1481P Singular immune-related adverse events and efficacy outcomes of immune checkpoint inhibitors in advanced non-small cell lung cancer

ICIs have transformed the treatment of advanced NSCLC patients, no real-world data are available about the immune-related adverse events (irAEs). This retrospective study aimed to assess the safety and effectiveness of PD-1/PD-L1 inhibitors in patients with non-small cell lung cancer (NSCLC) and to analyze the association between singular irAEs and effectiveness. This was a retrospective study of the clinical data of patients with NSCLC treated with PD-1/PD-L1 inhibitors as 1a or 2a lines from Marzo 2015 to Marzo 2022 at Hospital Universitario Regional de Málaga. We evaluated association of irAE with efficacy, response and overall survival. Kaplan-Meier and Cox proportional hazard analyses were performed. A total of 510 patients were included in this analysis. Any grade IrAEs were seen in 307 (60%) patients. Of these (Table), 135 (43,9%) patients had grade 1 toxicities, most commonly cutaneous (96), colitis (54), rheumatologic (46) and hepatitis (42). 112 (36,4%) patients had grade 2 toxicities pneumonitis (47), cutaneous (29), colitis (28). 53 (17,2%) patients had grade 3 toxicities: hepatitis (15), pneumonitis (13), cutaneous (10). 8 (2,6 %) patients had grade 4 toxicities hepatitis (5), pneumonitis (2), DRESS syndrome (1). For patients assessed for efficacy, objective response rate (ORR) to ICI was higher in patients with irAEs [46% vs 14%] p=0,001. In fact, the presence of any irAEs had a significantly improved median OS compared to those without irAEs (19,3 months vs 6,5 p = 0.0001) (Median OS in G1-2 20 months and G 3-4 16,2 months had significally higher OS vs non irAEs 6,1 months; p=0,0001). Singular toxicities that predict greater OS >30 months were (Hepatitis G4, endocrine G1 and cutaneous G2); point out toxicities with deleterious effects (colitis G3 and pneumonitis G4). Multivariable analysis demonstrated that the development of any irAEs was related to a significantly improved OS (HR 0.47, 95% 0.26-0.68, p = 0.0001). Table: 1481PSummary of singular toxicities and OS (overall survival) in monthsIrAEsN 307Cutaneous 135 OSPneumo92 OSColitis89 OSHepatitis79 OSRheuma76 OSEndocrine61 OSRenal40 OSG1 13596 28.229 18.354 21.442 18.746 28.840 37.819 21.4G2 11229 31.147 13.828 21.417 1928 20.118 28.814 28.2G3 5310 13.413 15.37 7.215 20.62 3.83 -7 7.2G4 8-3 1.9-5 40.6---Non N Ir 203375 9.0 p=0.0001418 11.4 p=0.54421 11.2 p=0.018431 11.6 p=0.146434 11.1 p=0.001449 11.1 p=0.001470 12.6 p=0.05 Open table in a new tab This study confirms the feasibility and the safety of ICIs in a large, real-world cohort of patients with NSCLC. The development of irAEs in NSCLC patients treated with immunotherapy may predict better treatment efficacy and overall survival.