On June 15, 2023 REVEAL GENOMICS, S.L., a Barcelona-based biotech start-up seeking to revolutionize precision oncology through diagnostic innovation, reported another validation of HER2DX, the world’s first specialized genomic test for HER2+ breast cancer (Press release, REVEAL GENOMICS, JUN 15, 2023, View Source [SID1234632762]). The results were obtained from analysis of HER2DX in tumor samples from the PHERGAIN phase II clinical trial, led by MEDSIR (Spain). Last year, REVEAL GENOMICS and MEDSIR announced a strategic partnership.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

MEDSIR´s PHERGAIN trial, the first results of which were published in the Lancet Oncology in 2021 and recently announced at ASCO (Free ASCO Whitepaper) Congress, randomized 356 patients with newly diagnosed HER2+ breast cancer to neoadjuvant systemic therapy with 6 cycles of multi-agent chemotherapy, trastuzumab, and pertuzumab (i.e., arm A) or 2 cycles of chemotherapy-free dual HER2 blockade with trastuzumab and pertuzumab (i.e., arm B). After 2 cycles of treatment in arm B, patients underwent a 18F-FDG-PET. If a metabolic response was observed, patients continued treatment with 6 additional cycles of chemotherapy-free dual HER2 blockade (i.e., a total of 8 cycles). If no metabolic response was observed by 18F-FDG-PET, patients received 6 cycles of multi-agent chemotherapy, trastuzumab, and pertuzumab. The co-primary endpoints were pathological complete response (pCR) rate after surgery following 8 cycles of chemotherapy-free dual HER2 blockade, and 3-year invasive disease-free survival (iDFS) of patients in arm B.

HER2DX genomic test was applied in 292 (82.0%) baseline pre-treatment tumor biopsies. The HER2DX pCR-score was found to be significantly associated with pCR, regardless of the treatment regime, 18F-FDG-PET metabolic response, and hormone receptor status. Despite a short median follow-up of 3.6 years, 85.0% and 100.0% of events were identified as high-risk according to the 2 pre-specified cutoffs of the HER2DX risk-score. In contrast, 98% and 100% of patients with HER2DX low-risk were disease-free at last follow-up, according to the 2 pre-specified cutoffs of the HER2DX risk-score.

"The results of HER2DX in PHERGAIN are remarkable and support the strong predictive and prognostic value of the test in patients with early-stage HER2+ breast cancer. The test will help to select which patients might be treated with trastuzumab and pertuzumab without chemotherapy, a treatment strategy with better quality of life than multi-agent chemotherapy," commented Dr. Antonio Llombart, Principal Investigator of the PHERGAIN trial, Co-founder of MEDSIR, and Head of the Medical Oncology Department at Hospital Arnau de Vilanova (Valencia, Spain).

Dr. Javier Cortés, Chief of the International Breast Cancer Center (IBCC, Spain) and Co-founder of MEDSIR, added, "Today’s positive results confirm the ability of the HER2DX scores to predict pCR and survival outcome following different anti-HER2-based treatments, including chemotherapy-free regimes. The test has extensive clinical validation across many studies and patients, and, in my opinion, should be recommended and included in clinical guidelines".

Dr. Patricia Villagrasa, CEO and Co-founder of REVEAL GENOMICS concluded, "Today’s positive results for 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.

HER2DX️ 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.

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 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.