Analysis of MINDACT Study Confirms MammaPrint Accurately Identifies Extremely Indolent Ultra Low Risk Breast Cancers

Oral presentation at ASCO 2021 highlights long term data with higher than 99% 8-year breast cancer specific survival for patients with MammaPrint Ultra Low Risk status regardless of clinical risk

Agendia, Inc., a world leader in precision oncology for breast cancer, today announced that data from the landmark MINDACT study will be shared at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting in an oral presentation. The presentation will detail an additional risk threshold previously established within the MammaPrint Low Risk category, identifying patients with an Ultra Low Risk of distant recurrence, essentially meaning the patient’s tumor is very unlikely to recur or metastasize over at least 20 years of follow-up, according to prior studies. This information could be helpful in further tailoring adjuvant treatment for patients with early stage breast cancer.

In the oral presentation, titled “Outcome of patients with an ultralow risk 70-gene signature in the MINDACT trial,” Josephine Lopes Cardozo, MD, first author of the abstract, PhD Candidate at the Netherlands Cancer Institute and fellow at the EORTC, will outline that in the MINDACT study, patients with an UltraLow Risk signature have an excellent prognosis, with 8-year breast cancer specific survival above 99% regardless of clinical risk status, and an 8-year distant metastasis free interval of 97%. The presentation, part of ASCO 2021’s Breast Cancer track, can be accessed here.

“The Ultra Low threshold identifies patients who may be candidates for further de-escalation of treatment,” said Dr. Lopes Cardozo. “To give the patient’s care team this kind of prognostic insight at the time of diagnosis will hopefully allow for many patients to avoid over treatment and further reduce the risk of side effects while maintaining excellent survival.”

The MINDACT trial, an independent, phase III, prospective, randomized clinical trial sponsored by the European Organization for Research and Treatment of Cancer (EORTC), was conducted with the primary goal of determining whether Agendia’s 70-gene MammaPrint^® test could be used to de-escalate clinically high risk patients with early stage breast cancer from chemotherapy treatment. The study enrolled nearly 7,000 patients with newly-diagnosed breast cancer, and at median long-term follow-up of 8.7 years, 46% of clinically high risk patients with a MammaPrint Low Risk result could forgo chemotherapy without negatively affecting their outcomes. These data were recently published in The Lancet Oncology.

The current study to be presented at ASCO focuses on the clinical characteristics and outcomes of the 1,000 women with a MammaPrint Ultra Low risk status enrolled in MINDACT. Consistent with three prior studies presented since 2017, these data show a nearly 100% breast cancer specific survival at 8 years, with 5 years of anti-estrogen therapy, and excellent outcomes (97.8% DMFI) for the 157 Ultra Low Risk women who received no systemic therapy.

“The confirmation of the clinical importance and excellent prognosis of the MammaPrint Ultra Low Risk category provides further support for the inclusion of this information in the management of endocrine therapy, particularly for those women experiencing severe side effects, and struggling to remain on their prescribed treatment,” said William Audeh, MD, Chief Medical Officer at Agendia. “We are extremely proud to have contributed to the EORTC’s MINDACT study, which has influenced the clinical treatment of patients and will inspire ongoing translational research that will contribute to the library of data we need to personalize the treatment of breast cancer.”

Beyond answering the traditional adjuvant chemotherapy question, the MINDACT study continues to produce a wealth of insights with immediately meaningful clinical implications and access to an unprecedented full genome dataset for further research, resulting in widespread health system cost savings.

At ASCO 2021, Agendia also presented a larger suite of data from the company’s groundbreaking FLEX registry, a large-scale, prospective, observational breast cancer study using whole transcriptome sequencing, recruiting patients from various ethnicities, ages and genders representative of the total breast cancer population as part of an ongoing effort to increase representation of diverse populations and data in clinical trials.

About Agendia

Agendia is a precision oncology company headquartered in Irvine, California, committed to bringing patients with early stage breast cancer 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 patients with breast cancer 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.

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