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Repurposing HER2 IHC: Pan-HER2 and Low-HER2.

Megan L Troxell1

  • 1Stanford University Medical Center, Stanford, CA.

Applied Immunohistochemistry & Molecular Morphology : AIMM
|March 24, 2026
PubMed
Summary
This summary is machine-generated.

New antibody drug conjugates targeting HER2 protein offer advanced breast cancer therapy. This necessitates refined companion diagnostics and assays to accurately assess HER2 expression levels for optimal patient treatment.

Keywords:
DESTINY trialsHER2T-DXdimmunohistochemistrytrastuzumab deruxtecanultralow

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Area of Science:

  • Oncology
  • Pathology
  • Molecular Diagnostics

Background:

  • Recent advancements in antibody drug conjugates targeting HER2 protein, such as trastuzumab deruxtecan (T-DXd), have significantly improved therapeutic outcomes for breast cancer and other solid tumors.
  • The expanding indications and development of novel HER2-targeted therapies underscore the critical need for precise and reliable companion diagnostics.

Purpose of the Study:

  • To address the evolving landscape of HER2-targeted therapies and their diagnostic requirements.
  • To highlight the challenges and considerations for pathologists in adapting immunohistochemistry (IHC) and other assays for companion diagnostics.
  • To discuss the implications of new approvals on assessing lower HER2 expression levels and tumor-agnostic indications.

Main Methods:

  • Review of current clinical trials and regulatory approvals for HER2-targeted antibody drug conjugates.
  • Analysis of the impact on diagnostic methodologies, including immunohistochemistry (IHC), mutation testing, and circulating tumor DNA (ctDNA).
  • Discussion of HER2 expression levels, including "low" and "ultralow" in breast cancer, and the application of gastric scoring for tumor-agnostic approvals.

Main Results:

  • New HER2-targeted therapies require adapted diagnostic assays, including IHC, to evaluate varying HER2 expression levels.
  • Attention is drawn to "low" and "ultralow" HER2 expression in breast cancer and tumor-agnostic approvals for high HER2 expression (3+ gastric scoring).
  • The field is rapidly evolving with ongoing clinical trials, necessitating continuous adaptation of diagnostic strategies.

Conclusions:

  • The advent of new HER2-targeted therapies necessitates the refinement of companion diagnostics to ensure accurate patient stratification.
  • Pathologists must adapt IHC and other assays to meet the demands of evolving treatment paradigms, including assessing low and ultralow HER2 expression.
  • Ensuring assay comparability, applicability, reproducibility, and standardized reporting is crucial in this dynamic field.