REVEAL GENOMICS S.L. announced positive top-line results for its HER2DX® genomic test in patients with advanced HER2+ breast cancer. The study, conducted in collaboration with F. Hoffmann-La Roche Ltd, analyzed tumor samples from 214 patients in the CLEOPATRA phase III clinical trial (NCT00567190) who were treated with docetaxel, trastuzumab, and pertuzumab.
The results demonstrated a significant association between the ERBB2 mRNA levels, as determined by HER2DX®, and both progression-free survival (PFS) and overall survival (OS). This suggests that HER2DX® could be a valuable tool in predicting long-term outcomes and guiding treatment decisions in this patient population.
HER2DX® and the CLEOPATRA Trial
The CLEOPATRA trial randomized patients with advanced HER2+ breast cancer to first-line docetaxel-trastuzumab with or without pertuzumab until disease progression or unacceptable toxicity. The addition of pertuzumab to docetaxel and trastuzumab (THP) showed superior PFS and OS compared to docetaxel and trastuzumab alone, 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 months.
Clinical Implications of HER2DX®
Dr. Javier Cortés, Chief of the International Breast Cancer Center (IBCC, Spain) and Co-founder of MEDSIR, commented on the results, stating, "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." He further 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."
About HER2DX®
HER2DX® is the world’s first diagnostic test specifically designed for HER2+ breast cancer. Marketed by REVEAL GENOMICS since January 2022, it is a standardized 27-gene expression test for patients with early-stage HER2+ breast cancer. The test integrates clinical information, such as tumor size and nodal status, with biological information, including immune response, luminal differentiation, tumor cell proliferation, and expression of the HER2 17q12-21 chromosomal amplicon, which includes the ERBB2 gene.
The Significance of HER2+ Breast Cancer
HER2+ breast cancer accounts for approximately 20% of all diagnosed breast tumors, representing more than 390,000 new cases worldwide each year. The disease is clinically and biologically heterogeneous, and standard clinical-pathologic assessments may not fully capture this heterogeneity. Understanding this biological diversity is crucial for determining prognosis and predicting the benefit from systemic therapies targeting HER2.
REVEAL GENOMICS' Vision
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 the study are slated for presentation at an upcoming medical congress and submission for publication.
