TY - JOUR
T1 - TDM-Based Tailored Dosing of Durvalumab in Lung Cancer Patients
T2 - A Comprehensive Population Pharmacokinetic-Pharmacoeconomic Evaluation
AU - de Vries, Fenna
AU - Franssen, Eric J F
AU - Smit, Arthur A J
AU - Moes, Dirk Jan A R
AU - van der Wekken, Anthonie J
AU - Munnink, Thijs Oude
AU - Hendrikx, Jeroen J M A
AU - Dumoulin, Daphne W
AU - Koolen, Stijn L W
AU - Kievit, Wietske
AU - van den Heuvel, Michel M
AU - Ter Heine, Rob
N1 - Publisher Copyright:
© The Author(s) 2025.
PY - 2025/10
Y1 - 2025/10
N2 - BACKGROUND: The increasing use of immune checkpoint inhibitors, such as durvalumab, places a significant financial burden on healthcare systems, strains hospital capacities, and contributes to environmental concerns.OBJECTIVE: We aimed to develop alternative dosing strategies to optimize durvalumab administration, reduce unnecessary drug use, and ensure sustainable cancer care without sacrificing efficacy.METHODS: Using the population pharmacokinetic model developed by the licensing holder, we designed two alternative dosing strategies for non-small cell lung cancer based on therapeutic drug monitoring. Adjustments were made to the dose or administration interval, following regulatory standards for in silico dose optimization. A pharmacoeconomic evaluation was conducted to estimate potential cost savings from a medical perspective.RESULTS: Both alternative strategies achieved high exposure levels, with 98.1-99.0% of patients exceeding a predefined efficacy target, surpassing the 95.4% predicted by the license holder for the approved 10 mg/kg 2-weekly regimen. They also reduced overall drug exposure by 7-24% and eliminated drug wastage, resulting in an average annual cost reduction of €25,163 (22.9%) per patient.CONCLUSION: Therapeutic drug monitoring-guided adjustments for durvalumab offer a potentially cost-saving way to optimize drug use, reduce healthcare burdens, and lessen environmental impact while ensuring adequate patient exposure. Our proposal's evidence provides a solid basis for a non-inferiority study.
AB - BACKGROUND: The increasing use of immune checkpoint inhibitors, such as durvalumab, places a significant financial burden on healthcare systems, strains hospital capacities, and contributes to environmental concerns.OBJECTIVE: We aimed to develop alternative dosing strategies to optimize durvalumab administration, reduce unnecessary drug use, and ensure sustainable cancer care without sacrificing efficacy.METHODS: Using the population pharmacokinetic model developed by the licensing holder, we designed two alternative dosing strategies for non-small cell lung cancer based on therapeutic drug monitoring. Adjustments were made to the dose or administration interval, following regulatory standards for in silico dose optimization. A pharmacoeconomic evaluation was conducted to estimate potential cost savings from a medical perspective.RESULTS: Both alternative strategies achieved high exposure levels, with 98.1-99.0% of patients exceeding a predefined efficacy target, surpassing the 95.4% predicted by the license holder for the approved 10 mg/kg 2-weekly regimen. They also reduced overall drug exposure by 7-24% and eliminated drug wastage, resulting in an average annual cost reduction of €25,163 (22.9%) per patient.CONCLUSION: Therapeutic drug monitoring-guided adjustments for durvalumab offer a potentially cost-saving way to optimize drug use, reduce healthcare burdens, and lessen environmental impact while ensuring adequate patient exposure. Our proposal's evidence provides a solid basis for a non-inferiority study.
UR - https://www.scopus.com/pages/publications/105011667461
U2 - 10.1007/s40262-025-01555-8
DO - 10.1007/s40262-025-01555-8
M3 - Article
C2 - 40711703
SN - 0312-5963
VL - 64
SP - 1507
EP - 1515
JO - Clinical Pharmacokinetics
JF - Clinical Pharmacokinetics
IS - 10
ER -