IRVINE, Calif. & AMSTERDAM--(BUSINESS WIRE)--Agendia, Inc., a world leader in personalized medicine and molecular cancer diagnostics, today announced further details on three studies presented at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago earlier this week. These studies further demonstrate the clinical utility of Agendia’s MammaPrint® 70-Gene Breast Cancer Risk-of-Recurrence Test.
A scientific presentation by David Dabbs et al. compared breast cancer risk stratification using the MammaPrint 70-gene signature, and the 21-gene signature in a large multi-center analysis. The results demonstrated that the 70-gene signature identified 30% more Low Risk patients than the 21-gene signature with fewer distant metastases and deaths resulting in an excellent 5-year distant metastasis free interval (DMFI) of 98.5%. Furthermore, the MammaPrint 70-gene signature detected 30% more high risk patients. Among the patients who had a distant event or death, when the two tests provided discordant results, the 70-gene signature correctly predicted a High Risk classification in 72% of the cases compared to 0% (zero) correct for the 21-gene assay.1
“The decision to use chemotherapy for the treatment of early breast cancer is one of the most challenging decisions that we face as physicians,” said Dr. William Audeh, Chief Medical Officer at Agendia. “We believe that it is important for patients to know what their options are and to work with their physician to make their treatment decision with confidence. For patients with early-stage breast cancer, MammaPrint is the only test with the highest level of evidence (Level 1A), to help physicians make the critical decision that chemotherapy might not be part of the treatment management plan.”
A second scientific presentation reported results from the I-SPY 2 multi-center trial. Rita Nanda et al. investigated how adding the anti-PD-1 immunotherapy, pembrolizumab, to standard neoadjuvant treatment impacted pathological complete response (pCR) rate in a selected HR+ MammaPrint High Risk patient cohort. The results demonstrated that adding pembrozilimab to standard neoadjuvant therapy improved pCR rates in all HER2 negative breast cancers within the I-SPY 2 trial, and marks the first time that an agent has graduated to phase III in HR+/HER2- patients.2
The third scientific presentation reported follow-up results for the landmark prospective, controlled, randomized Microarray In Node-negative and 1 to 3 positive lymph node Disease may Avoid ChemoTherapy (MINDACT) trial published in the New England Journal of Medicine in August 2016. Fatima Cardoso et al. analyzed the patient cohort within the trial who received and were randomized to chemotherapy. The optional randomization compared standard anthracycline-based regimens (AT) in the control arm to an experimental docetaxel + oral capecitabine (DC) regimen.
This study found that in all study endpoints, DC did not improve patient outcomes compared to AT, including those patients that were in the concordant clinical high risk/MammaPrint High Risk arm of trial.3
According to Dr. Audeh, “The breadth of data presented at ASCO this year is testament to the many valuable applications of the MammaPrint test in improving how patients with early-stage breast cancer are managed. Of particular interest is the new data from MINDACT which demonstrated that patients with MammaPrint High Risk results that were randomized to receive chemotherapy showed good survival at five years whether they had received a standard chemotherapy regimen, or an experimental regimen. These are higher rates of response than previously seen in immunotherapy trials in ER positive cancer, and may be due to the selection of only MammaPrint High Risk patients. It is also encouraging to see the efficacy data from the I-SPY 2 trial which explores MammaPrint’s utility in aiding to tailor treatment in the neoadjuvant setting.”
1 Multi-institutional comparison of breast cancer risk stratification by 70-gene signature and 21-gene assay. Poster presented at the ASCO Annual Meeting. June 2017; Chicago Illinois.
2 Pembrolizumab plus standard neoadjuvant therapy for high-risk breast cancer (BC): Results from I-SPY 2. Poster presented at the ASCO Annual Meeting. June 2017; Chicago, Illinois.
3 Cardoso F, et al. Standard anthracycline-based vs. docetaxel-capecitabine in early breast cancer: Results from the chemotherapy randomization (R-C) of EORTC 10041/ BIG 3-04 MINDACT phase III trial. Poster presented at ASCO Annual Meeting. June 2017; Chicago, Illinois.
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MammaPrint is a FDA-cleared in vitro diagnostic test, performed in a central laboratory, using the gene expression profile of breast cancer tissue samples to assess a patients’ risk for distant metastasis within 5 years. MammaPrint also carries the CE Mark which certifies that the test complies with the quality standards set by the European In Vitro Diagnostic Directive, enabling the use of the test in the European Union. MammaPrint is indicated for use by physicians as a prognostic marker only, along with other clinical-pathological factors. The test is not intended to determine the outcome of disease, nor to suggest or infer an individual patient’s response to therapy.
Agendia is a privately held, leading molecular diagnostics company that develops and markets genomic diagnostic products, which help support physicians with their complex treatment decisions. Agendia’s breast cancer tests were developed using an unbiased gene selection by analyzing the complete human genome. Our offerings include MammaPrint®, a 70-Gene Breast Cancer Risk-of-Recurrence test, and BluePrint®, a Molecular Subtyping Assay that provides deeper insight leading to more clinically actionable breast cancer biology.
In addition, Agendia has a pipeline of other genomic products in development. The company collaborates with pharmaceutical companies, leading cancer centers and academic groups to develop companion diagnostic tests in the area of oncology.