Monogram Presents Three Studies at The 45th ASCO Meeting Describing HERmark’s® Ability to Select Trastuzumab Responders &...
02 Giugno 2009 - 1:30PM
Business Wire
Monogram Biosciences, Inc. (Nasdaq:MGRM) today announced results
from three separate studies at the American Society for Clinical
Oncology (ASCO) meeting in Orlando on the use of HERmark� and the
VeraTag� technology to identify distinct sub-populations of patient
with HER-positive disease. Monogram�s unique measures of HER family
protein levels resulted in improved correlations with the response
to trastuzumab and with the histopathologic characteristics of
breast cancer, as compared to conventional tests.
�Even when tumors are defined as �HER2-positive�, clinical
responses to HER2-target therapies are varied, but it hasn�t been
clear what accounts for the observed differences in outcome,� said
Michael Bates, M.D. Monogram Vice President of Clinical Research.
�Taken together, our studies demonstrate the promise of the VeraTag
technology to further differentiate those tumors likely to respond
to HER2-targeted therapies and aid in the development of
personalized treatment strategies for patients with breast
cancer.�
The three studies presented at ASCO are:
Quantitative measure of HER3 total protein (H3T) and
association with clinical outcomes in HER2 positive metastatic
breast cancer patients treated with trastuzumab (abstract
#1021):
Study results showed for the first time that adding a
quantitative measure of HER3 protein level results in improved
stratification of outcomes in patients treated with trastuzumab.
Researchers analyzed 81 formalin-fixed tissue embedded tumor
samples and sub-divided the patients into HER2 normal and
HER2-overexpressing subgroups. The median time to progression (TTP)
in the HER2 normal group was 4.1 months whereas the HER2
overexpression patient group has a TTP of 11.1 months (p=0.0002).
In this HER2 overexpressing group, high HER3 expression predicted
shorter median TTP (6.1 months) compared with low HER3 expression
where the median TTP was 13.1 months (p=0.002). The presentation
also described enhancements to the performance of the HER3 total
protein measure by increasing the sensitivity of the test down to
1,000 receptors per cell and the dynamic range of the assay by 30
fold.
Identification of a sub-population of metastatic breast
cancer patients with very high HER2 expression levels and possible
resistance to trastuzumab (abstract #1059):
Recent findings demonstrate that a precise and quantitative
measure of HER2 protein levels allows for the identification of
multiple sub-populations of HER2 positive patients that exhibit
different clinical outcomes on trastuzumab. Using the HERmark
breast cancer assay, a quantitative measure of HER2 total protein
expression was assessed in primary breast tumor specimens from 99
women treated with trastuzumab for their metastatic disease who
were also tested for HER2 by FISH. Using sub-population treatment
effect pattern plot (STEPP) analysis, a progression free survival
(PFS) rate was generated at 12 months after treatment with
trastuzumab. Kaplan Meier analyses demonstrated that patients
testing HER2 positive with FISH but with very high HER2 protein
levels had a PFS that was no better than patients who tested HER2
negative with FISH and had low HER2 protein levels (median PFS of
4.6 months vs. 4.5 months; Hazard ratio = 0.87; p=0.68). In
contrast, patients who were FISH positive with intermediate levels
of HER2 total protein expression by HERmark had a significantly
longer PFS than patients who were FISH negative with low HER2 total
protein levels (median PFS 12.6 months vs. 4.5 months; Hazard ratio
= 0.34; p
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