STUDY LINKS REVEAL GENOMICS ASSAYS HER2DX AND DNADX TO RESPONSE TO TRASTUZUMAB DERUXTECAN IN METASTATIC BREAST CANCER
- HER2DX and DNADX show significant association with real-world clinical outcomes in patients with metastatic breast cancer treated with T-DXd.
- Molecular biomarkers outperform conventional HER2 (IHC) classification, reinforcing the value of multi-omic and liquid biopsy–based precision oncology.
REVEAL GENOMICS, S.L., a Barcelona-based biotechnology start-up seeking to revolutionize precision oncology through biomarker innovation, has announced the publication of new research in npj Precision Oncology demonstrating that its HER2DX and DNADX assays are associated with clinical outcomes to trastuzumab deruxtecan (T-DXd) in metastatic breast cancer.
The study, led by investigators at Dana-Farber Cancer Institute, evaluated tumor tissue and plasma samples from patients with metastatic breast cancer treated with T-DXd to identify biomarkers associated with treatment benefit.
The findings show that higherHER2DX ERBB2 mRNA scores and HER2 amplicon expression were associated with longer treatment benefit and improved survival outcomes in patients receiving T-DXd.
In parallel, DNADX liquid biopsy profiling identified a circulating tumor DNA–based HER2 signature associated with response to T-DXd, highlighting the potential of blood-based molecular profiling as a non-invasive approach to predict therapy response.
Advanced biomarkers to predict response to T-DXd
These molecular biomarkers demonstrated stronger associations with clinical outcomes than conventionalHER2 immunohistochemistry classification, which showed limited predictive value in the study cohort.
The study also demonstrated that dynamic changes in HER2 expression across the course of disease may influence treatment outcomes, highlighting the need for more precise and quantitative methods to evaluate HER2 biology in metastatic breast cancer.
The findings also highlight the broader potential of quantitative HER2 biology in guiding treatment decisions across disease settings. HER2DX is currently used to inform prognosis and treatment decisions in early-stageHER2-positive breast cancer, where antibody–drug conjugates such as trastuzumab deruxtecan are being actively studied and may expand treatment options in the near future.
Overall, the results support the potential of multi-omic and circulating tumor DNA approaches to refine the prediction of treatment response and enable more personalized treatment strategies for patients with metastatic breast cancer.
Toward a new generation of HER2 classification in precision oncology
“Antibody–drug conjugates like trastuzumab deruxtecan have transformed the treatment landscape for metastatic breast cancer, but reliable biomarkers to guide their use remain limited,” said Paolo Tarantino, MD, PhD, medical oncologist, advanced fellow at Dana-FarberCancer Institute and first author of the study. “Our findings suggest that tests,including tissue-based HER2DX and plasma-based DNADX, may help better identify patients most likely to benefit from this therapy.”
“These findings reinforce the importance of moving beyond conventional HER2 classification toward more quantitative and biologically informative biomarkers,” said Joel S. Parker,PhD, Chief Scientific Officer of REVEAL GENOMICS. “HER2DX and DNADX provide complementary insights from tumor tissue and circulating tumor DNA, helping to capture the complexity of tumor biology and potentially improve prediction of response to antibody–drug conjugates such as trastuzumab deruxtecan.”
“This publication highlights the power of collaboration between leading academic investigators and innovative diagnostics companies to advance precision oncology,” said Patricia Villagrasa,Chief Executive Officer and co-founder of REVEAL GENOMICS. “By combining strong clinical research with advanced genomic technologies, we aim to translate cutting-edge science into tools that help physicians make more informed treatment decisions for patients with cancer.”
The article, “Quantitative HER2 tissue and plasmaprofiling predicts the activity of trastuzumab deruxtecan for breast cancer,” is available online in npj Precision Oncology.
