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New HER2-negative breast cancer subtype responsive to anti-HER2 therapy identified

Ian A MacNeil1, David J Burns1, Benjamin E Rich1

  • 1Celcuity Inc., 16305 36th Ave N, Suite 100, Minneapolis, MN, 55446, USA.

Journal of Cancer Research and Clinical Oncology
|February 10, 2020
PubMed
Abstract

Insights

A new HER2 Signaling Function (CELx HSF) test identifies HER2-negative breast cancer patients with abnormal HER2 signaling who may benefit from anti-HER2 therapies. This functional assay shows promise for guiding treatment decisions in a significant patient subgroup.

Area of Science:

  • Oncology
  • Biomarker Discovery
  • Molecular Diagnostics

Background:

  • HER2 protein quantification is standard for HER2-targeted therapy selection.
  • HER2 signaling functional activity may offer additional predictive value.
  • Identifying patients with HER2-negative status but high HER2 signaling is crucial for treatment optimization.

Purpose of the Study:

  • To evaluate the CELx HSF test for detecting abnormal HER2 signaling in HER2-negative breast cancer.
  • To assess the efficacy of anti-HER2 therapies in patients identified by the CELx HSF test.
  • To determine the prevalence of abnormal HER2 signaling in HER2-negative breast cancer patients.

Main Methods:

  • The CELx HSF test was used to characterize HER2 signaling sensitivity and specificity.
  • Inhibitory effectiveness of five anti-HER2 therapies was evaluated.
  • Correlation between CELx HSF test results and HER2 therapy response was assessed in xenograft models.
  • Prevalence of abnormal HER2 signaling was confirmed in HER2-negative breast cancer patient samples.

Main Results:

  • The CELx HSF test demonstrated sensitivity to approved anti-HER2 therapies in HER2-negative/HSFs+ samples.
  • CELx HER2 signaling status was a better predictor of HER2 inhibitor efficacy than HER2 receptor status in xenograft models.
  • Abnormal HER2 signaling (HSFs+) was found in 23.7% of 114 HER2-negative breast cancer patients.
  • The CELx HSF Test is projected to have >90% sensitivity and specificity for detecting the HER2-/HSFs+ population.

Conclusions:

  • The CELx HSF test is a validated functional biomarker assay for identifying HER2-driven signaling dysfunction in HER2-negative breast cancer.
  • The test demonstrated the efficacy of HER2-targeted therapies in the HSFs+ population and correlated with drug response in preclinical models.
  • The significant prevalence (20-25%) of abnormal HER2 signaling in HER2-negative breast cancer warrants a clinical trial to evaluate anti-HER2 therapies in this group.
Keywords:
Breast cancerCell signalingHER2Targeted therapyXenograft

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