New Data Demonstrate Improved Patient Outcomes with Matched Cancer Therapy Informed by Comprehensive Genomic Profiling with FoundationOne®

May 31, 2015

New Data Demonstrate Improved Patient Outcomes with Matched Cancer Therapy Informed by Comprehensive Genomic Profiling with FoundationOne®

Study Aims to Advance Precision Medicine through the Integration of Molecular Information into Clinical Cancer Care

Data Presented by Foundation Medicine and Collaborators at the 2015 ASCO Annual Meeting

CAMBRIDGE, Mass. & CHICAGO--(BUSINESS WIRE)-- Foundation Medicine, Inc. (NASDAQ:FMI) and collaborators from the University of Texas MD Anderson Cancer Center and Sarah Cannon Research Institute at HealthOne today announced compelling new data demonstrating that matching patients to targeted therapies based on the unique molecular profile of the patient's advanced cancer leads to improved outcomes across a variety of key measures, including overall survival.

These findings were presented today at the 2015 American Society of Clinical Oncology (ASCO) Annual Meeting in a poster titled, "Prospective study comparing outcomes in patients with advanced malignancies on molecular alteration-matched versus non-matched therapy" (abstract # 11019), by Jennifer J. Wheler, M.D., Associate Professor, Department of Investigational Cancer Therapeutics, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center. In the study, 95% of patients had one or more clinically relevant genomic alterations, demonstrating the potential clinical utility of integrating FoundationOne® comprehensive genomic profiling into clinical practice, and supporting the investigation of this approach in earlier stage disease.

"This study represents one of the first completed prospective trials testing the concept of comprehensive genomic profiling, an important clinical application of next generation sequencing, to match patients to targeted therapies," said Dr. Wheler.

"Despite the fact that these patients had advanced, refractory cancer and were heavily pretreated, the matching of therapy to genomic alterations using this hybrid capture-based NGS approach was independently associated with improvement in all outcome variables," said Razelle Kurzrock, M.D., Chief, Division of Hematology and Oncology, University of California San Diego (UCSD) School of Medicine. "This study establishes that NGS has clinical utility in patients with refractory cancer, and that NGS merits exploration earlier in the disease course."

Tumor samples from patients with clinically relevant molecular alterations as identified by FoundationOne were preferentially treated on pathway-matched therapies. A direct match was defined when the drug targeted an alteration or its immediate downstream effector; an indirect match when the drug targeted a protein with more than one effector removed from the alteration. Based on matching and the number of alterations in patients' tumors, an exploratory scoring system was evaluated.

Molecular profiling was performed for 339 patients and, of those, 95% of patients had one or more clinically relevant genomic alterations. Of these patients, 110 patients were treated with a pathway-matched therapy, while 65 patients were treated with a non-matched therapy. Of the patients receiving matched therapy and based on the scoring system, median overall survival of 10.8 months was achieved versus 7.5 months for those patients treated with non-matched therapy. These data provide evidence of the clinical utility of using comprehensive genomic profiling to guide therapeutic choices.

"Mortality rates for patients with advanced, metastatic cancer have until recently gone relatively unchanged over the last three decades, driven largely by a lack of new, FDA-approved therapies for this patient group," said Vincent Miller, M.D., Chief Medical Officer of Foundation Medicine. "The generally low response rate and short progression-free survival common in advanced cancer is indicative of the need for better identification of molecular characteristics associated with potential treatment response and better targeting of treatment in order to achieve higher response rates with less toxicity and adverse side effects. These data validate the positive clinical outcomes resulting from comprehensive genomic profiling and further support the need for reimbursement, enabling patient access to this critical component in modern cancer care."

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 and sarcomas, provide a comprehensive 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.

Cautionary Note Regarding Forward-Looking Statements

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 ability of FoundationOne to identify clinically relevant genomic alterations, the benefits to patients of comprehensive genomic profiling of their tumors, the utility of comprehensive genomic profiling in informing treatment of certain patient populations, and the ability of comprehensive genomic profiling to improve efficacy of outcomes for cancer patients, including survival. 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 risks that Foundation Medicine's products 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, 2014, 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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Source: Foundation Medicine, Inc.

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