Kaitanni (cadonilimab) / Akesobio - LARVOL DELTA

MORNING-RWS: The Real-world Study of AK104 Combining With TACE for Resectable Hepatocellular Carcinoma (MORNING) (clinicaltrials.gov) - P=N/A | N=100 | Recruiting | Sponsor: Sun Yat-sen University

Checkpoint inhibition • New trial • Real-world evidence • Hepatocellular Cancer • Oncology • Solid Tumor

Cadonilimab combined with trastuzumab and chemotherapy for HER2-positive gastric cancer with bone marrow metastasis and DIC: a case report and literature review. (PubMed, Front Immunol) - "Given her ECOG performance status of 2, initial therapy consisted of trastuzumab combined with docetaxel and fluorouracil, alongside supportive care...Treatment was then escalated to a combination of cadonilimab, trastuzumab, and FLOT (5-FU, leucovorin, oxaliplatin, docetaxel)...This case demonstrates that intensive anti-tumor therapy combining HER-2-targeted agents, ICIs, and chemotherapy, alongside supportive care, can prolong survival and improve life quality in GC patients with BMM and DIC. Hematologic toxicities were the main adverse events but were tolerable, supporting the regimen's feasibility and safety."

IO biomarker • Journal • Review • Allergy • Gastric Adenocarcinoma • Gastric Cancer • Hematological Disorders • Hematological Malignancies • Immunology • Oncology • Pain • Solid Tumor • HER-2 • PD-L1

Efficacy and safety of cadonilimab (PD-1/CTLA-4 bi-specific antibody) and adjuvant anti-angiogenesis therapy in treated, recurrent, or metastatic cervical cancer. (PubMed, Front Oncol) - "This study aimed to evaluate the efficacy and safety of cadonilimab(PD-1/CTLA-4 bispecific)with anti-angiogenesis adjuvant therapy (bevacizumab or anlotinib) in pretreated patients with r/mCC...The findings suggest that this regimen might be potentially efficacious and safe with relatively manageable toxicity. Further trials with a control arm are required to validate our findings."

Journal • Cardiovascular • Cervical Cancer • Hypertension • Oncology • Renal Disease • Solid Tumor • CTLA4 • PD-1

DAB: RC48 in Combination With AK104 and Bevacizumab in OCCC (clinicaltrials.gov) - P2 | N=39 | Recruiting | Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Not yet recruiting ➔ Recruiting

Enrollment open • Platinum resistant • Platinum sensitive • Oncology • Ovarian Cancer • Ovarian Clear Cell Cancer • Solid Tumor

A Prospective, Phase II, Single-Arm Trial Evaluating Efficacy and Safety of the Regimen of Induction Cadonilimab plus Chemotherapy Followed by Concurrent Chemoradiotherapy and Consolidative Cadonilimab Therapy for Unresectable Stage III NSCLC (ASTRO 2025) - No abstract available

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

A Phase II Clinical Study of AK104/AK112 in Combination With TT-00420 Tablet for Advanced HCC. (clinicaltrials.gov) - P2 | N=100 | Not yet recruiting | Sponsor: Akeso

New P2 trial • Hepatocellular Cancer • Oncology • Solid Tumor

Bispecific Antibodies in Solid Tumors: Advances and Challenges. (PubMed, Int J Mol Sci) - "There are currently five BsAbs approved by the FDA in the United States for solid tumors-amivantamab, tarlatamab, tebentafusp, zanidatamab and zenocutuzumab-and two BsAbs approved in China-cadonilimab and ivonescimab. Currently, several BsAbs are under clinical development for solid tumors, but are mostly in early phase I and II trials. This review provides an overview of the basic mechanism of action of BsAbs, current FDA-approved BsAbs, and current BsAbs under clinical development, their challenges in clinical use, the management of toxicities, and future directions."

Journal • Review • Hematological Disorders • Hematological Malignancies • Oncology • Solid Tumor

Neoadjuvant Cadonilimab Combined With Perioperative Oxaliplatin Plus S1 for Diffuse or Mixed Type of Locally Advanced Gastric/Gastroesophageal Junction Adenocarcinoma (clinicaltrials.gov) - P3 | N=668 | Recruiting | Sponsor: Zuoyi Jiao | Not yet recruiting ➔ Recruiting

Enrollment open • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor • PD-L1

Cost-effectiveness analysis of cadonilimab plus bevacizumab and chemotherapy for persistent, recurrent, or metastatic cervical cancer. (PubMed, Front Immunol) - "When the price of cadonilimab reduced by 72%, cadonilimab plus bevacizumab and chemotherapy would represent an economically viable treatment regime. Cadonilimab plus bevacizumab and chemotherapy may not be a cost-effective option as the first-line treatment in persistent, recurrent, or metastatic cervical cancer."

HEOR • Journal • Cervical Cancer • Oncology • Solid Tumor

Patient with HR-proficient advanced ovarian cancer achieved a complete response with Cadonilimab combined chemotherapy (PD-1/CTLA-4 bispecific): a case report and literature review. (PubMed, Gynecol Oncol Rep) - P2 | "For advanced ovarian cancer (OC), particularly OC with HR-deficient, surgery combined with adjuvant chemotherapy and maintenance therapy with PARPi/bevacizumab is the standard effective first-line treatment regimen...In this case study, a patient with Stage IVB OC, who tested HR-proficient, but PD-L1 positive, experienced significant tumor shrinkage (>90 %) after undergoing 3 cycles of neoadjuvant chemotherapy using TC (Paclitaxel with Carboplatin) with Cadonilimab (a PD-1/CTLA-4 bispecific antibody) therapy...Identifying the population that may benefit from immune therapy is crucial. The novel PD-1/CTLA-4 bispecific antibody merits further attention for managing advanced epithelial ovarian cancer.Trial registration: NCT05430906, registration date: June 20,2022."

Journal • Epithelial Ovarian Cancer • Oncology • Ovarian Cancer • Solid Tumor • MUC16 • PD-L1

Literature case analysis of immune checkpoint inhibitors-associated lipodystrophy. (PubMed, Melanoma Res) - "Treatment regimens included pembrolizumab (n = 3), nivolumab (n = 6), cadonilimab (n = 1), and nivolumab/ipilimumab combination (n = 1)...None of the eight patients who discontinued treatment resumed immunotherapy. ICI-associated lipodystrophy presents similar clinical features to conventional lipodystrophy but shows limited reversibility with treatment cessation or steroid intervention, necessitating increased clinical awareness."

Checkpoint inhibition • Journal • Genito-urinary Cancer • Lipodystrophy • Lung Cancer • Melanoma • Metabolic Disorders • Oncology • Renal Cell Carcinoma • Solid Tumor • LEP

Depression in gastric cancer patients: Integrated therapeutic strategies and clinical implications. (PubMed, World J Clin Oncol) - "Future research should focus on biomarker-guided approaches, such as targeting β2-adrenergic signaling, and developing personalized psychosocial care models. A holistic approach that integrates both physical and psychological care is vital to improving outcomes and quality of life in GC patients."

IO biomarker • Journal • CNS Disorders • Depression • Gastric Cancer • Mood Disorders • Oncology • Pain • Psychiatry • Solid Tumor

Inhibition of human gastric cancer growth by cytokine-induced killer cells plus chemotherapy with or without cadonilimab in a mouse xenograft tumor model. (PubMed, Front Immunol) - "However, the tumor lysis ability showed no significant difference between the chemotherapy-based combination treatment groups and the chemotherapy-alone group. The combination of CIK cells and chemotherapy with or without ICIs can serve as a potential therapeutic option for treating GC, with promising efficacy and good tolerability."

Journal • Preclinical • Gastric Cancer • Oncology • Solid Tumor

Matching-adjusted indirect comparison (MAIC) of iparomlimab and tuvonralimab (QL1706) vs cadonilimab for previously treated recurrent/metastatic cervical cancer (r/mCC) (ESMO-GC 2025) - P1/2, P2 | "Prior bevacizumab treatment and radiotherapy in addition to the abovementioned variables were adjusted for efficacy analysis...QL1706 may be a novel standard of care for this population. Legal entity responsible for the study Zhejiang Cancer Hospital."

Metastases • Cervical Cancer • Oncology • Solid Tumor

The comparison of efficacy and safety between cadonilimab (PD-1/CTLA-4) and anti-PD-1 inhibitors in patients with recurrent or metastatic cervical cancer: a retrospective real-world study. (PubMed, Front Immunol) - "Cadonilimab improved survival in R/M CC patients with previous anti-PD-1 treatment failure, achieving higher ORR in patients with negative PD-L1 expression compared to ati-PD-1 inhibitors. However, this benefit was associated with a notable increase in irAEs."

IO biomarker • Journal • Real-world evidence • Retrospective data • Cervical Cancer • Endocrine Disorders • Oncology • Pulmonary Disease • Solid Tumor • Squamous Cell Carcinoma • CTLA4

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

A Phase III Clinical Study of Cadonilimab Plus SOX as Perioperative Treatment for Patients With Resectable G/GEJ Adenocarcinoma (clinicaltrials.gov) - P3 | N=760 | Not yet recruiting | Sponsor: Akeso

New P3 trial • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology

Subgroup Analysis of Cadonilimab as First-Line Therapy for Advanced Cervical Cancer Reported in an Oral Presentation at ASCO 2025 (The Manila Times) - P3 | N=445 | COMPASSION-16 (NCT04982237) | Sponsor: Akeso | "Clinical Benefit in PFS and OS Regardless of Prior CCRT Treatment: In patients previously treated with CCRT, mPFS was 16.1 months in the cadonilimab arm vs. 7.9 months in the control arm (HR=0.55), and mOS was not reached in the cadonilimab arm vs. 22.8 months in the control arm (HR=0.54). Clinical Benefit in PFS and OS Regardless of Bevacizumab Use: In real-world settings, approximately 40% of patients are considered unsuitable for bevacizumab due to underlying conditions or bleeding/perforation risks. Cadonilimab demonstrated clinically meaningful improvements in both PFS and OS, whether or not bevacizumab was included in the treatment. In the bevacizumab-naive groups, mPFS was 11.7 months in the cadonilimab arm vs. 6.7 months in the control arm (HR=0.44), and mOS was 28.2 months in the cadonilimab arm vs. 15.1 months in the control arm (HR=0.5)."

P3 data • Cervical Cancer

Efficacy and safety of cadonilimab (PD-1/CTLA-4 bi-specific antibody) and adjuvant anti-angiogenesis therapy in treated, recurrent, or metastatic cervical cancer (Front Oncol) - P=NA | N=19 | "The median follow-up was 15.5 months study patients. Among all 19 patients, 2 patients (10.5%) achieved complete response (CR), 2 patients (10.5%) achieved partial response (PR) and 4 patients (21.1%) achieved stable disease (SD), with an ORR of 21.1% and DCR of 42.1%.Moreover, the median PFS was 10.5 months (95% CI: 6.1-14.9 months) and 1-year OS rate was 78.3%. Proteinuria (47.4%) and hypertension (42.2%) were the most common treatment-related adverse events (TRAE), with 5 (26.3%) patients experiencing Grade 3 TRAEs, while no treatment related deaths were observed."

Clinical data • Cervical Cancer

Phase Ⅱ Clinical Trial of Cadonilimab Combined With Anti-angiogenic Agents in Metastatic dMMR/MSI-H CRC (clinicaltrials.gov) - P2 | N=40 | Recruiting | Sponsor: Fudan University

dMMR • MSI-H • New P2 trial • Colorectal Cancer • Microsatellite Instability • Oncology • Solid Tumor

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

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

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

Cadonilimab with surufatinib as second-line treatment of extensive stage small cell lung cancer : a prospective, phase II study (ChiCTR) - P2 | N=32 | Recruiting | Sponsor: Chinese PLA General Hospital; Chinese PLA General Hospital

New P2 trial • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

An exploratory, single-arm, phase II clinical study of the feasibility of cadonilimab in combination with chemotherapy for the translational treatment of advanced gastric/gastroesophageal conjugate adenocarcinoma (ChiCTR) - P2 | N=34 | Not yet recruiting | Sponsor: The First Affiliated Hospital of Anhui Medical University; The First Affiliated Hospital of Anhui Medical University

New P2 trial • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor