In three new studies presented at the recent annual meeting of the American Society of Clinical Oncology (ASCO)
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A multicentre trial has demonstrated that MammaPrint identified 30 % of patients with low-risk more genomic testing 21 genes, with an excellent DMFS (Distant Metastasis Free Survival) at 5 years (98.5 per cent).
The test data I-SPY-2 show that the addition of pembrozilimab (immunotherapy) to neo-adjuvant treatment standard improves the “pathologic complete response” (CPR) in patients with hormone-receptor-positive (HR+) and identified at high risk by MammaPrint.
The follow-up data of the study MINDACT comparing treatment with chemotherapy classical Anthracyclines (AT) with an experimental protocol of docetaxel and capecitabine (DC), shows no significant difference between the two types of treatment.
IRVINE, CA and AMSTERDAM – June 13, 2017 – Agendia Inc., a global leader in the personalized medicine and molecular diagnostics of cancer, focusing on the three studies presented at the recent annual meeting of the American Society of Clinical Oncology (ASCO) in Chicago (2 to 6 June). These studies enrich the scientific data confirming the clinical utility of MammaPrint® prognostic test for breast cancer recurrence, developed by Agendia.
1 – Dr. David Dabbs, et al, presented the results of the stratification of the risk of breast cancer recurrence determined by the expression signature of 70 genes (MammaPrint of Agendia) and, secondly, by the signature of expression of the 21 genes in the context of a large multicenter analysis.
The results demonstrate that the signature of 70 genes from Agendia (MammaPrint) allowed us to identify 30 % of patients with low-risk more genomic testing 21 genes, and this, without impacting the prognosis of patients, since the DMFS in these patients is 98.5% at 5 years. The signature of 70 genes was used to detect 30 % of patients with high-risk genomic more. When the results of the two tests were discordant among patients having presented an event with metastatic distance or who died, 72 % of the cases were correctly classified in the category of high risk by the signature of 70 genes compared to 0 % (zero) of cases classified correctly by the test of the 21 genes.1
“To take the decision to prescribe chemotherapy in a patient with breast cancer is a difficult decision and a tricky one for a doctor,” recalls Dr. William Audeh, ” It is important that patients are informed of the different options available to them and help the doctors in making this decision. In this sense, MammaPrint is now the only test with the level of utility the higher offering this possibility. ”
2 – Results of the multicenter I-SPY-2 Rita Nanda et al., studying the impact of the addition of the immunotherapy anti-PD-1 (pembrolizumab) for the treatment of neo-adjuvant standard on the pathologic complete response (PCR) in a cohort of patients HR+ identified as high-risk by MammaPrint. It has been shown that the addition of pembrolizumab in the neo-adjuvant standard improves CPP in all cases of breast cancer HER2-negative trial I-SPY-2. This is the first time that an agent is retained for evaluation in a phase III trial in patients with HR+/HER2-.2
3 – follow-up Results of the prospective study, and randomized controlled MINDACT (Microarray In Node-negative and 1 to 3 positive lymph node Disease may Avoid Chemotherapy), published in the medical journal New England Journal of Medicine in August 2016 by Fatima Cardoso et al., This follow-up was the cohort of patients who received treatment with chemotherapy and were randomized. The randomization was designed to compare the therapeutic protocol classic by anthracyclines (AT) with an experimental treatment by the association of docetaxel and capecitabine is taken orally (DC). The results showed that the treatment of type DC did not improve the clinical outcome of patients compared to treatment by AT, including in patients at clinical high risk and high-risk genomic according to MammaPrint.3
For Dr. William Audeh, Medical Director of Agendia, ” The abundance of data presented at ASCO 2017 evidenced by the many applications of the test MammaPrint to improve the care of patients with breast cancer at early stage. The latest data of the MINDACT are of particular interest because they demonstrate that patients randomized into the group in need of chemotherapy by the test MammaPrint, had excellent rates of survival at five years, they have been processed according to the classic standard of care or by a protocol of chemotherapy experimental. ”
“The efficacy data from trial I-SPY 2, which corroborates the usefulness of MammaPrint for individualized patient care protocol in the framework of a neoadjuvant treatment offer good prospects,” says Dr. William Audeh.
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; And Chicago, Illinois.
2 Pembrolizumab over standard neoadjuvant therapy for high-risk breast cancer (BC): Results from I-SPY 2. Poster presented at the ASCO Annual Meeting. June 2017; And Chicago, Illinois.
3 Cardoso F, et al, is a Standard anthracycline-based versus 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; And Chicago, Illinois.
MammaPrint® test is an in vitro diagnostic approved by the FDA and which has also obtained the CE mark. Made from tumor samples, it allows to assess the risk of distant metastases at 5 years. MammaPrint® is indicated to be used by doctors as a marker for prognosis in conjunction with other clinico-pathological factors. The information obtained by MammaPrint® promote the therapeutic care, but do not determine the outcome of the disease, or the prediction of the response of each patient to the treatment.
Agendia is a privately held company, number one in molecular diagnostics, which develops and sells products of genomic tests to a diagnostic to promote the personalised therapeutic cancer patients, especially in the most difficult cases. The development of tests for breast cancer of Agendia is based on an objective selection of genes, based on the analysis of the whole genome. Agendia offers MammaPrint®, a test in the prognosis of breast cancer recurrence, which analyzes the expression signature of 70 genes and BluePrint®, a test for molecular subtyping, which provides a better understanding of the biology of breast cancer, allowing the adoption of clinical measures much more nuanced.
Agendia develops other genomic signatures in cancer. The company cooperates with pharmaceutical companies, international research centres of excellence in cancer and academic groups to develop companion diagnostic tests in oncology, more efficient.
For more information on Agendia, or the tests MammaPrint and BluePrint, please do not hesitate to visit the website of Agendia reserved for patients to the address www.KnowYourBreastCancer.com or the website of the company at the address www.agendia.com.
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