Foundation Medicine Identifies Patients Likely to Respond to Certain MET Inhibitor Targeted Therapies; Durable Responses in Non-Small Cell Lung Cancer (NSCLC) Presented at ASCO Annual Meeting

Data Support Role of MET Exon 14 Alterations as a Viable Therapeutic Target and Highlight Need for Reimbursement of Comprehensive Genomic Profiling in Leading Cancer Killer

CAMBRIDGE, Mass. & CHICAGO--()--Foundation Medicine, Inc. (NASDAQ:FMI) today announced new data demonstrating the role of MET exon 14 (METex14) alterations as drivers of growth of non-small cell lung cancer (NSCLC), resulting in the identification of a unique subset of patients likely to benefit from certain MET inhibitor targeted therapies. Strikingly, the analysis showed that the METex14 alterations occurred in more than 3% of non-small cell lung cancers and identified NSCLC patients who derived meaningful clinical benefit from treatment with MET targeted therapies.

Identification of this patient population by comprehensive genomic profiling with FoundationOne® is an important step towards making targeted therapy available for a wider range of patients with NSCLC. Further, the addition of METex14 alterations to the growing list of oncogenic drivers in NSCLC supports the need for broad reimbursement coverage of comprehensive genomic profiling to allow a full understanding of the genomic drivers of a patient’s tumor and the matched targeted therapeutic approaches to drive improved outcomes.

“Due to the diversity of METex14 alterations, many of these alterations can only be detected in the clinical setting using comprehensive genomic profiling methods, such as FoundationOne,” said Ignatius Ou, M.D., Ph.D., health science associate clinical professor, University of California, Irvine. “METex14 alterations define a distinct and previously underappreciated molecular subtype of lung adenocarcinoma that does not occur with other known drivers of this type of cancer. By identifying METex14 as an oncogenic driver across multiple tumor types and encouraged by convergent evidence from several groups of associated susceptibility to MET inhibitor targeted therapy, we have identified new therapeutic options for a subpopulation of patients with this most lethal cancer.”

“There is an ever-increasing body of clinical evidence demonstrating that comprehensive genomic profiling is an important and necessary step to stratify patients for appropriate targeted therapy, and by conducting such profiling, to optimize the opportunity for improved outcomes,” said Vincent Miller, M.D., chief medical officer of Foundation Medicine. “These data, in particular, point to the significance of precision medicine. They also amplify the critical importance of identifying patients that heretofore would likely have received cytotoxic agents that deliver only modest therapeutic response. These data support earlier studies showing that patients now have the opportunity to experience significant clinical benefit based on matching the unique genomic drivers of disease with targeted therapies.”

Focal amplification and certain activating, albeit uncommon, point mutations of MET are well-characterized oncogenic drivers that confer susceptibility to targeted MET inhibitors. However, the full diversity and prevalence of recurrent somatic splice site alterations at METex14 that result in exon skipping and MET activation were previously unknown. Researchers from Foundation Medicine undertook an analysis of its molecular information knowledgebase, FoundationCORETM, to determine the frequency of METex14 alterations in advanced cancers. Foundation Medicine analyzed genomic profiles from 38,048 patients who underwent comprehensive genomic profiling with FoundationOne to identify 221 patients with METex14 alterations. These alterations displayed remarkably diverse sequence composition, with 126 different genomic sequence variants represented. METex14 alterations are important recurrent alterations that are clinically and therapeutically relevant and detected most frequently in lung adenocarcinoma (3.0%), but also frequently in other lung neoplasms (2.3%), brain glioma (0.5%) and tumors of unknown primary origin (0.5%). Further in vitro studies demonstrated sensitivity to MET inhibitors in cells harboring METex14 alterations. The diversity of METex14 alterations indicates that testing via a comprehensive genomic profile like FoundationOne is necessary for detection in a clinical setting.

These data were presented today in an oral presentation at the 2015 American Society of Clinical Oncology (ASCO) Annual Meeting titled, “Comprehensive genomic profiling of advanced cancers to identify MET exon 14 alterations that confer sensitivity to MET inhibitors” (abstract #11007), by Dr. Ou.

These data expand on previously published data in Cancer Discovery1.

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 and sarcomas, provide a comprehensive 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 and FoundationCORETM is a trademark 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 ability of FoundationOne to identify specific clinically relevant genomic alterations and targeted therapies for a wider range of patients, the utility of FoundationOne in informing treatment of certain patient populations, the need for broad reimbursement coverage of comprehensive genomic profiling, and clinical data related to FoundationOne and certain genomic alterations. 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 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, 2014, 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. Frampton, G. et al. Activation of MET via diverse exon 14 splicing alterations occurs in multiple tumor types and confers clinical sensitivity to MET inhibitors. Cancer Discovery CD-15-0285; Published Online First May 13, 2015; doi:10.1158/2159-8290.CD-15-0285.

Contacts

Media Contact:
Pure Communications, Inc.
Dan Budwick, 973-271-6085
dan@purecommunicationsinc.com
or
Investor Contact:
Susan Hager, 617-418-2258
ir@foundationmedicine.com
or
Matt Clawson
949-370-8500
matt@purecommunicationsinc.com

Release Summary

Foundation Medicine Identifies Patients Likely to Respond to Certain MET Inhibitor Targeted Therapies; Durable Responses in Non-Small Cell Lung Cancer (NSCLC) Presented at ASCO Annual Meeting

Contacts

Media Contact:
Pure Communications, Inc.
Dan Budwick, 973-271-6085
dan@purecommunicationsinc.com
or
Investor Contact:
Susan Hager, 617-418-2258
ir@foundationmedicine.com
or
Matt Clawson
949-370-8500
matt@purecommunicationsinc.com