Kaitanni (cadonilimab) / Akesobio - LARVOL DELTA

Cadonilimab Induction and Consolidation for Unresectable Stage III NSCLC Receiving Concurrent Chemoradiation: A Phase 2 Trial (IASLC-WCLC 2026) - P2 | "Introduction : PACIFIC regimen is the standard of care for unresectable stage III NSCLC, yet about 30% of patients cannot proceed to durvalumab consolidation due to disease progression or unresolved toxicity...Conclusions : Cadonilimab induction and consolidation therapy demonstrated a promising efficacy and a manageable safety profile in patients with stage III NSCLC receiving cCRT. Survival outcomes, as well as biomarker analyses will be updated."

IO biomarker • P2 data • Gastroenterology • Gastrointestinal Disorder • Immunology • Infectious Disease • Inflammation • Leukopenia • Lung Cancer • Neutropenia • Non Small Cell Lung Cancer • Pneumonia • Respiratory Diseases • Solid Tumor • CTLA4 • PD-1

Stereotactic body radiotherapy plus cadonilimab and lenvatinib as conversion therapy for potentially resectable hepatocellular carcinoma (UniRTX): A phase II study. (ASCO 2026) - P=N/A | "SBRT plus cadonilimab and lenvatinib showed encouraging efficacy and manageable toxicity as a conversion strategy for potentially resectable HCC."

P2 data • Gastrointestinal Disorder • Hematological Disorders • Hepatocellular Cancer • Hepatology • Leukopenia • Neutropenia • Oncology • Solid Tumor • PD-1

…Nearly 30 Akeso Studies to Be Presented at ESMO 2026 (PRNewswire) - "Cadonilimab, the world's first PD-1/CTLA-4 bispecific antibody, will be featured in 15 presentations covering more than ten tumor types, including gastric cancer, renal cell carcinoma, lung cancer, esophageal squamous cell carcinoma, colorectal cancer, nasopharyngeal carcinoma, ovarian cancer, soft tissue sarcoma, pleural mesothelioma, and rectal cancer. These studies span neoadjuvant settings as well as first- and second-line treatment of advanced disease, underscoring the broad anti-tumor potential of this dual checkpoint inhibitor."

Clinical data • Colorectal Cancer • Esophageal Squamous Cell Carcinoma • Gastric Cancer • Nasopharyngeal Carcinoma • Non Small Cell Lung Cancer • Ovarian Cancer • Pleural Mesothelioma • Rectal Cancer • Renal Cell Carcinoma • Soft Tissue Sarcoma

Cadonilimab (Cado) plus chemotherapy (chemo) versus chemotherapy as first-line (1L) treatment for advanced gastric or gastroesophageal junction (G/GEJ) adenocarcinoma: Final results of the phase III COMPASSION-15 trial (ESMO 2025) - P3 | "Pts were randomized 1:1 to receive Cado (10mg/kg Q3W) or placebo plus chemo (XELOX Q3W)...These authors contributed equally: Lin Shen, Yanqiao Zhang, Ziyu Li, Xiaotian Zhang. Lin Shen and Jiafu Ji are the corresponding authors."

Clinical • IO biomarker • Metastases • P3 data • Gastric Adenocarcinoma • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • CTLA4 • HER-2 • PD-1 • PD-L1

Neoadjuvant cadonilimab plus CapeOX in patients with clinical stage III gastric or esophagogastric junction adenocarcinoma (GC/EGJC): A prospective, single-arm phase II study. (ASCO 2026) - P2 | "Neoadjuvant cadonilimab plus CapeOX appears safe and effective in patients with clinical stage III GC/EGJC, achieving a moderate pCR rate and warranting further exploration of neoadjuvant immunochemotherapy combination strategies."

Clinical • P2 data • Cardiovascular • Endocrine Disorders • Gastroesophageal Junction Adenocarcinoma • Hematological Disorders • Infectious Disease • Nephrology • Neutropenia • Oncology • Pulmonary Embolism • Renal Disease • Respiratory Diseases • CTLA4

Perioperative AK104 Plus Chemotherapy for PD-L1-Negative Resectable NSCLC (IB [=4 cm]-IIIB [N2]): A Single-Center,Single-Arm Phase II Study (IASLC-WCLC 2026) - "Neoadjuvant ipilimumab (a CTLA-4 inhibitor) plus nivolumab (a PD-1 inhibitor) and chemotherapy has demonstrated a higher major pathological response (MPR) rate compared with nivolumab plus chemotherapy alone...Twenty eligible patients will receive 3 cycles of neoadjuvant therapy: AK104 10 mg/kg intravenously (iv) every 3 weeks (q3w); paclitaxel 175 mg/m2 or albumin-bound paclitaxel 260 mg/m2 iv on day 1 (d1), q3w; and carboplatin area under the curve (AUC) 5 iv on d1, q3w...pCR will be analyzed using the same method to generate 95% CIs. Baseline comparisons will use the paired t-test or Wilcoxon signed-rank test, depending on data distribution.The study was approved by the institutional ethics committee of the participating hospital (SCCHEC-02-2024-124)."

Clinical • IO biomarker • P2 data • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor

Cadonilimab combined with chemotherapy with or without bevacizumab as first-line treatment in recurrent or metastatic cervical cancer (COMPASSION-13): a phase 2 study. (PubMed, Clin Cancer Res) - P2 | "Cadonilimab combined with standard therapy was acceptable, with encouraging antitumor activity in patients with R/M CC."

Journal • Metastases • P2 data • Cervical Cancer • Hematological Disorders • Oncology • Solid Tumor

Fruquintinib plus cadonilimab and S-1 in previously treated unresectable locally advanced or metastatic esophageal squamous cell carcinoma: preliminary efficacy and safety results from a phase Ib/II study (ESMO 2026) - No abstract available

Clinical • Metastases • P1/2 data • Esophageal Squamous Cell Carcinoma • Oncology • Squamous Cell Carcinoma

Distal cholangiocarcinoma mimicking pancreatic ductal adenocarcinoma successfully converted to resection following PD-1/CTLA-4 bispecific immunotherapy (cadonilimab) combined with nab-paclitaxel-based chemotherapy: a case report providing preliminary real-world insight. (PubMed, Front Oncol) - "While PDAC is commonly treated with gemcitabine plus nab-paclitaxel (AG regimen) or FOLFIRINOX as neoadjuvant or conversion therapy, first-line treatment for cholangiocarcinoma (CCA) typically consists of gemcitabine plus cisplatin (GC regimen), with or without immunotherapy...This report offers a preliminary real-world therapeutic insight from a single case, suggesting that dual immune checkpoint blockade combined with chemotherapy may enable conversion surgery in selected patients with CCA. Further studies are warranted to elucidate the underlying immunological mechanisms."

Journal • Real-world evidence • Biliary Cancer • Biliary Tract Cancer • Cholangiocarcinoma • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor

Efficacy and Safety of Cadonilimab Plus Pulocimab in NSCLC Patients Who Progressed Following Prior Immunotherapy: A Phase 1b/2 Study (IASLC-WCLC 2025) - P1/2 | "These findings suggest that this combination may overcome immunotherapy resistance and offer a potential new option for second-line treatment of NSCLC. A further phase III clinical trial is currently in planning."

Clinical • P1/2 data • Hypertension • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Renal Disease • Solid Tumor • Thrombocytopenia • CTLA4 • PD-1

Beyond approval: a mechanism-based review of novel anti-tumour agents in cervical cancer and when to use them. (PubMed, Front Immunol) - "Cervical cancer remains a leading cause of cancer death in women, and outcomes in recurrent or metastatic disease remain poor despite chemoradiation and bevacizumab...We cover immune checkpoint inhibitors, bispecific antibodies, antibody-drug conjugates (ADCs), therapeutic HPV vaccines and adoptive cell therapy, and integrate China-developed agents-including the PD-1/CTLA-4 bispecific cadonilimab and the Nectin-4 conjugate 9MW2821-into the global landscape...We further argue that, because access to newly approved agents varies widely between health systems, the line of therapy at which an agent is introduced-rather than its approval status alone-may influence survival, a decision-relevant question that current guidelines leave unanswered. This mechanism-based, decision-oriented synthesis is intended to guide rational agent selection, sequencing and combination strategy across diverse clinical settings."

IO biomarker • Journal • Review • Cervical Cancer • Oncology • Solid Tumor • NECTIN4 • PD-1

Cadonilimab plus Chemotherapy ± Bevacizumab as 1L Treatment for Persistent, Recurrent, or Metastatic Cervical Cancer (R/M CC): A Randomized, Double-blind, Placebo-controlled Phase 3 Study (COMPASSION-16) (ESMO 2024) - No abstract available

Clinical • Late-breaking abstract • Metastases • P3 data • Cervical Cancer • Gynecologic Cancers • Oncology

Correspondence on "Cadonilimab for recurrent small cell neuroendocrine carcinoma of the cervix: a phase 2 study" by Clark et al. (PubMed, Int J Gynecol Cancer) - No abstract available

Journal • P2 data • Cervical Cancer • Endocrine Cancer • Gynecologic Neuroendocrine Carcinoma • Neuroendocrine Carcinoma • Oncology • Small Cell Neuroendocrine Cervical Carcinoma • Solid Tumor

Safety and antitumour activity of cadonilimab, an anti-PD-1/CTLA-4 bispecific antibody, for patients with advanced solid tumours (COMPASSION-03): a multicentre, open-label, phase 1b/2 trial. (PubMed, Lancet Oncol) - P1/2 | "Cadonilimab showed an encouraging tumour response rate, with a manageable safety profile, suggesting the potential of cadonilimab for the treatment of advanced solid tumours."

Journal • Metastases • P1/2 data • P2 data • Cardiovascular • Cervical Cancer • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Gastrointestinal Cancer • Hematological Disorders • Hepatocellular Cancer • Hepatology • Myocardial Infarction • Oncology • Solid Tumor • Squamous Cell Carcinoma

Real-World Study of Cadonilimab Plus Docetaxel Versus Docetaxel in Advanced NSCLC Progressing on PD-(l)1 Inhibitors (IASLC-WCLC 2026) - "Conclusions : Cadonilimab plus docetaxel demonstrated superior survival outcomes and antitumour activity compared with docetaxel monotherapy in patients with advanced NSCLC resistant to prior PD-(L)1 inhibitor therapy, with a tolerable safety profile. These findings suggest that this combination shows potential as a therapeutic option for this population and warrants confirmation in randomised controlled trials."

Clinical • IO biomarker • Metastases • Real-world • Real-world evidence • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor • CTLA4 • PD-1

A prospective, multi-center, phase Ib/II trial of first-line cadonilimab plus axitinib in advanced non–clear cell renal cell carcinoma. (ASCO 2026) - P1/2 | "Cadonilimab combined with axitinib demonstrated encouraging efficacy and tolerability as first-line therapy in advanced nccRCC across subtypes in this multi-center phase Ib/II study. Summary of efficacy analysis and tumor response review per RECIST v1.1."

Clinical • Metastases • P1/2 data • Clear Cell Renal Cell Carcinoma • CNS Disorders • Dyslipidemia • Genito-urinary Cancer • Hypertriglyceridemia • Myasthenia Gravis • Non Clear Cell Renal Cell Carcinoma • Oncology • Renal Disease • Solid Tumor • PD-L1

Immunotherapy rechallenge with cadonilimab (anti PD-1 and CTLA-4 bispecific antibody) versus PD-1 inhibitors in anti-PD-1 resistant recurrent/metastatic nasopharyngeal carcinoma (ESMO 2026) - No abstract available

Bispecific • Metastases • Nasopharyngeal Carcinoma • Oncology • Solid Tumor

CNCMT：a Multi-center, Prospective, Single-arm Study (clinicaltrials.gov) - P=N/A | N=20 | Enrolling by invitation | Sponsor: Hubei Cancer Hospital | Trial primary completion date: Dec 2025 ➔ Dec 2026

Trial primary completion date • Cervical Cancer • Oncology • Solid Tumor

Late-Breaking Abstract: CADONILIMAB PLUS CHEMOTHERAPY ± BEVACIZUMAB AS 1L TREATMENT FOR PERSISTENT, RECURRENT, OR METASTATIC CERVICAL CANCER (R/M CC): A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PHASE 3 STUDY (COMPASSION-16) (IGCS 2024) - "Grade ≥ 3 TEAEs occurred in 85.4% of pts in cadonilimab group and 80.4% in placebo group. Conclusion/Implications Cadonilimab significantly improved PFS and OS with manageable safety profile in patients with 1L R/M CC, which may be a new treatment option for this population."

Clinical • Late-breaking abstract • Metastases • P3 data • Cervical Cancer • Oncology • Solid Tumor • PD-L1

Cadonilimab plus Anlotinib in Patients with Advanced Soft Tissue Sarcoma After Failure of Standard First-Line Therapy: A Prospective Phase II Trial (ESMO 2026) - No abstract available

Clinical • Metastases • P2 data • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor

Durable Antitumor Activity of Cadonilimab Plus Lenvatinib After Frontline IO+TKI Failure in Advanced Clear Cell RCC: Updated Phase II CLEAR-IT Results (ESMO 2026) - No abstract available

Metastases • P2 data • Clear Cell Renal Cell Carcinoma • Oncology • Renal Cell Carcinoma

Cadonilimab or ivonescimab plus axitinib in metastatic mucosal melanoma: Results from a phase Ib trial. (ASCO 2026) - P1 | "The combination therapy involving cadonilimab or ivonescimab plus axitinib demonstrates a promising safety and efficacy profile. These findings suggest that such dual-antibody-based regimens could provide synergistic anti-tumor activity with an improved therapeutic index, warranting further clinical investigation."

Metastases • P1 data • Anorexia • Cutaneous Melanoma • Dyslipidemia • Endocrine Disorders • Hypertension • Melanoma • Mucosal Melanoma • Musculoskeletal Pain • Renal Disease • Solid Tumor • BRAF

The Efficacy and Safety of Cadonilimab plus Trastuzumab and SOX as First-line Treatment for Advanced HER2-positive Gastric or Gastroesophageal Junction Adenocarcinoma (G-COAST-01): A Prospective Phase II Study (ESMO 2026) - No abstract available

Clinical • Metastases • P2 data • Gastric Adenocarcinoma • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor • HER-2

THIO and Cadonilimab in Resectable Hepatocellular Carcinoma (clinicaltrials.gov) - P1 | N=60 | Recruiting | Sponsor: University of Texas Southwestern Medical Center | Not yet recruiting ➔ Recruiting

Enrollment open • Hepatocellular Cancer • Oncology • Solid Tumor

Perioperative Cadonilimab and Chemotherapy in Stage II-IIIA Non-Small-Cell Lung Cancer: Primary Analysis of a Phase 2 Study (IASLC-WCLC 2026) - P2 | "Methods : Eligible patients with resectable stage II-IIIA NSCLC received three cycles of neoadjuvant cadonilimab (10 mg/kg every 3 weeks) plus nab-paclitaxel and carboplatin, followed by surgery and nine cycles of adjuvant cadonilimab monotherapy...Long-term follow-up for EFS is ongoing. (ClinicalTrials.gov: NCT05377658.)"

IO biomarker • P2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor