CAMBRIDGE, Mass.--(BUSINESS WIRE)--

Foundation Medicine, Inc. (NASDAQ:FMI) today announced that new data generated with FoundationOne^®Heme, its comprehensive genomic profiling (CGP) assay for hematologic malignancies and sarcomas, will be presented at the American Society of Hematology (ASH) Annual Meeting. Data from a broad range of blood cancers, including acute myeloid leukemia (AML), myeloproliferative neoplasms (MPN), and non-Hodgkin lymphoma (NHL), including primary central nervous system lymphoma (PCL), demonstrate the value of integrating FoundationOneHeme into clinical care. The data presented is expected to demonstrate the potential for CGP to improve disease classification, to offer personalized prognostic information and to support therapeutic treatment decision making by informing treating physicians about the use of novel treatment options, including cancer immunotherapies.

“Comprehensive genomic profiling (CGP) is proving to be an essential component for personalized cancer care, particularly as we learn more about the diverse genomic alterations in blood cancers,” said Vincent Miller, M.D., chief medical officer at Foundation Medicine. “FoundationOneHeme is at the forefront of helping to identify new treatment approaches, including cancer immunotherapy, for individuals with blood cancers. Our new findings to be presented at ASH support the ability of CGP to address high unmet medical needs across a wide range of hematologic malignancies, including rare conditions for which there are few treatment options.”

Cancer immunotherapy is emerging as a therapeutic tool for patients with diverse hematologic malignancies. New results to be presented at ASH using FoundationOneHeme show that more than one-quarter of patients with PCL had high tumor mutational burden (TMB), a genomic biomarker that has been shown across several cancer types to predict response to immuno-oncology treatment strategies, such as checkpoint inhibitors. Less than 50 percent of PCL patients achieve complete remission with current standard of care treatments, underscoring a need for new treatment options for these patients.

New results also support the role of FoundationOneHeme to guide therapy selection and predict response to treatment. In an oral study to be presented, FoundationOneHeme detected NTRK fusions in a wide variety of hematologic malignancies, and clinical response to a TRK inhibitor was subsequently observed in a patient with refractory AML and an ETV6-NTRK2 fusion. In another study to be presented, CGP offered insights that may facilitate risk-adapted clinical management decisions in patients with intermediate-and favorable-risk AML, potentially informing optimal use of autologous stem cell transplantation (auto-SCT) over conventional consolidation chemotherapy. For example, the study showed the presence of PTPN11 mutations to predict long term clinical outcomes following an auto-SCT.

Other results to be presented at ASH demonstrate the ability of FoundationOneHeme to detect both known and novel BCL6 rearrangements in NHL, including cases that previously tested negative with standard-of-care single marker testing. BCL6 rearrangements have known diagnostic and prognostic utility in specific subtypes of NHL.

Foundation Medicine and collaborators will present a total of nine studies, including four oral presentations and five poster presentations, at the ASH Annual Meeting from December 9-12, 2017 in Atlanta. The planned presentations are as follows:

Dec 9:

• 115 – Unrecognized clonal hematopoiesis of indeterminate potential in solid tumors: Implications for interpretation of molecular testing, Dec 9, 9:30am, C208-210 (Oral Presentation)
• 1423 – The role of comprehensive mutational profiling in predicting patients who may benefit from autologous hematopoietic cell transplant for acute myeloid leukemia, Dec 9, 5:30pm-7:30pm, Hall A2 (Poster Presentation)
• 1657 – A distinct mutation profile might contribute to the dismal outcome of triple negative patients with primary myelofibrosis, Dec 9, 5:30pm-7:30pm, Hall A2 (Poster Presentation)

Dec 10:

• 417 – Comprehensive genomic profiling identifies novel BCL6 rearrangements in diverse subtypes of Non-Hodgkin lymphoma as well as known rearrangements not detected using standard of care assays, Dec 10, 12:30pm, Marcus Auditorium (Oral Presentation)
• 476 – Comprehensive genomic profiling identifies genomic alterations that define Philadelphia-like B-acute lymphoblastic leukemia, Dec 10, 4:45pm, B213-B214 (Oral Presentation)

Dec 11:

• 794 – Characterization of NTRK fusions and therapeutic response to NTRK inhibition in hematologic malignancies, Dec 11, 4:45pm, B207-208 (Oral Presentation)
• 3800 – Recurrent copy number variants are highly prevalent in acute myeloid leukemia, Dec 11, 6:00pm-8:00pm, Hall A2 (Poster Presentation)
• 3996 – Comprehensive genomic profiling demonstrates differences in primary CNS lymphoma and systemic diffuse large B cell lymphoma and reveals biomarkers indicating potential benefit from immune checkpoint inhibitors, Dec 11, 6:00pm-8:00pm, Hall A2 (Poster Presentation)
• 4016 – Next generation sequencing of Castleman disease and follicular dendritic cell sarcomas associated with Castleman disease, Dec 11, 6:00pm-8:00pm, Hall A2 (Poster Presentation)

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 offers a full suite of comprehensive genomic profiling assays to identify the molecular alterations in a patient's cancer and match them with relevant targeted therapies, immunotherapies 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^®Heme 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 value of comprehensive genomic profiling utilizing FoundationOneHeme for informing clinical care, guiding the use of targeted therapy or immunotherapy, advancing personalized medicine, and addressing unmet medical needs across a wide range of hematologic malignancies; and the ability of FoundationOneHeme to predict treatment response and detect 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 risk that the results presented are found to lack scientific, medical or clinical merit or utility; that subsequent research renders the results presented less useful or not useful in clinical practice; Foundation Medicine's services and molecular information platform is notable 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, 2016, 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.

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