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A Chinese two-armed antibody that blocks PD-1 and CTLA-4 together, approved in China for cervical cancer and extending survival even in PD-L1-negative tumours.
Cadonilimab is Akeso's tetravalent PD-1/CTLA-4 bispecific. NMPA approval June 2022 (second-line cervical cancer, ORR ~33%) and 2024 for first-line combination with chemotherapy ± bevacizumab (COMPASSION-16, OS HR 0.64). Also approved in China for first-line gastric cancer (COMPASSION-15, 2024). Designed for tumour-enriched dual blockade with lower immune toxicity than ipilimumab + nivolumab. It had not been approved in the US or EU by 2026.
1.Two arms bind PD-1 and CTLA-4 on the same exhausted T cell
Not FDA-approved, so there is no US coverage; access is only through a clinical trial or an FDA expanded-access request.
Not FDA-approved, so there is no US coverage; access is only through a clinical trial or an FDA expanded-access request.
Sources: CMS Medicare Coverage Database (NCDs and LCDs). Not medical or financial advice; verify with your plan.
Sources: NICE search: cadonilimab. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
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First PD-1×CTLA-4 bispecific approved anywhere
First-line cervical cancer (COMPASSION-16) source
| Region | Year | Indication |
|---|---|---|
| China | 2022 | Recurrent/metastatic cervical cancer after platinum |
| China | 2024 | First-line persistent/recurrent/metastatic cervical cancer with chemotherapy ± bevacizumab; first-line gastric cancer with chemotherapy |
| Adverse event | Any grade | Grade 3+ |
|---|---|---|
| Grade ≥3 treatment-related adverse events | - | 82% |
| Immune-related adverse events, any grade | 52% | - |
COMPASSION-16 cadonilimab arm (mostly chemotherapy-related haematologic). Events listed without rates were not read from a primary source; see the label. Blank cells mean the figure was not sourced, not that it is zero.
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Query for this drug: (TITLE:"Cadonilimab" OR ABSTRACT:"Cadonilimab" OR TITLE:"Kaitanni" OR ABSTRACT:"Kaitanni" OR TITLE:"AK104" OR ABSTRACT:"AK104") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Cadonilimab, not a curated reading list.
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Shares Michelle Xia (Xia Yu), Akeso, Bispecific antibodies, PD-1.
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Shares Michelle Xia (Xia Yu), Akeso, Bispecific antibodies, PD-1.
Shares Recurrent or metastatic cervical cancer, PD-1, Cervical cancer, Immune checkpoint inhibitors.