Comprehensive Genomic Profiling May Lead To New Therapeutic Options For Patients; Data Presented at American Society of Hematology Annual Meeting

Cambridge, MA (Press Release) - Foundation Medicine today announced new data from a pilot study demonstrating that its fully informative genomic profile for hema­to­logic malig­nan­cies, FoundationOne™ Heme, identified both novel and pre­vi­ously reported clin­i­cally actionable¹ genomic alterations in multiple myeloma cases. These data were presented in an oral presentation titled Pilot Study To Evaluate The Prevalence Of Actionable Oncogenic Mutations In Patients With Relapsed Refractory Multiple Myeloma (abstract number 755) by Alexander Lesokhin, M.D., medical oncologist, Memorial Sloan-Kettering Cancer Center, at the 55th American Society of Hematology Annual Meeting in New Orleans.

“Advances in clin­i­cal next-generation sequencing have made it possible to rapidly identify genomic alterations that may be driving a patient’s cancer and could inform treat­ment options leading to ad­vances in clin­i­cal devel­op­ment of new targeted ther­a­pies in multiple myeloma patients.”

“Multiple myeloma is a treatable, but ultimately incurable, blood cancer that eventually becomes resistant to all cur­rently avail­able ther­a­pies,” said Dr. Lesokhin. “Advances in clin­i­cal next-generation sequencing have made it possible to rapidly identify genomic alterations that may be driving a patient’s cancer and could inform treat­ment options leading to ad­vances in clin­i­cal devel­op­ment of new targeted ther­a­pies in multiple myeloma patients.”

In this study, researchers at Memorial Sloan-Kettering used FoundationOne Heme to analyze whole bone marrow aspirate samples from 28 newly diag­nosed and 27 heavily pre-treated multiple myeloma patients. High coverage and high quality sequence data was obtained in 98% (54/55) of cases, and alteration prev­a­lence was examined in 63% of (35/55) samples with sufficient plasma cell content. In the analysis:

• A high frequency of alterations in the MAPK pathway was observed, including mutually exclusive alterations in NRAS and KRAS in 48% of cases, and BRAF V600E alteration in 3% of cases.
• Fourteen percent of cases had TET2 frameshift/nonsense alterations or IDH2 alterations, suggesting the DNA hydroxymethylation pathway is targeted by recurrent somatic alterations in multiple myeloma.
• Alterations in epigenetic modifiers were identified in 41% of cases, including alterations in TET2/IDH, chromatin modifying enzymes/scaffolds (ARID1A, ASXL1) and DNA methyltransferases (DNMT3A).
• Novel alterations in DNA repair pathways (ATM, FANCA, FANCD2) and in FAT3 were identified, suggesting there are novel disease alleles which require functional investigation for their role in multiple myeloma pathogenesis.

“These data sup­port the clin­i­cal utility of FoundationOne Heme and the benefit of our com­pre­hen­sive genomic profiling ap­proach in identifying oncogenic drivers in multiple myeloma,” said Vincent Miller, M.D., chief medical officer, Foundation Medicine. “MEK/RAF inhibition has dem­onstrated clin­i­cal efficacy in a range of cancers and there are emerging data that epigenetic and targeted ther­a­pies may provide benefit in patients with TET2/IDH mutations. Therefore, these results dem­onstrate that FoundationOne Heme can identify clin­i­cally actionable alterations that may sup­port the clin­i­cal devel­op­ment of new treat­ment options and ad­vance precision medicine for multiple myeloma patients.”

About FoundationOne™ Heme

FoundationOne Heme is a fully informative genomic profile for hema­to­logic cancers (leukemia, lym­phoma and myeloma), as well as many sarcomas and pediatric cancers, designed to provide physicians with clin­i­cally actionable in­for­ma­tion to guide treat­ment options for patients based on the genomic profile of their cancer. It is Foundation Medicine’s second commercially avail­able targeted sequencing assay and was developed in col­lab­o­ration with Memorial Sloan-Kettering Cancer Center. Using next-generation sequencing in routine cancer specimens, FoundationOne Heme interrogates all genes somatically altered in these cancers that are val­i­dated targets for ther­apy or unambiguous drivers of oncogenesis based on current knowledge. The test employs RNA sequencing in addi­tion to DNA sequencing to simultaneously detect all classes of genomic alterations, in­­clud­ing base pair substitutions, insertions and deletions, copy number alterations and rearrangements, and gene fusions (a type of alteration that is a common driver of hema­to­logic malig­nan­cies. sarcomas and pediatric cancers). FoundationOne Heme 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 Heme is a laboratory-developed test per­formed at Foundation Medicine’s CLIA-certified lab. 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, FoundationOneTM for solid tumors and FoundationOneTM Heme for hema­to­logic malig­nan­cies, each provide a fully informative genomic profile to identify a patient’s individual molecular alterations 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 www.FoundationMedicine.com or follow Foundation Medicine on Twitter (@FoundationATCG).

Foundation Medicine® is a registered trademark, and FoundationOneTM is a trademark, of Foundation Medicine, Inc.

Cautionary Notes 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 benefits to patients with hema­to­logic cancers of next-generation sequencing, the ability of FoundationOne™ Heme to identify actionable alterations relevant to hema­to­logic cancers, the feasibility and utility of FoundationOne Heme for use in routine clin­i­cal practice, and the release of data from a clin­i­cal study demonstrating the value FoundationOne Heme FoundationOne Heme in the treat­ment of hema­to­logic cancers. All such forward-looking state­ments are based on 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 FoundationOne Heme may not meet the clin­i­cal standards ex­pec­ted for the test; FoundationOne Heme may not be suitable for use in routine clin­i­cal practice; FoundationOne Heme may not have value in the treat­ment hema­to­logic cancers; and FoundationOne Heme may not be readily avail­able for clin­i­cal use as a result of FoundationOne Heme not achieving sig­nif­i­cant commercial adoption or reim­burse­ment sup­port or Foundation Medicine not achieving profitability, competing suc­cess­fully, managing its growth, devel­op­ing its molecular in­for­ma­tion plat­form, or not addressing other risks described under the caption "Risk Factors" in Foundation Medicine's Form 10-Q, 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. Alterations are defined as clin­i­cally actionable if linked to an FDA approved targeted ther­apy in the tumor under study or to another tumor type, or to an open clin­i­cal trial targeting a relevant path­way.

Source: Foundation Medicine.