104P - The efficacy and safety of a novel PD-1/CTLA-4 bispecific antibody cadonilimab (AK104) as second- or later-line therapy for metastatic non-small cell lung cancer

Background

Although checkpoint inhibitors have improved first-line treatment for non–small cell lung cancer (NSCLC), a therapeutic need remains for patients whose disease does not respond or who experience disease progression after anti-PD-L1/PD-1 immunotherapy. Cadonilimab (AK104) is a bispecific antibody targeting PD-1 and CTLA-4 simultaneously. Here, we reported the efficacy and safety of cadonilimab with or without single-agent chemotherapy as a second- or later-line setting for metastatic NSCLC who developed disease progression after checkpoint inhibitor and chemotherapy.

Methods

The study population derived from retrospectively analyzed data (08/2022-04/2024) of patients treated with cadonilimab as second- or later-line therapy for metastatic NSCLC at Affiliated Hospital of Guangdong Medical University. Baseline characteristics, treatment patterns, and clinical outcomes, including objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS) and treatment-related adverse events (TRAEs) were analyzed.

Results

21 patients were enrolled, of which 11 (52.3%) received cadonilimab as a third or later line therapy. The median age was 66 years old (range: 54-87), 16 (76.2%) were male, 10 (47.6%) had ECOG PS 2 or 3, and 4 (19.0%) had brain metastasis. Among evaluable patients, 5 reached partial response (PR) and 9 were stable disease (SD). The ORR was 29.4% and DCR was 82.4%. The median PFS was 6.77 months (95% confidence interval: 5.28-8.27) and median OS was not mature. Three patients (14.3%) experienced grade≥3 TRAEs. The most common TRAEs (≥10%) included anemia (42.9%), hypoleukocytosis (28.6%), and aspartate aminotransferase increased (19.1%), hypothyroidism(14.3%), alanine aminotransferase increased(14.3%). No treatment-related deaths were reported.

Conclusions

This real-world analysis further confirmed the promising efficacy and safety of cadonilimab as a second- or later-line setting for metastatic NSCLC who developed disease progression after checkpoint inhibitor and chemotherapy. Further exploration is ongoing and the updated analysis in a larger population is expected in the future.

Legal entity responsible for the study

Hualin Chen.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.