Impact of pre-existing autoimmune disease on outcomes of immune checkpoint inhibitors in non–small cell lung cancer: A real-world multi-institutional cohort study.

Abstract

e20612 Background: Immune checkpoint inhibitors (ICIs) targeting PD-1, PD-L1, and CTLA-4 have become a cornerstone of treatment for advanced non-small cell lung cancer (NSCLC). Patients with pre-existing autoimmune disease (AD) are routinely excluded from ICI trials, resulting in limited data on the real-world safety and efficacy of ICIs in this population. We evaluated the real-world impacts of AD on survival and treatment-related outcomes in patients with NSCLC treated with ICIs. Methods: Using the TriNetX Research Network, we conducted a retrospective cohort study of adults (≥18 years) with NSCLC who received ICI therapy following diagnosis. ICI regimens included PD-1, PD-L1, and CTLA-4 based treatment. Patients with documented AD prior to ICI initiation were compared to those without AD. Propensity score matching (1:1) was performed for demographics, co-morbidities, laboratory values, and baseline steroid use. Outcomes included overall survival (OS) at 90 days, 1 year, and 3 years; infections, any hospital admission, ICU admission, and steroid exposure within 90 days; and immune-related adverse events (irAEs) within 180 days of ICI initiation. Outcomes were assessed using hazard ratios (HR), risk ratios (RR), and 95% confidence intervals (CI). Results: 426 patients with pre-existing AD and 10,027 patients without AD met inclusion criteria. Following 1:1 PSM there were 425 patients in each cohort. Patients with AD demonstrated similar OS at 90 days, 1 year, and 3 years compared with patients without AD (90-day HR = 0.99[0.68-1.43]; 1-year HR =1.15 [0.92-1.45]; 3-year HR =1.09 [0.90-1.32]). Rates of irAEs were comparable between cohorts (RR = 0.93 [0.51-1.70]). Steroid exposure was similar in the AD cohort compared with the non-AD cohort (RR =1.07 [0.97-1.18]). Rates of all-cause hospitalization and ICU admission were also similar between groups (all-cause RR = 0.95 [0.81-1.12]; ICU RR = 1.30 [0.88-1.92]). There was no statistically significant difference in rates of infection between patients with pre-existing AD compared to the no-AD group (RR =1.17 [0.93-1.48]). Conclusions: In this large real-world cohort study of NSCLC patients treated with ICIs, pre-existing AD was associated with similar OS, irAEs, rates of infection, and hospitalizations as patients without pre-existing AD. Our findings suggest that pre-existing AD alone should not affect candidacy for ICIs in appropriately selected patients. Outcome Pre-existing AD[n= 425] No-AD[n= 425] HR/RR [95% CI] 90-day OS 86.6% 86.4% 0.99 [0.68-1.43] 1-year OS 58.4% 63.9% 1.15 [0.92-1.45] 3-year OS 35.2% 37.9% 1.09 [0.90-1.32] Any irAE (180 days) 5.3% 5.7% 0.93 [0.51-1.70] Any Infection (90 days) 27.1% 23.1% 1.17 [0.93-1.48] Hospitalization (90 days) 40.0% 42.1% 0.95 [0.81-1.12] ICU Admission (90 days) 12.2% 9.4% 1.30 [0.88-1.92] Steroid Exposure (90 days) 67.5% 63.3% 1.07 [0.97-1.18]