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BARCELONA, Spain, Dec. 12, 2022 /PRNewswire/ -- REVEAL GENOMICS, S.L., a biotech start-up dedicated to revolutionizing precision oncology through biomarker innovation, has announced positive results from its HER2X® test in various clinical settings , which demonstrates the reliability of the test. These new validation data confirm its suitability for widespread use in clinical practice.
The results of four studies (APT, ATEMPT, DAPHNe and GOM) have been made public during the San Antonio Breast Cancer Symposium (SABCS) held last week from December 6 to 10 in San Antonio, Texas (USA). USA).
“It is a pleasure to share these important new results from HER2DX® at SABCS, which confirm the robust ability of the test to predict long-term survival and response to anti-HER2 treatment. The HER2DX® risk score and pCR score have been validated in more than 1,800 and 800 patients, respectively,” says Dr. Aleix Prat, Co-Founder and CSO of REVEAL GENOMICS®.
“These extraordinary results will undoubtedly be key to achieving our goal of making HER2DX® available worldwide and reaching all HER2 breast cancer patients. We are very excited about what the future holds for us as a company," adds Dr. Patricia Villagrasa-González, co-founder and CEO of REVEAL GENOMICS®.
APT and ATEMPT Studies: Confirmation of the HER2DX® Risk ScoreThe HER2DX® analysis in the APT and ATEMPT studies is the result of an agreement between REVEAL GENOMICS® and the Dana-Farber Cancer Institute (USA), which has used the test to analyze tumor samples from 471 patients with HER2 breast cancer in the early phase of both phase II trials.
The APT clinical trial, published in the New England Journal of Medicine in 2015, demonstrated the high efficacy of a treatment reduction strategy based on weekly administration of paclitaxel for three months and trastuzumab for one year in a large percentage of patients. in stage 1.
The ATEMPT clinical trial, published in the Journal of Clinical Oncology in 2021, demonstrated that 17 cycles of the anti-HER2 conjugate with trastuzumab emtansine chemotherapy (T-DM1, Kadcyla, Roche) is highly useful in a large percentage of stage 1 patients and helps prevent alopecia compared to paclitaxel.
Results presented at SABCS 2022 during a Spotlight Session showed that the HER2DX® risk score was significantly associated with relapse-free interval, despite the small number of cases in both studies. Overall, these results show that HER2DX® can reliably identify patients who are candidates for less intensive systemic treatment than usual.
DAPHNe and GOM Studies: Confirmation of the HER2DX® pCR ScoreThe HER2DX® analysis in the DAPHNe and GOM studies is the result of an agreement between REVEAL GENOMICS®, the Dana-Farber Cancer Institute (USA) and the University Hospital Gregorio Marañón (Spain), who has used the test to analyze tumor samples from 235 patients with early-stage HER2 breast cancer from both trials.
The DAPHNe clinical trial was a phase II, single-arm, prospective academic trial in which patients with previously untreated HER2 stage II-III breast cancer received a reduced neoadjuvant regimen of weekly paclitaxel for 12 cycles along with trastuzumab and pertuzumab (THP) every 3 weeks for 4 cycles. The results of this study have led to the COMPASS-HER2-pCR study, led by ECOG-ACRIN, and which aims to recruit more than 2000 patients.
The GOM study is a prospective observational study, ongoing since 2018, in which consecutive patients recently diagnosed with stage I III HER2 breast cancer who are candidates to receive 6 cycles of docetaxel, carboplatin and trastuzumab (TCH) have been included. or neoadjuvant TCH plus pertuzumab (TCHP) in seven public hospitals in Spain.
Results presented at SABCS 2022 showed that HER2DX® pCR scores were a robust predictor of pCR in both trials, independent of known clinicopathologic variables and intrinsic subtype. In addition, it was observed that the group with elevated HER2DX® pCR probability benefited from the addition of pertuzumab to trastuzumab-based neoadjuvant chemotherapy, unlike the group with low pCR. In particular, the pCR rate for the group of patients who participated in DAPHNe and who had a HER2DX® High Probability pCR result was 93%.
These results show that the HER2DX® pCR score can reliably identify patients who might be ideal candidates for neoadjuvant paclitaxel, trastuzumab, and pertuzumab.
About HER2DX®️ HER2DX®️ is the world's first diagnostic test created 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®️ provides a prognostic and predictive report based on clinical and genomic data. The test integrates clinical information (tumor size and lymph node status) with biological information (immune infiltration, luminal differentiation, tumor cell proliferation, and expression of the HER2 chromosomal amplicon 17q12-21, including the ERBB2 gene).
HER2DX®️ provides:
About REVEAL GENOMICS®️REVEAL GENOMICS, S.L. is a biotechnology start-up that seeks to develop innovative diagnostic tools to define the best therapeutic options for cancer patients. The company uses pioneering techniques, sophisticated computing applications, and machine learning to reveal new cancer research data and develop new biomarkers with clear clinical utility. REVEAL GENOMICS® is a spin-off of Hospital Clínic de Barcelona, IDIBAPS, the University of Barcelona (U.B.) and the Vall d'Hebrón Institute of Oncology (VHIO).
REVEAL GENOMICS® and HER2DX® are registered trademarks of REVEAL GENOMICS, S.L.
Web: www.reveal-genomics.com. Twitter: @revealgenomics
For more information: Adriana Herrera, aherrera@reveal-genomics.com
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