Foundation Medicine Announces Its Collaboration with the National Cancer Institute on Exceptional Responders Initiative

First-of-its-kind Exploratory Study Investigates Unique Molecular Indicators of Tumors Associated with Exceptional Treatment Responses to Drug Therapies in Patients With Cancer

CAMBRIDGE, Mass.--()--Foundation Medicine, Inc. (NASDAQ:FMI) today announced that it has entered into a Collaboration Agreement with the National Cancer Institute (NCI) on the Exceptional Responders Initiative (ERI), a nationwide research study to further understand the molecular underpinnings that may lead to exceptional responses to drug therapies in patients with cancer. In this exploratory NCI-led study that includes participation from Baylor College of Medicine, Nationwide Children’s Hospital and Foundation Medicine, tumor samples collected from individuals prior to initiation of the therapy of interest, in addition to pertinent clinical data from each patient, will be obtained from more than 300 patients identified as exceptional responders. The samples will be analyzed to determine whether novel therapeutic vulnerabilities can be identified. The outcomes from the ERI could improve the biologic and genomic understandings of cancer and ultimately lead to the enhancement of existing cancer assays and/or the development of new ones that could inform targeted therapeutic treatments and potentially improve clinical outcomes for a greater number of cancer patients.

‘Exceptional Responders’ are patients who have experienced an unexpected and durable response to a systemic anti-cancer treatment. Specifically, these individuals received a treatment in which fewer than 10 percent of patients had a complete response or a durable partial response (lasting at least 6 months) based on previous clinical trial data or extensive historical experience in the context of the patient’s tumor type. The reasons why some patients experience these unexpected and prolonged responses to therapy following certain treatments are largely unclear and have never been studied systematically. The ERI will seek to identify these patients and understand, through comprehensive genomic profiling, whether molecular alterations or changes in gene expression may explain these exceptional responses.

“At Foundation Medicine, we are focused on understanding the unique molecular changes that contribute to a patient’s individual disease to inform treatment decisions,” said Vincent Miller, M.D., chief medical officer, Foundation Medicine. “The ERI represents a significant opportunity to utilize advances in precision medicine to better understand outcomes, which can be applied to the future selection of treatments for patients with cancer. Every oncologist can point to a small number of their patients who have had unusually favorable responses to systemic therapies. By beginning to leverage this experience, largely rooted in community practice, we hope to learn more quickly and generate critical hypotheses which can then be validated in larger cohorts. We are thrilled to participate with Baylor College of Medicine and Nationwide Children’s Hospital in this important NCI-led initiative, which we believe represents the future of oncology care.”

In this study, tissue and clinical data from exceptional responders will be obtained from several sources, including NCI-supported clinical trials, clinical studies that are actively enrolling at other institutions, and cases submitted by physicians in community centers or other oncology practices. Patients could have been enrolled in early phase clinical trials in which fewer than 10 percent of patients responded or enrolled in later phase clinical trials of single agents or investigational combination therapies, or the individuals could have been treated with an FDA-approved drug for another indication and had an exceptional response to treatment. Once the tissue is collected and processed at the Biospecimen Core Resource at Nationwide Children’s Hospital, it will be analyzed using Foundation Medicine’s FoundationOne® comprehensive genomic profile test for patients with solid tumors and by whole exome and transcriptome RNA sequencing through the Baylor College of Medicine. The resulting molecular characterization and concordance data will be utilized to hypothesize and inform opportunities for broader clinical testing to potentially accelerate development of targeted therapies.

More information about the Exceptional Responders Initiative is available at https://clinicaltrials.gov/ct2/show/NCT02243592 Researchers and physicians who are interested in submitting exceptional responder cases for consideration should contact NCIExceptionalResponders@mail.nih.gov.

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 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 the study outcomes to improve the biologic and genomic understandings of cancer and to enhance or develop cancer assays; the ability of the study to identify exceptional responders to cancer treatment and relevant molecular alterations for such responders; and the impact of such identified molecular alteration on drug development. 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 the exceptional responder patients are not properly identified; 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.

Contacts

Media Contact:
Dan Budwick, Pure Communications, Inc.
973-271-6085
dan@purecommunicationsinc.com
or
Investor Contact:
Susan Hager
617-418-2283
ir@foundationmedicine.com

Release Summary

Foundation Medicine Announces Its Collaboration with the National Cancer Institute on Exceptional Responders’ Initiative

Contacts

Media Contact:
Dan Budwick, Pure Communications, Inc.
973-271-6085
dan@purecommunicationsinc.com
or
Investor Contact:
Susan Hager
617-418-2283
ir@foundationmedicine.com