This monocentric cohort study evaluated whether baseline tumor mutational burden (TMB), assessed by OncoPanel next-generation sequencing, predicts immune-related adverse events (irAEs) in 1,215 patients with advanced NSCLC receiving ICI ± chemotherapy. Logistic regression, Cox proportional hazard models, and multiplex immunofluorescence were used.
34.7% of patients (421/1,215) developed irAEs. TMB ≥19 mut/Mb (90th percentile) was the strongest predictor: doubled irAE risk (aOR 2.14, p<0.001) and 58% earlier onset (aHR 1.58, p=0.004) vs. TMB <90th percentile. High-TMB tumors were also enriched in CD8+ cells (p=0.04).
Single-center design limits generalizability. irAE severity grading and organ-specific patterns are not detailed in the abstract. Causal directionality between CD8+ enrichment and irAEs cannot be confirmed from this observational data.
Consider baseline TMB ≥19 mut/Mb as a flag for heightened irAE vigilance in advanced NSCLC patients starting ICI therapy. Earlier and more frequent monitoring may be warranted for this subgroup, independent of treatment duration.
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