Roughly 600 tissue samples will be used to estimate whether HERmark is better than available assays.

Monogram Biosciences initiated a study with the Dana-Farber Cancer Institute to evaluate its HERmark™ Breast Cancer Assay in metastatic breast cancer. Approximately 600 tissue samples will be analyzed.

Half the samples will come from patients with breast cancer who were eligible for Herceptin® on the basis of prior HER2 IHC and/or FISH testing. HERmark measurements of HER2 total protein and HER2 homodimer levels will be compared with the results of IHC and/or FISH testing as well as response to treatment with Herceptin.

“Results from prior studies in metastatic breast cancer have suggested that HERmark can identify subsets of patients with different responses to Herceptin even though they had all been previously assessed as HER2-positive by IHC and/or FISH, tested centrally,” points out Michael Bates, M.D., Monogram’s vp of clinical research.

“The aim of this study is to test the hypothesis that HERmark selects patients for Herceptin treatment in the metastatic setting better than other currently available assays as well as to test cutoff values that have been previously defined for HERmark. In addition, we will also measure HER3 expression levels in these tumors and see if they correlate with clinical outcomes in this cohort. The study will also provide enough tissue to facilitate testing of assays that are in advanced development at Monogram, including assays for HER1 expression, p95 expression, as well as heterodimers of HER2 such as HER2:HER3 and HER1:HER2.”

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