727P - Real-world efficacy and safety of cadonilimab in recurrent or metastatic cervical cancer: A multicenter retrospective analysis in China

Background

Several clinical studies has demonstrated promising tumor response rates with cadonilimab, a bi-specific antibody targeting PD-1 and CTLA-4, in patients with recurrent or metastatic cervical cancer (R/M CC). Cadonilimab received approval for the treatment of R/M CC in patients who have experienced progression following platinum-based chemotherapy, as of 29 June 2022, in China. This study aims to evaluate the efficacy and safety of cadonilimab in a real-world clinical setting.

Methods

We conducted a multicenter, retrospective study across 13 centers in China, examining cadonilimab’s efficacy and safety in 139 R/M CC patients treated at least one cycle of cadonilimab from July 2022 to October 2023. Treatment outcomes, including objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and safety profile, were analyzed. Biomarkers were explored.

Results

The median progression-free survival (PFS) was 8.1 months (95% CI, 5.8-10.2), while the median overall survival (OS) was not reached (95% CI, 8.1 to not estimable). Of the 129 efficacy-evaluable patients, The ORR was 38.8%, and the DCR was 72.1%. Additionally, 95.7% of the paitents experienced treatment-related adverse events. The most frequent adverse events were anemia (71.9%), hypoalbuminemia (70.5%) and decreased white blood cell count (56.1%). Grade 3-4 adverse events, with anemia (20.1%), decreased white blood cell count (17.2%), and decreased neutrophil count (14.4%) being the most common. Immune-related adverse events (irAEs) affected 78 patients (55.7%). The most common were hypothyroidism (31, 22.3%) and rash (20, 14.4%). Furthermore, 12 patients (8.6%) experienced Grade 3-4 irAE. Multivariate analysis confirmed that combined with radiotherapy and chemotherapy are independent predictors of OS. For progression-free survival (PFS), multivariate analysis specifically highlighted combined with radiotherapy and liver metastasis as independent prognostic factors.

Conclusions

Cadonilimab is efficacious and safe for patients with R/M CC, even in patients with PD-L1 CPS<1, in a real-world setting.

Clinical trial identification

NCT06140589.

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.