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TMCNet:  Foundation Medicine and Its Collaborators to Present New Data at ASCO 2017 Supporting the Integration of Comprehensive Genomic Profiling (CGP) in Personalized Clinical Care in Oncology

[May 18, 2017]

Foundation Medicine and Its Collaborators to Present New Data at ASCO 2017 Supporting the Integration of Comprehensive Genomic Profiling (CGP) in Personalized Clinical Care in Oncology

Foundation Medicine, Inc. (NASDAQ:FMI) today announced that data from its suite of comprehensive genomic profiling (CGP) assays, including FoundationOne®, FoundationACT® liquid biopsy, FoundationOne® Heme, and FoundationFocus CDxBRCA will be presented during the American Society of Clinical Oncology (ASCO) Annual Meeting from June 2-6, 2017 in Chicago. The company and its collaborators will present a total of 33 studies at the meeting, including two oral presentations, eight poster discussions and twenty-three posters, ranging across 15 different tumor types. Data demonstrate the impact of tissue- and blood-based CGP on guiding targeted therapy, immunotherapy, or clinical trial decisions in advanced cancers. In addition, the clinical value of CGP as evidenced through real world evidence and outcomes research (HEOR) studies, as well as data highlighting the ability of CGP to accelerate clinical trial enrollment will be presented.

"Together these studies highlight the importance of our CGP approach in advancing precision medicine in cancer care and build upon the growing body of evidence supporting its use in clinical practice," said Vincent Miller, M.D., chief medical officer at Foundation Medicine. "Previous findings from Foundation Medicine have shown that measuring tumor mutational burden (TMB) with FoundationOne can predict responses to FDA-approved anti-PD-1/anti-PD-L1 immunotherapies across multiple tumor types. New results will be presented at this year's ASCO which help describe the landscape of TMB in triple-negative breast cancer, ovarian cancer, metastatic melanoma, biliary tract cancer and cancer of unknown primary, pointing to potentially new subsets of patients who may benefit from this therapeutic strategy. We believe these data will be critical to advancing the field of immunotherapy, and will be particularly insightful for clinicians, as well as biopharma companies seeking to advance immunotherapeutic agents. In addition, we'll present exciting new data demonstrating the impact of our decision support tools on accelerating clinical trial enrollment - - helping to address an important need in cancer care."

New results include an oral presentation titled "Comprehensive genomic profiling with loss of heterozygosity to identify therapeutically relevant subsets of ovarian cancer," which shows that CGP can reveal molecular, rather than histologic, patient subsets who may benefit from poly (ADP-ribose) polymerase (PARP) inhibitor targeted therapy or immunotherapy. These results also provide support for insurance coverage and further integration of CGP into clinical trials in ovarian cancer.

Further supporting the integration of CGP at diagnosis, results from health economic and outcomes studies will be presented, demonstrating that early integration of CGP into a patient's clinical and diagnostic work-up leads to improved patient outcomes associated with reasonable incremental costs to the payer that are largely driven by increased survival time on treatment. One poster titled "Estimated Cost of Anti-Cancer Therapy Directed by CGP in a Single-Center Study" discusses estimated anti-cancer drug costs and the associated cost impact of overall survival (OS) for matched vs. unmatched therapy in patients enrolled in a previously reported clinical trial using FoundationOne to guide therapeutic decisions.

In addition, important new studies will be presented on the ability of FoundationACT liquid biopsy assay to identify ESR1 and PIK3CA mutations in metastatic breast cancer, acquired resistance mutations in non-small cell lung cancer and BRCA1/2 reversion mutations in prostate cancer, all of which could help guide tretment decisions for these indications.

Other studies demonstrate the ability of CGP to accelerate clinical trial enrollment. Results from "Accelerating clinical trial enrollment with comprehensive genomic profiling (CGP) and 'Just-in-Time' clinical trial sites: An index case of a paradigm shift", reveal a new approach for matching patients to clinical trials that focus on rare genomic findings. Combined with a computational matching infrastructure, this approach could accelerate drug development and improve access to novel targeted therapies.

Following is a list of selected abstracts, including those referenced above.

Visit http://info.foundationmedicine.com/annual-meeting-2017 for a complete list of abstracts and to stay connected with Foundation Medicine during the ASCO meeting.

Immunotherapy/TMB Data

  • Oral Presentation: Abstract 5512 - Comprehensive genomic profiling (CGP) with loss of heterozygosity (LOH) to identify therapeutically relevant subsets of ovarian cancer (OC), June 5, E450ab, 8:48am - 9:00am
  • Abstract 9536 - Landscape of genomic alterations (GA) and tumor mutational burden (TMB) in different metastatic melanoma (MM) subtypes, June 3, Hall A, 1:15pm - 4:45pm
  • Abstract 4086 - Tumor mutational burden (TMB) and co-existing actionable mutations in biliary tract cancers (BTC), June 3, Hall A, 8:00am - 11:30am
  • Abstract 3039 - Mutational burden of tumors with primary site unknown, June 5, Hall A, 8:00 am - 11:30am
  • Abstract 9072 - BRAF fusions in clinically advanced non-small cell lung cancer: An emerging target for anti-BRAF therapies, June 3, Hall A, 8:00am - 11:30am

Targeted Therapy Data

  • Oral Presentation: Abstract 11001 - Impact of next-generation sequencing (NGS) on diagnostic and therapeutic options in soft-tissue and bone sarcoma, June 2, S100bc, 3:12pm - 3:24pm
  • Abstract 3583 - Targeted therapy for HER2 driven colorectal cancer, June 3, Hall A, 8:00am - 11:30am

Health Economic Data

  • Abstract 6599 - Comprehensive genomic profiling (CGP) versus conventional molecular diagnostic testing of patients with advanced non-small cell lung cancer (NSCLC): Overall survival (OS) and cost in US health plan population, June 5, Hall A, 1:15pm - 4:45pm
  • Abstract 6605 - Estimated cost of anti-cancer therapy directed by comprehensive genomic profiling (CGP) in a single-center study, June 5, Hall A, 1:15pm - 4:45pm

Liquid Biopsy Data

  • Abstract 1016 - Genomic profiling of circulating tumor DNA (ctDNA) from patients (pts) with metastatic breast cancer (mBC), June 4, Hall B1, 4:45pm - 6:00pm
  • Abstract 9025 - Genomic profiling of circulating tumor DNA (ctDNA) from patients (pts) with advanced non-small cell lung cancer (NSCLC), June 3, Hall A, 8:00am - 11:30am
  • Abstract 5024 - BRCA1/2 reversion mutations in prostate cancer identified from clinical tissue and liquid biopsy samples, June 5, Hall A, 1:15pm - 4:45pm
  • Abstract 4128 - Genomic profiling of circulating tumor DNA (ctDNA) from patients (pts) with pancreatic ductal adenocarcinoma (PDA), June 3, Hall A, 8:00am - 11:30am

Clinical Trial and Partnerships Data

  • Abstract 6539 - Accelerating clinical trial enrollment with comprehensive genomic profiling (CGP) and just-in-time clinical trial sites: An index case of a paradigm shift, June 5, Hall A, 1:15pm - 4:45pm
  • Abstract 2512 - Personalized, molecularly matched combination therapies for treatment-naïve, lethal malignancies: The I-PREDICT study, June 5, Arie Crown Theater, 11:30am - 12:45pm

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 (News - Alert) (@FoundationATCG).

Foundation Medicine®, FoundationOne® and FoundationACT® are registered trademarks and FoundationFocusis 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 of comprehensive genomic profiling, including FoundationOne, FoundationOne Heme, FoundationACT and FoundationFocus, and molecular information from CGP, in cancer care, acceleration of clinical trial enrollment, and the development of targeted therapies; the ability of TMB to predict responses to certain types of FDA-approved therapies; and the ability of CGP to improve patient outcomes associated with reasonable incremental costs to the payer. 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 services 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, 2016, 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.


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