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Evaluating clinical impact of a shortened infusion duration for ramucirumab: a model-based approach

Ling Gao1, Yiu-Keung Lau1, Ran Wei1

  • 1Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, 46285, USA.

Cancer Chemotherapy and Pharmacology
|February 3, 2021
PubMed
Abstract

Insights

Shortening ramucirumab infusion time to 30 minutes does not affect drug exposure or increase infusion-related reactions. This change is unlikely to impact ramucirumab efficacy or safety.

Area of Science:

  • Pharmacokinetics and Pharmacodynamics
  • Oncology Drug Administration
  • Clinical Trial Analysis

Background:

  • Ramucirumab is an angiogenesis inhibitor used in cancer treatment.
  • Optimizing drug administration, including infusion duration, is crucial for patient safety and treatment efficacy.
  • Understanding infusion-related reactions (IRRs) is important for managing cancer therapies.

Purpose of the Study:

  • To evaluate the impact of shortening ramucirumab infusion duration from 60 to 30 minutes on its pharmacokinetic profile.
  • To assess the relationship between ramucirumab infusion rate and the incidence of immediate infusion-related reactions (IRRs).

Main Methods:

  • Population pharmacokinetic (PopPK) modeling was used to analyze ramucirumab concentration profiles with different infusion durations.
  • Logistic regression analysis was applied to clinical trial data to correlate infusion rates with IRR incidence.
  • Data from 2522 patients were used for PopPK modeling, and pooled data from clinical studies were used for IRR analysis.

Main Results:

  • Ramucirumab concentration-time profiles were equivalent for both 30-minute and 60-minute infusion durations.
  • The incidence of immediate IRRs (any grade or grade ≥3) was similar across different infusion rate quartiles.
  • Multivariate logistic analysis did not reveal an association between faster ramucirumab infusion rates and an increased risk of immediate IRRs.

Conclusions:

  • Shortening ramucirumab infusion duration to 30 minutes does not alter ramucirumab exposure.
  • There is no evidence of increased risk for immediate IRRs with faster infusion rates.
  • Changing the infusion duration is unlikely to affect the overall clinical efficacy or safety of ramucirumab.
Keywords:
Infusion durationInfusion-related reactionsPharmacokineticsRamucirumabVascular endothelial growth factor receptor-2 antagonist

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