IRVINE, Calif. & AMSTERDAM--(BUSINESS WIRE)--Agendia, Inc., a world leader in personalized medicine and molecular cancer diagnostics, announces that the company’s MammaPrint® 70-Gene Breast Cancer Risk-of-Recurrence test is now included with the highest medical evidence level 1A in the latest version of AGO (German Association of Gynecological Oncology) guidelines for the care of breast cancer patients in Germany.
AGO is a joint expert group of the German Society for Gynecology and Obstetrics e. V. and the German Cancer Society. The expert group publishes a yearly update for cancer clinicians entitled “Diagnosis and Treatment of Patients with Primary and Metastatic Breast Cancer”. In the March 2, 2017 Guideline, AGO Mamma Commission addresses genomic testing, including Agendia’s MammaPrint test which is supported with the highest medical evidence level 1A for the identification of patient subgroups with a low genomic risk of recurrence to justify withholding potentially unnecessary chemotherapy.1 Although other tests were described by the AGO, MammaPrint currently remains the only test that has reported positive primary objective results from a phase 3, prospective trial where patients were randomized to chemotherapy vs no chemotherapy, which is the critical clinical utility question these tests must answer. MammaPrint has achieved clinical validation with the pivotal MINDACT trial which randomized patients to chemotherapy versus no chemotherapy based on the genomic test result, establishing the only Level 1A clinical evidence for patient treatment decisions based on the 70-gene genomic test result even in the presence of a high risk clinical assessment. The results of this landmark trial showed that a large number of women with breast cancer could be spared chemotherapy and still achieve excellent outcomes, free of recurrent disease.2
Dr. William Audeh, Chief Medical Officer of Agendia said: “The AGO’s positive recognition of the patient benefit of MammaPrint is a further validation of the clinical utility that MammaPrint provides for making treatment decisions and improving outcomes for women with early stage breast cancer with a high risk clinical assessment and the possible indication for chemotherapy. It is encouraging to see yet another professional cancer organization recognize the significant value that MammaPrint can bring to making evidence-based clinical decisions about the treatment of breast cancer. Furthermore, MammaPrint is currently the only test that provides physicians and patients guidance in making treatment management decisions that truly add de novo molecular information to the clinical assessment”
The AGO guidelines referenced the MINDACT trial, a phase 3, prospective, randomized trial including nearly 7,000 patients, across 112 institutions in nine countries was published in the prestigious New England Journal of Medicine in August 2016. The trial demonstrated that 46% of patients, identified as at high risk of recurrence based on clinical indicators received a low risk genomic test result, and may not benefit from chemotherapy. Of the 7,000 patients, 1550 patients (23.3%) had a discordant risk assessment (clinically High Risk/Mammaprint Low Risk), which accounted for 23.3% of patients in the trial that represented the most critical subset of patients, where de-escalation of treatment based on a genomic test result is now supported by the highest level of clinical evidence (1A). Overall, 63% of patients in the trial and 75% of the most common type of early breast cancer (hormone receptor positive, HER2 negative, lymph node negative) were identified as MammaPrint Low Risk and likely to not benefit from chemotherapy. As stated in the AGO guidelines, “Low absolute risk implies low absolute benefit”. As the MINDACT trial demonstrated, MammaPrint can potentially identify the majority of them with a low risk of recurrence result (75% in the hormonal positive, Her2 negative LN negative subgroup).2
The AGO guidelines presented a comparison to the results from the TAILORx and PlanB trials of the OncotypeDx test which only identified 16% and 15.3% of patients as low risk respectively and showed 67.3% and 60.4% of patients having an intermediate risk with the caveat that all patients in the intermediate group of the PlanB study were deemed to receive chemotherapy by trial design.1 The MINDACT trial demonstrated that the 70-gene signature identified a significantly larger proportion of patients that may potentially safely forego chemotherapy (MammaPrint 75% in MINDACT vs OncotypeDx 16% in TAILORx), providing better patient management and cost efficiency.2,3
“Acknowledgment in the AGO guidelines is a major milestone for the many women in Germany who will benefit from the MammaPrint test.” said Mark Straley, Chief Executive Officer of Agendia. “We commend AGO for recognizing the evidence supporting MammaPrint and look forward to its inclusion in additional guidelines as we move forward.”
MammaPrint is already recommended for use in a number of other important best-practice breast cancer treatment guidelines, including the European Society for Medical Oncology (ESMO) and St. Gallen Consensus Guidelines.
2 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.
3 Sparano JA, Gray RJ, Makower DF, et al. Prospective validation of a 21-gene expression assay in breast cancer. N Engl J Med 2015; 373: 2005-14
Notes to editors
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. For more information, visit www.agendia.com.