Real-world data of cadonilimab in recurrent or metastatic cervical cancer in China: a multicentric study
BackgroundImmunotherapy has become a powerful clinical strategy for treating recurrent or metastatic cervical cancer (R/M CC). Cadonilimab, a novel anti-PD-1/CTLA-4 bispecific antibody, has shown substantial clinical benefits in cancer treatment. However, there is no real-world evidence of cadonilim...
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Frontiers Media S.A.
2025-07-01
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| author | Jian Chen Haijuan Yu Yingtao Lin Dan Hu Li Liu Renliang Fan Jianping Zou Lele Zang Yao Lin Rong Lin Dezhao Chen Xiaoying Weng Fenfang Shen Shaoyu Wang Wei Zeng Qihua Tian Yun Yi Yuanfeng Chen Jinjin Miao Bo Zhang Yinxia Zou Fengming Gao Fengming Gao Rong Lian Lin Yang Yang Sun |
| author_facet | Jian Chen Haijuan Yu Yingtao Lin Dan Hu Li Liu Renliang Fan Jianping Zou Lele Zang Yao Lin Rong Lin Dezhao Chen Xiaoying Weng Fenfang Shen Shaoyu Wang Wei Zeng Qihua Tian Yun Yi Yuanfeng Chen Jinjin Miao Bo Zhang Yinxia Zou Fengming Gao Fengming Gao Rong Lian Lin Yang Yang Sun |
| author_sort | Jian Chen |
| collection | DOAJ |
| description | BackgroundImmunotherapy has become a powerful clinical strategy for treating recurrent or metastatic cervical cancer (R/M CC). Cadonilimab, a novel anti-PD-1/CTLA-4 bispecific antibody, has shown substantial clinical benefits in cancer treatment. However, there is no real-world evidence of cadonilimab with a considerable sample size in R/M CC. Hence, we aim to assess the efficacy and safety of cadonilimab in R/M CC patients and explore its potential mechanism.MethodsThis retrospective real-world study examined a sample of R/M CC patients treated with cadonilimab at 13 large academic medical centers in China from July 6, 2022, to October 1, 2023. The outcomes were objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS), as well as safety profiles. Additionally, the programmed cell death 1 ligand 1 (PD-L1) was detected by immunohistochemistry to confirm its predictive values. Whole exome sequencing (WES) was also performed to investigate its potential antitumor mechanisms.ResultsAmong the 129 patients with measurable disease, the ORR was 38.8%, consisting of complete and partial responses in 8.5% and 30.2% of patients, respectively. The DCR was 72.1%. The median PFS was 12.4 months, while the median OS has not yet been reached. Subgroup analysis showed a numerical trend toward longer median PFS in patients with PD-L1 CPS ≥ 1 compared with CPS < 1 (14.0 vs. 12.8 months; P = 0.235). Moreover, combined therapy of cadonilimab and radiotherapy was identified as an independent prognostic factor for both OS and PFS. The most common grade 3 or worse adverse event was anemia (28 [20.1%]), decreased white blood cell count (24 [17.2%]), and decreased neutrophil count (20 [14.4%]). The most prevalent genetic variant was PIK3CA, highlighting the importance of the PI3K-AKT pathway in the antitumor mechanism of cadonilimab.ConclusionsCadonilimab shows an encouraging tumor response rate, with a manageable safety profile in patients with R/M CC. Notably, cadonilimab is also effective for those with PD-L1 CPS <1, suggesting a broad range of application prospects in R/M CC.Clinical Trial Registrationhttps://www.clinicaltrials.gov, identifier NCT06140589. |
| format | Article |
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| publishDate | 2025-07-01 |
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| spelling | doaj-art-d875e3c461c44bcaa74b6590a4b0032f2025-07-14T05:25:29ZengFrontiers Media S.A.Frontiers in Immunology1664-32242025-07-011610.3389/fimmu.2025.16116961611696Real-world data of cadonilimab in recurrent or metastatic cervical cancer in China: a multicentric studyJian Chen0Haijuan Yu1Yingtao Lin2Dan Hu3Li Liu4Renliang Fan5Jianping Zou6Lele Zang7Yao Lin8Rong Lin9Dezhao Chen10Xiaoying Weng11Fenfang Shen12Shaoyu Wang13Wei Zeng14Qihua Tian15Yun Yi16Yuanfeng Chen17Jinjin Miao18Bo Zhang19Yinxia Zou20Fengming Gao21Fengming Gao22Rong Lian23Lin Yang24Yang Sun25Department of Gynecology, Clinical Oncology School of Fujian Medical University, Fujian Cancer Hospital, Fuzhou, ChinaDepartment of Gynecology, Clinical Oncology School of Fujian Medical University, Fujian Cancer Hospital, Fuzhou, ChinaDepartment of Clinical Medical Research Center, Clinical Oncology School of Fujian Medical University, Fujian Cancer Hospital, Fuzhou, ChinaDepartment of Pathology, Clinical Oncology School of Fujian Medical University, Fujian Cancer Hospital, Fuzhou, ChinaDepartment of Gynecology, Clinical Oncology School of Fujian Medical University, Fujian Cancer Hospital, Fuzhou, ChinaDepartment of Oncology, Fujian Medical University Affiliated Nanping First Hospital, Nanping, ChinaDepartment of Gynecology, Clinical Oncology School of Fujian Medical University, Fujian Cancer Hospital, Fuzhou, ChinaDepartment of Gynecology, Clinical Oncology School of Fujian Medical University, Fujian Cancer Hospital, Fuzhou, ChinaDepartment of Obstetrics and Gynecology, The First Hospital Affiliated to Fujian Medical University, Fuzhou, ChinaDepartment of Obstetrics and Gynecology, Fujian Provincial Hospital, Fuzhou, ChinaDepartment of Obstetrics and Gynecology, Fujian Medical University Union Hospital, Fuzhou, ChinaDepartment of Obstetrics and Gynecology, Fujian Provincial Hospital, Fuzhou, ChinaDepartment of Obstetrics and Gynecology, Fujian Provincial Hospital, Fuzhou, ChinaDepartment of Obstetrics and Gynecology, The First Hospital Affiliated to Fujian Medical University, Fuzhou, ChinaDepartment of Obstetrics and Gynecology, Gutian Hospital, Ningde, ChinaDepartment of Gynecology, People’s Hospital Affiliated to Fujian University of Traditional Chinese Medicine, Fuzhou, China0Department of Gynecology, Jiangxi Cancer Hospital, Nanchang, China1Department of Gynecology, Shunde Women and Children’s Hospital (Maternity and Child Healthcare Hospital of Shunde Foshan), Guangdong Medical University, Foshan, China2Department of Obstetrics and Gynecology, Lianyungang Donghai County People’s Hospital, Lianyungang, China3Department of Gynecology, Changsha Maternal and Child Health Hospital, Changsha, China4Department of Gynecology, Pingxiang Maternal and Child Health Hospital, Pingxiang, ChinaDepartment of Obstetrics and Gynecology, The First Hospital Affiliated to Fujian Medical University, Fuzhou, China5Department of Obstetrics and Gynecology, Huinan County People’s Hospital, Huinan, China6Beijing GenePlus Technology Co. Ltd., Beijing, ChinaDepartment of Gynecology, Clinical Oncology School of Fujian Medical University, Fujian Cancer Hospital, Fuzhou, ChinaDepartment of Gynecology, Clinical Oncology School of Fujian Medical University, Fujian Cancer Hospital, Fuzhou, ChinaBackgroundImmunotherapy has become a powerful clinical strategy for treating recurrent or metastatic cervical cancer (R/M CC). Cadonilimab, a novel anti-PD-1/CTLA-4 bispecific antibody, has shown substantial clinical benefits in cancer treatment. However, there is no real-world evidence of cadonilimab with a considerable sample size in R/M CC. Hence, we aim to assess the efficacy and safety of cadonilimab in R/M CC patients and explore its potential mechanism.MethodsThis retrospective real-world study examined a sample of R/M CC patients treated with cadonilimab at 13 large academic medical centers in China from July 6, 2022, to October 1, 2023. The outcomes were objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS), as well as safety profiles. Additionally, the programmed cell death 1 ligand 1 (PD-L1) was detected by immunohistochemistry to confirm its predictive values. Whole exome sequencing (WES) was also performed to investigate its potential antitumor mechanisms.ResultsAmong the 129 patients with measurable disease, the ORR was 38.8%, consisting of complete and partial responses in 8.5% and 30.2% of patients, respectively. The DCR was 72.1%. The median PFS was 12.4 months, while the median OS has not yet been reached. Subgroup analysis showed a numerical trend toward longer median PFS in patients with PD-L1 CPS ≥ 1 compared with CPS < 1 (14.0 vs. 12.8 months; P = 0.235). Moreover, combined therapy of cadonilimab and radiotherapy was identified as an independent prognostic factor for both OS and PFS. The most common grade 3 or worse adverse event was anemia (28 [20.1%]), decreased white blood cell count (24 [17.2%]), and decreased neutrophil count (20 [14.4%]). The most prevalent genetic variant was PIK3CA, highlighting the importance of the PI3K-AKT pathway in the antitumor mechanism of cadonilimab.ConclusionsCadonilimab shows an encouraging tumor response rate, with a manageable safety profile in patients with R/M CC. Notably, cadonilimab is also effective for those with PD-L1 CPS <1, suggesting a broad range of application prospects in R/M CC.Clinical Trial Registrationhttps://www.clinicaltrials.gov, identifier NCT06140589.https://www.frontiersin.org/articles/10.3389/fimmu.2025.1611696/fullrecurrent or metastatic cervical cancerPD-1CTLA-4bi-specific antibodycadonilimabreal world |
| spellingShingle | Jian Chen Haijuan Yu Yingtao Lin Dan Hu Li Liu Renliang Fan Jianping Zou Lele Zang Yao Lin Rong Lin Dezhao Chen Xiaoying Weng Fenfang Shen Shaoyu Wang Wei Zeng Qihua Tian Yun Yi Yuanfeng Chen Jinjin Miao Bo Zhang Yinxia Zou Fengming Gao Fengming Gao Rong Lian Lin Yang Yang Sun Real-world data of cadonilimab in recurrent or metastatic cervical cancer in China: a multicentric study Frontiers in Immunology recurrent or metastatic cervical cancer PD-1 CTLA-4 bi-specific antibody cadonilimab real world |
| title | Real-world data of cadonilimab in recurrent or metastatic cervical cancer in China: a multicentric study |
| title_full | Real-world data of cadonilimab in recurrent or metastatic cervical cancer in China: a multicentric study |
| title_fullStr | Real-world data of cadonilimab in recurrent or metastatic cervical cancer in China: a multicentric study |
| title_full_unstemmed | Real-world data of cadonilimab in recurrent or metastatic cervical cancer in China: a multicentric study |
| title_short | Real-world data of cadonilimab in recurrent or metastatic cervical cancer in China: a multicentric study |
| title_sort | real world data of cadonilimab in recurrent or metastatic cervical cancer in china a multicentric study |
| topic | recurrent or metastatic cervical cancer PD-1 CTLA-4 bi-specific antibody cadonilimab real world |
| url | https://www.frontiersin.org/articles/10.3389/fimmu.2025.1611696/full |
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