December 23, 2019

PROMIS study findings presented at SABCS 2019

PRESS RELEASE

New Data Compare Genomic Profiling Results for Premenopausal Women with Early-Stage Breast Cancer

 

IRVINE, CALIF., U.S., and AMSTERDAM, NETHERLANDS, December 12, 2019 – Agendia, Inc., a world leader in precision oncology for breast cancer, announced today new data comparing genomic profiling results for patients under the age of 50 with early-stage breast cancer. The data, which are being presented for the first time today at the 2019 San Antonio Breast Cancer Symposium (SABCS), show that the MammaPrint 70-gene assay may more effectively identify premenopausal women who may safely avoid chemotherapy.

One of the biggest challenges physicians face when treating patients with early stage, curable breast cancer is choosing a treatment path that will mitigate the risk of disease recurrence, while avoiding over- or undertreatment. Genomic profiling has helped address this clinical need but recent findings suggest age may impact the veracity of results for some assays. A follow up to the TAILORx study published in 2018 showed that, especially for those breast cancer patients age 50 and under with a breast cancer recurrence score (RS) of 16-25 by the 21-gene assay, clinical risk assessment is critical in determining treatment strategy. However, treatment strategy for patients with a 21-gene assay RS of 21-25 has remained unclear.

“There is increasing evidence that factors such as age, menopausal status and ethnicity can meaningfully impact prognosis and response to treatment among women with breast cancer,” said William Audeh, MD, MS, chief medical officer, Agendia. “Understanding whether certain populations will benefit from chemotherapy is a critically important question that has needed further exploration and clarification.”

The Agendia Prospective Study of MammaPrint in Breast Cancer Patients with an Intermediate Recurrence Score (PROMIS) trial previously demonstrated that the MammaPrint test, which provides a binary, High Risk or Low Risk of recurrence, delivers clinically actionable results for patients who receive an intermediate RS of 18-30 by the 21-gene assay.

The findings presented today at SABCS represent a sub-analysis of the PROMIS data, which Agendia conducted to help determine the potential of the MammaPrint test to clarify adjuvant chemotherapy decisions for premenopausal women age 50 and under with early-stage breast cancer and an intermediate RS by the 21-gene assay.

For this sub-analysis, researchers determined MammaPrint risk of recurrence for 840 women with intermediate RS by the 21-gene assay (18-30). Researchers also assessed clinical risk (clin-low/clin-high) using the MINDACT modified Adjuvant!Online Algorithm. Women with MammaPrint High and Low Risk classifications were then subdivided by RS groups 18-20, 21-25, and 26-30 and by clinical risk stratification (n=181).

Results – which are statistically significant – demonstrate that 58 percent of women age 50 and under with RS 18-20 and 46 percent of those with RS 21-25 are categorized as MammaPrint Low, indicating that they may safely forgo chemotherapy. Additionally, 15 percent of women with RS 26-30 were found to be MammaPrint Low Risk and may be potential candidates for de-escalation of adjuvant chemotherapy.

“These data suggest that making clinical decisions based on recurrence score alone in this patient population may lead to overtreatment with chemotherapy,” said Dr. Audeh. “Further studies should evaluate the integration of MammaPrint classification to inform treatment decisions among premenopausal women age 50 and under with intermediate recurrence scores by the 21-gene assay.”

“Treatment recommendations in ER+ patients <50 years: Comparison of the 21-gene assay and 70-gene signature in the PROMIS study” can be found here » 

About Agendia
Agendia is a molecular diagnostics company committed to improving clinical outcomes and informing the journey for patients with early stage breast cancer. The company currently offers two commercially-available genomic profiling tests, processed through its state-of-the-art facility in Irvine, California. Agendia also provides a next generation sequencing kit for use by local laboratories outside of the United States.

MammaPrint®, the 70-gene breast cancer recurrence assay, is the first FDA-cleared risk-of-recurrence test backed by peer-reviewed, prospective outcome data and included in both national and international treatment guidelines. BluePrint®, the 80-gene molecular subtyping assay, is a 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, Agendia aims to support the evolving clinical needs of breast cancer patients and their physicians.

Agendia’s assays can be ordered on core biopsies or surgical specimens with results provided in as little as 5-7 days 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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