Foundation Medicine Announces Its Collaboration with the National Cancer Institute on Exceptional Responders Initiative
First-of-its-kind Exploratory Study Investigates Unique Molecular Indicators of Tumors Associated with Exceptional Treatment Responses to Drug Therapies in Patients With Cancer
‘Exceptional Responders' are patients who have experienced an unexpected and durable response to a systemic anti-cancer treatment. Specifically, these individuals received a treatment in which fewer than 10 percent of patients had a complete response or a durable partial response (lasting at least 6 months) based on previous clinical trial data or extensive historical experience in the context of the patient's tumor type. The reasons why some patients experience these unexpected and prolonged responses to therapy following certain treatments are largely unclear and have never been studied systematically. The ERI will seek to identify these patients and understand, through comprehensive genomic profiling, whether molecular alterations or changes in gene expression may explain these exceptional responses.
"At Foundation Medicine, we are focused on understanding the unique
molecular changes that contribute to a patient's individual disease to
inform treatment decisions," said
In this study, tissue and clinical data from exceptional responders will
be obtained from several sources, including NCI-supported clinical
trials, clinical studies that are actively enrolling at other
institutions, and cases submitted by physicians in community centers or
other oncology practices. Patients could have been enrolled in early
phase clinical trials in which fewer than 10 percent of patients
responded or enrolled in later phase clinical trials of single agents or
investigational combination therapies, or the individuals could have
been treated with an
More information about the Exceptional Responders Initiative is available at https://clinicaltrials.gov/ct2/show/NCT02243592 Researchers and physicians who are interested in submitting exceptional responder cases for consideration should contact NCIExceptionalResponders@mail.nih.gov.
Cautionary Note Regarding Forward-Looking Statements for
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 the study outcomes to improve the biologic and genomic understandings of cancer and to enhance or develop cancer assays; the ability of the study to identify exceptional responders to cancer treatment and relevant molecular alterations for such responders; and the impact of such identified molecular alteration on drug development. 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 the exceptional responder patients are not properly identified; 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.
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