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
These findings were presented today at the 2015
"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
"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,"
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,
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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