BARCELONA, Spain--(BUSINESS WIRE)--REVEAL GENOMICS S.L., a biotech start-up seeking to revolutionize precision oncology through diagnostic innovation, today released further evidence supporting HER2DX®, the world’s first specialized genomic test for HER2+ breast cancer. These results were obtained in collaboration with F. Hoffmann-La Roche Ltd (Basel, Switzerland) after analyzing HER2DX® in tumor samples from the CLEOPATRA phase III clinical trial (NCT00567190).
Despite the well-established benefit of the standard taxane-trastuzumab-pertuzumab (THP) treatment regimen, the evolving landscape of HER2-positive breast cancer may offer new therapies and combinations in the future. The potential for future therapies underscores the need for precise biomarkers to guide treatment decisions, emphasizing the appropriate anti-HER2 treatment sequence. Previous real-world evidence studies in HER2+ advanced breast cancer have shown that the HER2DX® ERBB2 score is significantly associated with patient survival outcomes both in the first-line setting with THP1 and in later lines with T-DM1 monotherapy2.
For the first time, the investigators evaluated the ability of the HER2DX® ERBB2 mRNA score to predict long-term survival outcomes in 214 patients treated with THP in the pivotal CLEOPATRA phase III trial3. The results showed a strong association of HER2DX® ERBB2 mRNA score with PFS and OS.
The CLEOPATRA trial had randomized patients with advanced HER2+ breast cancer to first-line docetaxel-trastuzumab +/- pertuzumab (i.e., TH vs. THP) until progression of the disease or unacceptable toxicity3. THP showed superior PFS and OS compared to docetaxel-trastuzumab, leading to the FDA approval of pertuzumab in 2012. The median follow-up period for patients at the conclusion of the trial was 99.9 months3.
“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", commented Dr. Javier Cortés, Chief of the International Breast Cancer Center (IBCC, Spain) and Co-founder of MEDSIR. He added, “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.”
Dr. Patricia Villagrasa, CEO and Co-founder of REVEAL GENOMICS, concluded, "Today’s positive results for HER2DX® are another significant step forward for our company. We look forward to working with healthcare payers and providers to make this test reimbursed and available worldwide for both early and metastatic settings."
Detailed results of this study will be presented at an upcoming medical congress and submitted for publication.
About the HER2DX® test
HER2DX® is the world’s first diagnostic test formulated specifically for HER2+ breast cancer. Marketed by REVEAL GENOMICS since January 2022, the HER2DX® is a standardized 27-gene expression test for patients with early-stage HER2+ breast cancer.
HER2DX®️ is a prognostic, predictive assay based on clinical and genomic data. The test integrates clinical information (i.e., tumor size and nodal status) with biological information tracking immune response, luminal differentiation, tumor cell proliferation, and expression of the HER2 17q12-21 chromosomal amplicon, including the ERBB2 gene.
About HER2+ breast cancer
HER2+ breast cancer accounts for 20% of all diagnosed breast tumors. This represents more than 390,000 new cases diagnosed worldwide every year, meaning that, on average, 3 women are diagnosed with HER2+ breast cancer every 4 minutes. HER2+ breast cancer is clinically, and biologically heterogeneous, and standard clinical-pathologic assessment is not sufficient to capture this heterogeneity. Understanding this biological heterogeneity is key to identifying the prognosis of each patient and the benefit from systemic therapies targeting HER2.
About REVEAL GENOMICS
REVEAL GENOMICS, S.L. is a biotechnology start-up seeking to change the way biomarkers are used in oncology. It is focused on developing innovative diagnostic tools to define the best therapeutic options for patients with cancer. The company uses pioneering techniques, sophisticated computer applications, and machine learning to reveal new cancer research data.
REVEAL GENOMICS, S.L. is a spin-off of Hospital Clínic of Barcelona, IDIBAPS, the University of Barcelona (U.B.), and the Vall d’Hebron Institute of Oncology (VHIO).
REVEAL GENOMICS® and HER2DX® are registered trademarks of REVEAL GENOMICS, S.L.
For more information, visit www.reveal-genomics.com or follow us on X @revealgenomics.
References:
1. Bayona RS, Martínez-Sáez O, Romero DR, et al: 13P HER2DX ERBB2 mRNA score in first-line metastatic HER2-positive (HER2+) breast cancer (BC): Implications for treatment stratification. ESMO Open 9, 2024
2. Brasó-Maristany F, Griguolo G, Chic N, et al: HER2DX ERBB2 mRNA expression in advanced HER2-positive breast cancer treated with T-DM1. JNCI: Journal of the National Cancer Institute 115:332-336, 2022
3. Swain SM, Miles D, Kim S-B, et al: Pertuzumab, trastuzumab, and docetaxel for HER2-positive metastatic breast cancer (CLEOPATRA): end-of-study results from a double-blind, randomised, placebo-controlled, phase 3 study. The Lancet Oncology 21:519-530, 2020
