Observational studyFrontiers in immunology2026
Real-world efficacy, safety, and associated biomarkers of cadonilimab in cervical cancer: a prospective observational study.
Observational study in Frontiers in immunology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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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 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.
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