CA-AGENDIA

Agendia, Inc., a world leader in precision oncology for breast cancer, today announced that long-term follow up data from MINDACT, the prospective, randomized trial designed to further confirm the clinical utility of MammaPrint® risk scoring when determining a breast cancer patient’s need for chemotherapy, was published in The Lancet Oncology , and can be viewed online here .

As previously reported at the ASCO conference in May 2020, the European Breast Cancer Conference in October 2020, and highlighted in an oral presentation at SABCS in December 2020, the data published in The Lancet Oncology confirm MINDACT as a positive de-escalation study, and show that nearly half of women who would have received chemotherapy may avoid it and achieve the same excellent results.

Additional key findings include:

• With 5-year data available for 92 percent of enrolled patients, the study’s primary endpoint continued to be met. Distant metastasis free survival (DMFS) at 5 years in women with breast cancer who were clinically-high risk but genomically-Low Risk and were not treated with chemotherapy was 95.1 percent, demonstrating that MammaPrint® Low Risk patients have excellent outcomes without adjuvant chemotherapy.
• The difference in 5-year DMFS between patients in this cohort treated with and without chemotherapy is now a non-significant 0.9 percent, a notable decrease from the 1.5 percent previously reported in the New England Journal of Medicine in 2016.
• When stratifying clinically high risk/MammaPrint Low Risk patients by age, investigators found that for women over 50, there was no difference in DMFS between women who received adjuvant chemotherapy and those who did not, indicating that these patients could safely avoid chemotherapy and achieve the same outcome.
• To the research community, the observations in women 50 years or younger, where there was a 5 percent benefit seen from chemotherapy at 8.7 years, are intriguing and should provoke investigation of the respective merits of chemotherapy or ovarian function suppression through an LHRH analogue in this specific young patient population with a high clinical risk and a Low genomic Risk.
• As presented in 2016, the long -term MINDACT results were consistent for lymph node negative as well as 1-3 lymph node positive patients, showing that a MammaPrint Low Risk classification should be considered Low Risk regardless of other clinical factors, and that patients in this population may forgo chemotherapy.

“We are immensely proud of these results being published in The Lancet Oncology – the longer term follow up clearly shows the utility that MammaPrint provides to clinicians and their patients. In particular, it confirms that Low genomic Risk means Low Risk, and that we can safely de-escalate patients, especially those older than 50 years, who were traditionally treated aggressively, including those with lymph node positive disease,” said Martine Piccart, MD, PhD, Honorary Professor of Oncology at the Université Libre de Bruxelles, Scientific Director at the Institut Jules Bordet, Member of the Breast Cancer Research Foundation’s Scientific Advisory Board, previous president of the EORTC, former president of ESMO and ECCO and the principal investigator of the MINDACT trial. “These findings reinforce that all early breast cancer patients should have access to risk of recurrence testing – it should be considered the standard of care at diagnosis for all women.”

The findings at 8.7 years further demonstrate what was found at 5 years: a Low-Risk MammaPrint® result identifies a subset of breast cancer patients with up to three positive lymph nodes who can successfully forgo adjuvant chemotherapy, regardless of their clinical risk. An “age effect” has now emerged and must be taken into account. These data reinforce the essential need to examine the biology of a tumor before jointly deciding on a treatment path, as the additional insight can be used to optimize treatment strategy for patients of any age.

“There has been growing interest from across the breast cancer community in understanding the chemotherapy benefit seen for pre-menopausal women,” said Laura van’t Veer, PhD, Co-founder and Chief Research Officer at Agendia. “There is great value in exploring this trend and its connection to ovarian suppression, and in ensuring all women – no matter their age – have access to genomic testing, as it will ultimately allow doctors and their patients to consider all possible options based on their confirmatory genomic profile as part of an informed treatment plan.”

By using MammaPrint and BluePrint to gain an understanding of the biology of a patient’s tumor, physicians are able to confidently determine the need for chemotherapy, endocrine therapy and the timing for surgery. These long-term follow up data confirm the clinical utility of MammaPrint in the post-operative treatment setting and underscore Agendia’s commitment to improving patient outcomes.

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.

Agendia develops evidence-based novel genomic tests and forges partnerships with groundbreaking companies to develop next-generation digital treatment tools. The ongoing research builds an arsenal of data that 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 to inform pre- and post-operative treatment decisions. For more information on Agendia’s assays and ongoing trials, please visit www.agendia.com .

About the MINDACT Trial

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 of the Breast International Group 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 46 percent of clinically high risk patients, those with a MammaPrint® Low Risk result, could forgo chemotherapy without negatively affecting their outcomes.

View trial information here .

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