- PRIMe trial included 452 women at 27 centers in Germany, Austria, and Switzerland
- Based on the outcome of the MammaPrint test, 28.4% of patients’ treatment plans were changed, compared to conventional clinico-pathological tests; preventing under and overtreatment
- Confidence provided by gene expression-based tests meant that physicians and patients strongly adhered to the results
IRVINE, CA and AMSTERDAM, 15 December 2016 – Agendia, Inc., a world leader in personalized medicine and molecular cancer diagnostics, has presented new prospective data1 demonstrating the strong impact of its 70-Gene Breast Cancer Recurrence assay, MammaPrint®, and the corresponding 80-Gene Molecular Subtyping Assay BluePrint®, in clinical decision-making for patients with early-stage breast cancer in Germany.
The PRospective study to measure the Impact of MammaPrint on adjuvant treatment in hormone receptor-positive HER2-negative breast cancer patients (PRIMe) study was undertaken by the West German Study Group (WSG). It included 452 patients from 27 centers and evaluated the impact of gene expression-based tests MammaPrint and BluePrint, compared to conventional clinico-pathological factors, in deciding whether or not patients would benefit from, and should therefore be treated with adjuvant chemotherapy.
The results, presented at the San Antonio Breast Cancer Conference last week showed a 28.4% change in patients’ treatment plans, originally based on clinico-pathological factors, as a direct result of the data provided by MammaPrint and BluePrint.
Prof. Nadia Harbeck, MD, PhD, PI of the PRIMe study, Scientific Director of the West German Study Group and chair for Conservative Oncology at the Department for OB&GYN of the University of Munich (LMU), Germany, said: “The discordance between conventional clinico-pathological assessment and the results of gene expression-based tests like MammaPrint is substantial. Our study demonstrated that, in Germany, physicians not only welcomed these tests but showed a strong adherence to the test results, even actively changing their previous treatment plans. The > 90% adherence rate to the MammaPrint results regarding adjuvant treatment decisions demonstrated the confidence of physicians in these gene-expression results.”
Bastiaan van der Baan, Chief Clinical and Business Development Officer at Agendia said: “The final analysis of the WSG PRIMe study makes plain the importance of gene expression-based tests like MammaPrint, in giving physicians in Germany, and beyond, the definitive results and the confidence they need to provide the safest and most effective treatment plans for their patients.
“As the data shows, the current clinico-pathological approach leaves a significant number of women in an unpleasant situation where they are under or over-treated. We believe strongly that early-stage breast cancer patients and their physicians in Germany should be able to access the benefits of a gold-standard gene-expression test like MammaPrint, to enable individualized treatment based on quantitative, reliable, genomic data.”
The clinical performance of MammaPrint and its ability to accurately inform and guide treatment decisions was definitively proven by the publication of the MINDACT trial in the New England Journal of Medicine in August. This unique phase III prospective, randomized, controlled study provides the highest level of clinical evidence to MammaPrint (Level 1A), above any other genomic assay, for making adjuvant chemotherapy decisions in early-stage breast cancer. The MINDACT trial included almost 7,000 patients (over 800 from Germany), across 112 institutions in nine different European countries.
1Wuerstlein R, et al. Results of multigene assay (MammaPrint®) and molecular subtyping (BluePrint®) substantially impact treatment decision making in early breast cancer: Final analysis of the WSG PRIMe Decision Impact Study. Poster presented at San Antonio Breast Cancer Symposium. December 2016; San Antonio, Texas.
MammaPrint is a FDA-cleared in vitro diagnostic test, available from FFPE sample, performed in a single laboratory, using the gene expression profile of breast cancer tissue samples to assess a patients’ risk for distant metastasis. The MammaPrint result is indicated for use by physicians as a prognostic marker only, along with other clinical-pathological factors. MammaPrint is not intended for diagnosis, or to predict or detect response to therapy, or to help select the optimal therapy for patients. Results should be taken in the context of other relevant clinical-pathological factors and standard practice of medicine.
Agendia is a privately held, leading molecular diagnostics company that develops and markets FFPE-based 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 FDA-cleared MammaPrint FFPE 70-gene breast cancer recurrence assay as well as BluePrint®, a molecular subtyping assay that provides deeper insight leading to more clinically actionable breast cancer biology. These tests can help physicians assess a patient’s individual risk for metastasis – that is, which patients are more sensitive to chemo, hormonal, or combination therapy, and which patients may not require these treatments and which patients may be treated with other, less arduous and costly methods.
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, visit www.agendia.com
Samantha Schmidt / Jen Lewis / Léon Melens
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