New Data from Foundation Medicine and Collaborators Supports Use of Comprehensive Genomic Profiling to Inform Therapeutic Choices in Advanced Breast Cancer
Genomic Information Revealed by FoundationOne® Leads to 41% Physician-Directed Change in Therapeutic Treatment Selection
Biomarkers of Immune Checkpoint Inhibitors Identify Opportunity for Clinical Response to Immunotherapies
- Molecular information elucidated from FoundationOne led physicians to change their recommended course of therapy for 41 percent of patient cases;
- 77 percent of patients profiled with FoundationOne harbored an alteration matched to an
FDA -approved therapy; - 98 percent of patients with advanced breast cancer had genomic alterations that matched therapeutics being studied in clinical trials; and
- 20 percent of advanced breast cancers possess high tumor mutational burden, suggesting a potential role for FoundationOne as a predictive biomarker for immune checkpoint inhibition.
"It's no longer sufficient to classify or treat breast cancer as a single disease, and we must continue to acknowledge and understand its vast, complex genomic variability in order to provide individuals with every opportunity for improved outcomes," said
Key Data Highlights:
The poster "Decision impact analysis of comprehensive genomic profiling (CGP) in advanced breast cancer: A prospective study," presented by
- Comprehensive genomic profiling noted the existence of an
FDA approved drug for 77 of 83 patients, with everolimus (n=72), temsirolimus (n=70), ponatinib (n=23) and pazopanib (n=20) being the most frequently selected by physicians - At least one clinical trial was identified for 98 percent of patients
- A change in therapy was recommended by the treating physician for 34 of 83 patients (41 percent), and of these, 17 patients (50 percent) pursued the suggested treatment
A second poster "Biomarkers of Immune Checkpoint Inhibitor Response in Metastatic Breast Cancer: PD-L1 Protein Expression, PD-L1 Gene Amplification and Total Mutational Burden," presented by Jeffrey S. Ross, M.D., medical director,
Key findings include:
- PD-L1 protein expression in infiltrating immunocytes was found to be a significant favorable prognostic factor, which significantly correlated with increased overall survival whereas lack of PD-L1 staining in both tumor cells and immunocytes was a significant adverse prognostic factor associated with decreased patient survival
- PD-L1 gene amplification was identified in only 57 of 6,751 (0.1 percent) metastatic breast cancer tumor samples, correlating with the potential for response to immune checkpoint inhibitors
- High tumor mutational burden was found in 1,351 of 6,643 (20 percent) metastatic breast cancer cases underscoring the potential for further studies measuring tumor mutational burden with FoundationOne to identify breast cancer patients as candidates for immunotherapy
Breast cancer is the most common type of cancer among women in
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Foundation Medicine® and FoundationOne® are registered trademarks of
Cautionary Note Regarding Forward-Looking Statements
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the ability of comprehensive genomic profiling, including FoundationOne, to identify genomic alterations, approved therapies or therapies in clinical trials; the ability of FoundationOne to inform therapeutic choices in advanced breast cancers, including leading to physician-directed therapy changes and to improve patient outcomes; the relevance of comprehensive genomic profiling in oncology clinical care; and the ability of certain identified criteria in predicting potential response to certain therapies. All such forward-looking statements are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include the risk that the results presented are found to lack scientific, medical or clinical utility or that subsequent research renders the results presented less useful or not useful in clinical practice; Foundation Medicine's services and molecular information platform will not be able to identify genomic alterations in the same manner as prior clinical data; and the risks described under the caption "Risk Factors" in
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