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Foundation Medicine to Collaborate with NCI on Exceptional Responders Initiative

NEW YORK (GenomeWeb) – Foundation Medicine will collaborate with the National Cancer Institute on its Exceptional Responders Initiative to study why some cancer patients have a dramatic response to therapy.

The NCI is leading the study and Baylor College of Medicine and Nationwide Children's Hospital are also collaborating.

Researchers will collect tumors samples from over 300 patients who have been identified as having a significant and lasting response to a systemic anti-cancer treatment. These participants have received a treatment in which the typical response rate is less than 10 percent, and have achieved a complete response or a partial response of at least six months. The response can be to an experimental therapy or standard treatment within the context of a trial or just a clinical setting.

Researchers will process samples at the Biospecimen Core Resource at Nationwide Children's Hospital and then analyze them using Foundation Medicine's FoundationOne test, a next-generation sequencing-based panel that assesses mutation status in over 300 genes, as well as by exome and transcriptome sequencing at Baylor. The data will then be used to generate hypotheses for additional clinical testing with the goal of identifying the molecular underpinnings of the exceptional response to better choose which patients should receive the drug.

"Every oncologist can point to a small number of their patients who have had unusually favorable responses to systemic therapies," Vincent Miller, Foundation's chief medical officer, said in a statement. "By beginning to leverage this experience, largely rooted in community practice, we hope to learn more quickly and generate critical hypotheses which can then be validated in larger cohorts."

The researchers will obtain patient samples from NCI-supported clinical trials, clinical studies that are actively enrolling patients at other institutions, and cases submitted individually by oncologists. To qualify, patients should have been enrolled in an early clinical trial in which fewer than 10 percent of patients responded, or in a later phase trial of a single agent or investigational combination therapy, or treated with an approved drug for another indication and had an exceptional response.

The NCI launched the study in September 2014 and it is currently reviewing more than 70 cases.

Oncologists have always identified exceptional responders, but with advances in NGS technology, researchers can now look to pinpoint the genomic alteration responsible for that response to better inform treatments. The NCI launched the initiative after a number of case reports in which sequencing explained the reasons behind exceptional response, including a study by Memorial Sloan Kettering where sequencing identified the reason why a patient with metastatic bladder cancer had a dramatic response to an mTOR inhibitor.