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Real-world efficacy, safety, and associated biomarkers of cadonilimab in cervical cancer: a prospective observational study

Year: 2026

Type: article

Abstract: Objective To evaluate the real-world efficacy and safety of cadonilimab (a bispecific antibody targeting PD-1 and CTLA-4) in combination with chemotherapy with or without bevacizumab for cervical cancer and to identify potential biomarkers. Methods This preliminary report analyzes the first 51 consecutive patients from a protocol-driven observational cohort initiating cadonilimab (≥2 cycles) between June 2022 and August 2025. The treatment regimens were: cadonilimab + chemotherapy + bevacizumab (n=22), cadonilimab + chemotherapy (n=24), or cadonilimab alone (n=5). Standardized data collection included clinicopathological variables, peripheral blood biomarkers, and protocol-defined tumor assessments (RECIST v1.1 every 6 weeks). Interim efficacy endpoints (objective response rate [ORR], disease control rate [DCR], median progression-free survival [mPFS]) and safety (CTCAE v5.0) were evaluated, with multivariate analyses to identify predictive factors. Interim results The median follow-up was 11.0 months. At the first tumor evaluation timepoint after completing two treatment cycles, 15 patients achieved complete response (CR), 22 patients achieved partial response (PR), and 9 patients achieved stable disease (SD), with an ORR of 72.5% and a DCR of 90.2%. At the data cutoff date (December 2025), the median PFS was 7.0 months (IQR: 4.0-10.0) and the DCR was 37.3% (19/51). Multivariable analysis revealed that squamous cell carcinoma histology (OR = 4.471, 95% CI = 1.037–21.699; P = 0.045) and baseline IL-6 levels ≤5.4 pg/mL (OR = 4.494, 95% CI = 1.089–18.541; P = 0.038) were independently associated with higher odds of achieving an objective response. Regarding safety, hematologic toxicities were the most common (74.5%), which may be related to the chemotherapeutic agents used in the combination therapy. Immune-related adverse events (irAEs) included liver function abnormalities in 39.2% of patients and skin and subcutaneous tissue disorders in 23.5% of patients. Analysis of immune-related dermal toxicity identified that a baseline Systemic Immune-Inflammation Index (SII) ≥660 (OR = 8.742, 95% CI = 1.372–55.648, P = 0.022) and CD4 + PD-1 + >42.10% (OR = 18.121, 95% CI = 1.368–239.948, P = 0.028) were independent risk factors, whereas IL-17 >21.4 pg/mL (OR = 0.042, 95% CI = 0.003–0.542, P = 0.015) was an independent protective factor. Conclusions In this real-world cohort, cadonilimab showed promising early efficacy and a manageable safety profile in cervical cancer. Identified biomarkers for response and immune-related dermal toxicity require validation in larger, prospective studies with longer follow-up.

Source: Frontiers in Immunology

DOI: 10.3389/fimmu.2026.1723923

Authors: Xiaotong Lian, Huatao Qi, Dan Lin, Qiong Wu, Yu Lei

Institutions: Guangxi Medical University, Tumor Hospital of Guangxi Medical University

Language: English

Topic: Cancer Immunotherapy and Biomarkers

Subfield: Oncology

Field: Medicine

Domain: Health Sciences

SDG: Good health and well-being

Open Access status: gold

Estimated APC paid: $3,801