FoundationOne® Identifies High Frequency of Clinically Relevant Genomic Alterations (GA) Previously Missed by Conventional Genomic Tests, Enabling Successful Targeted Treatment in Patients with Non-Small Cell Lung Cancer

Foundation Medicine, Inc. (NASDAQ:FMI) today announced that FoundationOne®, the company's flagship comprehensive genomic profile for patients with solid tumors, successfully identified clinically relevant genomic alterations in 65 percent of patients with lung adenocarcinoma whose tumors previously tested negative for alterations using multiple conventional approaches. Overall, these findings support the first-line use of comprehensive genomic profiling to detect the broadest range of genomic alterations in lung adenocarcinomas while preserving tissue. This study, conducted in collaboration with Memorial Sloan Kettering Cancer Center, was published online in Clinical Cancer Research and will appear in an upcoming print edition of the journal in a paper titled, “Broad, hybrid capture-based next-generation sequencing identifies actionable genomic alterations in ‘driver-negative’ lung adenocarcinomas.”

Lung cancer is the leading cancer killer in both men and women in the United States¹. An estimated 159,260 Americans died from lung cancer in 2014, accounting for approximately 27 percent of all cancer deaths². There are two major types of lung cancer: non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC). NSCLC is the most common and accounts for approximately 85 percent of all lung cancer cases³. Adenocarcinoma is the most common subtype of NSCLC.

“Lung cancer has emerged among major cancers as one of the richest in potential therapeutic targets,” said Marc Ladanyi, M.D., Chief, Molecular Diagnostics Service, Memorial Sloan Kettering Cancer Center and co-author of the study. “By using a comprehensive profiling approach such as FoundationOne, one can evaluate and identify targetable lung-cancer driving alterations across the entire cancer genome using a single test, saving precious tissue that can often be exhausted when multiple tests are run, resulting in fewer invasive procedures and saving money at the same time. It is our belief that this type of broad assay should be part of the primary testing algorithm for patients with NSCLC and many other types of solid tumors, which is why we have now implemented a similar test at Memorial Sloan Kettering Cancer Center for our patients.”

In this study, researchers from Foundation Medicine and Memorial Sloan Kettering Cancer Center conducted comprehensive genomic profiling using FoundationOne on 31 patients with lung adenocarcinomas who were never smokers (smoked <100 cigarettes in a lifetime) or light smokers (≤15 pack-years) of cigarettes and who harbored no evidence of a genomic alteration based on extensive prior testing using previously standard testing technologies. Key study findings include:

• A genomic alteration with a corresponding targeted therapeutic based on the National Comprehensive Cancer Network (NCCN) guidelines for NSCLC was identified in 26 percent of patients (n=8)
  • The drivers identified in tumors from these eight patients are as follows: EGFR G719A, BRAF V600E, SOCS5-ALK, CLIP4-ALK, CD74-ROS1, KIF5B-RET (n=2) and CCDC6-RET
  • In these eight patients, mass spectrometry genotyping and break apart FISH testing had not detected these alterations
• Of these eight patients, 75 percent (n=6) went on to receive their targeted therapy, and all six of these patients derived clinical benefit from targeted therapy initiation
• An additional 39 percent of patients (n=12) harbored at least one potentially actionable alteration linked to a targeted therapy approved for an indication other than non-small cell lung cancer or an active clinical trial at MSKCC; to-date, two of these 12 patients have enrolled in a matched clinical trial
• In 84 percent of patients (n=26), ≥ 2 tumor biopsies were required to complete testing
  • Of these patients, 69 percent (n=18/26) underwent multiple biopsies in order to complete conventional testing

“This compelling study demonstrates that FoundationOne uncovered clinically actionable genomic alterations in patients with lung adenocarcinomas, where other testing approaches, including FISH and multiplex mass spectrometry, failed to detect any targetable driver alterations,” said Vincent Miller, M.D., chief medical officer, Foundation Medicine and co-author of the study. “As a result, we were able to identify a targeted therapy or ongoing clinical trial for approximately two-thirds of these patients, several of whom remain on therapy and are progression-free today. In addition, a number of patients previously relegated to salvage cytotoxic chemotherapies have been afforded the opportunity for a molecularly matched clinical trial upon disease progression. We believe these peer-reviewed data further support the opportunity for FoundationOne comprehensive genomic profiling to open up new treatment options for patients with cancer.”

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. 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 http://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 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 ability of FoundationOne to identify clinically relevant genomic alterations, the benefits to patients of comprehensive genomic profiling of their tumors, the utility of FoundationOne in informing treatment of certain patient populations, the ability of FoundationOne to affect the prognosis, treatment or diagnosis of cancer patients, the ability of FoundationOne to predict which patients would benefit from certain commercially available therapies or clinical trials, and clinical data related to FoundationOne. 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 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 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 Centers for Disease Control and Prevention. National Center for Health Statistics. CDC WONDER On-line Database, compiled from Compressed Mortality File 1999-2012 Series 20 No. 2R, 2014.

² American Cancer Society. Cancer Facts and Figures, 2014.

³ U.S. National Institutes of Health. National Cancer Institute: SEER Cancer Statistics Review, 1973-2006.