REVEAL GENOMICS® HER2DX® Genomic Test to Be Validated in Pivotal ECOG-ACRIN CompassHER2 pCR Trial in HER2+ Breast Cancer
2024年5月14日 - 9:05PM
ビジネスワイヤ(英語)
- The CompassHER2 pCR Trial protocol has been amended to
include the evaluation of the HER2DX® genomic test as a key
secondary endpoint.
- HER2DX® pCR-score and HER2DX® risk-score will be analyzed in
baseline pre-treatment samples from trial participants, linking
these scores directly to patient outcomes.
- The inclusion of HER2DX® in the CompassHER2 pCR Trial seeks
to corroborate initial findings to provide Level 1 evidence in
supporting the selection of an optimized therapy regimen.
- The CompassHER2 pCR Trial places the ECOG-ACRIN Cancer
Research Group at the forefront of assessing an optimized therapy
regimen with reduced chemotherapy across nearly 2200 patients with
HER2-positive breast cancer.
REVEAL GENOMICS, S.L., a Barcelona-based biotechnology start-up
seeking to revolutionize precision oncology through biomarker
innovation, today announced the forthcoming prospective validation
of its groundbreaking diagnostic tool HER2DX® within the framework
of the ongoing CompassHER2 pCR Trial. This study is led by the
ECOG-ACRIN Cancer Research Group (ECOG-ACRIN), a scientific
organization that designs and conducts cancer research involving
adults who have or are at risk of developing cancer, comprising
nearly 1400 member institutions in the United States and around the
world.
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The CompassHER2 pCR Trial (also EA1181) is a single-arm phase II
neoadjuvant study that successfully enrolled 2175 patients with
stage II or IIIa HER2-positive (HER2+) breast cancer. Now in
follow-up, this trial seeks to determine if it is safe to omit
adjuvant chemotherapy after surgery for patients with a pathologic
complete response (pCR) after 3 months of pre-operative treatment
with standard THP (single-agent taxane chemotherapy plus
trastuzumab and pertuzumab [HP], both targeted drugs). If testing
shows pCR at the time of surgery, patients will then complete a
year of HP plus hormonal therapy and radiation, if indicated.
If the study's results validate this approach, it would allow
patients to have fewer side effects and better quality of life. The
neoadjuvant setting offers the opportunity to use pCR as a
functional biomarker to identify patients with excellent outcomes
and refine treatment to maximize benefit and minimize toxicity. The
primary objective of the trial is 3-year recurrence-free survival,
and pCR is a secondary endpoint.
In this collaboration, the CompassHER2 pCR Trial protocol has
been amended to include the evaluation of the HER2DX® genomic test
as a key secondary correlative endpoint. HER2DX® pCR-score and
HER2DX® risk-score will be analyzed in baseline pre-treatment
samples from most trial participants, linking these scores directly
to patient outcomes.
The principal investigator of the CompassHER2 pCR Trial, Dr.
Nadine M. Tung, commented, "Integrating HER2DX®'s predictive
capabilities into our trial represents a significant opportunity in
our quest to tailor treatments to the individual, not just the
cancer type. If proven and validated, this assay could
fundamentally change our approach to treating HER2-positive breast
cancer."
Previous retrospective validation involving 765 patients with
early-stage HER2+ breast cancer who received neoadjuvant therapy
highlighted the HER2DX® pCR-score's ability to distinguish patients
with a high pCR rate of 80-90% after treatment with single taxane,
trastuzumab, and pertuzumab.
REVEAL GENOMICS' CEO, Patricia Villagrasa, added, "The inclusion
of HER2DX® in the CompassHER2 pCR Trial is a testament to our
commitment to advancing breast cancer treatment. By providing a
more nuanced understanding of HER2-positive cancers, HER2DX® will
play a crucial role in shaping the future of personalized therapy
and improving patient outcomes."
HER2DX® in the CompassHER2 pCR Trial: Guiding the way to
personalized medicine
The inclusion of HER2DX® in the CompassHER2 pCR Trial seeks to
corroborate these initial findings, providing Level 1 evidence to
support the selection of an optimized therapy regimen.
Specifically, it seeks to validate the use of a single taxane-based
regimen over traditional multi-agent chemotherapy, potentially
revolutionizing the treatment approach for HER2-positive breast
cancer by enabling more personalized, less intensive treatment
strategies.
This pivotal collaboration represents a significant step towards
personalized medicine in the management of early-stage
HER2-positive 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, 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.
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 ECOG-ACRIN
ECOG-ACRIN is renowned for advancing precision medicine and
biomarker research through its leadership of major clinical trials
that integrate cutting-edge genomic approaches. Through the
CompassHER2 (COMprehensive use of Pathologic response ASSessment to
escalate or de-escalate therapy in HER2-positive breast cancer)
Trial Program, ECOG-ACRIN is collaborating with the Alliance for
Clinical Trials in Oncology to investigate the optimization of
therapy in patients with HER2+ breast cancer. The CompassHER2 pCR
Trial (NCT04266249) was the first to open in this program, funded
by the National Cancer Institute, part of the US National
Institutes of Health.
Web: www.ecog-acrin.org, X: @eaonc. Other:
Facebook, LinkedIn, and Instagram.
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, University of Barcelona (U.B.), and Vall
d’Hebron Institute of Oncology (VHIO).
REVEAL GENOMICS® and HER2DX® are registered trademarks of REVEAL
GENOMICS, S.L.
Web: www.reveal-genomics.com. X:
@revealgenomics
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Further information: Adriana Herrera,
aherrera@reveal-genomics.com