ABSTRACT NUMBER: ESOC2026A447 EFFICACY AND SAFETY OF TAFOLECIMAB IN PATIENTS WITH CEREBROVASCULAR DISEASE AND HYPERCHOLESTEROLEMIA: A POST-HOC ANALYSIS OF POOLED DATA FROM THREE PHASE 3 TRIALS

Abstract Background and aims Patients with cerebrovascular disease and concomitant hypercholesterolemia face a substantially elevated risk of recurrent vascular events. Tafolecimab, a novel monoclonal antibody targeting proprotein convertase subtilisin/kexin type 9 (PCSK9), has demonstrated efficacy in reducing low density lipoprotein cholesterol (LDL-C) levels in hypercholesterolemic patients. However, its clinical performance in Chinese patients with cerebrovascular disease remains understudied. We hypothesized that tafolecimab would significantly improve lipid control in patients with cerebrovascular disease and concomitant hypercholesterolemia. Methods Data were pooled from three randomized, double-blind, placebo-controlled phase 3 trials evaluating tafolecimab 450 mg every 4 weeks in patients with hypercholesterolemia. A total of 148 patients with documented cerebrovascular disease were identified: 106 received tafolecimab and 42 received placebo. The efficacy endpoint was the change in lipid profiles at 12 weeks of treatment. Results At week 12, tafolecimab significantly reduced LDL-C levels from baseline compared to placebo (mean percent change: -61.67% vs. 8.27%, P<0.001; Table). A greater proportion of patients in the tafolecimab group achieved LDL-C 1.8 mmol/L (97.1% vs. 7.5%, P<0.001). The incidence of treatment-emergent adverse events was similar between groups (tafolecimab: 62.3%; placebo: 68.3%). No serious adverse events related to tafolecimab were reported. Conclusions In patients with cerebrovascular disease and hypercholesterolemia, tafolecimab significantly reduced LDL-C levels with a favorable safety profile. These findings support the use of tafolecimab as an effective lipid-lowering therapy in this high-risk population. Conflict of interest Hua Shen: nothing to disclose. Litong Qi: nothing to disclose. Meng Chai: nothing to disclose. Lei Qian: nothing to disclose. Jianwei Zhang: nothing to disclose. Haoyu Li: nothing to disclose. Yujie Zhou: nothing to disclose. Yong Huo: nothing to disclose. Table 1 - belongs to Results