85eP Targeting regulatory T cells in solid tumors: A clinical development analysis of 55 drug candidates

conducted.All data processing and statistical analyses were performed in R (version 2025.09.2+418).Results: A total of 105,088 reports of PD-1 inhibitors labeled as Primary Suspect (PS) were identified, of which 2,893 (2.7%) included at least one adverse event.and 151 cases (5.2%) exhibited the full Triple-3M overlap.Cemiplimab demonstrated the highest disproportionality for individual toxicities (myasthenia gravis: ROR 31.47;myocarditis: 44.85; myositis: 21.75), whereas Pembrolizumab showed the strongest signal for the Triple-3M syndrome (ROR 218.57).Most affected patients were males (59%) and aged 65-85 years, with treatment indications including non-small cell lung cancer (23.6%), melanoma (23.3%), and renal cell carcinoma (13.0%).3M events occurred predominantly within the first month of treatment initiation. Conclusions:Although FAERS cannot confirm true clinical diagnoses, 3M toxicities accounted for 2.7% of PD-1-related reports and revealed strong signals, particularly for pembrolizumab in the full 3M overlap.These findings emphasize the need for early recognition and multidisciplinary management of neuromuscular and cardiac immune toxicities in patients receiving PD-1 inhibitors.