Exposure-Response and Subgroup Analyses to Support Body Weight-Based Dosing of Brentuximab Vedotin in Children and Young Adults with Newly Diagnosed High-risk Classical Hodgkin Lymphoma

Zhang Z, Zhang D, Guo W, Fenton K, Narayanan S, Jain S, Jiang J, Castellino SM, Kelly KM, Cole PD, Keller FG, Garg A, Chia YL. Exposure-Response and Subgroup Analyses to Support Body Weight-Based Dosing of Brentuximab Vedotin in Children and Young Adults with Newly Diagnosed High-risk Classical Hodgkin Lymphoma. Clin Cancer Res. 2024 Aug 1;30(15):3273-3281. doi: 10.1158/1078-0432.CCR-23-3655. PubMed PMID: 38810021; PubMed Central PMCID: PMC11292200.

The purpose of the study was to evaluate the relationships between brentuximab vedotin (BV) pharmacokinetics, age, and body weight (BW) with efficacy and safety in pediatric and young adult patients with previously untreated, high-risk classical Hodgkin lymphoma in the phase III AHOD1331 study. Overall, 296 patients (age 2–21 years) in the overall population were randomized to and received BV + chemotherapy; the pharmacokinetic subpopulation comprised 24 patients (age <13 years). Age- and/or BW-based (pharmacokinetic surrogates) subgroup analyses of efficacy and safety were conducted for the overall population. Exposure–response analyses were limited to the pharmacokinetic subpopulation.