FoundationOne® Identifies Clinically Relevant Alterations In Adolescent and Young Adult Solid Tumors

Jun 2, 2014

FoundationOne® Identifies Clinically Relevant Alterations In Adolescent and Young Adult Solid Tumors

Analysis of Solid Tumors in 669 Patients Reveals Genomic Alterations Distinct to a Commonly Overlooked Population That May Lead to More Effective Treatment Decisions

CAMBRIDGE, Mass. & CHICAGO--(BUSINESS WIRE)-- Foundation Medicine, Inc. (NASDAQ: FMI) today announced results from a new study demonstrating that fully informative genomic profiling with FoundationOne® revealed clinically relevant genomic alterations across solid tumor types in adolescent and young adults (AYA), potentially providing novel insight for targeted treatment decisions in this population. These data will be presented today in an oral abstract session at the 2014 American Society of Clinical Oncology (ASCO) Annual Meeting, abstract number 110081.

"Similar to pediatric patients, cancers in adolescents and young adults present unique challenges for clinicians. Genomic alterations specific to this patient population have not been widely characterized until now and this investigation strongly suggests they are indeed distinct from those which occur in tumors of older adults," said Brandon Hayes-Lattin, M.D., Associate Professor of Medicine in the Hematology/Oncology department of Oregon Health and Science University and a leading clinician in AYA, as well as a young adult cancer survivor. "The results of this study show that the tumors in this population are biologically distinctive in ways that are clinically meaningful and may help guide physicians' treatment decisions for these patients with approved and emerging targeted therapies."

Across 26 tumor types profiled among 669 adolescents and young adults studied, the most common were breast (15%), brain (13%), colorectal (9%), sarcomas (9%), gyneologic (7%) and lung (7%). Potentially actionable genomic alterations - cases where a patient's unique genomic profile could be linked to approved targeted therapies or clinical trials - were identified in 71 percent of the total cases. With regard to specific tumor types, potentially actionable alterations were found in 87% of breast, 85% of colon and 75% of lung tumors.

In lung tumors, it was found that this population harbored eight times the number of ALK rearrangements compared to patients in the data set greater than 39 years old. In one notable case, a 19-year-old patient with lung cancer was admitted to hospice after failure of a standard chemotherapy regimen. FoundationOne testing revealed an ALK fusion not detected with prior FISH testing. The discovery of that alteration led to use of crizotinib, and within five days, the patient was discharged from hospice and her 2-month scans revealed a PR by resict criteria.

"It is exciting to see such a leap forward in our understanding of the unique aspects of cancer in the AYA population," said Heidi Adams, President & CEO of Critical Mass, a leading young adult advocacy organization. "Cancer in patients between 15 and 39 years old presents distinct issues and challenges on every front—psychosocial, physical, practical and biological. A deeper understanding of the biological differences of cancer in young adult patients brings us one step closer to ensuring that young adult patients receive appropriate support and treatment based on their specific clinical needs."

"Cancer possesses unique attributes when it presents in adolescents and young adults, due in part to the body's modulating chemistry during that stage of development. Since we are now able to provide a diagnostic tool for employing precision medicine in cancer genomics, we must also begin to understand the nuances in tumor development at each stage of life to determine how that information translates into therapeutic decisions," said Deborah Morosini, M.D., vice president, clinical development, of Foundation Medicine and co-author of the study. "The results from our evolving data-set of clinical cases using FoundationOne demonstrate promise for a greater understanding of the unique genomic underpinnings driving tumor growth in these young patients to better tailor treatment decisions for this population and, ultimately, improve outcomes."

About FoundationOne®

FoundationOne, the company's first clinical product, is a fully informative genomic profile for solid tumors used by oncologists to identify the molecular alterations in a patient's tumor and match those alterations with relevant targeted therapies and clinical trials. Using next-generation sequencing in routine cancer specimens, FoundationOne interrogates all genes somatically altered in human cancers that are validated targets for therapy or unambiguous drivers of oncogenesis based on current knowledge. It reveals all classes of genomic alterations including base substitutions, insertions, deletions, copy number alterations and select rearrangements. FoundationOne fits easily into the clinical workflow of the ordering physician, and test results are provided in an easy-to-interpret report supported by a comprehensive review of published literature. FoundationOne is a laboratory-developed test performed at Foundation Medicine's CLIA-certified lab. Please visit for more information.

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, sarcomas and pediatric cancers, provide a fully informative 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 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 benefits to patients of next-generation sequencing of their tumors, the utility of FoundationOne in informing treatment of certain patient populations, and clinical data related to FoundationOne. 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 studies; 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, 2013, 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.

1. Morosini, D. et al, "Comprehensive genomic profiling of solid tumors from 669 adolescents and young adults reveals a distinct spectrum of targetable genomic alterations." 2014 American Society of Clinical Oncology (ASCO) Annual Meeting, abstract number 11008.

Media Contact:
Pure Communications, Inc.
Dan Budwick, 973-271-6085
Investor Contact:
Foundation Medicine, Inc.
Matt Clawson, 617-418-2283

Source: Foundation Medicine, Inc.

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