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Treatment for relapsed multiple myeloma patients guided by FoundationOne® Heme results in promising clinical activity

, has announced new data demonstrating that its comprehensive genomic profile, FoundationOne® Heme, identified genomic alterations in patients with heavily pre-treated that informed treatment with trametinib, an FDA-approved targeted therapeutic agent[1]. 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 for whom other have largely been exhausted.

These findings are being presented 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


    [1] Trametinib is approved by the U.S. Food and Drug Administration as a single agent for treatment of BRAF V600E or V600Kmutation-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.

    Source: Foundation Medicine