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REVEAL GENOMICS® Reports Positive Top-line Results for HER2DX® in Phase III CLEOPATRA Trial

NextEdge Admin

11 Sep 2024

2 min 8 sec

REVEAL GENOMICS S.L., a biotech start-up pioneering precision oncology, has unveiled new evidence supporting HER2DX®, the world’s first genomic test specifically designed for HER2-positive breast cancer. In collaboration with F. Hoffmann-La Roche Ltd, the study analyzed tumor samples from the CLEOPATRA phase III trial (NCT00567190), highlighting HER2DX®'s potential to enhance treatment decisions in this evolving landscape.

While the standard taxane-trastuzumab-pertuzumab (THP) regimen has shown significant benefits, the future of HER2-positive breast cancer treatment may introduce new therapies and combinations. The need for accurate biomarkers like HER2DX® becomes crucial in guiding anti-HER2 treatment sequences. Previous real-world studies have linked the HER2DX® ERBB2 score to improved survival in HER2+ advanced breast cancer.

For the first time, the HER2DX® ERBB2 mRNA score was evaluated in 214 patients treated with THP in the CLEOPATRA trial, demonstrating a strong correlation with progression-free survival (PFS) and overall survival (OS). The trial had previously established THP as superior to docetaxel-trastuzumab, leading to the 2012 FDA approval of pertuzumab.

Dr. Javier Cortés, Chief of the International Breast Cancer Center (IBCC), emphasized the test’s value in predicting patient outcomes, while REVEAL GENOMICS CEO, Dr. Patricia Villagrasa, noted, "These results are a significant step forward, bringing us closer to making HER2DX® available worldwide."

Full study details will be presented at an upcoming medical congress.