Agendia’s MammaPrint receives level 1A clinical utility evidence of chemotherapy benefit

19 April 2016 (Last Updated April 19th, 2016 18:30)

Agendia, along with the European Organisation for Research and Treatment of Cancer (EORTC) and Breast International Group (BIG), announced results from the initial analysis of the primary objective of the Microarray In Node-negative (and 1 to 3 positive lymph node) Disease may Avoid ChemoTherapy (MINDACT) study.

Agendia, along with the European Organisation for Research and Treatment of Cancer (EORTC) and Breast International Group (BIG), announced results from the initial analysis of the primary objective of the Microarray In Node-negative (and 1 to 3 positive lymph node) Disease may Avoid ChemoTherapy (MINDACT) study.

The analysis found that using the Agendia's MammaPrint assay, patients with early-stage breast cancer who were considered at high-risk of disease recurrence, based on clinical and biological criteria, had distant metastasis-free survival at five years in excess of 94%.

The MammaPrint test is claimed to be the first and only genomic assay with FDA 510(k) clearance for use in risk assessment for women of all ages with early-stage breast cancer.

"It gives the level 1A clinical evidence (prospective, randomised and controlled) that empowers physicians to clearly and confidently know when chemotherapy is part of optimal early-stage breast cancer therapy."

Agendia CRO and UCSF Helen Diller Family Comprehensive Cancer Center Breast Oncology Programme leader, and Applied Genomics director Prof. Laura van 't Veer said: "The MINDACT trial design is the optimal way to prove clinical utility of a genomic assay."

"It gives the level 1A clinical evidence (prospective, randomised and controlled) that empowers physicians to clearly and confidently know when chemotherapy is part of optimal early-stage breast cancer therapy."

The MINDACT trial is the first prospective, randomised, controlled clinical trial of a breast cancer recurrence genomic assay with level 1A clinical evidence and the first prospective translational research study of huge magnitude in breast cancer to report the results of its primary objective.

Among the 3,356 patients enrolled in the MINDACT trial, who were categorised as having a high-risk of breast cancer recurrence based on common clinical and pathological criteria (C-high), the MammaPrint assay reduced the chemotherapy treatment prescription by 46%.

MINDACT is a randomised phase III trial that investigates the clinical utility of MammaPrint, when compared to, or used in conjunction with the standard clinical pathological criteria, for the selection of patients unlikely to benefit from adjuvant chemotherapy.

From 2007 to 2011, 6,693 women who had undergone surgery for early-stage breast cancer enrolled in the trial at 111 centres in nine countries.

The MINDACT trial is managed and sponsored by the EORTC as part of an extensive partnership with Agendia and BIG, and many other academic and commercial partners, as well as patient advocates.