• First time 10-year prospective outcome data confirms clinical utility of MammaPrint for lymph node-negative and lymph node-positive patients
  • MINDACT sub-study shows that even tumors less than 1cm in size can be aggressive with 24% reclassified by MammaPrint from low risk based on clinico-pathological factors to High Risk

 
IRVINE, CA and AMSTERDAM – 13 September 2017 – Agendia, Inc., a world leader in personalized medicine and molecular cancer diagnostics, announces three important studies presented at the 2017 ESMO Congress in Madrid earlier this week.
Two posters provided impressive 10-year outcome data, confirming the prognostic value of the MammaPrint® 70-Gene Breast Cancer Risk-of-Recurrence Test for both lymph node-negative and lymph node-positive patients, based on findings from the observational MicroarRAy prognoSTics in breast cancER (RASTER) trial.
This is the first time that 10-year data for MammaPrint has been reported in a prospective trial and the first time that data from lymph node-positive RASTER patients have been considered. This demonstrates the long-term outcome and clinical benefit of using MammaPrint to help patient management decisions for early-stage breast cancer patients, independent of lymph-node status.
10 years follow up of the RASTER study; implementing a genomic signature in daily practice1
Dr. Sonja Vliek of the Netherlands Cancer Institute presented 10-year distant recurrence-free interval (DRFI) follow-up data for the original 427 patients from the RASTER study. Patients identified as having a Low Risk of cancer recurrence by MammaPrint had an excellent prognosis with a DRFI of 93.7% 10 years after diagnosis, confirming the prognostic utility of the test.
The 70-gene signature in node-positive breast cancer; 10 years follow-up of the observational RASTER study2
10-year follow-up data for 164 lymph node-positive patients from the RASTER study were also reported for the first time. MammaPrint Low Risk patients with 1-3 affected lymph nodes had an excellent prognosis with a 10-year DRFI of 94.9%, MammaPrint High Risk patients had a 10-year DRFI of 80.7%. Adding MammaPrint reclassified 34% of patients with 1-3 affected lymph nodes from high risk of recurrence based on clinico-pathological factors alone to genomic Low Risk of recurrence, this group having a 10-year DRFI of 95.2% after chemotherapy.
Overall, these 10-year findings confirm MammaPrint’s value in predicting recurrence in patients with early-stage lymph node-positive breast cancer and demonstrate that adding a genomic signature to clinico-pathological assessment is the most effective way to individualize treatment.
Dr. William Audeh, Chief Medical Officer at Agendia, said:
“The landmark MINDACT trial published in 2016 proved the clinical utility of MammaPrint as a prognostic tool in identifying genomic Low Risk patients who have no significant benefit of chemotherapy with the highest level of evidence and five years’ follow up.3 We are very pleased to now see this excellent outcome data from RASTER which provides prospective evidence to confirm the value of MammaPrint in determining risk-of-recurrence, 10 years after diagnosis.
“The ability of MammaPrint to add proven, objective, genomic information to clinico-pathological factors is invaluable in enabling patients and their physicians to make confident and informed treatment management decisions, personalizing care and avoiding over- and under-treatment for early-stage breast cancer.”
The presentation of the 10-year RASTER data closely follows news of MammaPrint’s inclusion in the American Society of Clinical Oncology (ASCO) breast cancer clinical practice guidelines in July as the only test of its kind recommended for both lymph node-positive and lymph node-negative patients, in a dedicated update based on a review of the MINDACT data.
Not all small node negative (pT1abN0) breast cancers are similar: Outcome results from an EORTC 10041/BIG 3-04 (MINDACT) trial substudy4
A sub-study of the MINDACT trial was also presented by the European Organization of Research and Treatment of Cancer (EORTC), which managed and sponsored MINDACT. The sub-analysis included 826 patients with a primary tumor size of less than 1cm. Of these, 196 were clinical low risk and genomic High Risk with MammaPrint. These patients were randomized to receive or not to receive chemotherapy and 24% were identified by MammaPrint to have a High Risk profile, and were found to benefit from chemotherapy.
These findings demonstrate that not all small tumors are alike and that early breast cancer patients who may benefit from chemotherapy can be safely identified by combining clinico-pathological assessment with MammaPrint.
 
1) Vliek S, et al. 10 years follow up of the RASTER study; implementing a genomic signature in daily practice. Poster presented at ESMO Congress. September 2017; Madrid, Spain
2) Vliek S, et al. The 70-gene signature in node-positive breast cancer; 10 years follow-up of the observational RASTER study. Poster presented at ESMO Congress. September 2017; Madrid, Spain
3) Cardoso F, van’t Veer LJ, Bogaerts J et al. 70-Gene Signature as an Aid to Treatment Decisions in Early-Stage Breast Cancer. N Engl J Med 2016; 375: 717-29.
4) Tryfonidis K, et al. Not all small node negative (pT1abN0) breast cancers are similar: Outcome results from an EORTC 10041/BIG 3-04 (MINDACT) trial substudy. Presentation at ESMO Congress. September 2017; Madrid, Spain

– Ends –

About MammaPrint
MammaPrint is an 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. MammaPrint is cleared by the US FDA and 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.
About Agendia
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 the MammaPrint® 70-Gene Breast Cancer Risk-of-Recurrence Test, and the BluePrint® Molecular Subtyping Test 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.
For more information on Agendia or the MammaPrint and BluePrint tests, you can visit Agendia’s patient site at www.KnowYourBreastCancer.com or the corporate site at www.agendia.com.
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