194P - Real-world outcomes of cadonilimab (PD-1/CTLA-4 bispecific antibody) plus chemotherapy as first-line treatment in advanced gastric (G) or gastroesophageal junction (GEJ) cancer with PD-L1 CPS≤5

Background

Immune checkpoint inhibitors plus chemotherapy has been approved as first-line treatment for advanced HER2-negative G/GEJ cancer, but its efficacy is poor in low PD-L1–expressing or PD-L1–negative G/GEJ cancer. Cadonilimab, a PD-1/CTLA-4 bispecific antibody, has showed promising activity and manageable safety in previously untreated patients (pts) with advanced G/GEJ cancer, as well as in advanced G/GEJ cancer with PD-L1 CPS<5. Here, we report the efficacy and safety of the combination for advanced G/GEJ cancer pts with PD-L1 CPS≤5 in a real-world setting.

Methods

Pts with advanced G/GEJ cancer and PD-L1 CPS≤5 who has received first-line cadonilimab combined with chemotherapy were included in this real-world study. 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

From Aug 2022 to Aug 2023, 22 pts were enrolled, of which 14 (63.6%) received cadonilimab (10mg/kg, q3w) plus SOX, 4 (18.2%) received cadonilimab (10mg/kg, q3w) plus XELOX and 3 (13.6%) received cadonilimab (6mg/kg, q2w) plus FOLFOX. The median age was 55.5 (range: 30-71), 11 (50.0%) were male, 16 (72.7%) had ECOG PS 0 or 1, 14 (63.6%) were PD-L1 CPS≤1 and 6 (27.3%) had liver metastasis. Among all pts, 15 reached partial response (PR) and 7 were stable disease (SD). The ORR was 68.2% and DCR was 100.0%. Median PFS was 7.50 months (95%Cl:4.59-10.41) and median OS was not mature. TRAEs were observed in 86.4% pts, including 13.6% grade 3 TRAEs. The common grade 3 TRAEs were neutropenia (9.1%, 2/22), thrombocytopenia (4.5%, 1/22) and diabetes (4.5%, 1/22). There were no grade 4/5 toxicities.

Conclusions

This real-world analysis further confirmed the promising efficacy and safety of cadonilimab plus chemotherapy as first-line treatment in advanced G/GEJ cancer pts with PD-L1 CPS≤5. Further exploration is ongoing and the updated analysis in a larger population is expected in the future.

Clinical trial identification

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.