REVEAL GENOMICS® REVEALS POSITIVE TOP-LINE OUTCOMES FOR HER2DX® IN MEDSIR’S PHERGAIN TRIAL

• HER2DX^® pCR-score was substantially related to pathological total reaction in clients with HER2+ breast cancer treated with trastuzumab and pertuzumab, with or without chemotherapy.

• HER2DX^® risk-score recognized 85% of clients with an intrusive illness occasion as high-risk, and 98% of clients recognized as HER2DX^® low-risk were disease-free at last follow-up.

• HER2DX^® is the world’s very first diagnostic test developed particularly for HER2+ breast cancer.

  

BARCELONA, Spain, June 15, 2023 /PRNewswire/ — REVEAL GENOMICS, S.L., a Barcelona-based biotech start-up looking for to reinvent accuracy oncology through diagnostic development, today revealed another recognition of HER2DX^®, the world’s very first specialized genomic test for HER2+ breast cancer. The outcomes were obtained from analysis of HER2DX^® in growth samples from the PHERGAIN stage II medical trial, led by MEDSIR (Spain). Last year, REVEAL GENOMICS^® and MEDSIR announced a strategic partnership.

MEDSIR´s PHERGAIN trial, the very first outcomes of which were released in the Lancet Oncology in 2021 and just recently revealed at ASCO Congress, randomized 356 clients with freshly detected HER2+ breast cancer to neoadjuvant systemic treatment with 6 cycles of multi-agent chemotherapy, trastuzumab, and pertuzumab (i.e., arm A) or 2 cycles of chemotherapy-free double HER2 blockade with trastuzumab and pertuzumab (i.e., arm B). After 2 cycles of treatment in arm B, clients went through a ¹⁸F-FDG-PET. If a metabolic reaction was observed, clients continued treatment with 6 extra cycles of chemotherapy-free double HER2 blockade (i.e., an overall of 8 cycles). If no metabolic reaction was observed by ¹⁸F-FDG-PET, clients received 6 cycles of multi-agent chemotherapy, trastuzumab, and pertuzumab. The co-primary endpoints were pathological total reaction (pCR) rate after surgical treatment following 8 cycles of chemotherapy-free double HER2 blockade, and 3-year intrusive disease-free survival (iDFS) of clients in arm B.

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HER2DX^® genomic test was used in 292 (82.0%) standard pre-treatment growth biopsies. The HER2DX^® pCR-score was discovered to be substantially related to pCR, despite the treatment program, ¹⁸F-FDG-PET metabolic reaction, and hormonal agent receptor status. Despite a brief average follow-up of 3.6 years, 85.0% and 100.0% of occasions were recognized as high-risk according to the 2 pre-specified cutoffs of the HER2DX^® risk-score. In contrast, 98% and 100% of clients with HER2DX^® low-risk were disease-free at last follow-up, according to the 2 pre-specified cutoffs of the HER2DX^® risk-score.

“The outcomes of HER2DX^® in PHERGAIN are amazing and support the strong predictive and prognostic worth of the test in clients with early-stage HER2+ breast cancer. The test will help to pick which clients may be treated with trastuzumab and pertuzumab without chemotherapy, a treatment technique with much better lifestyle than multi-agent chemotherapy,” commented Dr. Antonio Llombart, Principal Investigator of the PHERGAIN trial, Co-creator 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-creator of MEDSIR, included, “Today’s positive outcomes validate the capability of the HER2DX^® ratings to anticipate pCR and survival result following various anti-HER2-based treatments, consisting of chemotherapy-free routines. The test has comprehensive medical recognition throughout lots of research studies and clients, and, in my viewpoint, ought to be advised and consisted of in medical standards“.

Dr. Patricia Villagrasa, CEO and Co-creator of REVEAL GENOMICS^® concluded, “Today’s positive outcomes for HER2DX^® are a considerable advance for our business. We eagerly anticipate continuing to deal with health care payers and companies to make this test repaid and available around the world.“

Detailed outcomes of this research study will exist at a future medical congress and sent for publication.

About the HER2DX^® test
HER2DX^® is the world’s very first diagnostic test developed particularly for HER2+ breast cancer. Marketed by REVEAL GENOMICS^® considering that January 2022, the HER2DX^® is a standardized 27-gene expression test for clients with early-stage HER2+ breast cancer.

HER2DX^®️ is a prognostic, predictive assay based upon medical and genomic information. The test incorporates medical info (i.e., growth size and nodal status) with biological info tracking immune reaction, luminal distinction, growth cell expansion, and expression of the HER2 17q12-21 chromosomal amplicon, consisting of the ERBB2 gene.

HER2DX^® forecasts:

• Risk of regression rating (high vs. low): the threat of reoccurrence in clients with freshly detected HER2+ breast cancer.

• pCR probability rating (high vs. medium vs. low): the probability of a client to react to anti-HER2-based treatment prior to surgical treatment.

• ERBB2 rating (high vs. medium vs. low): the quantitative expression of ERBB2 mRNA throughout HER2-negative, HER2-low and HER2+ breast cancer.

About HER2+ breast cancer
HER2+ breast cancer represent 20% of all detected breast growths. This represents more than 390,000 brand-new cases detected around the world every year, implying that, usually, 3 ladies are detected with HER2+ breast cancer every 4 minutes. HER2+ breast cancer is medically, and biologically heterogeneous, and basic clinical-pathologic evaluation is not enough to catch this heterogeneity. Understanding this biological heterogeneity is crucial to determining the diagnosis of each client and the take advantage of systemic treatments that target HER2.

About MEDSIR
Founded in 2012, MEDSIR works carefully with its partners to drive development in oncology research study. Based in Spain and the United States, the business handles all elements of medical trials, from research study style to publication, making use of a worldwide network of professionals and incorporated innovation to improve the procedure. The business provides proof-of-concept assistance and a tactical method that assists research study partners experience the very best of both worlds from industry-based medical research study and investigator-driven trials. To promote independent cancer research study worldwide, MEDSIR has a tactical alliance with Oncoclínicas, the leading oncology group in Brazil with the best research study capacity in South America. Learn how MEDSIR brings concepts to life: www.medsir.org

About REVEAL GENOMICS^®️
REVEAL GENOMICS, S.L. is a biotechnology start-up looking for to alter the method biomarkers are utilized in oncology. It is concentrated on establishing ingenious diagnostic tools to specify the very best healing alternatives for clients with cancer. The business utilizes pioneering strategies, advanced computer system applications, and artificial intelligence to reveal brand-new cancer research study information.

REVEAL GENOMICS, S.L. is a spin-off of Hospital Clínic of Barcelona, IDIBAPS, University of Barcelona (UB), and Vall d’Hebron Institute of Oncology (VHIO).

REVEAL GENOMICS^® and HER2DX^® are signed up hallmarks of REVEAL GENOMICS, S.L.

Web: www.reveal-genomics.com. Twitter: @revealgenomics

Further info: Adriana Herrera, [email protected]

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SOURCE REVEAL GENOMICS, S.L.