HONG KONG,Oct. 16,2024 -- Akeso Biopharma (9926.HK) (" Akeso",the "Company" ) announced positive results in progression-free survival (PFS) and overall survival (OS) from its Phase 3 clinical study (COMPASSION-16/AK104-303). This study evaluated the efficacy of its independently developed PD-1/CTLA-4 bispecific antibody,开坦尼® (cadonilimab),in combination with or without platinum-based chemotherapy and bevacizumab,compared to placebo with platinum-based chemotherapy and bevacizumab for first-line treatment of persistent,recurrent,or metastatic cervical cancer. These findings were presented as a Late-Breaking Abstract (LBA) in an oral session at the 2024 annual global meeting of the International Gynecologic Cancer Society (IGCS 2024).

The principal investigator of the study,Professor Wu Xiaohua from the Fudan University-affiliated Cancer Hospital,presented the results in an oral report,sharing these remarkable outcomes with global experts in gynecological oncology. Concurrently,the findings of the COMPASSION-16 study have been published in the medical journal The Lancet. This also highlights the study's pivotal role in advancing the frontiers of international clinical cancer research and its potential role in cervical treatment options.

The COMPASSION-16 study shows that the cadonilimab regimen,with or without bevacizumab,demonstrates promising efficacy in treating persistent,or metastatic cervical cancer,addressing a critical unmet need for patients without access to bevacizumab. Additionally,cadonilimab offers significant benefits for all patients,regardless of PD-L1 expression status. This study highlights the clinical value and commercialization potential of cadonilimab to advance standard treatment for advanced cervical cancer.

The primary endpoints of the COMPASSION-16 study were progression-free survival (PFS) and overall survival (OS) assessed by independent central imaging review (BICR) based on RECIST v1.1 criteria. A total of 445 patients were enrolled in the COMPASSION-16 study,with 27.9% of patients in the cadonilimab combined with chemotherapy ± bevacizumab treatment group having a CPS < 1,compared to 24.2% in the control group.

The study results indicate that the cadonilimab regimen significantly prolonged survival in the overall population,substantially decreasing the risk of disease progression and the risk of death.

In the intention-to-treat (ITT) population,the median overall survival (OS) for the cadonilimab regimen has not yet been reached,while the control group exhibited a median OS of 22.8 months (the hazard ratio [HR] 0.64,P=0.0011). The 12-month OS rates were 83.1% for the cadonilimab group compared to 73.7% for the control group,and the 24-month OS rates were 62.6% and 48.4%,respectively.

In the ITT population,the median progression-free survival (PFS) for the cadonilimab regimen was 12.7 months,compared to 8.1 months in the control group (HR 0.62,P<0.0001). The 12-month PFS rates were 51.1% and 35%,respectively. As the follow-up time extended (as of April 30,2024),the benefits of the cadonilimab regimen became increasingly evident,with updated median PFS rates of 13.3 months and 8.2 months (HR 0.62).

Regardless of whether it is combined with bevacizumab,the cadonilimab regimen shows a significant improvement in overall survival (OS).

In the absence of bevacizumab,the cadonilimab regimen is associated with a 50% reduction in the risk of death compared to the control group (OS HR 0.5),thereby effectively addressing the clinical need for patients who are ineligible for bevacizumab.

Regardless of PD-L1 expression levels,cadonilimab regimen significantly reduces the risk across the entire patient population.

In the CPS < 1 cohort,thecadonilimab regimen was associated with a 23% reduction in the risk of death (OS HR 0.77). In the CPS ≥ 1 cohort,there was a 31% reduction in the risk of death.(OS HR 0.69). Notably,in the CPS ≥ 10 cohort,the regimen led to a 32% reduction in the risk of death (OS HR 0.68).

The cadonilimab regimen exhibits a high and sustained antitumor response.

The objective response rate (ORR) for the cadonilimab group was 82.9%,compared to 68.6% in the control group. The complete response (CR) rates were 35.6% and 22.9%,respectively. The median duration of response (DOR) was 13.2 months in the cadonilimab group,compared to 8.2 months in the control group.

The combination of cadonilimab with chemotherapy ± bevacizumab has a manageable safety profile,with no new safety signals identified.