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Foundation Medicine Announces Initial Data Demonstrating Clinical Utility of FoundationOne® in Advanced Solid Tumors; Clinical Data to Be Presented at 2014 ASCO Annual Meeting

Companies mentioned in this article: Foundation Medicine, Inc.

CAMBRIDGE, Mass. & CHICAGO -- (BUSINESS WIRE) -- Foundation Medicine, Inc. (NASDAQ: FMI) today announced new data demonstrating that the FoundationOne® fully informative genomic profile for solid tumors identified genomic alterations that prompted physicians to change therapeutic decisions for 28 percent of patients tested in a prospective study that is being conducted in partnership with US Oncology. These data will be presented today in a general poster session at the 2014 American Society of Clinical Oncology (ASCO) Annual Meeting, abstract number 111091.

“Cancer treatment has undergone a fundamental change with the introduction of targeted therapeutics. The ongoing development and introduction of these therapies necessitates a robust method for characterizing the genomic alterations in a tumor to allow appropriate treatment selection,” said Fadi Braiteh, M.D., a medical oncologist and clinical researcher at Comprehensive Cancer Centers of Nevada and US Oncology Research. “FoundationOne is the first and only clinical diagnostic assay utilizing next generation sequencing to fully interrogate all classes of genomic alterations in all of the relevant genes driving human cancer, and then to empower physicians with the information to match each patient with targeted therapies and clinical trials relevant to the molecular changes in the patient’s tumor. This approach to uncovering and utilizing molecular information is necessary to realize the power of precision medicine for patients with cancer.”

A total of 132 patients with refractory metastatic advanced solid tumors of many types were evaluated in this prospective, multi-center, single-arm trial. Nearly half of the patients evaluated had tumors of the breast, lung or colon (20 percent, 16 percent and 14 percent, respectively). The results indicated that physicians recommended a switch in therapy in 36 of the 132 patients (27.3 percent) based on the alterations reported by FoundationOne. Therapy switch rates exceeded 20 percent in all three major tumor types. Of the 98 patients ultimately treated, 27 patients (27.5 percent) received a different therapy from their original treatment. This study was begun in 2011, and it is reasonable to believe that as more targeted therapeutics advance to larger trials and are approved, the therapy switch rate will increase.

“These data, taken together with the 16 additional Foundation-related abstracts presented at the ASCO meeting, demonstrate the growing importance of FoundationOne in informing the treatment decision process of an oncologist practicing in the era of precision medicine,” said Gary Palmer, M.D., J.D., M.P.H., senior vice president, medical affairs, of Foundation Medicine. “We expect to observe further impact of fully informative genomic profiling on treatment selection as more targeted treatments are introduced to the market, and we look forward to realizing the ultimate result of improved outcomes in patients with cancer. With more than 500 new targeted therapies in the development pipeline, we are proud to offer an accurate genomic profiling platform that will enable physicians practicing in a community setting to easily and successfully navigate this rapidly changing landscape to deliver better outcomes for their patients.”

About FoundationOne®

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. 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 (@FoundationATCG).

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

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 benefits to patients of next-generation sequencing of their tumors, the utility of FoundationOne in informing patient treatment, clinical data related to FoundationOne including therapy switch rates, and Foundation Medicine's participation in the ASCO annual meeting. 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 risks that Foundation Medicine's products will not be able to identify genomic alterations in the same manner as prior clinical studies; 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 Foundation Medicine's subsequent filings with the Securities and Exchange Commission. 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.

1. Braiteh, F. et al, "Effect of clinical NGS-based cancer genomic profiling on physician treatment decisions in advanced solid tumors." 2014 American Society of Clinical Oncology (ASCO) Annual Meeting, abstract number 11109.


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