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

Background

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.

Methods

This was a retrospective study of the clinical data of patients with NSCLC treated with PD-1/PD-L1 inhibitors as 1^a or 2^a 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.

Results

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: 1481P

Summary of singular toxicities and OS (overall survival) in months

Conclusions

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.

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.