Akademik Veri Yönetim Sistemi
ESMO Immuno-Oncology Congress 2025, London, İngiltere, 10 - 12 Aralık 2025, ss.12, (Özet Bildiri)
Background: Hemophagocytic lymphohistiocytosis (HLH) is a rare but life-threatening immune activation syndrome increasingly reported with immune checkpoint inhibitors (ICIs). Although case reports exist, large-scale pharmacovigilance data comparing PD-1 and PD-L1 inhibitors are limited. Methods: We queried the FDA Adverse Event Reporting System (FAERS, 2013—2025) for HLH using MedDRA preferred terms. Cases were grouped by PD-1 inhibitors (pembrolizumab, nivolumab, cemiplimab, sintilimab, tislelizumab, camrelizumab, retifanlimab, toripalimab) and PD-L1 inhibitors (atezolizumab, durvalumab, avelumab). Disproportionality was assessed by reporting odds ratio (ROR) with 95% confidence intervals (CI), using PD-1 inhibitors as reference. Results: A total of 734 HLH cases were identified: PD-1 (n=594) and PD-L1 (n=140). Median age was 61 years (range 2—89), with 43.8% ≥65 years and 54% male. Frequent malignancies included hepatocellular carcinoma (5.9%), non-small cell lung cancer (5.6%), and triple-negative breast cancer (4.8%). Pembrolizumab showed a significant signal (ROR 1.52; 95% CI 1.31—1.75), whereas nivolumab was below expected (ROR 0.82; 95% CI 0.70—0.96). Atezolizumab was borderline (ROR 1.20; 95% CI 0.99—1.47), while durvalumab and avelumab showed lower associations. Overall, PD-L1 inhibitors were less associated with HLH compared to PD-1 inhibitors (ROR 0.80; 95% CI 0.66—0.96). Conclusions: This pharmacovigilance analysis suggests differential HLH risk among ICIs, with pembrolizumab showing the strongest signal, whereas nivolumab and PDL1 inhibitors showed lower associations. Clinicians should remain vigilant for HLH―especially early fever, cytopenias, and rising ferritin―and seek prompt hematology input with diagnostic workup, which may be lifesaving. Differences may reflect pharmacodynamics, indication mix, combinations, and reporting bias; prospective, mechanism-