[December 09, 2014]

FoundationOne® Identifies Clinically Relevant Genomic Alterations in Patients with Advanced Breast Cancers

Foundation Medicine, Inc. (NASDAQ:FMI) today announced new data further demonstrating the clinical utility of FoundationOne® across several types of breast cancer, including metastatic and inflammatory breast cancer. Collectively, these studies support the use of comprehensive genomic profiling to identify distinct genomic alterations that may further tailor treatment options and result in improved outcomes for patients with breast cancer. These data are being presented by Foundation Medicine and its collaborators during the 2014 San Antonio Breast Cancer Symposium.

Breast cancer is the most common type of cancer among women in the United States, excluding cancers of the skin. The American Cancer Society estimates that approximately 233,000 women will be diagnosed with breast cancer in 2014, accounting for approximately 29 percent of all newly diagnosed cancers. The risk of breast cancer increases with age, and inherited genomic alterations or a family history also predispose patients to this malignancy.

FoundationOne, the company's flagship clinical test for patients with solid tumors, is a comprehensive genomic profile that identifies the genomic alterations in a patient's unique cancer and matches them with relevant targeted therapies and clinical trials. The test also contributes to a large and growing database of molecular information that can be leveraged to gain new insights into the biology and treatment of breast cancer and other solid tumors.

"Breast cancer is increasingly considered to be not one disease, but a group of diseases distinguished by different molecular subtypes, risk factors, clinical behaviors and responses to treatment," said Vincent Miller, M.D., chief medical officer, Foundation Medicine. "As such, we believe there is high value in utilizing a comprehensive genomic profiling approach in order to inform potential treatment options that may improve outcomes for breast cancer patients. We are pleased to share these data from real-world, clinical settings that further support the value and actionability of FoundationOne in this important patient population."

Key Poster Data:

• "Incidence of actionable genomic alterations in metastatic breast cancer: A prospective study" (P2-03-03), assesses the feasibility and impact of FoundationOne genomic profiling among patients with advanced breast cancer. In this prospective, ongoing single-arm trial conducted at The Ohio State University Comprehensive Cancer Center, 40 patients were tested with FoundationOne. Across the 37 cases reported to date, a total of 192 genomic alterations were detected, with a median of five alterations per patient. Among all patients who received a report, 97% were matched with at least one potential FDA-approved treatment or clinical trial. Specifically, investigators matched 65% of patients (n=24) with an FDA-approved breast cancer therapy. The report also matched 24 patients (65%) with an FDA-approved therapy for an indication other than breast cancer based on their specific genomic alteration. Nearly all patients were suggested at least one potential clinical trial. These findings demonstrate that FoundationOne was successful in dentifying clinically relevant genomic alterations in the majority of women with advanced breast cancer who participated in the trial.
• "Activating mutations in ERBB2/HER2 as found by FoundationOne® represent potential therapeutic targets in breast cancer" (P4-15-03), describes the use of FoundationOne in 7,300 patients with solid tumors, including a large number of breast cancer patients, to determine how many of these patients could benefit from HER2-targeted therapy due to activating mutations in ERBB2, and how widespread these alterations are across the solid tumor spectrum. Comprehensive genomic profiling using FoundationOne, as compared to conventional diagnostic testing which uses IHC or FISH to detect only ERBB2 amplifications, resulted in the identification of 25% more breast cancers that may be amenable to HER2 targeted therapy due to the presence of activating mutations in ERBB2. Known oncogenic ERBB2 alterations were identified in approximately 6% of all solid tumors across 27 different histologies. Of all the ERBB2 alterations, activating mutations in ERBB2 were identified in 131 samples and amplifications were observed in 246 samples. These data highlight the potential clinical implications of comprehensive genomic profiling to test for both activating ERBB2 mutations and amplifications, and suggest that the current approach of testing only breast and gastric tumors for HER2 amplifications is potentially limiting the application of ERBB2/HER2 targeted therapeutics.
• "Genomic profiling by FoundationOne® analysis of inflammatory breast cancer cases reveals a high frequency of clinically relevant genomic alterations (GA)" (P6-14-02), demonstrates the potential clinical impact of comprehensive genomic profiling on patients with inflammatory breast cancer (IBC), a rare and aggressive form of breast cancer with limited treatment options and which is commonly associated with a particularly poor prognosis. In 55 patients with IBC whose tumors were analyzed using FoundationOne, a total of 274 genomic alterations were detected with an average of five alterations per tumor. Among these patients, 96% (n=53) had at least one alteration that suggested a potential responsiveness to therapies that are FDA approved or being studied in clinical trials. Of these, two patients were directed to targeted therapy that led to positive clinical outcomes after FoundationOne uncovered their unique and unanticipated alterations. These data support the use of FoundationOne to identify potential new treatment options in patients with metastatic IBC.

FoundationOne, the company's first clinical product, is a fully informative genomic profile for solid tumors used by oncologists to identify the molecular alterations in a patient's tumor and match those alterations with relevant targeted therapies and clinical trials. Using next-generation sequencing in routine cancer specimens, FoundationOne interrogates all genes somatically altered in human cancers that are validated targets for therapy or unambiguous drivers of oncogenesis based on current knowledge. It reveals all classes of genomic alterations including base substitutions, insertions, deletions, copy number alterations and select rearrangements. FoundationOne fits easily into the clinical workflow of the ordering physician, and test results are provided in an easy-to-interpret report supported by a comprehensive review of published literature. FoundationOne is a laboratory-developed test performed at Foundation Medicine's CLIA-certified lab. The test is accredited by CAP, is approved by the New York State Department of Health and has received a CE Mark. Please visit www.FoundationOne.com for more information.

About Foundation Medicine

Foundation Medicine (NASDAQ:FMI) is a molecular information company dedicated to a transformation in cancer care in which treatment is informed by a deep understanding of the genomic changes that contribute to each patient's unique cancer. The company's clinical assays, FoundationOne for solid tumors and FoundationOne Heme for hematologic malignancies, sarcomas and pediatric cancers, provide a fully informative genomic profile to identify the molecular alterations in a patient's cancer and match them with relevant targeted therapies and clinical trials. Foundation Medicine's molecular information platform aims to improve day-to-day care for patients by serving the needs of clinicians, academic researchers and drug developers to help advance the science of molecular medicine in cancer. For more information, please visit www.FoundationMedicine.com or follow Foundation Medicine on Twitter (News - Alert) (@FoundationATCG).

Foundation Medicine^® and FoundationOne^® are registered trademarks of Foundation Medicine, Inc.

Cautionary Note Regarding Forward-Looking Statements for Foundation Medicine

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 clinical utility of FoundationOne, including for patients with breast cancer; the ability of FoundationOne or comprehensive genomic profiling to identify genomic alterations that inform treatment options or result in improved outcomes for cancer patients; and the ability of FoundationOne to predict which patients would benefit from certain targeted therapies or new treatment options. 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 FoundationOne 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 Foundation Medicine's Annual Report on Form 10-K for the year ended December 31, 2013, which is on file with the Securities and Exchange Commission, as well as other risks detailed in subsequent filings with the Securities and Exchange Commission, may be realized. All information in this press release is as of the date of the release, and Foundation Medicine undertakes no duty to update this information unless required by law.

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