PRESS RELEASE
First clinical impact data of HER2DX® according to two independent studies presented at the SEOM congress
· The first study found that there is great heterogeneity among professionals in the management of early HER2+ breast cancer and 75% of respondents considered HER2DX® to be a reliable tool.
· In the second study, it was observed that the implementation of HER2DX® in clinical practice changed the intention to treat in 60% of cases.
· HER2DX® is the first genomic test in the world specialized in HER2+ breast cancer and has been marketed by REVEAL GENOMICS® since January 2022.
Madrid. October 19, 2022. REVEAL GENOMICS, S.L., a biotech start-up dedicated to revolutionizing precision oncology through innovation in biomarkers, has participated in two studies that have sought to demonstrate the clinical potential of HER2DX®, as well as its usefulness in the therapeutic management of patients with early HER2+ cancer.
The results of these studies were presented during the congress of the Spanish Society of Medical Oncology (SEOM) held from October 18 to 21 in Madrid.
HER2+ breast cancer accounts for 20% of all breast tumors diagnosed, which represents more than 390,000 new cases diagnosed worldwide each year and which means that, on average, 3 women are diagnosed with HER2+ breast cancer every 4 minutes.
HER2+ breast cancer is clinically and biologically heterogeneous, and standard clinicopathologic evaluation has proven insufficient to capture this heterogeneity. Understanding it is key to identifying each patient's prognosis and the benefit of HER2-targeted systemic therapies.
THERAPEUTIC MANAGEMENT OF EARLY HER2+ BREAST CANCER
The first study, entitled “National survey on the management of early HER2+ breast cancer and interest in the HER2DX test”, sought to understand the current therapeutic management of early HER2+ breast cancer throughout the country, as well as to gain first impressions on the clinical utility of HER2DX®.
The study, conducted by Adelphi Targis, collected information from 70 oncologists from 17 autonomous communities who were asked to answer a 20-minute online questionnaire consisting of 37 questions, created ad hoc for this research. The selected oncologists were specialized in breast cancer and had previous experience in the use of genomic tests.
The study observed great heterogeneity in the therapeutic management of early HER2+ breast cancer, both in stage I and stage II-III. For example, in T1a-b tumors, only 13% of oncologists use neoadjuvant treatment always or almost always, while 34% use it sometimes and 53% never. In addition, there was great heterogeneity among oncologists regarding the pharmacological treatment regimen used. In clinical stage II (T2N0), 66% of oncologists use neoadjuvant treatment with trastuzumab, pertuzumab and polychemotherapy while 34% use trastuzumab, pertuzumab and a single chemotherapy agent (paclitaxel). A large proportion of oncologists (69%) commented that they would agree to use 6 months of adjuvant trastuzumab therapy versus 12 months if there were a recommendation from clinical guidelines. Finally, 57% of oncologists believe that there is overtreatment with adjuvant T-DM1.
In this study, 75% of the oncologists interviewed considered HER2DX® as a reliable tool both in predicting the prognostic value and the probability of complete pathologic response, which are two of the three indicators provided by the test. Also, 66% of respondents felt that the test can help today in making treatment decisions in selected patients and 86% felt that a prospective study should be conducted with HER2DX®for certain indications.
Among the potential benefits that HER2DX® can offer to clinical practice are: providing information on neoadjuvant treatment, on treatment selection, reducing the use of chemotherapy or anti-HER2 therapy, or increasing its use in selected more aggressive cases.
Dr. Javier Cortés, Director of the International Breast Cancer Center (IBCC), and first signatory of the study, says “this study demonstrates the need for a tool such as HER2DX® to help oncologists make more precise therapeutic decisions without so much heterogeneity among professionals. In addition, the survey shows the great confidence that already exists with the test, which I believe will be enhanced by the new results that will be presented soon”.
FIRST STUDY ON THE CLINICAL IMPACT OF HER2DX®
During the SEOM congress, the results of the study “Analysis of the impact of the HER2DX® genomic test in HER2-positive breast cancer: first pilot study” were also presented. This is a prospective, single-center study being conducted at Hospital Clínic de Barcelona since November 2021 and which remains open.
The study consisted of capturing the impact of HER2DX® in routine clinical practice. For this purpose, the oncologists of the Breast Unit completed two surveys on intention to treat, one before requesting the test, and the other after receiving the result. The study also collected clinical and pathological variables, as well as response to neoadjuvant treatment.
A total of 67 cases were evaluated. The HER2DX® risk-score was low risk in 49% of cases and high risk in 51% of cases. HER2DX®️ impacted the decision on the type of systemic treatment in 60% of cases (58% de-escalation and 42% escalation). Furthermore, in 44 patients who have already undergone surgery after neoadjuvant treatment, the HER2DX® pCR-score was significantly associated with pathologic complete response (pCR). In this regard, the pCR rates in patients with a high or medium pCR-score was 75% versus 25% in patients with a low pCR-score. Finally, the test increased the oncologist's confidence in his or her final treatment decision in 76% of cases.
Dr. Olga Martínez-Sáez, oncologist at the Breast Unit of the Hospital Clínic de Barcelona and head researcher of the study commented, “This study is the first to demonstrate that HER2DX® can impact the oncologist's decision on the best drug treatment for each patient with newly diagnosed early HER2+ breast cancer. In cases where the therapeutic attitude does not change, the test reinforces the confidence that the chosen treatment is the most appropriate.”
About HER2DX®️
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 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:
· 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 responding 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-pathological assessment has proven insufficient in capturing this heterogeneity. Understanding this biological heterogeneity is key to identifying the prognosis of each patient and the benefit from systemic therapies that target HER2.