On June 8, 2017 The American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), Inc. (ASCO) (Free ASCO Whitepaper) and Foundation Medicine (NASDAQ: FMI) reported entry into an agreement to create efficiencies for research sites participating in ASCO (Free ASCO Whitepaper)’s TAPUR Study in identifying potential participants for the study. ASCO (Free ASCO Whitepaper) is announcing that reports from Foundation Medicine’s comprehensive genomic profiling (CGP) assays, FoundationOne, FoundationOne Heme and FoundationACT will receive the new "optimized for TAPUR reporting" designation available to entities that demonstrate reporting of nearly 75% of TAPUR-specific genes in a format that meets criteria established for the TAPUR Study. The TAPUR Study is a first-of its-kind clinical trial designed to evaluate molecularly targeted cancer drugs and collect data on clinical outcomes to learn about additional uses of these drugs outside of indications already approved by the Food and Drug Administration. Schedule your 30 min Free 1stOncology Demo! As part of this pilot program, Foundation Medicine will use its SmartTrials technology to create reports for TAPUR sites that identify patients who may qualify to participate in the TAPUR Study. SmartTrials is a molecularly-matched, location-specific, clinical trials database that informs physicians about clinical trials to accelerate patient enrollment. Early use of the SmartTrials report by one TAPUR site was associated with a significant increase in patient accrual with the site reporting identification of more than 60 patients whose genomic profiles matched TAPUR drug targets within a few months of implementing the SmartTrials technology. As part of this arrangement, Foundation Medicine will be launching its SmartTrials reporting to an initial pilot set of the TAPUR Study’s participating clinical sites.
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"We are excited to designate Foundation Medicine’s CGP assays as providing reports that are optimized for TAPUR participation and work with Foundation Medicine to allow TAPUR Sites to incorporate SmartTrials reporting to streamline identification of patients who may qualify for the TAPUR study," said ASCO (Free ASCO Whitepaper) Chief Medical Officer and TAPUR Study Principal Investigator, Richard L. Schilsky, MD, FACP, FASCO, FSCT. "It is our hope that Foundation Medicine’s unique expertise in genomics will enable many more patients to access investigational therapies through the TAPUR Study clinical trial."
"The TAPUR Study’s innovative, biomarker-driven design will expand access for patients to innovative new targeted therapies, while enhancing the collective understanding of the genomic basis of cancer biology," said Vincent Miller, M.D., chief medical officer at Foundation Medicine. "Applying the SmartTrials reporting to the TAPUR Study can facilitate rapid and accurate patient identification, accelerating patient enrollment."
About the TAPUR Study
The TAPUR Study is a non-randomized clinical trial that aims to describe the performance (both safety and efficacy) of commercially available, targeted anticancer drugs prescribed for treatment of patients with advanced cancer that has a potentially actionable genomic variant. The TAPUR Study provides approved targeted therapies that are contributed to the program by collaborating pharmaceutical companies, catalogues the choice of genomic profiling test by clinical oncologists and aims to learn about the utility of registry data to develop hypotheses for additional clinical trials.