Reveal Genomics, S.L. says it has received more validation of HER2DX, the world’s first specialized genomic test for HER2+ breast cancer.
Valentina Guarneri from the University of Padova presented the data at the European Society of Medical Oncology Congress 2022 in Paris, France.
The data obtained from the analysis of tumor samples from the PerELISA phase II clinical trial showed that the HER2DX pCR-score and the HER2DX ERBB2-score predicted the probability of a patient responding to the triple-drug combination of trastuzumab, pertuzumab and letrozole, when given before surgery (i.e., the neoadjuvant setting).
These findings in patients with newly diagnosed HER2+/hormone receptor positive (HER2+/HR+) breast cancer can help identify better who might benefit from dual HER2 blockade with trastuzumab and pertuzumab.
“This is the first study to show the ability of HER2DX to predict response to trastuzumab and pertuzumab in the absence of chemotherapy. The performance of the test in PerELISA is remarkable and supports the predictive value of the test in the neoadjuvant setting,” Guarneri said.
Aleix Prat, CSO of Reveal Genomics, added: “The ability of HER2DX to predict response to trastuzumab-based neoadjuvant therapies has now been demonstrated in more than 590 patients across five studies. Our commitment is to keep providing patients and physicians with the highest level of test evidence to help them make the right treatment decision.”
The PerELISA trial led by Guarneri and Pierfranco Conte, investigators from the University of Padova, evaluated the efficacy of a chemotherapy-free neoadjuvant regimen of trastuzumab and pertuzumab in 64 patients with HER2+/HR+ breast cancer. The results of the trial were published in 2019 in Annals of Oncology.
Patients recruited in PerELISA were first treated with two-weeks of letrozole monotherapy and a tumor biopsy was performed. A relative decrease of Ki67 of more than 20% was observed in 44 (69%) patients; these patients continued in the trial and received trastuzumab, pertuzumab and letrozole for five cycles, after which surgery was performed. The overall response to this non-chemotherapy-based regimen, measured as the rate of pathological complete response (pCR), was observed in approximately 1 out of 5 patients.
Reveal Genomics said results obtained in the new study endorse the value of HER2DX in predicting response to anti-HER2-based treatments before surgery and supports the prospective incorporation of HER2DX in dedicated trials focused on HER2+ breast cancer.
About Reveal Genomics’ HER2DX
Reveal Genomics’ HER2DX is the world’s first diagnostic test formulated specifically for HER2+ breast cancer. It is a standardized 27-gene expression test for patients with early-stage HER2+ breast cancer.
HER2DX is a prognostic and 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.
HER2DX predicts the risk of relapse score, pCR likelihood score and ERBB2 score.
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, three women are diagnosed with HER2+ breast cancer every 4 minutes. HER2+ breast cancer is clinically and biologically heterogeneous, and standard clinical-pathological assessment has proven insufficient in capturing this heterogeneity.