February 18, 2020

Results from the IMPACt Trial Show Agendia Assays Consistently Inform Treatment Planning and Increase Physician Confidence when Caring for Patients with Early Stage Breast Cancer

PRESS RELEASE

Laura van ’t Veer, PhD, Co-Inventor of MammaPrint, Honored with the PMWC Luminary Award at Precision Medicine World Conference 2020

 

IRVINE, CALIF., U.S., and AMSTERDAM, NETHERLANDS – February 13, 2020 – Agendia, Inc., a world leader in precision oncology for breast cancer, announced today 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.

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.”

To learn more about this and other published studies, please visit: https://www.agendia.com/evidence

About Agendia
Agendia is a molecular diagnostics company committed to improving clinical outcomes and informing the journey for patients with early stage breast cancer. The company currently offers two commercially-available genomic profiling tests, processed through its state-of-the-art facility in Irvine, California. Agendia also provides a next generation sequencing kit for use by local laboratories outside of the United States.

MammaPrint®, the 70-gene breast cancer recurrence assay, is the first FDA-cleared risk-of-recurrence test backed by peer-reviewed, prospective outcome data and included in both national and international treatment guidelines. BluePrint®, the 80-gene molecular subtyping assay, is a commercially-available test that evaluates the underlying biology of a tumor to determine what is driving its growth. Together, MammaPrint® and BluePrint® provide a comprehensive genomic profile to help physicians make more informed decisions in the pre- and post-operative treatment settings. By developing evidence-based, novel genomic tests, Agendia aims to support the evolving clinical needs of breast cancer patients and their physicians.

Agendia’s assays can be ordered on core biopsies or surgical specimens with results provided in as little as 5-7 days to inform pre- and post-operative treatment decisions. For more information on Agendia’s assays and ongoing trials, please visit agendia.com

Media Contact: Dina Scaglione
Director, Marketing
949.910.9401
[email protected]