HER2DX Offers Valuable Tool for Clinicians Treating HER2+ Breast Cancer

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The first a specialized genomic test for HER2-positive breast cancer, HER2DX, has shown its ability to predict patient outcomes, according to a recent study where the assay was used to evaluate tumor samples from 214 patients with advanced HER2-positive disease.¹

Patients included in this trial were those with HER2-positive breast cancer who received docetaxel with trastuzumab (Herceptin) and pertuzumab (Perjeta) in the phase 3 CLEOPATRA trial (NCT00567190).1 The results showed a strong association between the HER2DX ERBB2 score and both progression-free survival (PFS) and overall survival (OS).

Full data from this study evaluating HER2DX are expected to be presented at an upcoming medical meeting and submitted for publication.

“The results of HER2DX in the CLEOPATRA trial are remarkable and highlight the test’s strong value in selecting patients who are more likely to achieve disease control and extended survival outcomes with the existing HER2 standards of care,” said Javier Cortés, MD, PhD, chief of the International Breast Cancer Center in Barcelona, Spain, and co-founder of MedSIR, in the press release. “HER2DX in this setting will help decide the type of anti-HER2 therapies and their sequence. Patients with a HER2DX ERBB2-low score require closer attention, as they may not respond as well and may need alternative therapeutic strategies to improve their outcomes.”

In the CLEOPATRA trial, patients were randomized to receive first-line docetaxel with trastuzumab with or without pertuzumab until progression of the disease or unacceptable toxicity. Patients treated with docetaxel plus trastuzumab and pertuzumab had better PFS and OS outcomes vs those given docetaxel plus trastuzumab at a median follow-up of 99.9 months.

The results from this study supported the 2012 FDA approval of the combination of docetaxel plus trastuzumab and pertuzumab for the treatment of this patient population.²

About HER2DX

The HER2DX 27-gene expression test was developed for use in patients with early-stage, HER2-positive breast cancer.³ HER2DX aims to help with the identification of suitable candidates for escalation and deescalation treatment strategies in some clinical situations.

The biological information from 4 gene signatures, including immune infiltration, luminal differentiation, tumor cell proliferation, and HER2 amplicon expression, is combined with clinical data like tumor stage and nodal stage.

Real-world evidence studies have already shown that in patients with HER2-positive advanced breast cancer, the HER2DX ERBB2 score correlates with patient survival outcomes in the first-line setting with standard taxane, trastuzumab, and pertuzumab, as well as in later lines with T-DM1 (ado-trastuzumab emtansine; Kadcycla) monotherapy.

“[The latest] positive results for HER2DX are another significant step forward for our company. We look forward to working with health care payers and providers to make this test reimbursed and available worldwide for both early and metastatic settings,” added Patricia Villagrasa, PhD, chief executive officer and co-founder of Reveal Genomics, in the press release.¹

REFERENCES:

1. REVEAL GENOMICS announces positive top-line results for HER2DX in CLEOPATRA phase III trial. News release. Reveal Genomics. September 10, 2024. Accessed September 10, 2024. https://tinyurl.com/sb7xyd7v

2. Blumenthal GM, Scher NS, Cortazar P, et al. First FDA approval of dual anti-HER2 regimen: pertuzumab in combination with trastuzumab and docetaxel for HER2-positive metastatic breast cancer. Clin Cancer Res. 2013;19(18):4911-4916. doi:10.1158/1078-0432.CCR-13-1212

3. HER2DX. Reveal Genomics. Accessed September 10, 2024. https://www.reveal-genomics.com/her2dx