REVEAL GENOMICS® Announces Positive Top-line Results for HER2DX® in CLEOPATRA Phase III Trial
September 10 2024 - 8:05AM
Business Wire
- 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).
This press release features multimedia. View
the full release here:
https://www.businesswire.com/news/home/20240910563143/en/
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® ERBB2 score is
significantly associated with patient survival outcomes both in the
first-line setting with THP1 and in later lines with T-DM1
monotherapy2.
For the first time, the 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 in
2012. 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 HER2 standards 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 be presented at an upcoming
medical congress and submitted for publication.
About the HER2DX® test 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, 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.
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-pathologic assessment is not
sufficient to capture this heterogeneity. Understanding this
biological heterogeneity is key to identifying the prognosis of
each patient and the benefit from systemic therapies targeting
HER2.
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 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.
For more information, visit www.reveal-genomics.com or follow us
on X @revealgenomics.
References:
1. Bayona RS, Martínez-Sáez O, Romero DR, et al: 13P HER2DX
ERBB2 mRNA score in first-line metastatic HER2-positive (HER2+)
breast cancer (BC): Implications for treatment stratification. ESMO
Open 9, 2024 2. Brasó-Maristany F, Griguolo G, Chic N, et al:
HER2DX ERBB2 mRNA expression in advanced HER2-positive breast
cancer treated with T-DM1. JNCI: Journal of the National Cancer
Institute 115:332-336, 2022 3. Swain SM, Miles D, Kim S-B, et al:
Pertuzumab, trastuzumab, and docetaxel for HER2-positive metastatic
breast cancer (CLEOPATRA): end-of-study results from a
double-blind, randomised, placebo-controlled, phase 3 study. The
Lancet Oncology 21:519-530, 2020
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240910563143/en/
Adriana Herrera aherrera@reveal-genomics.com