Agendia’s Genomic Risk Assay Cuts Need for Chemotherapy in Early Breast Cancer Patients by 46% in Phase 3 Trial

Agendia’s Genomic Risk Assay Cuts Need for Chemotherapy in Early Breast Cancer Patients by 46% in Phase 3 Trial

Agendia, Inc., announced initial positive results of a clinical trial investigating a genomic assay’s ability to accurately predict the need for chemotherapy in early stage breast cancer patients thought at risk of disease reoccurrence. The Phase 3 trial, conducted by the company using its MammaPrint assay and in collaboration with the European Organisation for Research and Treatment of Cancer (EORTC) and Breast International Group (BIG),  achieved a 46 percent overall reduction in adjuvant chemotherapy use by detecting a low probability of metastasis in high-risk patients.

The analysis of the primary objective of the Microarray In Node-negative (and 1 to 3 positive lymph node) Disease may Avoid ChemoTherapy (MINDACT) trial was presented at the 2016 American Association for Cancer Research Annual Meeting.

MammaPrint, a 70-gene assay, is the first and only genomic assay approved by the U.S. Food and Drug Administration (510(k) clearance) for use in the risk assessment of women with early stage breast cancer.

The MINDACT trial was designed to assess the clinical utility of the assay, and its potential use as a management and treatment-decision tool for breast cancer, in addition to the other factors relied upon by physicians, such as age, tumor size, tumor grade, lymph node involvement, and hormone receptor status. The Phase 3 randomized clinical trial (NCT00433589) enrolled 6,693 women who had undergone surgery for early stage breast cancer. Participants were then categorized as low- and high-risk for tumor recurrence by two strategies. In the first, MammaPrint was used to analyse the tumor tissue and, in the second one, researchers used Adjuvant! Online, a tool that calculates breast cancer recurrence risk based on common clinical and biological factors. Patients who received a low-risk diagnosis were spared chemotherapy, and those with conflicting results were further randomized to either clinical or genomic risk (MammaPrint) evaluation to decide on chemotherapy treatment.

“The MINDACT trial design is the optimal way to prove clinical utility of a genomic assay,” Professor Laura van ’t Veer, CRO at Agendia, and director of Applied Genomics at UCSF Helen Diller Family Comprehensive Cancer Center, said in a news release. “It gives the level 1A clinical evidence (prospective, randomized and controlled) that empowers physicians to clearly and confidently know when chemotherapy is part of optimal early-stage breast cancer therapy. In this trial, MammaPrint (70-gene assay) was compared to the standard of care physicians use today, to decide what is the best treatment option for an early-stage breast cancer patient.”

Among the 3,356 patients who were categorized as having a high risk of breast cancer recurrence based on common clinical and pathological criteria, the MammaPrint assay reduced the chemotherapy treatment prescription by 46 percent. Furthermore, 48 percent of lymph-node positive breast cancer patients considered at clinical high risk but genomic low risk (using the MammaPrint assay) had metastasis-free survival at five years in excess of 94 percent.

“These MINDACT trial results are a testament that the science of the MammaPrint test is the most robust in the genomic breast recurrence assay market. Agendia will continue to collaborate with pharmaceutical companies, leading cancer centers and academic groups on additional clinical research and in the pursuit of bringing more effective, individualized treatments within reach of cancer patients,” said Mark Straley, chief executive officer at Agendia. “We value the partnership with the EORTC and BIG and it’s a great honor to share this critical milestone.”