Foundation Medicine and its Collaborators Present New Findings Supporting Tissue- and Blood-based Comprehensive Genomic Profiling (CGP) to Inform Targeted and Cancer Immunotherapy Treatment Strategies

--Data to be Presented at the 2018 Annual Meeting of the American Association for Cancer Research--

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Foundation Medicine, Inc. (NASDAQ:FMI) today announced the presentation of new findings at the American Association for Cancer Research (AACR) Annual Meeting. The data supports the use of both tissue- and blood-based comprehensive genomic profiling (CGP) to advance personalized cancer care and inform the use of targeted and immunotherapy treatment approaches. Presentations span several of Foundation Medicine’s suite of molecular information products including its recently FDA approved assay, FoundationOne CDx^™, as well as FoundationOne^®, FoundationACT^® and the company’s novel blood-based assay to measure tumor mutational burden (bTMB).

The AACR Annual Meeting will be held April 14-18, 2018 at McCormick Place in Chicago, Illinois.

“Personalized oncology care is rapidly evolving, underscoring the need for the identification of new biomarkers that may help predict response to treatment and improve access to, and success of, targeted therapeutic trials in oncology,” said Vincent Miller, M.D., chief medical officer at Foundation Medicine. “As such, we are excited to present new data generated from the use of our suite of CGP tests at this year’s AACR meeting that advance both of these goals. These data identify novel genomic biomarkers of response to important new treatment options using either a tissue sample or a blood sample across a diverse range of tumor types, helping to demonstrate the broad impact CGP can have on advancing cancer care.”

In the area of immunotherapy, new data will be presented highlighting the use of Foundation Medicine’s bTMB assay, which is currently being utilized in a global clinical trial setting to investigate bTMB as a non-invasive biomarker of response to first-line atezolizumab in advanced non-small cell lung cancer (NSCLC) patients as part of Roche/Genentech’s prospective, randomized Phase III Blood First Assay Screening Trial (BFAST). Previously this assay was shown to be associated with response to the anti-PD-L1 immunotherapy agent, atezolizumab, in individuals with previously-treated NSCLC. New data to be presented at AACR builds on these findings, showing that: (a) high TMB is significantly associated with improved survival on atezolizumab versus chemotherapy in second-line NSCLC, (b) measurement of high TMB using Foundation Medicine’s assays in blood versus tissue is correlated with, and is largely explained by, shared variants present in both sample types, and (c) a sufficiently-sized assay is required to reliably characterize patients with high TMB.

Additional findings to be presented may help further guide the use of checkpoint inhibitor cancer immunotherapy. For example, one study found that tumor mutational burden (TMB), which has been shown to predict response to immunotherapy in many cancer types, varied between patients of different ancestries, suggesting that the likelihood of benefit from immunotherapy may differ in these patients as well. Another study, performed on the largest sequenced cohort of Merkel cell carcinoma to date, identified TMB-high and TMB-low subsets linked to distinct disease etiologies, providing evidence that TMB and or presence of the etiologic virus may help guide therapy in these patients.

Data generated utilizing the FoundationACT liquid biopsy assay will be presented, which supports its potential utility in predicting clinical outcomes. An oral presentation will highlight a retrospective analysis utilizing FoundationACT, as well as a custom liquid biopsy assay, to measure circulating tumor DNA (ctDNA) from a Phase II study of metastatic triple-negative breast cancer (mTNBC), showing that on-treatment quantitative changes in genomic alterations were associated with clinical outcomes to a targeted therapy/chemotherapy treatment combination.

Clinical validation data for FoundationOne CDx will also be presented, demonstrating high concordance with multiple FDA-approved companion diagnostics, as well as other assays, including another CLIA-validated next generation sequencing assay and other single marker assays, currently used to identify targeted therapies in patients with NSCLC, melanoma, colorectal cancer, ovarian cancer, and breast cancer.

Other studies include those that identify novel biomarkers of targeted therapy treatment response, such as novel PTEN alterations in metastatic triple negative breast cancer (mTNBC), or genomic loss of heterozygosity in non-BRCA positive ovarian cancer patients. Such findings could be used to broaden intent-to-treat populations in clinical trials and identify larger patient populations that may respond to approved treatments.

Following is a list of abstracts that will be presented at the meeting.

Presentation #	Title	Day/Time	Location
Immunotherapy/TMB
PO.EP01.04	Somatic genome alterations in cancer as compared to inferred patient ancestry	April 16; 8:00am-12:00pm	Poster Section 10
CTPL03-CT077 (Oral Presentation)	Nivolumab (nivo) + ipilimumab (ipi) vs platinum-doublet chemotherapy (PT-DC) as first-line (1L) treatment (tx) for advanced non-small cell lung cancer (NSCLC): initial results from CheckMate 227	April 16; 11:35am- 11:55am	N Hall B
CTPL03-CT078 (Oral Presentation)	Tumor mutational burden (TMB) as a biomarker for clinical benefit from dual immune checkpoint blockade with nivolumab (nivo) + ipilimumab (ipi) in first-line (1L) non-small cell lung cancer (NSCLC): identification of TMB cutoff from CheckMate 568	April 16; 12:05pm- 12:25pm	N Hall B
PO.TB11.02	Comprehensive genomic profiling of Merkel cell carcinoma samples reveals bimodal distribution of tumor mutational burden and two mutually exclusive candidate mechanisms of carcinogenesis	April 17; 1:00pm-5:00pm	Poster Section 1
PO.IM02.04	A Blood Based Next Generation Sequencing Assay to Determine Tumor Mutational Burden (bTMB) Is Associated with Benefit to an Anti-PD-L1 Inhibitor, Atezolizumab	April 18; 8:00am-12:00pm	Poster Section 32
Liquid Biopsy & Targeted Therapy
PO.ET04.05	Identification of potential resistance mechanisms to EGFR treatment in the real world using a clinicogenomic database	April 16; 8:00am-12:00pm	Poster Section 36
MS.CL10.02 (Oral Presentation)	On-treatment changes in circulating tumor DNA (ctDNA) level as an early predictor of clinical outcome in the LOTUS randomized phase II trial of first-line ipatasertib (IPAT) plus paclitaxel (PAC) for metastatic triple-negative breast cancer (mTNBC)	April 16; 4:35pm-4:50pm	Room S406
PO.CL10.02	A novel PI3K/Akt-pathway activation biomarker using comprehensive genomic profiling (CGP) for clinical trial assay	April 16; 1:00pm-5:00pm	Poster Section 25
PO.MCB09.03	Novel CDH1 mutations in breast invasive lobular carcinoma	April 16; 1:00pm-5:00pm	Poster Section 16
PO.CL10.06	A validated diagnostic assay for identifying patients with ovarian cancer with high genomic loss of heterozygosity (LOH) without deleterious BRCA mutations	April 17; 1:00pm-5:00pm	Poster Section 24
FoundationOne CDx
PO.MCB09.02	Comparative analysis of clinically validated NGS-based assays reveals high concordance across short variants	April 15; 1:00pm-5:00pm	Poster Section 19
PO.CL01.03	An ERBB2 follow-on companion diagnostic for clinical care of patients with breast cancer	April 16; 8:00am-12:00pm	Poster Section 27
PO.SHP01.01	A clinically-validated comprehensive companion diagnostic platform for care of patients with advanced cancer	April 17; 1:00pm-5:00pm	Poster Section 35

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^®, FoundationOne^®, and FoundationACT^® are registered trademarks and FoundationOne CDx^™ is a trademark 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 and impact of CGP, including FoundationOne, FoundationACT and FoundationOne CDx, and molecular information from CGP, in cancer care, predicting response to treatment, and improving access to and success of targeted trials in oncology; and the ability of tissue and blood based TMB to predict responses to certain types of cancer, including NSCLC. 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 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, 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.