Agendia Presents New Data Demonstrating Clinical Utility for MammaPrint and BluePrint at the 2020 European Breast Cancer Conference Virtual Event

Presentations to include follow-up MINDACT study data and evaluations on the use of MammaPrint to guide treatment decisions in lobular cancers and for screen-detected breast cancers versus interval-detected breast cancers

IRVINE, Calif., Oct. 2, 2020 /PRNewswire/ -- Agendia, Inc., a world leader in precision oncology for breast cancer, today announced the presentation of four studies at the 12^th European Breast Cancer Conference (EBCC-12). The data include a poster on further stratification of subtyping with BluePrint in breast cancer, as well as oral presentations that focus on the MINDACT trial, with a general trial update and in-depth analyses on screen- versus interval-detected breast cancers and the use of MammaPrint to evaluate lobular cancers.

Following are the four data sets accepted to the EBCC-12, which can be found at www.conferences.eortc.org/ebcc12:

• Screen-detected breast cancers have different tumor biology and better prognosis compared to interval breast cancers (Presentation #ORAL-011, 12:50-1:00PM CEST, 3 October)
• Clinical Utility of MammaPrint testing in Invasive Lobular Carcinoma: Results from the MINDACT phase III trial (Presentation #ORAL-007, 1:50-2:00PM CEST, 2 October)
• Updated results of the MINDACT trial: 70-gene signature to guide de-escalation of chemotherapy in early breast cancer (Presentation #ORAL-021, 1:00-1:10PM CEST, 3 October)
• BluePrint Molecular Subtyping Recognizes Single and Dual Subtype Tumors with Implications for Therapeutic Guidance (Abstract #518, Poster Session B, 2 October)

Oral presentations for MammaPrint focused on sub-studies within the 9-year follow-up data for the ground-breaking MINDACT study. These data included:

• An evaluation of the association between tumor biology and survival by mode of detection, which found that while both screen-detected and interval breast cancers showed very good 8-year DMFI rates, in patients with MammaPrint High Risk tumors, there was a significant difference in DMFI between screen- and interval-detected cancers. The results suggest that combining MammaPrint and the cancer detection method may improve risk stratification of patients with early stage breast cancer.
• An analysis that showed that MammaPrint is a clinically useful test for patients diagnosed with invasive lobular carcinoma, the second most common histological subtype of breast cancer. In this evaluation, MammaPrint classified 16% of lobular tumors as genomically High Risk, for which more aggressive treatment would be recommended. In contrast, the assay classified 38% of this type of cancer as genomically Low Risk, for which the standard should be omission of chemotherapy even if the patient is clinically high risk. These data reinforce MammaPrint's ability to help facilitate treatment decisions based on the biology of a tumor.

In addition, new data in a general MINDACT follow up was presented by Emiel Rutgers, M.D., Ph.D., FRCS, Chair and Professor in Surgical Oncology at the Netherlands Cancer Institute. The analysis confirmed the clinical utility of MammaPrint, with the data shown at EBCC-12 confirming that a MammaPrint Low Risk score can guide de-escalation of adjuvant chemotherapy in patients with clinically high risk breast cancer.

Finally, an Agendia-led study found that a small proportion of tissue samples (about 2%), when evaluated by the molecular subtyping test BluePrint, will display a dual genomic subtype instead of the typical single subtype. This secondary or even tertiary subtype, in some cases, has specific genomic characteristics that may help physicians understand the deeper biology of these tumors and the possible implications for treatment.

"These data are evidence of Agendia's continuing commitment to support research to further our knowledge of breast cancer, for optimal patient care," said William Audeh, M.D., M.S., Chief Medical Officer at Agendia. "We are proud to share these multi-faceted data with the researchers, physicians, and advocates who will attend EBCC-12 and apply this information to improve treatment outcomes for their patients."

The variety of data accepted for inclusion at EBCC-12 underscore Agendia's commitment to the pursuit of research that will allow for breast cancer patients and their care teams to confidently make the most personalized treatment decisions.

About MINDACT

MammaPrint, the 70-gene risk of recurrence assay for patients with early-stage breast cancer, is supported by level 1A clinical evidence from MINDACT, a landmark trial sponsored by the EORTC (EORTC-10041/BIG3-04). The study found that clinically high-risk patients with a MammaPrint Low Risk result could safely de-escalate treatment and forgo chemotherapy. Long-term follow-up data from MINDACT, presented at the 2020 Annual Meeting of the American Society of Clinical Oncology (ASCO), confirmed and built upon the findings published in the New England Journal of Medicine in 2016.

The MINDACT trial enrolled 6,693 breast cancer patients. At the five-year follow-up mark, the trial showed that tumor analysis and reclassification by the MammaPrint 70-gene expression signature enabled a 46 percent reduction in the use of chemotherapy for clinically high-risk patients that were reclassified by the genetic assay to be genomically Low Risk. Nine-year follow-up data will be published in depth later this year, and further validate MINDACT as a positive de-escalation study for chemotherapy and continues to demonstrate MammaPrint's clinical utility when determining a breast cancer patient's need for chemotherapy.

View trial information here.

About Agendia

Agendia is a precision oncology company headquartered in Irvine, California, committed to bringing early stage breast cancer patients and their physicians the information they need to make the best decisions for the full treatment journey. The company currently offers two commercially-available genomic profiling tests, supported by the highest levels of clinical and real world evidence that provide comprehensive genomic information that can be used to identify the most effective breast cancer treatment possible for each patient.

MammaPrint®, the 70-gene breast cancer recurrence assay, is the only FDA-cleared risk of recurrence test backed by peer-reviewed, prospective outcome data and inclusion in both national and international treatment guidelines. BluePrint®, the 80-gene molecular subtyping assay, is the only 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 and conducting groundbreaking research while building an arsenal of data that will help treat breast cancer, Agendia aims to improve patient outcomes and support the evolving clinical needs of breast cancer patients and their physicians every step of the way, from initial diagnosis to cancer-free.

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

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SOURCE Agendia