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Large Clinical Utility Study for MammaPrint May Lead to New Companion Dx Opportunities for Agendia

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This article was originally posted Oct. 20.

A large, randomized, prospective trial aimed at assessing the clinical utility of Agendia's MammaPrint breast cancer recurrence test in determining which patients should receive chemotherapy has finished recruiting study participants, the company announced last week.

Additionally, according to Agendia, the trial may also reveal new companion diagnostic opportunities for the firm.

According to the study sponsors — Agendia, the European Organization for Research and Treatment of Cancer, and the Breast International Group — the Microarray In Node Negative and 1-3 Positive Lymph Node Disease May Avoid Chemotherapy, or MINDACT, trial now involves more than 6,600 patients at 111 institutions in nine countries.

MINDACT will gauge how well Agendia's breast cancer recurrence test results, in addition to patients' clinical data, compares to the "Adjuvant! Online" clinicopathological criteria for the selection of breast cancer patients for adjuvant chemotherapy.

"The study aims to provide further evidence that early breast cancer patients with a low recurrence risk genomic profile by MammaPrint may not need chemotherapy," the company said in a statement. "This would spare patients from burdensome side effects without increasing the risk of metastasis or reducing survival."

Agendia received clearance from the US Food and Drug Administration for MammaPrint in 2007. According to the company, the test gauges breast cancer recurrence risk in patients who have ER-positive and -negative, as well as lymph node-negative and -positive, disease.

Through its inclusion in the MINDACT, the company is hoping to garner large-scale prospective validation of the test's clinical utility for selecting patients for adjuvant chemotherapy. The company has said that if MINDACT confirms the clinical utility of MammaPrint in this area then it will likely improve the reimbursement prospects for the test, which have been lagging behind its competitor, Genomic Health's Oncotype DX.

MINDACT is the largest European randomized prospective trial evaluating the clinical value of a genomic profile for risk assessment and adjuvant chemotherapy prescription for breast cancer. The trial’s complex logistics, including real-time collection of frozen tumor tissue, were proven feasible in a multinational, multicenter setting, Agendia said.

Depending on patients' clinical features and their risk classification by MammaPrint, researchers in the study will determine whether to randomize them to two adjuvant chemotherapy arms: anthrycycline-based regimens or a decetaxel/capecitabine regimen. If patients' tumors express hormone receptors, they may also receive endocrine treatment.

"The entire genomic profile of each patient’s tumor is also being analyzed, and this could allow research groups involved in the consortium to find new, specific companion diagnostics for the drugs administered in the trial," Agendia said in a statement. The firm added that it holds exclusive commercial rights to new RNA-based companion diagnostics that result from MINDACT. However, the clinical data "is open to the entire scientific community."

Agendia CEO Bernhard Sixt said in a statement that "MINDACT will likely generate new specific companion diagnostics that can be added to MammaPrint in Agendia’s Symphony decision support system to further improve its clinical value."

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