5/28/2023 0 Comments Only by Diane Zhou![]() ![]() Relationships between ADC/MMAE exposures, progression-free survival (PFS), and incidence of adverse events (AEs) were analyzed by logistic regression in patients receiving A+AVD. ![]() Exposure-response analyses included patients in study C25004 treated with brentuximab vedotin 48 mg/m 2 Q2W in combination with AVD. ADC exposures achieved by BSA-based dosing of brentuximab vedotin in pediatric patients were compared to those in adults who received weight-based dosing of brentuximab vedotin in the ECHELON-1 trial (NCT01712490). Sources of brentuximab vedotin pharmacokinetic variability were quantified using nonlinear mixed-effects modeling. Samples for measuring ADC and MMAE concentrations and immunogenicity assessment were collected. Methods Data from two open-label phase 1/2 pediatric studies were included in the PPK analysis: study C25002 (NCT01492088), which was a dose-escalation study (brentuximab vedotin 1.4-1.8 mg/kg every 3 weeks) in patients with relapsed or refractory systemic anaplastic large cell lymphoma or HL, and study C25004 (NCT02979522) in patients with advanced-stage, newly-diagnosed HL (brentuximab vedotin 48 mg/m 2 every 2 weeks +AVD A 25 mg/m 2, V 6 mg/m 2, D 375 mg/m 2). ![]()
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