Foundation Medicine Partners with Broad-based Coalition to Advance Revolutionary New Clinical Trial Design in Lung Cancer
Foundation Medicine Selected to Provide Comprehensive Genomic Testing Platform for Patients Enrolled in Master Protocol Trial
"We are excited to partner with leadership from some of our country's most innovative public and private organizations to advance the Master Protocol study and ultimately modernize the future of oncology clinical trials," stated
"It is challenging to recruit patients into clinical trials; the recruitment stage adds to the lengthy timeframes we currently face to bring investigational new drugs through the development process," said
The Master Protocol study is designed to address current issues in oncology drug development by bringing multiple investigational targeted therapies into one study under a single protocol to improve the efficiency, costs and success rates associated with moving investigational new drugs through the clinical development process, and ultimately expedite the timelines in which new treatment options are available to the patients who are most likely to benefit. Using a comprehensive genomic profile maximizes the amount of genomic information that can be obtained from a single patient tissue sample, and in turn, maximizes the likelihood that individuals will be successfully matched to a targeted therapy arm. It also reduces the need for pharmaceutical companies to use time and resources to identify a specific diagnostic partner to continue development of a targeted therapy.
"There is a fundamental shift in cancer care in which treatment options are informed by the molecular alterations driving a patient's cancer rather than solely from the anatomic site of origin," stated Dr. Miller. "Many new therapies in development are targeting alterations that are present in small percentages of patients, making it critical to confirm that the right patients are enrolled in a clinical trial to enhance the likelihood of success in the study and improve patient outcomes. To truly enable precision medicine in oncology, cancer patients must have broad access to comprehensive genomic testing in routine clinical care are well as oncology clinical trials, and we believe the Master Protocol study is an innovative step forward in this direction."
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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 design, initiation and timing of the Master Protocol study; the use of Foundation Medicine's genomic profile as the common platform for the Master Protocol study; the ability of the Master Protocol study to address issues in oncology drug development; and the adoption of the Master Protocol study as a model for future oncology trials. 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 parties participating in the Master Protocol study may not have the resources to organize and implement the Master Protocol study, the Master Protocol study may not successfully address issues facing oncology clinical trials,
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