NEW YORK – Agendia on Tuesday said it has partnered with the National Cancer Institute and NCI-funded Southwest Oncology Group (SWOG) Cancer Research Network on a clinical trial assessing neoadjuvant immunotherapy in certain high-risk, hormone receptor-positive breast cancer patients.
In the Phase III trial, dubbed SWOG Trial S2206, Agendia, NCI, and SWOG will randomize 960 stage II or III hormone receptor-positive breast cancer patients to receive either neoadjuvant chemotherapy plus AstraZeneca's Imfinzi (durvalumab) or neoadjuvant chemotherapy alone. Investigators will measure patients' event-free survival rates, pathologic complete response rates, and changes to residual cancer burden, among other endpoints.
In order to participate in the study, patients must have a category 2 high-risk score, as opposed to a category 1 high-risk score, according to Agendia's MammaPrint 70-gene expression profiling test. Patients in the MammaPrint High 2 category are more likely to respond to chemotherapy and have more aggressive tumors than those in the High 1 category.
Additionally, in the I-SPY2 trial, stage II or III estrogen receptor-positive, HER2-negative breast cancer patients had better pathologic complete response rates with neoadjuvant chemo plus an immune checkpoint inhibitor versus neoadjuvant chemotherapy alone.
"We have known for many years that gene expression profiling tests such as MammaPrint can be used in the clinic to determine if chemotherapy treatment will improve the likelihood of cure for patients with estrogen receptor-positive breast cancer, [and] we now have emerging evidence to suggest that gene expression profiling may help identify which estrogen receptor-positive breast cancers benefit from immunotherapy treatment," Erin Cobain, an oncologist at the University of Michigan and the SWOG trial's principal investigator, said in a statement. "The goal of this study is to further increase the likelihood of cure by delivering immunotherapy to the patients more likely to benefit based on the unique features of the tumor."