{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,27]],"date-time":"2026-04-27T06:50:13Z","timestamp":1777272613434,"version":"3.51.4"},"reference-count":39,"publisher":"Frontiers Media SA","license":[{"start":{"date-parts":[[2026,4,27]],"date-time":"2026-04-27T00:00:00Z","timestamp":1777248000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["frontiersin.org"],"crossmark-restriction":true},"short-container-title":["Front. Immunol."],"abstract":"<jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>This preliminary report analyzes the first 51 consecutive patients from a protocol-driven observational cohort initiating cadonilimab (\u22652 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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Interim results<\/jats:title>\n                    <jats:p>\n                      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\u00a0=\u00a04.471, 95% CI\u00a0=\u00a01.037\u201321.699; P\u00a0=\u00a00.045) and baseline IL-6 levels \u22645.4 pg\/mL (OR\u00a0=\u00a04.494, 95% CI\u00a0=\u00a01.089\u201318.541; P\u00a0=\u00a00.038) 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) \u2265660 (OR\u00a0=\u00a08.742, 95% CI\u00a0=\u00a01.372\u201355.648, P\u00a0=\u00a00.022) and CD4\n                      <jats:sup>+<\/jats:sup>\n                      PD-1\n                      <jats:sup>+<\/jats:sup>\n                      &amp;gt;42.10% (OR\u00a0=\u00a018.121, 95% CI\u00a0=\u00a01.368\u2013239.948, P\u00a0=\u00a00.028) were independent risk factors, whereas IL-17 &amp;gt;21.4 pg\/mL (OR\u00a0=\u00a00.042, 95% CI\u00a0=\u00a00.003\u20130.542, P\u00a0=\u00a00.015) was an independent protective factor.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.3389\/fimmu.2026.1723923","type":"journal-article","created":{"date-parts":[[2026,4,27]],"date-time":"2026-04-27T06:05:00Z","timestamp":1777269900000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":0,"title":["Real-world efficacy, safety, and associated biomarkers of cadonilimab in cervical cancer: a prospective observational study"],"prefix":"10.3389","volume":"17","author":[{"given":"Xiaotong","family":"Lian","sequence":"first","affiliation":[{"name":"Guangxi Medical University Affiliated Tumor Hospital","place":["Nanning, Guangxi, China"]},{"name":"Guangxi Medical University","place":["Nanning, Guangxi, 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