ESMO 2022: REVEAL GENOMICS®️ PRESENTS NEW VALIDATION DATA OF HER2DX®️ IN THE PerELISA TRIAL

• Presented during the ESMO Congress 2022, HER2DX^®️ predicts the response of trastuzumab, pertuzumab and letrozole in patients with HER2+ HR+ breast cancer.
• This is the first study to show the ability of HER2DX^®️ to indicate response to trastuzumab and pertuzumab in the absence of chemotherapy.
• These results endorse the value of HER2DX^®️ in predicting response to anti-HER2-based treatments administered before surgery.

BARCELONA, Spain, Sept. 12, 2022 /PRNewswire/ -- REVEAL GENOMICS, S.L., a Barcelona-based biotechnology start-up seeking to revolutionize precision oncology through biomarker innovation, announced today another validation of HER2DX^®️, the world's first specialized genomic test for HER2+ breast cancer.

Prof. Valentina Guarneri from the University of Padova presented the data at the European Society of Medical Oncology Congress 2022 held in Paris, France. The data obtained from the analysis of tumor samples from the PerELISA phase II clinical trial showed that the HER2DX^®️ pCR-score and the HER2DX^®️ ERBB2-score predicted the probability of a patient responding to the triple-drug combination of trastuzumab, pertuzumab and letrozole, when given before surgery (i.e., the neoadjuvant setting). These findings in patients with newly diagnosed HER2+/hormone receptor positive (HER2+/HR+) breast cancer can help identify better who might benefit from dual HER2 blockade with trastuzumab and pertuzumab.

"This is the first study to show the ability of HER2DX^®️ to predict response to trastuzumab and pertuzumab in the absence of chemotherapy. The performance of the test in PerELISA is remarkable and supports the predictive value of the test in the neoadjuvant setting", said Prof. Guarneri.

Dr. Aleix Prat, CSO of REVEAL GENOMICS^®️, added: "The ability of HER2DX^®️ to predict response to trastuzumab-based neoadjuvant therapies has now been demonstrated in more than 590 patients across 5 studies. Our commitment is to keep providing patients and physicians with the highest level of test evidence to help them make the right treatment decision".

HER2DX^®️ in the PerELISA trial

The PerELISA trial led by Prof. Valentina Guarneri and Prof. Pierfranco Conte, investigators from the University of Padova, evaluated the efficacy of a chemotherapy-free neoadjuvant regimen of trastuzumab and pertuzumab in 64 patients with HER2+/HR+ breast cancer. The results of the trial were published in 2019 in Annals of Oncology.

Patients recruited in PerELISA were first treated with 2-weeks of letrozole monotherapy and a tumor biopsy was performed. A relative decrease of Ki67 of more than 20% was observed in 44 (69%) patients; these patients continued in the trial and received trastuzumab, pertuzumab and letrozole for 5 cycles, after which surgery was performed. The overall response to this non-chemotherapy-based regimen, measured as the rate of pathological complete response (pCR), was observed in approximately 1 out of 5 patients.

HER2DX^®️ was evaluated in pre-treatment baseline tumor samples from 55 patients. HER2DX^®️ pCR score fairly accurately predicted the probability of responding to 2-weeks of letrozole monotherapy (AUC=0.780). In addition, in 40 patients who responded to letrozole and received 5 cycles of trastuzumab, pertuzumab and letrozole, HER2DX^®️ pCR score and HER2DX^®️ ERBB2-score predicted the probability of response with a good level of accuracy (AUC=0.80 and 0.90, respectively). The rates of pCR in HER2DX^®️ pCR-high, -medium and -low groups were 100%, 46% and 8%, respectively. The rates of pCR in HER2DX^®️ ERBB2-high, -medium and -low groups were 53%, 8% and 0%, respectively.

Results obtained in this new study endorse the value of HER2DX^®️ in predicting response to anti-HER2-based treatments before surgery and supports the prospective incorporation of HER2DX^®️ in dedicated trials focused on HER2+ breast cancer.

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 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-pathological assessment has proven insufficient in capturing this heterogeneity. Understanding this biological heterogeneity is key to identifying the prognosis of each patient and the benefit from systemic therapies that target HER2.

About this research collaboration

This study was led by investigators of the Translational Genomics and Targeted Therapeutics (TGTT) group at the Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS, Barcelona, Spain) and the University of Padova (Italy). The HER2DX^®️ Research Use Only (RUO) test was performed at the TGTT laboratory.

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

Further information: Adriana Herrera, aherrera@reveal-genomics.com

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