P2.05-13 Canakinumab with Standard of Care for Patients with Advanced NSCLC: T-cell Infiltration Analysis in CANOPY-1

CANOPY-1 (NCT03631199) was a Phase III study evaluating the efficacy and safety of pembrolizumab plus platinum-based doublet chemotherapy combined with canakinumab or placebo as first-line therapy for patients with advanced non-small cell lung cancer (NSCLC). The primary endpoints of progression-free survival (PFS) and overall survival (OS) were not met, and no significant difference in clinical response was observed across predefined biomarker subgroups (including PD-L1, TMB, CRP, and IL-6). CD8+ tumor-infiltrating lymphocytes play a pivotal role in antitumor immune responses and high infiltration is associated with improved clinical outcomes when combined with immune checkpoint inhibitor (ICI) therapy.