On February 18, 2020 Agendia, Inc., a world leader in precision oncology for breast cancer, reported that BMC Cancer published results from the IMPACt trial. The study measured changes in both treatment decisions and physician confidence when using the MammaPrint and BluePrint assays to support medical management for patients with early stage breast cancer (Press release, Agendia, FEB 18, 2020, View Source [SID1234554468]).

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Because breast cancer is not a single disease, outcomes and response to therapy vary greatly from patient to patient based on biology that is not always reflected in standard clinical and pathologic features. Genomic testing has become more widely utilized to help understand these differences with the goal of improving patient outcomes. MammaPrint is a 70-gene signature that offers clarity on a patient’s risk of recurrence, whereas BluePrint is an 80-gene signature that goes beyond the surface of the tumor to identify the functional pathway driving its growth. The IMPACt study aimed to evaluate the role of genomic profiling in treatment planning as well as the degree of physician confidence when utilizing the MammaPrint and BluePrint assays.

"Through Agendia’s comprehensive genomic profiling tools, we are increasing our understanding of an individual’s tumor biology," stated Hatem Soliman, MD. "It is important to evaluate how that information impacts treatment planning in a real world clinical setting."

IMPACt prospectively enrolled 452 patients between November 2015 and August 2017. In the real-world cohort, MammaPrint and BluePrint reclassified 40% of pathologically subtyped tumors. This highlights the utility for a BluePrint molecular subtyping profile in early stage breast cancer and a more personalized approach to treatment for patients. The study also showed that physicians’ treatment plans for patients were consistent with their MammaPrint results in 89% of cases, supporting the use of this signature to inform treatment decisions in clinical practice. For clinically high risk patients for whom chemotherapy was initially recommended, there was a 60% reduction in the use of chemotherapy when patients were classified as Low Risk by MammaPrint. Conversely, when clinically low risk patients had a High Risk genomic profile, chemotherapy was added to the treatment plan in 60% of cases that did not initially include it.

Additionally, physicians reported greater confidence in their treatment decisions for 72% of cases after receiving MammaPrint results, supporting the findings of the 2015 PROMIS trial, which showed increased physician confidence in 79% of patient treatment plans. Both studies demonstrate a high level of certainty that patients are being offered chemotherapy when appropriate and reassurance that Low Risk patients can safely forego chemotherapy and its associated toxicities.

"Physician confidence is an integral component to determining the most effective treatment plan and provides much-needed peace of mind for our patients," says Robert Gabordi, MD.

"We are very encouraged with the results of this important trial confirming the clinical utility of MammaPrint and BluePrint," commented Agendia’s Chief Medical Officer, William Audeh, MD, MS. "This not only underscores the reliability of our genomic assays, but it further reinforces the critical role they play when optimizing a personalized treatment strategy for patients with early stage breast cancer."