Akeso has announced that the AK104-303 Phase III trial, which investigated cadonilimab (Akeso's PD-1/CTLA-4 bispecific antibody) combined with platinum-based chemotherapy +/- bevacizumab, has met one of its primary endpoints of progression-free survival (PFS) for first-line treatment of recurrent/metastatic cervical cancer (R/M CC), with p-value of less than 0.0001. The AK104-303 trial represents a significant milestone as the first Phase III clinical trial investigating the combination of a PD-1/CT LA-4 bispecific antibody with platinum-based chemotherapy +/- beenvacizumab for first-line treatment of recurring/metastatic R/M CC. The primary endpoints of the study were progression-free survival (P FS) and overall survival (OS) assessed by blinded independent central review (BICR) based on RECIST v1.1 criteria.

In the study, approximately 26% of patients had tumors with PD-L1 CPS < 1. Public data indicates that approximately 11% of patients in the KEYNOTE-826 study had PD-L1 CPS <1. During a pre-specified interim analysis conducted by an independent data monitoring committee (IDMC) in the intent-to-treat (ITT) population, cadonilimab combined with platinum-based chemotherapy plus bevacizumab demonstrated a statistically significant and clinically meaningful PFS benefit compared to placebo combined with platinum-based chemotherapy = bevacizumab in all-comer patients, irrespective of their PD-L1 status, including both the PD-L1 CPS < one and PD-L1 CPS < One populations. A trend in improvement in overall survival (OS), which is the other primary endpoint, was observed for cadonilimab combination versus placebo in combination with platinum-based chemotherapy +/- beingvacizumab. Data for OS were not mature at this interim analysis and the trial will continue as planned to assess OS.

The safety profile of cadonilimab remains consistent with previous clinical results with no new safety signals identified. The successful achievement of the primary endpoint of PFS in the Phase III trial of cadonilimab for first-line treatment in first-line therapy, following the earlier achievement of the primary endpoint in first-line gastric cancer and the planned sNDA by Akeso. In June 2022, cadonilimab was approved for second/third line treatment of advanced cervical cancer.

The China National Medical Products Administration has approved cadonilimab for recurrent or metastatic cervical cancer.adonilimab has been included and recommended in multiple clinical guidelines such as CSCO. Cadonilimab has been engaged in more than 60 ongoing clinical trials including investigator-initiated studies. Phase 3 study of cadonilimab For first-line treatment of gastric cancer has met its endpoint of PFS.

A phase 3 study of cadonilIMab as an adjuvant treatment for hepatocellular carcinoma is ongoing. Furthermore, a Phase 3 study comparing cadonilimab with chemotherapy to tislelizumab Injection with chemotherapy is underway for the first-line treatment of PD-L1 expression-negative non-small cell lung cancer. Akeso is actively developing a diverse pipeline of over 30 innovative assets in areas such as cancer, autoimmune disease, inflammation, metabolic disease, and other therapeutic fields.

Among these, 19 assets have entered the clinical stage, with 3 innovative drugs already approved, 13 Phase III studies ongoing. Utilizing its proprietary Tetrabody technology, Akeso has successfully developed the first-in-class PD-1/CTLA -4 bispecific antibody drug for the market. Additionally, the company has five other innovative bispecific antibody drugs in the clinical stage, including ivonescimab (PD-1/VEGF), PD-1/VEGF), PS3, PD-1/LAG-3, TIGIT/TGF), PD-1/TGF), PD-2/LAG-1/LAG-LAG-3, TGF-3, TGF-1/LAG-1/TGF-3, TIGIT-3, TGF-Beta, PD-1/L AG-1/LAG-4 bispecific antibody drugs already approved, PD-3, PD-1/M CC, PD-1/MCC, PD-1/Lag-1/LAG-6/LAG-1/M CC, PFS), PD-3, PD-LAG-3, PD-1 and other innovative drugs already approved.