HONG KONG, Oct. 16, 2024
HONG KONG, Oct. 16, 2024 /PRNewswire/ -- 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, ???® (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).
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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.
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The COMPASSION-16 study shows that the cadonilimab regimen, with or without bevacizumab, demonstrates promising efficacy in treating persistent, recurrent, 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.
Regardless of whether it is combined with bevacizumab, the cadonilimab regimen shows a significant improvement in overall survival (OS).
Regardless of PD-L1 expression levels, cadonilimab regimen significantly reduces the risk across the entire patient population.
The cadonilimab regimen exhibits a high and sustained antitumor response.
The combination of cadonilimab with chemotherapy ± bevacizumab has a manageable safety profile, with no new safety signals identified.
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SOURCE Akeso, Inc.
