HER2DX® Genomic Test to Be Validated in ECOG-ACRIN CompassHER2 pCR Trial in HER2+ Breast Cancer

REVEAL GENOMICS, S.L., a biotechnology start-up based in Barcelona, has announced the prospective validation of its diagnostic tool HER2DX® within the ongoing CompassHER2 pCR Trial. The trial, led by the ECOG-ACRIN Cancer Research Group, aims to revolutionize precision oncology through innovative biomarker research. ECOG-ACRIN is a renowned scientific organization that designs and conducts cancer research involving adults, collaborating with nearly 1400 member institutions globally.

The CompassHER2 pCR Trial, also known as EA1181, is a single-arm phase II neoadjuvant study involving 2175 patients with stage II or IIIa HER2-positive breast cancer. Currently in the follow-up phase, this trial aims to evaluate the safety of omitting adjuvant chemotherapy after surgery for patients who achieve a pathologic complete response (pCR) following three months of pre-operative treatment with a standard regimen of single-agent taxane chemotherapy plus trastuzumab and pertuzumab (HP). If pCR is confirmed at the time of surgery, patients will continue with a year of HP combined with hormonal therapy and radiation if necessary.

The potential validation of this approach could significantly improve patients' quality of life by reducing side effects. The neoadjuvant setting allows pCR to be used as a functional biomarker, identifying patients who achieve excellent outcomes and refining treatment strategies to maximize benefits while minimizing toxicity. The primary objective of the trial is to achieve three-year recurrence-free survival, with pCR serving as a secondary endpoint.

A key amendment to the CompassHER2 pCR Trial protocol includes the evaluation of the HER2DX® genomic test as a secondary correlative endpoint. HER2DX® pCR-score and HER2DX® risk-score will be analyzed in baseline pre-treatment samples from most participants, directly linking these scores to patient outcomes.

Dr. Nadine M. Tung, the principal investigator of the CompassHER2 pCR Trial, emphasized the significance of integrating HER2DX®'s predictive capabilities into the trial, viewing it as a crucial step towards tailoring treatments to individual patients rather than just the cancer type. If proven and validated, this assay could fundamentally change the approach to treating HER2-positive breast cancer.

Previous retrospective validation involving 765 patients with early-stage HER2-positive breast cancer who underwent neoadjuvant therapy has shown the HER2DX® pCR-score's ability to differentiate patients with a high pCR rate of 80-90% after treatment with single taxane chemotherapy, trastuzumab, and pertuzumab.

Patricia Villagrasa, CEO of REVEAL GENOMICS, highlighted the inclusion of HER2DX® in the CompassHER2 pCR Trial as a testament to the company's commitment to advancing breast cancer treatment. By offering a more nuanced understanding of HER2-positive cancers, HER2DX® is expected to play a pivotal role in shaping the future of personalized therapy and improving patient outcomes.

HER2DX® aims to validate the use of a single taxane-based regimen over traditional multi-agent chemotherapy, potentially transforming the treatment approach for HER2-positive breast cancer by facilitating more personalized and less intensive treatment strategies. This collaboration marks a significant step towards personalized medicine in managing early-stage HER2-positive breast cancer.

HER2DX® is the world's first diagnostic test specifically formulated for HER2-positive breast cancer. Marketed since January 2022 by REVEAL GENOMICS, it is a standardized 27-gene expression test designed for patients with early-stage HER2-positive breast cancer. HER2DX® combines clinical information with biological data, predicting the risk of relapse, the likelihood of achieving pCR, and the quantitative expression of ERBB2 mRNA across different types of breast cancer.

ECOG-ACRIN is known for advancing precision medicine and biomarker research through major clinical trials that incorporate cutting-edge genomic approaches. The CompassHER2 Trial Program, a collaboration with the Alliance for Clinical Trials in Oncology, investigates the optimization of therapy in patients with HER2-positive breast cancer. The CompassHER2 pCR Trial is the first trial in this program funded by the National Cancer Institute, part of the US National Institutes of Health.

REVEAL GENOMICS, S.L. is dedicated to changing the way biomarkers are used in oncology, utilizing pioneering techniques and machine learning to uncover new cancer research data. It is a spin-off company of Hospital Clínic of Barcelona, IDIBAPS, University of Barcelona, and Vall d’Hebron Institute of Oncology.