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HERmark(TM) Assay Results in Metastatic Breast Cancer Presented at the San Antonio Breast Cancer Symposium
Date:12/14/2007

utcomes.

Study details: Those patients with higher HER2 expression levels (i.e. in the upper half of the distribution for the study cohort) experienced a 59% objective response rate while those with lower levels of HER2 expression (i.e. in the lower half of the distribution) had a response rate of only 18%. Additional analyses revealed that patients with higher HER2 expression values had a median time-to-progression of 12.8 months while those in the lower half of the distribution had a median time-to-progression of only 4 months. This result was statistically significant (p = 0.01). Finally, multivariate Cox proportional hazards models identified HER2 expression (HR = 0.16, p < 0.001) and HER2:HER2 dimer levels (HR = 0.32, p < 0.001) as measured by HERmark as being statistically significant predictors of time-to-progression.

"Current testing technologies do not provide an accurate or precise view of HER2 biology in breast cancer, classifying patients as either HER2 'positive' or HER2 'negative'," continued Young. "At best, conventional technologies provide a semi-quantitative analysis. However, only about half of metastatic patients selected by current technologies for Herceptin treatment respond to the drug. Data are now emerging to suggest that patients who could benefit from Herceptin may be missed by currently used assays. Our HERmark studies have provided data which consistently indicate that HERmark can precisely measure HER2 expression and HER2:HER2 dimer levels in clinical FFPE samples, and that those patients with higher levels of expression have significantly better clinical outcomes than those with lower levels. These data strongly suggest that HERmark can identify patients who are likely to respond to Herceptin better than the assays currently in use."

HERmark Assay in Metastatic Breast Cancer

At ASCO in June 2007, Monogram reported results of studies of HERmark in two patient cohorts. In the first of these studies, it was dem
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SOURCE Monogram Biosciences, Inc.
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