Foundation Medicine Publishes New Data in Nature Medicine Supporting Blood Tumor Mutational Burden (bTMB) as a Novel Predicto...

-- New publication details Foundation Medicine’s assay’s ability to measure bTMB and to identify patients who may benefit from anti-PD-L1 therapy --

Foundation Medicine, today announced the publication of the results of a large study demonstrating that its novel, investigational assay to measure blood tumor mutational burden (bTMB) can help predict response to the anti-PD-L1 immunotherapy, atezolizumab, (TECENTRIQ®) in patients with previously treated non-small cell lung cancer (NSCLC). The study, published in the journal Nature Medicine, was the result of a collaboration between Foundation Medicine and Genentech, a member of the Roche Group, and demonstrates the potential of bTMB to expand precision oncology approaches for patients with advanced cancers, including metastatic lung cancer. In addition, these results show that bTMB may be an independent predictor of clinical benefit, regardless of PD-L1 expression as assessed by immunohistochemistry.

“A significant proportion of patients with advanced lung cancer do not have adequate tissue for traditional biomarker testing. These study results represent an important advance for the liquid biopsy field and suggest that measuring TMB in the blood with our novel assay can help identify patients more likely to benefit from anti-PD-L1 immunotherapy,” said Vincent Miller, M.D., chief medical officer at Foundation Medicine. “We look forward to further developing this assay through ongoing clinical trials and ultimately as a companion diagnostic to help oncologists make the most informed decisions possible, even when a tissue sample is not feasible.”

In the study, clinical data for the novel bTMB assay was reported from a retrospective analysis of more than 1,000 samples from patients with previously treated, advanced NSCLC who participated in Genentech’s Phase II POPLAR and Phase III OAK clinical trials. The study used samples from the POPLAR trial to identify a range of bTMB thresholds that correlated with clinically meaningful outcomes, which were then confirmed using samples from the OAK study. Within the OAK study, patients with bTMB ≥ 16 total mutations (14 mut/Mb) showed significantly improved progression-free survival when treated with atezolizumab as compared to those patients with bTMB ≥ 16 total mutations (14 mut/Mb) treated with docetaxel chemotherapy (Hazard Ratio=0.65 [95% CI: 0.47, 0.92]; p=0.013). According to the study’s first author, David Gandara, M.D. of the UC Davis Comprehensive Cancer Center, “These are exciting times in lung cancer immunotherapy. Having a blood test that can identify those patients most likely to benefit would be a huge advantage for both physicians and patients. This publication is the first step toward what I anticipate will be full clinical application of this assay.”

This bTMB assay is being prospectively evaluated in two Genentech studies: in the Phase III Blood First Assay Screening Trial (BFAST) as a companion diagnostic assay to validate bTMB as a non-invasive biomarker of response to first-line atezolizumab in advanced NSCLC patients, and in the single arm Phase II Blood First-Line Ready Screening Trial (B-F1RST) evaluating atezolizumab monotherapy in first-line NSCLC.

In April 2018, the U.S. Food and Drug Administration (FDA) granted a Breakthrough Device designation for Foundation Medicine’s new liquid biopsy assay, which will expand upon its current liquid biopsy assay to include genomic biomarkers for microsatellite instability (MSI) and bTMB. If approved, this test could be the first FDA-approved liquid biopsy assay to incorporate multiple companion diagnostics (CDx) and multiple biomarkers to inform the use of targeted oncology therapies, including immunotherapies.

About Foundation MedicineFoundation Medicine 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).

Cautionary Note Regarding Forward-Looking Statements for Foundation MedicineThis 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 tissue and blood based TMB to predict response to immunotherapy, including the anti-PD-L1 immunotherapy, atezolizumab; the validation of bTMB as a biomarker in first-line immunotherapy; the benefits of Foundation Medicine’s bTMB assay in the treatment of patients with advanced NSCLC; the development of a bTMB assay as a companion diagnostic assay; the continuation of the Roche/Genentech BFAST and B-FIRST trials and the subsequent reporting of data from these trials; the technical specifications of Foundation Medicine’s new assay; the scope and timing of any approval of the liquid biopsy assay as a medical device by the FDA, including its potential approval and use as a companion diagnostic; and the liquid biopsy assay’s ability to inform the use of targeted oncology therapies, including immunotherapies, or enhance patient access to targeted therapies and clinical trials. 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 utility or that subsequent research renders the results presented less useful or not useful in clinical practice; Foundation Medicine's assays and molecular information platform will not be able to identify genomic alterations or biomarkers in the same manner as prior clinical data; the FDA does not approve Foundation Medicine’s assay as a medical device; the FDA is delayed in the completion of its review process; 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, 2017, 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.

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

TECENTRIQ® (atezolizumab) is a registered trademark of Genentech, a member of the Roche Group.

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Foundation MedicineLee-Ann Murphy, [e-mail]