Trials and Outcomes: Accelerating Precision Medicine at ASCO 2017

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At Foundation Medicine, our vision for precision oncology is based on fundamentally changing the way patients receive care. For us, this means enabling practical and clinically applicable solutions, no matter the stage or composition of the cancer, and regardless of where the patient lives or is being treated.

Having a complete picture of every genomic change associated with each tumor can help us make personalized treatment decisions – helping to match patients with the right therapy or clinical trial based on their individual profile. And we believe we are starting to see that comprehensive genomic profiling (CGP) can advance cancer care in other ways that could potentially improve clinical outcomes and accelerate drug development.

At this year’s American Society of Clinical Oncology (ASCO) Annual Meeting, we’re excited to present data that demonstrate the ability of CGP to do just that, bringing us one step closer to realizing the future of precision oncology.

Improving survival with CGP-matched therapy

Comprehensive genomic profiling offers the opportunity to tailor treatment to each patient. At this year’s ASCO Annual Meeting, we are presenting data demonstrating the potential clinical impact of CGP. In this study we assessed the effect of matched versus unmatched therapy on clinical outcomes (overall survival). The matched group underwent CGP with FoundationOne® to match specific genomic changes to therapies that target those changes; the unmatched group did not. In the set of 188 patients with diverse and refractory cancers, those who received matched therapy lived significantly longer than those with unmatched therapy, underscoring the value of using CGP to personalize treatment decisions.

These data support the use of CGP to help improve outcomes across diverse and advanced cancers through genomically-guided therapy.

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Matching patients to trials, matching trials to patients

Clinical trials also provide a way for patients to access new, personalized therapies and play an essential role in drug development. But in many cases, patient populations are small and widely distributed geographically, and trial access is limited in community settings where awareness and site availability are reduced. Currently, many trials do not reach their enrollment goals, which delays access to new treatments and slows the approval process.

In a push to improve the current system, Foundation Medicine has developed a novel platform for accelerating biomarker-driven clinical trials called SmartTrials™. SmartTrials is designed to increase patient access to genomically-matched clinical trials by building both awareness of target-matched trials and enabling access for patients being treated in community settings. The SmartTrials engine automatically identifies patients with select rare, actionable genomic findings. Oncologists at Foundation Medicine then facilitate access by reaching out to the treating providers of the patients to provide educational information about the trial. Through the SmartTrials program, patients, no matter where they are treated, have the opportunity to access precision-matched clinical trials and, as a result, cutting-edge cancer therapies.

In a new study at ASCO, we’re presenting data from our SmartTrials Precision Enrollment program. For this study, the program was used to match non-small cell lung cancer (NSCLC) patients with activating NTRK, ROS1 or ALK fusions to a Phase II study of an investigational targeted therapy.

One case from this program exemplified the power of this approach. A patient with NSCLC and a ROS1 fusion was made aware of and matched to this trial through SmartTrials. Despite being interested, this patient, like many others treated in the community, was too far from a trial site to participate. Through an extension of our SmartTrials program that enables sites to be activated “just in time,” a local trial site was identified, approved, and opened. As a result, the patient was identified, screened and enrolled in the trial within only 7 days. In contrast, traditional paths to enrollment can take months, often too long for many cancer patients who need treatment urgently.

This example is but one of many that shows the value of comprehensive genomic profiling – together with advanced technology solutions and innovative programs – to empower patients to access personalized treatment options whether they are being treated in an academic center or in a community practice. By expanding how we approach cancer research, treatment and care, we can help bring the potential of precision medicine to as many patients as possible, as quickly as possible.

Learn more about the data at ASCO:

June 5:

Accelerating clinical trial enrollment with comprehensive genomic profiling (CGP) and just-in-time clinical trial sites: An index case of a paradigm shift. (Abstract 6539, Poster Session: Health Services Research, Clinical Informatics, and Quality of Care, 1:15PM-4:45PM).

Estimated cost of anticancer therapy directed by comprehensive genomic profiling (CGP) in a single-center study. (Abstract #6605, Poster Session: Health Services Research, Clinical Informatics, and Quality of Care, 1:15PM-4:45PM).

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