The Massachusetts based Foundation Medicine, which develops, manufactures, and sells genomic analysis diagnostics for solid and circulating cancers, has announced a collaboration with the National Cancer Institute (NCI) on the Exceptional Responders Initiative (ERI). The alliance is for an exploratory study to investigate the unique molecular indicators of tumors associated with cancer patients with excellent prognosis to drug therapies.

The study will be led by NCI scientists and will include participation from Baylor College of Medicine, Nationwide Children's Hospital, as well as Foundation Medicine tumor samples collected from individuals prior to initiation of the therapy of interest. Samples will be analyzed to determine whether specific molecular determinants can be identified that could be exploited therapeutically. Data from the ERI could radically improve our knowledge of the fundamental differences in survival rates among cancer patients. Moreover, the findings could lead to better clinical diagnostics by identifying previously unknown tumor biomarkers.

“At Foundation Medicine, we are focused on understanding the unique molecular changes that contribute to a patient’s individual disease to inform treatment decisions,” said Vincent Miller, M.D., chief medical officer at Foundation Medicine. “The ERI represents a significant opportunity to utilize advances in precision medicine to better understand outcomes, which can be applied to the future selection of treatments for patients with cancer.”

Exceptional responders represent a small percentage of patients who have experienced an outstanding, but unexpected response to a systemic anticancer treatment. Specifically, these patients represent fewer than 10% of patients who have had a complete response or a durable partial response (lasting at least six months) based on previous data for the specific tumor type.

“Every oncologist can point to a small number of their patients who have had unusually favorable responses to systemic therapies,” explained Dr. Miller. “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. We are thrilled to participate with Baylor College of Medicine and Nationwide Children’s Hospital in this important NCI-led initiative, which we believe represents the future of oncology care.”

Tissue and clinical data from exceptional responders will be collected at several sources, including NCI-supported clinical trials, clinical studies that are actively enrolling at other institutions, and cases submitted by private practice or community center physicians. 

Once the tissue has been obtained and processed at the Biospecimen Core Resource at Nationwide Children's Hospital, the analysis phase will commence using Foundation Medicine's FoundationOne® comprehensive genomic profile test for patients with solid tumors, as well as by whole exome and transcriptome RNA sequencing through the Baylor College of Medicine. The resulting molecular characterization and concordance data will be utilized to determine if opportunities for broader clinical testing exists, in order to accelerate the development of targeted chemotherapies.

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