{"entity":{"id":"cadonilimab","kind":"drug","name":"Cadonilimab","aka":[],"tldr":"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.","summary":"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.","status":"approved","asOf":"2026-09-07","links":[{"label":"FDA label (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/search.cfm?query=Cadonilimab"}],"tags":[],"related":[],"cancers":["cervical","gastric"],"sections":[],"technologies":["bispecific-antibody","checkpoint-inhibitor"],"targets":["pd1","ctla4"],"drugs":[],"companies":["akeso"],"institutions":[],"pathways":["pd1-checkpoint"],"terms":[],"trials":["compassion-16","nct05489289","nct07412613","nct06617416","nct06371157","nct05932212","nct06646055","nct05904379","nct07052253","nct07245446","nct06560112","nct06530251","nct05235516","nct05944224","nct06221748","nct07023315","nct05859750"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"brand":"Kaitanni","code":"AK104","modality":"Bispecific antibody (PD-1×CTLA-4)","mechanism":"Binds PD-1 and CTLA-4 simultaneously; higher avidity for cells co-expressing both (tumour-infiltrating T cells) concentrates activity in the tumour.","approvals":[{"region":"China","year":2022,"indication":"Recurrent/metastatic cervical cancer after platinum"},{"region":"China","year":2024,"indication":"First-line persistent/recurrent/metastatic cervical cancer with chemotherapy ± bevacizumab; first-line gastric cancer with chemotherapy"}],"mechanismSteps":["Two arms bind PD-1 and CTLA-4 on the same exhausted T cell","Avidity concentrates the drug where both receptors are present","Both brakes are released at once","T cells kill tumour cells even when PD-L1 is low"],"dosing":{"route":"Intravenous","schedule":"10 mg/kg every 3 weeks with platinum-paclitaxel ± bevacizumab","monitoring":"Thyroid, liver, glucose, skin; immune-related adverse events"},"toxicity":[{"event":"Grade ≥3 treatment-related adverse events","grade3PlusPct":82,"note":"COMPASSION-16 cadonilimab arm (mostly chemotherapy-related haematologic)"},{"event":"Immune-related adverse events, any grade","anyGradePct":52}],"access":[],"regulatoryEvents":[{"date":"2022-06-29","type":"approval","region":"China","note":"First PD-1×CTLA-4 bispecific approved anywhere"},{"date":"2024-09","type":"approval","region":"China","note":"First-line cervical cancer (COMPASSION-16)","source":"https://www.onclive.com/view/china-s-nmpa-approves-cadonilimab-plus-chemo-with-without-bevacizumab-in-cervical-cancer"}]},"route":"/drugs/cadonilimab/","neighbours":{"cancer":[{"id":"cervical","kind":"cancer","name":"Cervical cancer","route":"/cancers/cervical/"},{"id":"gastric","kind":"cancer","name":"Gastric & gastro-oesophageal junction cancer","route":"/cancers/gastric/"},{"id":"msi-high-colorectal","kind":"cancer","name":"Mismatch-repair deficient (MSI-high) colorectal cancer","route":"/cancers/msi-high-colorectal/"},{"id":"recurrent-metastatic-cervical-cancer","kind":"cancer","name":"Recurrent or metastatic cervical cancer","route":"/cancers/recurrent-metastatic-cervical-cancer/"}],"technology":[{"id":"bispecific-antibody","kind":"technology","name":"Bispecific antibodies","route":"/technologies/bispecific-antibody/"},{"id":"checkpoint-inhibitor","kind":"technology","name":"Immune checkpoint inhibitors","route":"/technologies/checkpoint-inhibitor/"}],"target":[{"id":"ctla4","kind":"target","name":"CTLA-4","route":"/targets/ctla4/"},{"id":"pd1","kind":"target","name":"PD-1","route":"/targets/pd1/"}],"company":[{"id":"akeso","kind":"company","name":"Akeso","route":"/companies/akeso/"}],"pathway":[{"id":"pd1-checkpoint","kind":"pathway","name":"PD-1 / PD-L1 immune checkpoint & T-cell activation","route":"/pathways/pd1-checkpoint/"}],"trial":[{"id":"nct07052253","kind":"trial","name":"A Phase II Clinical Study of AK104/AK112 in Combination With TT-00420 Tablet for Advanced HCC.","route":"/trials/nct07052253/"},{"id":"nct07023315","kind":"trial","name":"A Phase III Clinical Study of Cadonilimab Plus SOX as Perioperative Treatment for Patients With Resectable G/GEJ Adenocarcinoma","route":"/trials/nct07023315/"},{"id":"nct05489289","kind":"trial","name":"A Phase III Study of AK104 as Adjuvant Therapy in HCC With High Risk of Recurrence After Curative Resection","route":"/trials/nct05489289/"},{"id":"nct06617416","kind":"trial","name":"A Study of AK104 in Subjects With Unresectable Locally Advanced NSCLC","route":"/trials/nct06617416/"},{"id":"nct05859750","kind":"trial","name":"A Study of AK104 With Chemotherapy as First-line Treatment in Patients With Advanced Pancreatic Cancer","route":"/trials/nct05859750/"},{"id":"nct05235516","kind":"trial","name":"A Study of AK104/Placebo Combined With Chemoradiotherapy For The Treatment of Locally Advanced Cervical Cancer","route":"/trials/nct05235516/"},{"id":"nct05990127","kind":"trial","name":"A Study of AK104/Tislelizumab With Chemotherapy as First-line Treatment in PD-L1 TPS < 1% Non-small Cell Lung 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First-Line Treatment for pMMR/MSS CRLM (APSOC)","route":"/trials/nct07544784/"},{"id":"nct05904379","kind":"trial","name":"AK112 and AK104 With or Without Chemotherapy in Advanced Non-small Cell Lung Cancer","route":"/trials/nct05904379/"},{"id":"nct06646055","kind":"trial","name":"AK112 and Cadonilimab Combined With Chemotherapy for 1L Treatment of Metastatic Pancreatic Cancer","route":"/trials/nct06646055/"},{"id":"nct06560112","kind":"trial","name":"An Exploratory, Multi-cohort Phase II Study of Combination Therapy With AK104 and AK112 for Recurrent Ovarian Cancer","route":"/trials/nct06560112/"},{"id":"nct07635290","kind":"trial","name":"Anlotinib+Cadonilimab+PULSAR in Advanced Biliary Tract Cancer","route":"/trials/nct07635290/"},{"id":"nct06566755","kind":"trial","name":"Cadonilimab (AK104) Combined With Chemotherapy and Bevacizumab as First-line Treatment for RAS Mutated or Right Sided-metastatic MSS Colorectal Cancer","route":"/trials/nct06566755/"},{"id":"nct06367088","kind":"trial","name":"Cadonilimab Combined With Chemotherapy as First or Second Line Treatment in Recurrent or Metastatic Triple Negative Breast Cancer","route":"/trials/nct06367088/"},{"id":"nct06168786","kind":"trial","name":"Cadonilimab Combined With Fruquintinib and SBRT as Athird-line and Posterior Line Treatment in Patients With MSS CRC","route":"/trials/nct06168786/"},{"id":"nct06438822","kind":"trial","name":"Cadonilimab Combined With Liposomal Irinotecan Plus Leucovorin and Fluorouracil for Advanced Cholangiocarcinoma","route":"/trials/nct06438822/"},{"id":"nct06532617","kind":"trial","name":"Cadonilimab Combined With S-1 or Capecitabine as Second-line Treatment for Advanced Pancreatic Cancer","route":"/trials/nct06532617/"},{"id":"compassion-16","kind":"trial","name":"COMPASSION-16 / AK104-303","route":"/trials/compassion-16/"},{"id":"nct06221748","kind":"trial","name":"DV Combined With Cadonilimab in Subjects With HER2-expressing Gastric Cancer and Gastroesophageal Junction Adenocarcinoma After Progression on First-line Therapy","route":"/trials/nct06221748/"},{"id":"nct07815834","kind":"trial","name":"FAPI-Guided Radiotherapy With Cadonilimab and Standard Chemotherapy for Colorectal Peritoneal Metastasis: A Phase III Randomized Controlled Trial (TORHC-PM02)","route":"/trials/nct07815834/"},{"id":"nct06789848","kind":"trial","name":"Ligufalimab and Cadonilimab in Advanced Liver Cancers","route":"/trials/nct06789848/"},{"id":"nct06405490","kind":"trial","name":"NALIRI-XELOX+AK104 for First-line Treatment of Advanced PDAC","route":"/trials/nct06405490/"},{"id":"nct07412613","kind":"trial","name":"Neoadjuvant/Adjuvant AK104 in Microsatellite Instability-high or Mismatch Repair-deficient, Resectable Colon Cancer","route":"/trials/nct07412613/"},{"id":"nct07003022","kind":"trial","name":"Phase II Clinical Trial of Cadonilimab Combined With Anti-angiogenic Agents in Metastatic dMMR/MSI-H CRC","route":"/trials/nct07003022/"},{"id":"nct06401005","kind":"trial","name":"SBRT, Chemotherapy, and AK104 Neoadjuvant Therapy for Triple-negative Breast Cancer (TNBC)","route":"/trials/nct06401005/"},{"id":"nct06202313","kind":"trial","name":"Study of Cadonilimab (AK104) Plus Eribulin vs. Eribulin Monotherapy for Recurrent or Metastatic Triple-negative Breast Cancer","route":"/trials/nct06202313/"}],"person":[{"id":"xia-michelle","kind":"person","name":"Michelle Xia (Xia Yu)","route":"/people/xia-michelle/"}]}}