to placebo in combination with chemotherapy. The safety profile of cadonilimab in this clinical trial was consistent with that observed in previously reported results of cadonilimab, no additional safety signals were identified. The results of AK104-302 will be presented at an upcoming medical conference.

The interim analysis results of this trial show that the superior results of cadonilimib combination therapies maintained over its results of Phase II clinical trials and demonstrated significant and meaningful overall survival (OS) improvements and benefits to all comers, regardless PD-L1 status: Cadonilimab in combination chemotherapy significantly reduce risk of death of all comers, including PD-L1 CPS5 group and PD-L1 CPS<5 group.adonilimab in combination With chemotherapy demonstrated superior efficacy in PD-L1 CPS< 5 group as well as PD-L1 negative group. The Company will constantly conduct this trial efficiently based on the interim analysis results, and review results with the Center for Drug Evaluation (CDE) of the National Medical Product Administration (NMPA) in China to submit a supplemental new drug application (SNDA) of cadonILimab.