Efficacy and safety of cadonilimab for malignant solid tumor treatment: a systematic review and meta-analysis

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.