• New data from the I-SPY 2 trial highlights residual cancer burden as a prognostic indicator for long-term outcomes in patients pre-selected using MammaPrint
  • NBRST trial reports three-year patient outcomes showing that the use of MammaPrint and BluePrint testing in the neoadjuvant setting can help indicate improved outcomes and survival in patients with a specific subtype of breast cancer

IRVINE, CA, AMSTERDAM, NETHERLANDS – 29 May 2018 – Agendia, Inc., a world leader in precision oncology, announced two studies scheduled to be presented at the American Society of Clinical Oncology (ASCO) Annual Meeting on Saturday, June 2, 2018. New results from the I-SPY 2 and NBRST trials highlight the importance of implementing Agendia’s MammaPrint 70-Gene Breast Cancer Risk of Recurrence and BluePrint 80-Gene Molecular Subtyping tests to inform personalized treatment decisions for early-stage breast cancer patients.
Residual cancer burden (RCB) as prognostic in the I-SPY 2 Trial (Abstract 520: Poster Session: Saturday, June 2, 8:00-11:30 a.m. CDT, Hall A, Poster Board #12; Poster Discussion Session: Saturday, June 2, 3:00-4:15 p.m. CDT, Hall D1)1

I-SPY 2 is a neoadjuvant Phase II study. A MammaPrint High Risk result as prerequisite for patients included in the trial which aims to establish which new targeted drug agents are most effective with which types of breast cancer tumors by learning more about which early indicators of response are predictors of treatment success.

Follow-up results from the I-SPY 2 trial will show that residual cancer burden (RCB) is a prognostic indicator for overall outcomes in patients pre-selected by MammaPrint. RCB quantifies the amount of residual cancer in patients who did not achieve pathologic complete response (pCR), which is defined as the complete absence of cancer after neoadjuvant therapy. Overall, estimates of three-year event free survival (EFS) for patients in the four RCB classes (pCR=RCB-0, RCB-I, RCB-II, RCB-III) are 94%, 87%, 80%, and 62%, respectively. These findings support the use of RCB as a prognostic measure in predicting long-term health outcomes in patients with high-risk breast cancer.

Pathological complete response in basal subtype tumors predicts improved distant metastasis free survival in the NBRST trial. (Abstract 590: Poster Session: Saturday, June 2, 8:00-11:30 a.m. CDT, Hall A, Poster Board #82)2

The prospective, observational NBRST trial included 1,072 eligible patients enrolled from June 2011 to December 2014. The long-term follow-up of these neoadjuvant-treated patients will be reported. Patients who had a pCR have significantly better 3-year distant metastasis-free interval (DMFI) (P<0.001) than those patients with residual disease (RD).

In particular, Basal-type patients with a pCR showed significantly better 3-year DMFI than those with RD (DMFI 94% vs. 68% respectively, HR 0.13, 95% CI: 0.048-0.36, p<0.001). Additionally, long-term follow-up showed that Low Risk Luminal A patients did not significantly benefit from neoadjuvant chemotherapy but do have an exceptional 3-year DMFI.

Using MammaPrint and BluePrint together identified which molecular subtypes (Basal, HER2, High Risk Luminal B and Low Risk Luminal A) were most responsive to neoadjuvant chemotherapy by both pCR rate and long-term survival.

Dr. William Audeh, Chief Medical Officer at Agendia, said:
“The new data from the I-SPY 2 and NBRST trials presented at ASCO show that pCR is a useful predictor of improved patient outcomes and provide further evidence supporting the benefits of MammaPrint and BluePrint testing in the neoadjuvant setting. These findings add to the wealth of data demonstrating the clinical utility and versatility of MammaPrint and BluePrint. The essential, unique genomic information provided by these tests supports physicians and their patients in making personalized treatment management decisions.”

1. Residual cancer burden (RCB) as prognostic in the I-SPY 2 Trial. Poster presented at ASCO. June 2018; Chicago, Illinois.
2. Pathological complete response in basal subtype tumors to predict improved distant metastasis free survival in the NBRST trial. Poster presented at ASCO. June 2018; Chicago, Illinois.

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About MammaPrint®
MammaPrint is an in vitro diagnostic medical device, performed as a testing service in a central laboratory, using the 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. 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.

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.

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 molecular diagnostics 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. Agendia’s offerings include the MammaPrint® 70-Gene Breast Cancer Risk-of-Recurrence Test, and the BluePrint® Molecular Subtyping Test, both on microarray technology, and the new MammaPrint BluePrint Recurrence and Molecular Subtyping test, on NGS technology.

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, you can visit Agendia’s patient site at www.KnowYourBreastCancer.com or the corporate site at www.agendia.com.

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Media Contacts:
Weber Shandwick
Jacqueline Karis