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Akeso's PD-1/CTLA-4 Bispecific Antibody Cadonilimab Approved for First-Line Treatment of Cervical Cancer in All-Comer Populations--Third Approved Indication for Cadonilimab
Akeso, Inc. (9926.HK) ("Akeso" or the "Company") is pleased to announce that the National Medical Products Administration (NMPA) has approved the company's first- in-class PD-1/CTLA-4 bispecific antibody, cadonilimab, for the first-line treatment of persistent, recurrent, or metastatic cervical cancer, in combination with platinum-based chemotherapy, with or without bevacizumab. The NMPA approval marks the third approved indication for cadonilimab.
About this update from Akeso, Inc.
[{"type":"text","content":"HONG KONG, June 4, 2025 /PRNewswire/ -- Akeso, Inc. (9926.HK) ("Akeso" or the "Company") is pleased to announce that the National Medical Products Administration (NMPA) has approved the company's first- in-class PD-1/CTLA-4 bispecific antibody, cadonilimab, for the first-line treatment of persistent, recurrent, or metastatic cervical cancer, in combination with platinum-based chemotherapy, with or without bevacizumab. The NMPA approval marks the third approved indication for cadonilimab.","length":526,"tagName":"p"},{"type":"text","content":"With the approval for first-line cervical cancer, cadonilimab has achieved comprehensive coverage for the treatment of advanced cervical cancer, offering an innovative treatment option for patients across all stages of advanced cervical cancer. This approval addresses the critical unmet need for immune-based therapies for first-line cervical cancer patients in China and represents a significant step forward in the treatment of this disease. In addition to the treatment for first-line cervical cancer, cadonilimab is also approved for first-line treatment of advanced gastric cancer, and for the treatment of relapsed or metastatic cervical cancer who progressed on or after platinum-based chemotherapy.","length":707,"tagName":"p"},{"type":"text","content":"The approval for cadonilimab's use in combination with chemotherapy (with or without bevacizumab) in first-line cervical cancer is based on the clinical data from the Phase III COMPASSION-16 (AK104-303) study. In COMPASSION-16, the cadonilimab combination regimen showed a notable efficacy benefit in patients with tumors that have a negative PD-L1 expression (CPS <1), comprising 27.9% of the population in the treatment group, compared to 24.2% in the control group. The study met both progression-free survival (PFS) and overall survival (OS) endpoints, demonstrating significant improvements in both endpoints for patients treated with the cadonilimab regimen compared to standard therapies in the first-line setting for cervical cancer.","length":748,"tagName":"p"},{"type":"text","content":"Subgroup analyses from COMPASSION-16 study indicated that both PD-L1-positive and PD-L1-negative populations, regardless of bevacizumab inclusion, benefited from the treatment. The results of the COMPASSION-16 trial were ...