The board of directors of Akeso, Inc. announced that AK104-303, a Phase III clinical trial of Kai Tan Ni (cadonilimab, PD-1/CTLA-4), a novel global first-in-class bi-specific antibody, in combination with platinum-based chemotherapy with or without bevacizumab as first line treatment for persistent, recurrent, or metastatic cervical cancer reached primary endpoint of progression-free- survival (PFS) at interim analysis conducted by the independent data monitoring committee (IDMC), and demonstrates significant survival benefits for all comers. This trial (AK104-303) is a randomized, double-blind, multi-centered Phase III clinical trial with primary endpoints of progression-free-survival (PFS) and overall survival (OS). The IDMC evaluated the PFS at the interim analysis, cadonilimab in combination with platinum-based chem with or without bevacIZumab demonstrated statistically significant and clinically meaningful improvements in PFS (for all comers, including patients with PD-L1 CPS1 and patients with PD-L1PS<1), compared to placebo in combination with platinum-based treatment with or without bevacuzumab.

No formal statistical analysis was conducted for the other primary endpoint OS because the pre-specified number of OS events has not been reached, while the trend of OS improvement was observed. The trial will continue as planned to confirm OS benefit. The safety profile of cadonilimab in this clinical trial was consistent with that observed in previously reported results of cadonilimab, no new safety signals were identified.