CAMBRIDGE, Mass. & SAN FRANCISCO--(BUSINESS WIRE)--Foundation Medicine, Inc. (NASDAQ:FMI) today announced new data demonstrating that its comprehensive genomic profile, FoundationOne® Heme, identified genomic alterations in patients with heavily pre-treated multiple myeloma that informed treatment with trametinib, an FDA-approved targeted therapeutic agent1. Notably, 68% of total patients who underwent treatment based on results provided by FoundationOne Heme experienced clinical benefit, supporting the clinical utility of this test in patients with refractory or relapsed multiple myeloma for whom other treatment options have largely been exhausted.
These findings are being presented today in a poster titled Targeted MEK Inhibition in Patients With Previously Treated Multiple Myeloma (abstract number 4775) by Christoph J. Heuck, M.D., Assistant Professor of Medicine, University of Arkansas for Medical Sciences (UAMS) Myeloma Institute, at the American Society of Hematology Annual Meeting in San Francisco.
“Despite diagnostic and therapeutic advances for patients with multiple myeloma, finding effective treatment options for patients who progress after initial therapies remains a key challenge,” said Gareth J. Morgan, M.D., Ph.D., Professor of Medicine and Pathology, Director of the Myeloma Institute at the University of Arkansas for Medical Sciences. “FoundationOne Heme helped us more accurately predict which patients with refractory and relapsed multiple myeloma would benefit from a commercially available, FDA-approved therapy targeting their unique oncogenic alterations. As a result, the majority of patients treated with trametinib experienced stabilization of their disease or disease regression, and we were thrilled to see a complete response in three patients. These data support the application of personalized treatment strategies and an individualized approach to the management of high-risk multiple myeloma patients.”
FoundationOne Heme is a comprehensive genomic profile that analyzes DNA in 405 genes and RNA in 265 genes that are most commonly altered in hematologic malignancies and sarcomas. The test was commercially launched in 2013, and is designed to provide physicians with clinically actionable information to guide treatment options for patients based on the genomic profile of their cancer.
“We are encouraged by these data demonstrating the clinical utility of our test in a heavily pretreated patient population,” said Vincent Miller, M.D., chief medical officer, Foundation Medicine. “These patients had exhausted all or nearly all therapeutic options for their disease, and would not have been identified as candidates for trametinib treatment using conventional diagnostics. These compelling results support the clinical utility of FoundationOne Heme in this advanced disease setting and underscore the importance of a personalized approach to cancer treatment.”
Key Study Findings:
-
51 patients who underwent comprehensive genomic profiling using the
FoundationOne or FoundationOne Heme assays were identified as likely
responders to the targeted agent trametinib based on the
identification of activating mutations in KRAS, NRAS or BRAF. An
additional seven patients were also treated with trametinib based on a
gene expression signature suggesting activation of the MAPK pathway
- The patient cohort represented a population of heavily pretreated patients (median 5 lines of prior therapy) with a high frequency of high-risk features (35% GEP defined high risk disease; adverse cytogenetic features in 61%)
- 21 of 58 patients received trametinib monotherapy only
- 26 of 58 patients began treatment with trametinib monotherapy and had other agents added during the course of therapy
- 11 of 58 patients were given trametinib in combination with other agents from the time of initiation of therapy
-
68% of all patients treated with trametinib therapy experienced
clinical benefit (n=43). Of these:
- 14 of 40 patients with measurable myeloma protein at the start of therapy experienced a reduction of their measurable myeloma protein by ≥60%
- 9 of 24 patients with PET positive disease experienced a complete resolution of FDG avid focal lesions
- 3 patients experienced a durable complete response
About FoundationOne® Heme
FoundationOne Heme is a fully informative genomic profile for hematologic cancers (leukemia, lymphoma and myeloma) and sarcomas, 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, 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® and FoundationOne® are registered trademarks of Foundation Medicine, Inc.
About the University of Arkansas for Medical Sciences Myeloma Institute
The Myeloma Institute at the University of Arkansas for Medical Sciences, an international leader in multiple myeloma treatment and research, has pioneered novel diagnostic procedures and therapeutic interventions, resulting in significantly improved patient outcomes. More than 11,000 patients from every state in the United States and more than 50 countries have come to the Myeloma Institute for treatment.
The University of Arkansas for Medical Sciences is Arkansas’ only comprehensive academic health center, with colleges of Medicine, Nursing, Pharmacy, Health Professions and Public Health; a graduate school; a hospital; a northwest Arkansas regional campus; a statewide network of regional centers; and seven institutes: the Winthrop P. Rockefeller Cancer Institute, the Jackson T. Stephens Spine & Neurosciences Institute, the Myeloma Institute, the Harvey & Bernice Jones Eye Institute, the Psychiatric Research Institute, the Donald W. Reynolds Institute on Aging and the Translational Research Institute.
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 clinical utility of FoundationOne Heme, including for heavily pretreated patient populations; the ability of FoundationOne Heme to accurately predict which patients would benefit from certain commercially available therapies; and the benefits of a personalized approach to cancer treatment. 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 FoundationOne Heme 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 subsequent filings with the Securities and Exchange Commission, may be realized. 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 Trametinib is approved by the U.S. Food and Drug Administration as a single agent for treatment of BRAF V600E or V600K mutation-positive unresectable or metastatic melanoma, as well as in combination with dabrafenib to treat patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation.
