On October 2, 2020 Agendia, Inc., a world leader in precision oncology for breast cancer, reported the presentation of four studies at the 12th European Breast Cancer Conference (EBCC-12) (Press release, Agendia, OCT 2, 2020, View Source [SID1234567987]). 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.

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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) (Free ASCO Whitepaper), 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.