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New Data from FoundationOne(R) Demonstrates Genomic Basis for Potential New Routes to Therapy and Improved Outcomes for Individuals with Cancers of Unknown Primary

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Foundation Medicine, Inc. (NASDAQ:FMI) today announced that new data utilizing FoundationOne(R) was published in the inaugural issue of JAMA Oncology. The peer-reviewed paper, titled “Comprehensive Genomic Profiling of Carcinoma of Unknown Primary Site Reveals New Routes to Targeted Therapies,” presents data from a retrospective study of 200 individuals diagnosed with cancer of unknown primary origin (CUP) in which FoundationOne identified clinically relevant genomic alterations in 85 percent of patients. Importantly, each of those patients harbored at least one genomic alteration that could be matched to approved targeted therapies or to investigational anti-cancer therapies currently in clinical trials, providing physicians with an immediate opportunity to influence therapy decisions and potentially improve outcomes for individuals living with CUP.

Today, CUP represents an area of critically high medical need: there are no FDA-approved therapies, and one- and five-year relative survival rates are estimated at 23 and 10.6 percent1, respectively. Recent evidence suggests that determining the tissue of origin of an unknown primary cancer may be less relevant than delineating the driver of genomic alterations that are fueling disease progression2. Therefore, comprehensive genomic profiling with FoundationOne could potentially offer a new, immediate and vitally important approach to the treatment and care management of individuals with CUP.

“Searching for the primary site of origin in patients with CUP is often a costly, time-consuming and sometimes futile process,” said Jeffrey S. Ross, M.D., Medical Director of Foundation Medicine and Chair of Pathology at Albany Medical Center, and lead author of the paper. “Our findings reveal that by utilizing FoundationOne, a singular comprehensive approach, we were able to uncover an extremely high rate of clinically relevant genomic alterations, while eliminating numerous costly and time-consuming diagnostic analyses. By identifying potential targeted therapeutic options that may be more effective and less toxic than standard therapies, we can bring new hope to individuals with CUP.”

A summary of key findings from the manuscript include:

  • The paper highlights individual cases in which outcomes could be ascertained and where CUP patients were known to have experienced benefit from treatment by targeted therapies that were identified by FoundationOne, including:
    • MET amplification in a patient who presented with new onset seizures. Treatment with crizotinib led to an ongoing complete clinical response currently exceeding two years
    • A patient who achieved a major response to targeted therapy when comprehensive profiling was performed “up-front” and revealed an ALK fusion that responded dramatically to crizotinib
  • Of 200 patients with CUP, 96 percent (192/200) harbored at least one genomic alteration
  • A total of 841 alterations were identified in 121 genes for a mean of 4.2 alterations per patient
  • Importantly, 85 percent of all patients (169/200) were found to have at least one clinically relevant genomic alteration; many of these alterations could be associated with approved anti-cancer drugs such as erlotinib, crizotinib or vemurafenib or with an active clinical study

CUP is the clinical term used when metastatic cancer is found, but the site where the cancer began cannot be determined. More than 30,000 patients in the United States each year, or between two and nine percent of all cancer patients, have a cancer whose primary site is never identified3. There are no drugs specifically approved for CUP, and patients are commonly treated with multi-agent cytotoxic chemotherapy4, a non-targeted approach associated with a modest response rate and a poor five-year survival5. The cost of a complete diagnostic workup for patients with CUP, including multimodality diagnostic imaging procedures, tissue IHC panels, serum tumor marker panels and mRNA profiling, commonly exceeds $10,000. For many of these patients, even after a thorough workup, determining the primary tumor site may be impossible or uninformative, and often treatment guided by knowing only the primary site does not improve outcomes or prognosis.

Foundation Medicine is performing retrospective analyses and planning prospective studies to determine the health economic benefit and clinical outcomes, which result from performing comprehensive genomic profiling with FoundationOne for individuals with CUP.

About FoundationOne(R)

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(R) and FoundationOne(R) 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 Surveillance, Epidemiology, and End Results (SEER) Program (www.seer.cancer.gov). SEER Stat Database: Incidence – SEER 9 Regs Research Data, Nov 2013 Sub (1973-2011).

2 Kandoth C, McLellan MD, Vandin F, Ye K, Niu B, Lu C, Xie M, Zhang Q, McMichael JF, Wyczalkowski MA, Leiserson MD, Miller CA, Welch JS, Walter MJ, Wendl MC, Ley TJ, Wilson RK, Raphael BJ, Ding L. Mutational landscape and significance across 12 major cancer types. Nature. 2013;502:333-9.

3Greco FA, Hainsworth JD: Cancer of unknown primary. In Cancer: Principles and Practice of Oncology.

4 Stella GM, Senetta R, Cassenti A, Ronco M, Cassoni P. Cancers of unknown primary origin: current perspectives and future therapeutic strategies. J Transl Med. 2012;10:12.

5 Varadhachary GR, Raber MN. Cancer of unknown primary site. N Engl J Med. 2014;371:757-765.

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