Presented at the ESMO Gastrointestinal Cancers Congress 2024 in Munich, the study demonstrates significant potential of HER2DX^® in refining patient selection for trastuzumab-based chemotherapy in advanced HER2-positive gastric cancer.

ERBB2 mRNA levels, as determined by HER2DX^®, showed a significant association with progression-free survival (PFS) and overall survival (OS).

REVEAL GENOMICS, S.L., a Barcelona-based biotechnology start-up seeking to revolutionize precision oncology through biomarker innovation, today announced the results of the study “HER2DX ERBB2 mRNA assay Following Trastuzumab-Based Chemotherapy in HER2-Positive Advanced Gastric Cancer” presented at ESMO Gastrointestinal Cancers Congress 2024 in Munich, showing that HER2DX^® genomic test demonstrates significant potential in refining patient selection for trastuzumab-based chemotherapy in HER2-positive advanced gastric cancer.

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HER2+ advanced gastric cancer treatment shows variable response to trastuzumab plus chemotherapy, indicating the need for precise biomarkers. The HER2DX^® is a promising tool for enhancing patient selection by quantifying ERBB2 mRNA expression levels, and classifying tumor samples into different groups: low, medium, and high.

Patricia Villagrasa, REVEAL GENOMICS' CEO, says, “This study marks the first time that HER2DX^® has been applied outside of breast cancer, illustrating its precision and potential across different oncological applications. Our findings underscore the test’s capability to improve patient selection, fundamentally transforming the treatment approach for those battling advanced gastric cancer. This represents a significant milestone in our ongoing commitment to advance personalized medicine.”

Dr. Tamara Saurí, medical oncologist, coordinator of upper- gastrointestinal cancers, and principal investigator of the study at Hospital Clinic of Barcelona, stresses: “Advanced HER2+ gastric cancer treatment shows variable response to trastuzumab plus chemotherapy, indicating the need for precise biomarkers. HER2DX^® not only addresses a crucial unmet need but also explains why HER2-positive gastric cancers often have poorer responses compared to HER2-positive breast cancers. By revealing tumor diversity and expression patterns, the test might guide the development of more effective, personalized treatment strategies. This insight is crucial as we explore novel anti-HER2 therapies alone or in combination, aiming to improve patient outcomes.”

HER2DX^®: beyond breast cancer

The study utilized the HER2DX^® genomic test with a focus on the ERBB2 score to evaluate its association with survival outcomes. The HER2DX^® genomic test was evaluated in 60 patients with HER2+ advanced gastric cancer treated at two hospitals in Spain (Hospital Clinic of Barcelona and Hospital General Granollers).

The study highlighted the test's effectiveness, showing a hazard ratio of 0.38 for PFS, indicating a 62% reduction in the risk of progression for patients with high ERBB2 mRNA levels compared to those with low levels. Additionally, the hazard ratio for OS was 0.53, reflecting a 47% reduction in the risk of death for patients in the high ERBB2 mRNA group compared to the low group.

Comparative Analysis with Breast Cancer

The study also included a comparative analysis of ERBB2 expression between gastric and breast cancers, revealing generally lower levels of ERBB2 in gastric cancer, including within the HER2 +3 immunohistochemical category. This comparison further highlights the nuanced role of ERBB2 across different cancers and the need for better methods to quantify this target.

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 GASTRIC CANCER

According to the article “The current and future incidence and mortality of gastric cancer in 185 countries, 2020−40: A population-based modeling study” published online by eClinicalMedicine in 2022: “In total, approximately 1.1 million new cases and 770,000 deaths of gastric cancer were estimated in 2020. Incidence rates were on average 2-fold higher in males than females (15.8 and 7.0 per 100,000, respectively) with variation across countries. The annual burden of gastric cancer is predicted to increase to approximately 1.8 million new cases and 1.3 million deaths by 2040.”

About REVEAL GENOMICS^®️

REVEAL GENOMICS, S.L. is a biotechnology start-up seeking to change the way biomarkers are used in oncology. It is focused on developing innovative diagnostic tools to define the best therapeutic options for patients with cancer. The company uses pioneering techniques, sophisticated computer applications, and machine learning to reveal new cancer research data.

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

REVEAL GENOMICS^® and HER2DX^® are registered trademarks of REVEAL GENOMICS, S.L.

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

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