Late Immune-Related Adverse Events After At Least Two Years of Immune Checkpoint Inhibitor Therapy: Incidence and Association With Survival in Patients With Advanced NSCLC

Late Immune-Related Adverse Events After At Least Two Years of Immune Checkpoint Inhibitor Therapy: Incidence and Association With Survival in Patients With Advanced NSCLC

Background: Limited data are available on late immune-related adverse events (IRAEs) in patients with metastatic NSCLC receiving immunotherapy (ICI) beyond 2 years. Methods: A single-institution retrospective analysis including patients who received longer than 2 years of ICI therapy for metastatic...

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Main Authors: Omar Elghawy, MD, Adam Barsouk, MD, Jonathan H. Sussman, BS, Benjamin A. Bleiberg, MD, Lauren Reed-Guy, MD, Christopher D’Avella, MD, Aditi Singh, MD, Christine Ciunci, MD, MSCE, Kyle Robinson, MD, John Kosteva, MD, Corey Langer, MD, Roger B. Cohen, MD, Charu Aggarwal, MD, MPH, Melina Marmarelis, MD, MSCE, Lova Sun, MD, MSCE
Format: Article
Language:English
Published: Elsevier 2025-09-01
Series:JTO Clinical and Research Reports
Subjects:
Immunotherapy
Non–small cell lung cancer
Immune-related adverse events
Drug toxicity
Overall survival
Online Access:http://www.sciencedirect.com/science/article/pii/S2666364325000682
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Summary:Background: Limited data are available on late immune-related adverse events (IRAEs) in patients with metastatic NSCLC receiving immunotherapy (ICI) beyond 2 years. Methods: A single-institution retrospective analysis including patients who received longer than 2 years of ICI therapy for metastatic NSCLC between 2012 and 2023 was performed. Late IRAEs were defined as those occurring longer than 2 years after initiation of ICI therapy. The association of late IRAE with OS and PFS was assessed using an extended Cox regression with late IRAE modeled as a time-varying covariate. Results: In a cohort of 76 patients who received longer than 2 years of ICI, the median duration of treatment was 41.9 months, and 44 out of 76 (58%) experienced an early IRAE before 2 years. After 2 years on ICI, 38 out of 76 (50%) of patients experienced a late IRAE, many of whom (39%) had no previous early IRAE. Higher rates of late IRAEs were seen in females (p = 0.032), White patients (p = 0.041), and patients with previous grade 2 or higher IRAE (p = 0.020). Late IRAE occurrence was not associated with median progression-free survival or median overall survival. Conclusions: In patients receiving extended-duration ICI beyond 2 years, late IRAEs were common and often occurred in patients without previous history of IRAE. These findings support consideration of ICI discontinuation at 2 years.
ISSN:2666-3643

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