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Panitumumab: A Review of Clinical Pharmacokinetic and Pharmacology Properties After Over a Decade of Experience in Patients with Solid Tumors

Advances in Therapy volume 38, pages 3712–3723 (2021)Cite this article

Abstract

Panitumumab is a fully human monoclonal antibody that binds to the epidermal growth factor receptor (EGFR), thereby inhibiting the growth and survival of tumors expressing EGFR. Panitumumab received approval in the USA in 2006 for the treatment of wild-type RAS (defined as wild-type in both KRAS and NRAS) metastatic colorectal cancer. Over the last 10 years, the pharmacokinetic and pharmacodynamic profile of panitumumab has been studied to further evaluate its safety, efficacy, and optimal dosing regimen. In this review, we summarize the key clinical pharmacokinetic and pharmacology data for panitumumab, and considerations for its use in special populations. Panitumumab has a nonlinear pharmacokinetic profile and its approved dosing regimen (6 mg/kg every 2 weeks) is based on body weight; dose adjustments are not needed based on sex, age, or renal or hepatic impairment. Drug interactions do not occur when panitumumab is combined with chemotherapy drugs including irinotecan, paclitaxel, and carboplatin. The level of tumor EGFR expression was found to have no effect on panitumumab pharmacokinetics or efficacy. The incidence of anti-panitumumab antibodies is low; when anti-panitumumab antibodies are produced, they do not affect the efficacy, safety, or pharmacokinetics of panitumumab. In summary, the pharmacokinetic and pharmacodynamic profile of panitumumab is well suited for standard dosing, and the approved body weight–based dosing regimen maintains efficacy and safety in the treatment of wild-type RAS metastatic colorectal cancer across a broad range of patients.

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Acknowledgements

Funding

Amgen Inc. funded this analysis and the journal’s Rapid Service fees.

Medical Writing/Editorial Assistance

The authors thank Lee Hohaia, PharmD, and Allison Gillies, PhD (ICON, North Wales, PA), whose work was funded by Amgen Inc., for medical writing assistance in the preparation of this manuscript.

Authorship

All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this article, take responsibility for the integrity of the work as a whole, and have given their approval for this version to be published.

Authors’ Contributions

All authors contributed equally to this manuscript’s conception, design, material preparation, data collection and analysis, reviewed and edited the manuscript, and read and approved the final manuscript.

Prior Presentation

Although based on previously conducted studies, the analyses in this article have not been presented or published previously.

Disclosures

Johannes Kast, Sandeep Dutta and Vijay V. Upreti are employees of and stockholders in Amgen Inc.

Compliance with Ethics Guidelines

This article is based on previously conducted studies and does not contain any new studies with human participants or animals performed by any of the authors.

Data Availability

Qualified researchers may request data from Amgen clinical studies. Complete details are available at the following: http://www.amgen.com/datasharing.

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Authors and Affiliations

  1. Clinical Pharmacology, Modeling and Simulation, Amgen Inc., 1120 Veterans Boulevard, South San Francisco, CA, 94080, USA

    Johannes Kast & Vijay V. Upreti

  2. Clinical Pharmacology, Modeling and Simulation, Amgen Inc., Thousand Oaks, CA, USA

    Sandeep Dutta

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  1. Johannes Kast
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Correspondence to Vijay V. Upreti.

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Kast, J., Dutta, S. & Upreti, V.V. Panitumumab: A Review of Clinical Pharmacokinetic and Pharmacology Properties After Over a Decade of Experience in Patients with Solid Tumors. Adv Ther 38, 3712–3723 (2021). https://doi.org/10.1007/s12325-021-01809-4

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  • DOI: https://doi.org/10.1007/s12325-021-01809-4

Keywords

  • Clinical pharmacology
  • Colorectal neoplasms
  • Dose–exposure relationship
  • Epidermal growth factor receptor antagonist
  • Panitumumab
  • Pharmacokinetics