Clinical Association Between Immune-Related Adverse Events and Treatment Efficacy in Non-Small Cell Lung Cancer Patients Treated with Nivolumab plus Ipilimumab-Based Therapy

Abstract

Abstract Nivolumab and ipilimumab combination therapy, explored for advanced non-small cell lung cancer (NSCLC) in trials like CheckMate 227 and CheckMate 9LA, raises questions about the relationship between immune-related adverse events (irAEs) and treatment efficacy in real-world settings. In our retrospective analysis of 28 advanced or recurrent NSCLC patients treated with nivolumab plus ipilimumab (with/without platinum-doublet chemotherapy) from February 2021 to January 2023, we aimed to understand the clinical association between irAEs and treatment efficacy. Among the 28 patients, 22 (78.6%) experienced irAEs. Patients with irAEs demonstrated significantly longer median progression-free survival (PFS) and overall survival (OS) than those without (P = 0.0158 and P = 0.000394, respectively). irAE severity did not significantly influence PFS or OS. The objective response rate was higher in patients with irAEs than those without (50.0% versus 0.0%, P = 0.0549). Multivariate analysis identified irAE occurrence as an independent factor for PFS (hazard ratio = 0.2084, P = 0.01383) and OS (hazard ratio = 0.0857, P = 0.001588). Interstitial lung disease was inferior to other irAE profiles for both PFS and OS. In conclusion, advanced NSCLC patients experiencing irAEs demonstrated superior clinical outcomes with nivolumab plus ipilimumab-based therapy, though interstitial lung disease may be less linked with PFS and OS than other irAE profiles.