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Population Pharmacokinetic Modeling and Simulation of TQ-B3101 to Inform Dosing in Pediatric Patients With Solid

Fen Yang1, Huali Wu2, Yunhai Bo1

  • 1Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), National Drug Clinical Trial Center, Peking University Cancer Hospital & Institute, Beijing, China.

Frontiers in Pharmacology
|February 4, 2022
PubMed

Insights

A population pharmacokinetic model was developed for TQ-B3101, a novel kinase inhibitor. This model optimizes dosing for pediatric patients with anaplastic large cell lymphoma, ensuring safe and effective treatment.

Area of Science:

  • Pharmacology
  • Oncology
  • Clinical Pharmacology

Background:

  • TQ-B3101 is an investigational kinase inhibitor targeting advanced solid tumors and relapsed/refractory ALK-positive anaplastic large cell lymphoma.
  • Understanding its pharmacokinetic profile is crucial for safe and effective therapeutic use.

Purpose of the Study:

  • To characterize the population pharmacokinetics of TQ-B3101 and its active metabolite, TQ-B3101M.
  • To optimize the dosing regimen of TQ-B3101 for pediatric patients (6-18 years) with anaplastic large cell lymphoma.

Main Methods:

  • A population pharmacokinetic model was constructed using data from Phase 1 and Phase 2 clinical studies.
  • The model incorporated a 1-compartment model for TQ-B3101 and a 2-compartment model with time-dependent clearance for TQ-B3101M.
  • Model simulations were used to project exposure in a virtual pediatric population.

Main Results:

  • The pharmacokinetic profiles of TQ-B3101 and TQ-B3101M were well-described by the developed model.
  • TQ-B3101M exhibited time-dependent clearance, with a maximum fractional reduction of 0.41.
  • Projected TQ-B3101M exposure in pediatric patients using a body surface area tiered dosing regimen was comparable to crizotinib's recommended dose.

Conclusions:

  • A robust population pharmacokinetic model for TQ-B3101 and TQ-B3101M has been established.
  • The model supports the optimization of TQ-B3101 dosing for pediatric patients with anaplastic large cell lymphoma.
  • This work facilitates the further clinical development of TQ-B3101 in pediatric oncology.
Keywords:
TQ-B3101modelpediatricpharmacokineticsolid tumor

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