REVEAL GENOMICS® Announces Positive Top-Line Results For HER2DX® in CLEOPATRA Phase III Trial

• ‍HER2DX^® was evaluated in tumor samples from 214 patients with advanced HER2+ breast cancer treated with docetaxel, trastuzumab, and pertuzumab.
• The ERBB2 mRNA levels determined by HER2DX^®have shown a significant association with progression-free survival(PFS) and overall survival (OS).‍
• HER2DX^®is the world’s first diagnostic test formulated specifically for HER2+ breast cancer.

REVEAL GENOMICS S.L., a biotech start-up seeking to revolutionize precision oncology through diagnostic innovation, today released further evidence supporting HER2DX^®,the world’s first specialized genomic test for HER2+ breast cancer. These results were obtained in collaboration with F.Hoffmann-La Roche Ltd (Basel, Switzerland) after analyzing HER2DX^®in tumor samples from the CLEOPATRA phase III clinical trial (NCT00567190).

Despite the well-established benefit of the standard taxane-trastuzumab-pertuzumab (THP) treatment regimen, the evolving landscape of HER2-positive breast cancer may offer new therapies and combinations in the future. The potential for future therapies underscores the need for precise biomarkers to guide treatment decisions, emphasizing the appropriate anti-HER2 treatment sequence. Previous real-world evidence studies in HER2+ advanced breast cancer have shown that the HER2DX^® ERBB2score is significantly associated with patient survival outcomes both in the first-line setting with THP¹ and in later lines withT-DM1 monotherapy².

For the first time, investigators evaluated the ability of the HER2DX^® ERBB2 mRNA score to predict long-term survival outcomes in 214 patients treated with THP in the pivotal CLEOPATRA phase III trial³. The results showed a strong association of HER2DX^® ERBB2 mRNA score with PFS and OS.

The CLEOPATRA trial had randomized patients with advanced HER2+ breast cancer to first-line docetaxel-trastuzumab+/- pertuzumab (i.e., TH vs. THP) until progression of the disease or unacceptable toxicity³. THP showed superior PFS and OS compared to docetaxel-trastuzumab, leading to the FDA approval of pertuzumab in2012. The median follow-up period for patients at the conclusion of the trial was 99.9 months³.

“The results of HER2DX^® in the CLEOPATRA trial are remarkable and highlight the test's strong value in selecting patients who are more likely to achieve disease control and extended survival outcomes with the existing HER2standards of care", commented Dr. Javier Cortés, Chief of the International Breast Cancer Center (IBCC, Spain) and Co-founder of MEDSIR. He added, “HER2DX^® in this setting will help decide the type of anti-HER2 therapies and their sequence. Patients with a HER2DX^®ERBB2-low score require closer attention, as they may not respond as well and may need alternative therapeutic strategies to improve their outcomes.”

Dr. Patricia Villagrasa, CEO and Co-founder of REVEAL GENOMICS, concluded, "Today’s positive results for HER2DX^® are another significant step forward for our company. We look forward to working with healthcare payers and providers to make this test reimbursed and available worldwide for both early and metastatic settings."

Detailed results of this study will bepresented at an upcoming medical congress and submitted for publication.

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