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Background: <p>Less frequent nivolumab dosing has been assessed for more efficient dosing, but there is no conclusive evidence. In this research, we suggested an appropriate model-informed drug dosing using virtual patients collected from the results of multiple clinical studies to provide a rationale for less frequent dosing.</p> Methods: <p>A pharmacokinetic model was developed using a virtual solid tumor cohort generated through simulation from final models of previous nivolumab pharmacokinetic studies. Simulations were performed for regimens ranging from standard doses to extended intervals of up to 8 weeks, specifically 12 mg/kg and 960 mg. The primary analysis focused on the attainment of a minimum effective concentration at steady state.</p> Results: <p>Here we show that nivolumab clearance increases as body weight increases, and that a higher clearance is observed in female patients and/or patients with greater physical restriction (baseline performance status ≥ 1). Volume of distribution also increases with body weight and is higher in female patients. The predicted steady-state trough concentrations remain well above the minimum effective concentration of 2.5 μg/mL across all evaluated scenarios, including the maximally extended 8-week intervals.</p> Conclusion: <p>The pooled population pharmacokinetic analysis using virtual patients provides evidence supporting the pharmacokinetic feasibility of extending the nivolumab dosing interval up to 8 weeks. These findings suggest that less frequent dosing regimens maintain therapeutic drug exposure while potentially reducing the treatment burden on patients and healthcare systems.</p>

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MODEL-informed nivolumab less frequent dosing using virtual patients with solid tumors

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年8月5日

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  • Hongjae Lee,
  • Heungjo Kim,
  • Ji Woo Lim,
  • Kyongkuk Ryu,
  • Min Jung Chang

摘要

Background:

Less frequent nivolumab dosing has been assessed for more efficient dosing, but there is no conclusive evidence. In this research, we suggested an appropriate model-informed drug dosing using virtual patients collected from the results of multiple clinical studies to provide a rationale for less frequent dosing.

Methods:

A pharmacokinetic model was developed using a virtual solid tumor cohort generated through simulation from final models of previous nivolumab pharmacokinetic studies. Simulations were performed for regimens ranging from standard doses to extended intervals of up to 8 weeks, specifically 12 mg/kg and 960 mg. The primary analysis focused on the attainment of a minimum effective concentration at steady state.

Results:

Here we show that nivolumab clearance increases as body weight increases, and that a higher clearance is observed in female patients and/or patients with greater physical restriction (baseline performance status ≥ 1). Volume of distribution also increases with body weight and is higher in female patients. The predicted steady-state trough concentrations remain well above the minimum effective concentration of 2.5 μg/mL across all evaluated scenarios, including the maximally extended 8-week intervals.

Conclusion:

The pooled population pharmacokinetic analysis using virtual patients provides evidence supporting the pharmacokinetic feasibility of extending the nivolumab dosing interval up to 8 weeks. These findings suggest that less frequent dosing regimens maintain therapeutic drug exposure while potentially reducing the treatment burden on patients and healthcare systems.