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Background <p>Cadonilimab, recognized as the most rapidly developed Chinese drug in the field of cervical cancer, received marketing approval in China in 2022. We conducted a study to investigate the safety and efficacy of Cadonilimab, combined with and without chemotherapy or bevacizumab treatment, in patients with recurrent / metastatic gynecological malignancies.</p> Methods <p>We retrospectively enrolled 60 patients with recurrent / metastatic gynecological malignant tumors, confirmed by pathology or cytology from July 2022 to December 2024. All patients received at least two cycles of Cadonilimab. The primary endpoints were the investigator-confirmed objective response rate and disease control rate according to RECIST v1.1. Secondary endpoints included progression-free survival and safety.</p> Results <p>Fifty-six patients were included in the efficacy analysis. In the study population, This study is a retrospective real-world study, although it lacks a control group. There were 16 first-line patients with advanced cervical cancer, ORR was 81.3%(13/16,95% CI,57 to 93.4),DCR was 93.8%(15/16,95% CI 71.7 to 98.9); There were 30&#xa0;second-line patients, ORR was 36.7%(11/30,95% CI,21.9 to 54.5),DCR was 90%(27/30,95% CI 74.4 to 96.5)。A total of 41 patients (73.2%) reported at least one treatment-related adverse event, with the most common being anemia (71.4%), nausea (28.6%), and myelosuppression (25%). 9 patients (16.1%) experienced G3-4 TRAEs. Additionally, 11 patients (19.6%) developed immune-related adverse events of G1-2. Importantly, no treatment-related deaths occurred during the study.</p> Conclusion <p>Cadonilimab with or without chemotherapy/bevacizumab had a promising antitumor activity and manageable safety profile in the treatment of recurrent/metastatic gynecological malignancies.</p>

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Clinical efficacy and safety of Cadonilimab in the treatment of advanced gynecological malignancies: a retrospective, real-world study

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年8月19日

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  • Yisidan Huang,
  • Yuting Zeng,
  • Cui Zhang,
  • Can Yang,
  • Hanqun Zhang,
  • Libo Li,
  • Xiaoqing Luo,
  • Yunchong Liu,
  • Jiaying Bai,
  • Fenghu Li,
  • Yong Li

摘要

Background

Cadonilimab, recognized as the most rapidly developed Chinese drug in the field of cervical cancer, received marketing approval in China in 2022. We conducted a study to investigate the safety and efficacy of Cadonilimab, combined with and without chemotherapy or bevacizumab treatment, in patients with recurrent / metastatic gynecological malignancies.

Methods

We retrospectively enrolled 60 patients with recurrent / metastatic gynecological malignant tumors, confirmed by pathology or cytology from July 2022 to December 2024. All patients received at least two cycles of Cadonilimab. The primary endpoints were the investigator-confirmed objective response rate and disease control rate according to RECIST v1.1. Secondary endpoints included progression-free survival and safety.

Results

Fifty-six patients were included in the efficacy analysis. In the study population, This study is a retrospective real-world study, although it lacks a control group. There were 16 first-line patients with advanced cervical cancer, ORR was 81.3%(13/16,95% CI,57 to 93.4),DCR was 93.8%(15/16,95% CI 71.7 to 98.9); There were 30 second-line patients, ORR was 36.7%(11/30,95% CI,21.9 to 54.5),DCR was 90%(27/30,95% CI 74.4 to 96.5)。A total of 41 patients (73.2%) reported at least one treatment-related adverse event, with the most common being anemia (71.4%), nausea (28.6%), and myelosuppression (25%). 9 patients (16.1%) experienced G3-4 TRAEs. Additionally, 11 patients (19.6%) developed immune-related adverse events of G1-2. Importantly, no treatment-related deaths occurred during the study.

Conclusion

Cadonilimab with or without chemotherapy/bevacizumab had a promising antitumor activity and manageable safety profile in the treatment of recurrent/metastatic gynecological malignancies.