Population Pharmacokinetics and Exposure-Response Analysis of Serplulimab in Small Cell Lung Cancer Patients.

ABSTRACT: While PD-L1 antibodies have demonstrated efficacy in small cell lung cancer, the therapeutic benefits remain limited. To address this unmet medical need, serplulimab was developed as an innovative monoclonal antibody targeting PD-1. This study evaluated the pharmacokinetic (PK) properties of serplulimab and their relationship with efficacy and safety in patients with extensive-stage small cell lung cancer (ES-SCLC), using population pharmacokinetics (PopPK) and exposure-response (E-R) analysis to inform dose selection. Data from 1144 patients across eight Phase I-III clinical trials supported a two-compartment PopPK model with time-dependent clearance. Cox proportional hazards models were employed to analyze the correlation between exposure (C_avg1 and C_min1) and overa

SUBMITTER: Wang K 

PROVIDER: S-EPMC12424064 | biostudies-literature | 2025 Sep

REPOSITORIES: biostudies-literature