· HER2DX® risk score was significantly associated with relapse-free interval in patients with clinically low-risk HER2+ breast cancer who took part in both trials.
· Completed APT and ATEMPT studies were essential in establishing new anti-HER2-based treatment strategies for patients with early-stage HER2+ breast cancer.
· HER2DX® is the world’s first diagnostic test formulated specifically for HER2+ breast cancer.
Barcelona, Spain. REVEAL GENOMICS, S.L., a Barcelona-based biotechnology start-up seeking to revolutionize precision oncology through diagnostic innovation, today announced another validation of HER2DX®, the world’s first specialized genomic test for HER2+ breast cancer.
The data was obtained from analysis of diagnostic tumor samples from the completed APT and ATEMPT phase II clinical trials. The APT clinical trial, published in the New England Journal of Medicine in 2015, demonstrated that a de-escalation treatment strategy based on weekly paclitaxel for 3 months and one year of trastuzumab (TH) is highly efficacious for patients with small node-negative HER2+ tumors. The ATEMPT clinical trial, published in the Journal of Clinical Oncology in 2021, demonstrated that 17 cycles of the anti-HER2 antibody drug-conjugate trastuzumab emtansine (T-DM1, Kadcyla, Roche) is highly effective for patients with stage 1 HER2+ breast cancer, and was associated with better quality of life compared to TH.
In both trials, the HER2DX® risk score was found to be significantly associated with relapse-free interval (RFI), allowing patients with an outstanding outcome to be identified. The HER2DX® risk score was found to be associated with RFI when evaluated using pre-established low- and high-risk categories. “The results of HER2DX® in APT and ATEMPT are remarkable, and support the test’s strong prognostic value in early-stage HER2+ breast cancer,” said Sara Tolaney, MD, MPH, Chief of Division of Breast Oncology at Dana-Farber Cancer Institute.
Dr. Aleix Prat, CSO of REVEAL GENOMICS® added “Today’s positive results mean the ability of HER2DX® to predict long-term survival outcome following trastuzumab-based therapy has now been demonstrated in more than 1800 patients across 7 studies. Our commitment is to provide patients and physicians with the highest level of evidence by analyzing tumors from well-designed, practice-changing clinical trials such as APT and ATEMPT”.
Dr. Patricia Villagrasa, CEO of REVEAL GENOMICS® concluded: “The positive results we now see around HER2DX® are a significant step forward for our company. We look forward to continuing to work with healthcare payers and providers to make this test reimbursed and available worldwide.”
Detailed results of this study will be presented at a future 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.
· Risk of relapse score (high vs. low): the risk of recurrence in patients with newly diagnosed HER2+ breast cancer.
· pCR likelihood score (high vs. medium vs. low): the likelihood of a patient to respond to anti-HER2-based treatment before surgery.
· ERBB2 score (high vs. medium vs. low): the quantitative expression of ERBB2 mRNA across HER2-negative, HER2-low and HER2+ breast cancer.
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 that target HER2.
HER2DX®️ is the world’s first specialized genomic test for HER2+ breast cancer. It is a 27-gene plus clinical feature-based classifier that predicts the risk of HER2+ breast cancer recurrence in newly diagnosed patients, and the likelihood that they will respond to anti-HER2 treatment. HER2DX®️ uses smart analytical software to stratify patients into risk groups. The HER2DX®️ algorithm was derived from a dataset of 434 patients and validated in an external dataset of 268 patients. The algorithm has also been validated using data of more than 1000 patients available from public datasets.