New Studies Show MammaPrint® and BluePrint® Tests Provide Greater Clarity Regarding Risk of Breast Cancer Recurrence and Classifications for Treatment

IRVINE, Calif. and AMSTERDAM, Dec. 7, 2018 /PRNewswire/ -- Agendia, Inc., a world leader in precision oncology, announced today findings from two key studies presented at the 2018 San Antonio Breast Cancer Symposium (SABCS) this week, reinforcing the utility and benefits of its MammaPrint® 70-Gene Breast Cancer Risk-of-Recurrence and BluePrint® Breast Cancer Molecular Subtyping tests. Both studies underscore the growing importance of genomic testing in helping physicians to personalize breast cancer treatment management.

BluePrint reclassifies 85 percent of HER2-positive, and clarifies HER2-equivocal breast cancers in a real-world diagnostic setting¹

The first study addressed challenges acknowledged within the Aphinity and ExteNET trials regarding the potential benefits of added HER2-targeted treatment in breast cancer as well as the uncertainty regarding the nature of tumors classified as HER2 "equivocal" by traditional immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH). A previous trial showed that BluePrint reclassified almost half of HER2-postive/ER-positive patients identified as HER2-positive using IHC/FISH to the Luminal subtype with differential neoadjuvant treatment response.^2,3

In this study, Agendia scientists analyzed HER2-positive and HER2-equivocal cancers (as defined by the 2013 CAP Guidelines), comparing IHC/FISH status from pathology results to BluePrint molecular subtype in a real-world diagnostic setting. In IHC/FISH HER2-amplified tumors, BluePrint reclassified 85 percent to non-HER2 molecular subtypes, mostly Luminal-type for ER-positive tumors and Basal-type for ER-negative tumors. BluePrint also classified all HER2-equivocal tumors to non-HER2 subtypes, Luminal and Basal, which could not be derived from IHC/FISH. No HER2 "equivocal" cancers by IHC/FISH displayed a HER2-driven genotype.

Dr. William Audeh, chief medical officer at Agendia, said: "The findings from this real-world study indicate that additional therapeutic options should be considered for some women with clinically HER2-positive cancers with genomic profiles of Luminal or Basal subtypes. These data also provide further precision to clarify the clinical uncertainty regarding the HER2 "equivocal" subtype. This study further reinforces the critical role BluePrint plays in helping to inform more personalized treatment decisions by adding to a growing body of evidence demonstrating the importance of tumor molecular subtyping in breast cancer."

MammaPrint identifies 46 percent of patients under 50 years of age with an intermediate recurrence score as Low Risk⁴

The second study reevaluated data from the PROMIS (PRospective Study Of MammaPrint in Patients With an Intermediate Recurrence Score) trial using the same subgroup analyses that was used in the TAILORx trial. It aimed to establish greater certainty regarding the benefits of chemotherapy among female breast cancer patients under 50 with an intermediate recurrence score from the 21-gene assay (RS 18-30). The new analyses found 46 percent of these women had a low genomic risk of recurrence as assessed by MammaPrint and were unlikely to benefit from chemotherapy. Researchers also found that in the MINDACT trial, MammaPrint patients younger than age 45 and between the ages of 45-55 who also have a Low Risk result had a favorable 5-year distant metastasis-free survival of 95-98 percent in both clinically low and high risk groups.

Dr. Hatem Soliman, medical director of clinical trials at the Moffitt Cancer Center and lead study author, said: "The TAILORx trial raised important questions about the benefits of chemotherapy in women under 50, so we were pleased to see that our new subgroup analysis of the PROMIS data, using the same approach as seen in TAILORx, showed that MammaPrint provides greater certainty regarding which women are unlikely to benefit from chemotherapy. Patient quality of life, in the short-term and longer-term, is paramount, so the role of MammaPrint in signaling where physicians can safely de-escalate their patients' treatments, and thus side effects, is important."

A full list of abstracts featuring MammaPrint and BluePrint presented during SABCS can be viewed here: https://www.agendia.com/pdf/M-USA-215-V3%20(2018NOV)%20-%20SABCS%202018%20Abstract%20Summary%20interactive.pdf

1. BluePrint molecular subtyping versus HER2 assessment by immunohistochemistry and FISH in the real-world diagnostic setting. Poster presented at SABCS. December 2018; San Antonio, Texas.

2. Whitworth P, et al., Chemosensitivity Predicted by BluePrint 80-Gene Functional Subtype and MammaPrint in the Prospective Neoadjuvant Breast Registry Symphony Trial (NBRST). Ann Surg Oncol. 2014; 21(10): 3261–3267.

3. Pathological complete response in basal subtype tumors predicts improved distant metastasis free survival in the NBRST trial. Poster presented at ASCO 2018; Chicago, Illinois.

4. MammaPrint identifies 46% of patients, age ≤50 years with oncotype RS 18-30, as low risk and safe to forgo chemotherapy. Poster presented at SABCS. December 2018; San Antonio, Texas.

About MammaPrint®

MammaPrint is an in vitro diagnostic medical device, performed as a testing service in a central laboratory, using the 70-gene expression profile of breast cancer tissue samples to assess a patient's risk for distant metastasis. The device is FDA-cleared and CE-marked, enabling use in the European Union. MammaPrint is indicated for use by physicians as a prognostic marker only, along with other clinical-pathological factors. It is not intended to determine the outcome of disease, nor to suggest or infer an individual patient's response to therapy. MammaPrint is the only test of its kind recommended for lymph node-negative and lymph node-positive patients by both the American Society of Clinical Oncology (ASCO) and National Comprehensive Cancer Network (NCCN). The test is also recommended by many other national and international clinical practice guidelines.

About BluePrint®

BluePrint is an 80-gene complementary test provided with MammaPrint which allows functional molecular subtyping of a breast cancer sample into three distinct subtypes: Luminal-type, HER2-type and Basal-type, each with marked differences in long-term outcome and response to neoadjuvant chemotherapy.

About Agendia

Agendia is a privately held, leading precision oncology company that develops and markets genomic diagnostic products, which help support physicians with their complex treatment decisions. Agendia's breast cancer tests were developed using an unbiased gene selection by analyzing the complete human genome. The company's offerings include the MammaPrint Breast Cancer Risk-of-Recurrence Test, and the BluePrint Molecular Subtyping Test, both on microarray technology, whereas the new MammaPrint BluePrint Breast Cancer Recurrence and Molecular Subtyping Kit, is on NGS technology.

The MammaPrint BluePrint next-generation sequencing-based kit is a CE-marked device currently available for use in cancer centers in select regions of the world.

In addition, Agendia has a pipeline of other genomic products in development. The company collaborates with pharmaceutical companies, leading cancer centers and academic groups to develop companion diagnostic tests in the area of oncology. For more information on Agendia or the MammaPrint and BluePrint tests, visit www.agendia.com. Follow Agendia, Inc. on Facebook, Twitter, or LinkedIn to keep up-to-date with the latest news.

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SOURCE Agendia, Inc.

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