A randomized, open-label, crossover study assessing the pharmacokinetic and pharmacodynamic bioequivalence of pegfilgrastim-cbqv via on-body injector vs prefilled syringe

• Published in: Journal of clinical oncology Vol. 40; no. 16_suppl; p. e18637
• Main Authors: Tang, Hong, Civoli, Francesca, Tatarewicz, Suzanna, Miyasaki, Lisa, O'Kelly, Hillary, Young, Alasdair, Finck, Barbara
• Format: Journal Article
• Language: English
• Published: American Society of Clinical Oncology 01.06.2022
• ISSN: 0732-183X; 1527-7755
• DOI: 10.1200/JCO.2022.40.16_suppl.e18637

e18637Background: Pegfilgrastim-cbqv, a pegfilgrastim biosimilar, is administered 24-72 h after myelosuppressive chemotherapy to prevent febrile neutropenia. Pegfilgrastim delivery via an on-body injector (OBI) applied on the day of chemotherapy eliminates the need for a second healthcare visit. This study evaluated the pharmacokinetic (PK), pharmacodynamic (PD) bioequivalence (BE), and the safety of pegfilgrastim-cbqv administered via OBI vs prefilled syringe. Methods: In this open-label, 2-period crossover study, healthy adult male participants were randomized 1:1 to 2 treatment sequences to receive a 6-mg subcutaneous (SC) injection of pegfilgrastim-cbqv via OBI or prefilled syringe in period 1 and an injection via the other method in period 2 (after a 6- to 8-wk washout). Primary endpoints (PK) were area under the concentration-time curve from time 0 to infinity (AUC0-inf), the AUC from time 0 to the last quantifiable concentration (AUC0-last), and the maximum plasma concentration (Cmax). Secondary endpoints (PD) were area under the absolute neutrophil count (ANC)-time curve from time 0 to the last quantifiable ANC (ANC AUC0-last) and maximum ANC (ANCmax). PK/PD BE was established if the 90% CI for the geometric mean ratios (GMRs) fell within 80-125%. Safety and immunogenicity were also assessed. Results: The 90% CIs of the GMRs for PK and PD endpoints in healthy participants fell within the predetermined range (Table). Treatment-emergent adverse events (TEAEs) occurred in 87.8% (OBI) vs 75.8% (prefilled syringe) of participants. Most TEAEs were musculoskeletal effects and mild in severity. The most common injection site-related TEAE was erythema (OBI 34.1%; prefilled syringe 2.5%). The injection site erythema reactions were mild in severity and self-limiting. The incidence of treatment-emergent antidrug antibodies (ADAs) in period 1 was similar with OBI (40.0%) vs prefilled syringe (36.6%); ADA titers were low, transient, and primarily directed to the polyethylene glycol (PEG) moiety of pegfilgrastim-cbqv. The ADAs had no apparent impact on PK, PD, or safety. Neutralizing antibodies were not detected in any participant. Conclusions: This study demonstrated PK and PD BE of pegfilgrastim-cbqv administered via OBI vs prefilled syringe in healthy adult males. OBI and prefilled syringe administration had similar safety and immunogenicity profiles. No unexpected safety signals were identified.PK and PD parameters.ParameterGMR (90% CI)AUC0-inf 115.8 (107.3-124.9)AUC0-last 115.8 (107.3-125.0)Cmax115.7 (107.2-124.8)ANC AUC0-last100.4 (98.4-102.4)ANCmax102.1 (99.8-104.5)