Kaitanni (cadonilimab) / Akesobio - LARVOL DELTA

Efficacy and safety of liposomal irinotecan combined with cadonilimab as second-line treatment for extensive-stage small cell lung cancer (ES-SCLC): A prospective, single arm phase II clinical study. (ASCO 2025) - P2 | "The preliminary results indicate that the combination of liposomal irinotecan and cadonilimab as a second-line treatment for ES-SCLC shows potential efficacy and tolerable safety, and is worthy of further exploration and research."

Clinical • P2 data • Anemia • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Clinical efficacy and safety of cadonilimab in the treatment of advanced gynecological malignancies: A retrospective, real-world study. (ASCO 2025) - "Cadonilimab with or without chemotherapy/bevacizumab had a promising antitumor activity and manageable safety profile in the treatment of recurrent/metastatic gynecological malignancies."

Metastases • Real-world • Real-world evidence • Retrospective data • Anemia • Cervical Cancer • Gynecologic Cancers • Oncology

Efficacy and safety of cadonilimab in recurrent/metastatic solid tumors including ICI-treated tumors in clinical practice: Cohorts of head and neck squamous cell carcinoma and cervical cancer. (ASCO 2025) - "Cadonilimab (AK104) is a PD-1/CTLA-4 bispecific antibody, which is expected to exert enhanced anti-tumor activity or reverse immunotherapy resistance after single target ICI... This real-world study first reported performance of cadonilimab (combined with anti-EGFR therapy) in R/M HNSCC, showing excellent ORR and PFS. In R/M CC, the combination regimen of cadonilimab based on clinical practice improved ORR (COMPASSION-16, ORR 82.9%; COMPASSION-03, ORR 32.3%). The overall safety is manageable."

Clinical • Metastases • Anemia • Cervical Cancer • Head and Neck Cancer • Leukopenia • Oncology • Pancreatitis • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • CTLA4 • PD-1

Real-world safety and efficacy of cadonilimab mono or combination therapy in recurrent/persistent/metastatic cervical cancer in Wuxi City, China. (ASCO 2025) - "4 patients received cadonilimab monotherapy, 22 patients received cadonilimab plus chemotherapy ± radiotherapy ± bevacizumab, the other 3 received a combination of bevacizumab... Cadonilimab shows good efficacy in the treatment of R/P/M CC, and the AEs are relatively mild, suggesting that adding cadonilimab to conventional chemo/chemoradiotherapy can be an important strategy for improving clinical outcome of patients with R/P/M CC."

Clinical • Combination therapy • IO biomarker • Metastases • Real-world • Real-world evidence • Cervical Cancer • Endocrine Disorders • Fatigue • Oncology • Solid Tumor • Squamous Cell Carcinoma • CTLA4 • PD-L1

Neoadjuvant immune-checkpoint blockade therapy in combination with TACE for resectable hepatocellular carcinoma with high recurrence risk: A phase II, single-arm clinical trial (MORNING). (ASCO 2025) - P2 | "Cadonilimab combined with TACE as a neoadjuvant therapy demonstrated acceptable safety profile and promising efficacy for high risk HCC patients. Clinical trial information:NCT05578430."

Checkpoint block • Checkpoint inhibition • Clinical • Combination therapy • P2 data • Hepatocellular Cancer • Oncology • Pain • Solid Tumor

Cadonilimab combined with gemcitabine and cisplatin in advanced biliary tract cancer (BicureX): A phase II, single-arm clinical trial. (ASCO 2025) - P2 | "Cadonilimab plus gemcitabine and cisplatin shown a promising efficacy and acceptable safety profile as first-line treatment for advanced BTC patients. Clinical trial information: NCT05978609."

Clinical • IO biomarker • Metastases • P2 data • Anemia • Biliary Cancer • Biliary Tract Cancer • Cholangiocarcinoma • Gallbladder Cancer • Leukopenia • Oncology • Solid Tumor • FGFR2 • HER-2 • IDH1

Cadonilimab in combination with ivonescimab and chemotherapy as first-line (1L) therapy in patients with advanced gastric (G) or gastroesophageal junction adenocarcinoma (GEJA). (ASCO 2025) - P2 | "Eligible pts were firstly enrolled into sequential part 1 including 10mg/kg and 15mg/kg AK104 (Q6W, D8) combined with AK112 (20mg/kg, Q3W, D1) and chemo (SOX or XELOX) following the conventional 3+3 design. AK104 combined with AK112 and chemo as 1L treatment showed a promising tolerable safety profile and highly encouraging efficacy in pts with advanced G/GEJA. The combinations may further improve benefits for advanced G/GEJA pts in the first-line setting."

Clinical • Combination therapy • IO biomarker • Metastases • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Hematological Disorders • Hepatology • Lung Cancer • Neutropenia • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

Dual targets, singular promise: A comprehensive analysis of bispecific antibodies in solid tumor oncology. (ASCO 2025) - "The distribution of clinical molecules also reflects such focus, with dual PD1-CTLA4 inhibitors (Cadonilimab, Volrustomig, Danviostomig) leading the highest number of trials (n=208, 30.5%). Other promising molecules include Ivonescimab (n=51, 7.5%), targeting PD1-VEGF, and Amivantamab-vmjw (n=29, 4.3%), targeting EGFR-MET... Since the first BsAb approval in 2014, the field has rapidly expanded, with solid tumor oncology advancing dynamically. The major focus has been on combining BsAbs with immunotherapy strategies, followed by targeting known oncogenic pathways. The shift toward biotechnology-led innovation underscores the growing therapeutic and financial interest in this field."

IO biomarker • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • ALK • EGFR • HER-2 • PD-L1

Cadonilimab plus platinum-based chemotherapy ± bevacizumab for persistent, recurrent, or metastatic cervical cancer: Subgroup analyses of COMPASSION-16. (ASCO 2025) - P3 | "Treatment effects on PFS and OS were evaluated in subgroups including age (<65 or ≥65 years), bevacizumab use (yes or no), prior concurrent chemoradiotherapy (CCRT; yes or no), metastatic disease at baseline (yes or no), PD-L1 CPS (<1, ≥1, or ≥10), and platinum use (cisplatin or carboplatin)... Subgroup analyses of COMPASSION-16 showed that the addition of cadonilimab to chemotherapy ± bevacizumab improved PFS and OS across subgroups defined by age, bevacizumab use, prior CCRT, metastatic disease, PD-L1 CPS, and platinum use, consistent with results for the overall population. Cadonilimab plus standard treatment is a potential treatment option for patients with R/M CC."

Metastases • Cervical Cancer • Oncology • Solid Tumor • PD-L1

A phase II, single-arm, open-label clinical trial to evaluate the combination of cadonilimab injection and gut microbiota modulation in the treatment of persistent, recurrent, or metastatic cervical cancer following second-line therapy. (ASCO 2025) - "In April 2024, China's NMPA accepted an application for Cadonilimab plus platinum-based chemotherapy (± bevacizumab) as second-line treatment, based on the global phase III AK104-303 trial. Trial status: The study is in the initiation phase, with plans to enroll 20 patients. As of this submission, patient enrollment has not yet begun."

Clinical • Gut Microbiota • Metastases • P2 data • Cervical Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • CTLA4 • PD-1 • PD-L1

Real-world efficacy and safety of cadonilimab (PD-1/CTLA-4 bispecific antibody) in patients with advanced, recurrent, and metastatic cervical cancer. (ASCO 2025) - "Cadonilimab showed encouraging efficacy and manageable safety in the treatment of A/R/M CC in real world, even in patients with PD-L1 negative. And it also present promising disease control in patients who have progressed on previous PD-1 monospecific antibody. The best overall response, PFS and OS in first-, second-, ≥ third-line and total patients."

Clinical • Metastases • Real-world • Real-world effectiveness • Real-world evidence • Cervical Cancer • Endocrine Disorders • Infectious Disease • Oncology • Pneumonia • Respiratory Diseases • Solid Tumor • CTLA4 • PD-1 • PD-L1

Induction cadonilimab combined with chemotherapy followed by chemoradiotherapy for locally advanced cervical cancer: A multicenter, single-arm, phase II trial. (ASCO 2025) - P2 | "Patients received 2 cycles of induction therapy consisting of cadonilimab at a dose of 10mg/kg plus nab-paclitaxel at a dose of 260 mg/m² and cisplatin at a dose of 75mg/m² followed by CCRT... Cadonilimab combined with chemotherapy as induction therapy shows promising anti-tumor activity and manageable safety profile in LACC patients. These findings suggest the potential of induction chemo-immunotherapy followed by CCRT and warrants further follow-up."

Clinical • Metastases • P2 data • Cervical Cancer • Endocrine Disorders • Gynecology • Leukopenia • Nephrology • Obstetrics • Oncology • Renal Disease • Solid Tumor • Squamous Cell Carcinoma

Neoadjuvant transhepatic arterial infusion chemotherapy (HAIC) with FOLFOX regime plus cadonilimab (PD-1/CTLA-4 bispecific antibody) for resectable multinodular CNLC Ib/IIa hepatocellular carcinoma (CAR_Hero study). (ASCO 2025) - "Neoadjuvant FOLFOX-HAIC combined with cadonilimab had a considerable antitumor activity, and a manageable safety for the resectable multinodular HCC. It brought the fewer MVIs of tumor and a better RFS."

Clinical • Dermatology • Hepatitis B • Hepatocellular Cancer • Hepatology • Infectious Disease • Liver Failure • Oncology • Solid Tumor • PD-1

Neoadjuvant immunotherapy in combination with chemotherapy in resectable locally advanced head and neck squamous cell carcinoma: A randomized, open label, phase II clinical trial. (ASCO 2025) - P2 | "Patients will be randomized into three cohorts: Cohort 1 will receive ivonescimab (PD-1/VEGF antibody, 10 mg/kg), Cohort 2 will receive cadonilimab (PD-1/CTLA-4antibody, 6 mg/kg), and Cohort 3 will receive penpulimab (PD-1 antibody, 200 mg), all in combination with cisplatin and nab-paclitaxel... Neoadjuvant single- or dual-target immunotherapy combined with chemotherapy showed promising pathological responses in resectable LAHNSCC. While dual-target therapy showed potential benefits, the small sample size limits definitive conclusions. The treatment was well-tolerated, with no serious TRAEs."

Clinical • Combination therapy • Metastases • P2 data • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

A phase II study of AK117 combined with cetuximab or AK104 in the treatment of recurrent or metastatic head and neck squamous cell carcinoma after the failure of PD-1 (L1) inhibitors and/or platinum-based therapy. (ASCO 2025) - P2 | "Funded by Akeso, Inc Clinical Trial Registration Number: NCT06508606 Background: The administration of first-line pembrolizumab monotherapy or pembrolizumab combined chemotherapy has been shown to improve survival among patients with recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC). The primary endpoints are incidence of adverse events and overall survival. Secondary endpoints are objective response rate, progression free survival, disease control rate, and duration of response."

Metastases • P2 data • Head and Neck Cancer • Immunology • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • CTLA4

Updated results from a phase II study of perioperative disitamab vedotin (RC48-ADC) plus cadonilimab (AK104) for HER2-expressing muscle-invasive bladder cancer (MIBC). (ASCO 2025) - P2 | "Neoadjuvant and adjuvant RC48-ADC plus AK104 demonstrated favorable efficacy and a manageable safety profile, supporting its potential as a valuable treatment modality for HER2-expressing MIBC. Long-term benefits and further understanding the role of this combination therapy in the perioperative setting of MIBC will be critical to advance treatment strategies."

IO biomarker • P2 data • Bladder Cancer • Cardiovascular • Genito-urinary Cancer • Oncology • Pneumonia • Solid Tumor • CTLA4 • HER-2 • PD-1 • PD-L1

Neoadjuvant mFOLFOXIRI chemotherapy with or without cadonilimab versus mFOLFOX6 alone in locally advanced colorectal cancer: A randomized phase II study (OPTICAL2). (ASCO 2025) - P2 | "mFOLFOXIRI with AK104 demonstrated a higher pCR rate, downstaging rate and MPR rtae compared with FOLFOX chemotherapy in patients with LACRC. This study suggests that the combination of Intensified chemotherapy and dual immunotherapy may be a promising approach for improving treatment outcomes. Pathologic outcome and surgical parameters.Footnote: pCR, pathological complete response; MPR, major pathological response."

Clinical • Metastases • P2 data • Colon Cancer • Colorectal Cancer • Oncology • Solid Tumor

Neoadjuvant cadonilimab (anti-PD-1/CTLA-4 bispecific antibody) plus chemotherapy in early or locally advanced triple-negative breast cancer: A single-arm phase II trial (CABIN study). (ASCO 2025) - P2 | "This phase II trial evaluates cadonilimab (AK104), a bispecific PD-1/CTLA-4 antibody, combined with nab-paclitaxel and carboplatin in neoadjuvant TNBC to improve pCR rates and assess safety. The combination of cadonilimab, nab-paclitaxel, and carboplatin in neoadjuvant treatment for stage IA-IIIC TNBC showed promising efficacy, with high response rates and significant tumor downstaging, particularly in stage III patients. The regimen was well tolerated with manageable adverse events, supporting its further investigation as a potential neoadjuvant treatment for TNBC."

Clinical • IO biomarker • Metastases • P2 data • Breast Cancer • Endocrine Disorders • Leukopenia • Neutropenia • Oncology • Solid Tumor • Triple Negative Breast Cancer • CCND1 • MST1R

Cost-effectiveness analysis of first-line cadonilimab plus chemotherapy in HER2-negative advanced gastric or gastroesophageal junction adenocarcinoma. (PubMed, Front Immunol) - "Across all groups, CAD-CHM resulted in an ICER exceeding the willingness-to-pay threshold of $41,511 per QALY, with a 0% probability of cost-effectiveness compared with PLA-CHM. From the perspective of the Chinese healthcare system, CAD-CHM is not cost-effective as a first-line treatment for HER2-negative advanced G/GEJ adenocarcinoma, either in the overall population or in subgroups stratified by PD-L1 CPS status, compared with chemotherapy alone."

HEOR • Journal • Esophageal Cancer • Gastric Adenocarcinoma • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor • HER-2 • PD-L1

Inhibition of human gastric cancer growth by cytokine-induced killer cells plus chemotherapy with or without cadonilimab in a mouse xenograft tumor model (Front Immunol) - "In the safety and efficacy evaluation of CIK cells + chemotherapy + cadonilimab, the results showed that the tumor inhibitory effects of the cadonilimab + chemotherapy, CIK cells + chemotherapy, and CIK cells + cadonilimab + chemotherapy groups were significantly higher with tolerable toxicity than those of the CIK cells and cadonilimab groups (p < 0.05)."

Preclinical • Gastric Cancer

SCALE: Second-line Treatment With CAdonilimab and LEnvatinib for Unresectable HCC (clinicaltrials.gov) - P2 | N=0 | Withdrawn | Sponsor: Shanghai Zhongshan Hospital | N=30 ➔ 0 | Not yet recruiting ➔ Withdrawn

Enrollment change • Trial withdrawal • Hepatocellular Cancer • Oncology • Solid Tumor

Cadonilimab Combined With S-1 or Capecitabine as Second-line Treatment for Advanced Pancreatic Cancer (clinicaltrials.gov) - P2 | N=30 | Recruiting | Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine | Not yet recruiting ➔ Recruiting

Enrollment open • Oncology • Pancreatic Cancer • Solid Tumor

Cadonilimab plus chemotherapy as neoadjuvant treatment for locally advanced gastric/gastroesophageal junction cancer (IGCC 2025) - "Methodology: In this ongoing, single-arm, phase 2 study, 37 patients with locally advanced G/GEJ adenocarcinomas (cT3-4a N+ M0, CY0, P0) will be enrolled and treated with 3 cycles of SOX (oxaliplatin 130mg/m2, IV, d1; S-1 40-60 mg, PO, bid, d1-d14; q21d) plus cadonilimab (10mg/Kg IV, d1, q21d), followed by radical D2 gastrectomy... Encouraging pCR rate and manageable safety suggested that cadonilimab plus SOX chemotherapy may provided a new neoadjuvant treatment option for patients with locally advanced gastric cancer."

Clinical • Metastases • Anemia • Dermatitis • Dermatology • Endocrine Disorders • Esophageal Cancer • Fatigue • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Hematological Disorders • Immunology • Leukopenia • Neutropenia • Oncology • Solid Tumor • Thrombocytopenia • CTLA4

A Phase II Study of AK104 Combination With Lenvatinib Versus Lenvatinib for Second-line HCC (clinicaltrials.gov) - P2 | N=120 | Not yet recruiting | Sponsor: Akeso

New P2 trial • Hepatocellular Cancer • Oncology • Solid Tumor

Efficacy and safety of cadonilimab combined with chemotherapy as the first-line treatment for primary advanced or recurrent endometrial cancer: a prospective single-arm open-label phase II clinical trial. (PubMed, BMJ Open) - P2 | "All patients will receive cadonilimab at a dosage of 10 mg/kg along with carboplatin (area under the curve (AUC)=4-5) plus paclitaxel (175 mg/m2) every 3 weeks (Q3W) for 6-8 cycles...Study findings will be disseminated in peer-reviewed publications. NCT06066216."

Clinical protocol • IO biomarker • Journal • P2 data • Endometrial Cancer • Gynecologic Cancers • Oncology • Solid Tumor • PD-L1