Agendia Reports Positive Results in IMPACt Trial for Breast Cancer

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One of the major scientific crusades in oncology has been to identify and validate biomarkers associated with recurrent breast cancer. [iStock / royaltystockphoto]

Breast cancer is a multifaceted disease with many different subtypes, each of which requires unique treatment strategies. The IMPACt trial tests the feasibly of using MammaPrint and BluePrint—genomic testing assays developed by Agendia—to see if a standardized genomic testing can provide much needed biological clarity for treating physicians.

These assays allow a breast cancer subtype to be quickly identified, removing the need for a physician to order different individual tests and simplifying which medications and treatments are known to work best.  Outcomes and response to therapy can vary greatly from patient to patient in breast cancer, based on biological information from standard clinical and pathologic features.  Genomic testing has become more widely utilized to help understand these differences with the goal of improving patient outcomes.

In instances where genomic testing is not used for treatment, physicians will use more broad spectrum medication, such as chemotherapy, to varying results. Genomic medicine is very much the future for cancer treatment, and allowing doctors outside of an academic setting easier access to genomic tests is an important aspect of providing care to a large patient population.

In a new study published in BMC Cancer, the results from the IMPACt trial were released. The IMPACt study aimed to evaluate the role of using genomic profiling in treatment planning, as well as the degree of physician confidence when utilizing the MammaPrint and BluePrint assays. The study measured changes in both treatment decisions and physician confidence, when using the assays, to support medical management of patients with early stage breast cancer.

MammaPrint is a 70-gene breast cancer recurrence assay that offers clarity on a patient’s risk of recurrence, and BluePrint is an 80-gene molecular subtyping assay that analyses a tumor to identify the functional pathway driving its growth. These assays can be performed on core biopsies or surgical specimens. IMPACt prospectively enrolled 452 patients between November 2015 and August 2017to take part in this study.

MammaPrint and BluePrint reclassified a surprising 40% of pathologically subtyped tumors, highlighting the need for an individualized, molecular subtyping profile in early stage breast cancer diagnosing for patients. The study also showed that the physicians’ original treatment plans for patients were consistent with MammaPrint results in 89% of cases, supporting the use of this assay to inform treatment decisions in clinical practice. For clinically high risk patients, where 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.

“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.”

The ability to consistently inform treatment planning and increase physician confidence when using genomic assays is something that is greatly lacking in rural oncology centers. Treating oncologists often times have difficulty in prescribing precision medicine, in that they must order a specific genomic test to see if a specific medication that targets a particular genomic mutation will work.  Being able to simplify that process will undoubtedly bring precision medicine to more people and help treat disease better.

“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.”

In the study, physicians also 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,” said Robert Gabordi, MD.

The results from IMPACt clearly show the importance of being able to use data in a clinical setting.  If a physician does not have confidence in a clinical tool, it is reasonable to assume they will not use it for clinical decision making.  By providing a simple, easy to use platform that clarifies both biological information and what it means in terms of patient care, it will be possible to utilize preexisting technology for what it was intended for.

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