
Agendia’s MammaPrint Test Will be Used to Risk Stratify Patients for NCI Neoadjuvant Immunotherapy Breast Cancer Trial
10-31-23 (by: Scott Gleason) Agendia has joined forces with the National Cancer Institute (NCI), a branch of the National Institutes of Health, and the SWOG Cancer Research Network, funded by the NCI to support a new clinical trial focused on assessing the effectiveness of neoadjuvant immunotherapy for high-risk Hormone Receptor (HR)+ breast cancer patients.
The trial, named SWOG Trial S2206 (NCT06058377), represents a prospective, randomized, Phase III investigation concentrating on the application of immunotherapy in patients with MammaPrint High 2 Hormone Receptor (HR)-Positive, Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Stage II-III Breast Cancer. Sponsored by the NCI and led by SWOG, with the participation of the National Clinical Trials Network (NCTN), this trial is set to provide insights into the role of immunotherapy in HR+ breast cancer treatment.
Agendia’s MammaPrint gene expression profiling test, which assesses 70 genes linked to breast cancer recurrence, categorizes early-stage breast cancer patients into four risk groups. The test will be utilized in the trial to risk stratify patients. The trial’s primary objective is to determine whether immunotherapy, when administered to HR+ breast cancer patients based on their MammaPrint test results, can lead to improved treatment outcomes. Patients stratified as MP high 2 by MammaPrint will be assigned to two study arms to determine whether adding durvalumab to neoadjuvant chemotherapy can increase pCR rates, reduce residual cancer burden, and enhance invasive breast cancer-free survival in HR-positive MP High 2 breast cancers. The trial is expected to enroll 960 patients with MP High 2 results at SWOG member sites and other locations within the National Cancer Institute’s National Clinical Trial Network across the United States.
The I-SPY2 trial has already indicated that patients with Stage II/III ER+/HER2- Breast Cancer and a MammaPrint High 2 (MP2) result benefited significantly from neoadjuvant chemotherapy combined with an immune checkpoint inhibitor, leading to a higher rate of pathologic complete response (pCR).
Dr. Pusztai emphasized the significance of the trial in addressing the specific needs of patients with HR+ breast cancer that exhibits high rates of recurrence, which are similar to triple-negative breast cancers. The study plans to further enhance the cure rates for these high-risk cancers by integrating immunotherapy into preoperative chemotherapy.