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Efficacy and safety of cadonilimab for malignant solid tumor treatment: a systematic review and meta-analysis
Xiaodong Mi1, Tong Lin1, Xiaogang Zhu2
1Department of Obstetrics and Gynecology, People's Hospital of Xiangxi Tujia and Miao Autonomous Prefecture, First Affiliated Hospital of Jishou University, Jishou, Hunan, China.
Objective:
To evaluate the efficacy and safety of cadonilimab in patients with solid tumors.
Methods:
We systematically searched seven databases-PubMed, Embase, Web of Science, Cochrane Library, Ovid MEDLINE, Scopus, and ProQuest-for clinical studies published up to July 19, 2025. Inclusion criteria encompassed randomized controlled trials (RCTs) and single-arm trials. Data collected included objective response rate (ORR), disease control rate (DCR), overall survival (OS), progression-free survival (PFS), and adverse events (AEs) incidence. A meta-analysis of relevant data was performed using a random-effects model.
Results:
This study encompassed a total of 13 investigations, comprising 11 single-arm clinical trials, and 2 randomized controlled trials. A total of 1,359 patients with solid tumors, including gastric cancer or adenocarcinoma of the gastroesophageal junction and cervical non-small cell lung cancer, were enrolled in the study. The pooled efficacy analysis demonstrated an ORR of 0.45 (95% CI: 0.31-0.59), a DCR of 0.84 (95% CI: 0.71-0.94), a median PFS of 7.47 months (95% CI: 4.98-9.97), and a median OS of 12.89 months (95% CI: 10.09-15.68). Subgroup analysis indicated the highest ORR in cervical cancer (0.63, 95% CI: 0.33-0.94), while the highest DCR was observed in gastric or gastroesophageal junction adenocarcinoma (0.91, 95% CI: 0.82-1.00). The administration of cadonilimab at a dosage of 10 mg/kg every three weeks resulted in the optimal ORR and DCR of 0.71 (95% CI: 0.63-0.80) and 0.95 (95% CI: 0.90-0.99), respectively. A comparison of cadonilimab plus chemotherapy with monotherapy or combination therapy with targeted agents revealed that the former demonstrated superior efficacy, with an ORR and DCR of 0.62 (95% CI: 0.56-0.69) and 0.94 (95% CI: 0.88-1.00), respectively. With respect to safety, the incidence rate of adverse events of any grade was 0.99 (95% CI: 0.98-1.00), the incidence of ≥Grade 3 treatment-related adverse events (TRAEs) was 0.49 (95% CI: 0.34-0.63), and the incidence of ≥Grade 3 immune-related adverse events (irAEs) was 0.11 (95% CI: 0.08-0.14). The most prevalent TRAEs included neutrophil count decreased, anemia, and platelet count decreased.
Conclusions:
Cadonilimab demonstrates a positive response in the treatment of various solid tumors, exhibiting good tolerability.
Systematic Review Registration:
https://www.crd.york.ac.uk/prospero/, identifier CRD420251103576.
Insights
Cadonilimab shows promise for treating solid tumors, including gastric and cervical cancers. This immunotherapy demonstrated significant objective response rates (ORR) and disease control rates (DCR), with manageable safety profiles.
Area of Science:
- Oncology
- Immunotherapy
- Clinical Trials
Background:
- Solid tumors represent a significant global health burden.
- Novel therapeutic strategies, including immunotherapies, are crucial for improving patient outcomes.
- Cadonilimab is an investigational agent targeting specific pathways in cancer treatment.
Purpose of the Study:
- To systematically evaluate the efficacy and safety of cadonilimab in patients with solid tumors.
- To determine the objective response rate (ORR), disease control rate (DCR), overall survival (OS), and progression-free survival (PFS).
- To assess the incidence and types of adverse events (AEs) associated with cadonilimab treatment.
Main Methods:
- A systematic literature search was conducted across seven major databases up to July 19, 2025.
- Inclusion criteria comprised randomized controlled trials (RCTs) and single-arm clinical trials.
- Data were pooled using a random-effects model for meta-analysis, focusing on efficacy and safety endpoints.
Main Results:
- The meta-analysis included 13 studies with 1,359 patients. Pooled ORR was 0.45 and DCR was 0.84.
- Median PFS was 7.47 months and median OS was 12.89 months. Higher efficacy was noted in cervical cancer and with cadonilimab plus chemotherapy.
- The overall incidence of AEs was 0.99, with 0.49 for Grade 3 TRAEs and 0.11 for Grade 3 irAEs. Neutropenia, anemia, and thrombocytopenia were common.
Conclusions:
- Cadonilimab demonstrates significant efficacy in treating various solid tumors, including gastric and cervical cancers.
- Combination therapy with cadonilimab and chemotherapy appears superior to monotherapy or other combinations.
- Cadonilimab exhibits a generally favorable safety profile with manageable adverse events.
