Additional research highlights integration of BluePrint molecular subtyping and ImPrint immune profiling to optimize prediction of neoadjuvant treatment response in HER2-positive early-stage breast cancer
Agendia, Inc., a leader in precision oncology for breast cancer, today announced new data to be presented at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place May 29 June 2 in Chicago. The company will present two posters highlighting how MammaPrint (MP) BluePrint (BP) provide biological insights into treatment response and help further refine therapeutic decision-making for patients with early-stage breast cancer (EBC).
Poster #46 June 1, 1:30 p.m. 4:30 p.m. CDT Presenter: Steven Isakoff
Association of the 70-gene assay and homologous recombination deficiency in patients with High Risk 2 breast cancers
This real-world analysis of 1,298 patients from the FLEX study evaluated whether MP BP classifications are associated with homologous recombination deficiency (HRD) in hormone receptor positive, HER2-negative (HR+HER2-) EBC. A 228-gene HRD signature and a refined 26-gene panel were used to assess HRD-related biology indicative of impaired DNA repair.
- Both signatures showed that MP High Risk 2 (H2) tumors demonstrated significantly higher HRD scores than High Risk 1 (H1) tumors (both p<0.001).
- Among Luminal tumors, Luminal H2 tumors had significantly higher HRD scores than Luminal H1 tumors across both HRD signatures (both p<0.001).
- Basal tumors demonstrated higher HRD scores than Luminal tumors within both H1 and H2 groups (all p=0.002), with Basal H2 tumors showing the highest overall HRD levels.
"These findings provide a biological rationale for the anthracycline chemotherapy benefit observed in patients with MammaPrint High Risk 2 tumors," said Steven Isakoff, M.D., Ph.D., Medical Oncologist and Clinical Director, Breast Oncology Program, Mass General Brigham Cancer Institute. "Following the recent NCCN Guidelines update recognizing MammaPrint as the only genomic test to personalize the use of anthracycline-based regimens in HR+HER2- early-stage breast cancer, the data further validate the assay's ability to stratify risk and guide treatment selection."
Poster #106 June 1, 1:30 p.m. 4:30 p.m. CDT Presenter: David Page
Integration of molecular subtyping and immune profiling to predict pathologic complete response in HER2+ breast cancer treated with neoadjuvant dual HER2 therapy
This study evaluates whether combining BP molecular subtyping with the ImPrint immune signature could accurately predict outcomes (pathologic complete response [pCR]) in HER2-positive (HER2+) EBC treated with neoadjuvant dual HER2-targeted therapy. pCR rates were assessed in a cohort of 252 patients, following treatment with neoadjuvant chemotherapy in combination with trastuzumab and pertuzumab.
- In the HR+HER2+ subgroup, 52% of tumors were further classified by BP as non-HER2 subtypes (Luminal A 6%, Luminal B 44%, Basal 2%), highlighting the genomic diversity within clinically HER2+ disease.
- The highest pCR rates were observed in tumors classified as BP-HER2/ImPrint+, indicating that patients whose tumors were genomically HER2-type and immune-active derived the greatest benefit from neoadjuvant therapy.
- In multivariate analysis, BP subtype and ImPrint status independently predicted pCR in HR+HER2+ disease, after controlling for nodal status and tumor size. The integration of molecular subtyping by BP and immune profiling by ImPrint maximized prediction of pCR, particularly in the HR+HER2+ subgroup.
"These findings demonstrate how integrating molecular subtyping with immune profiling may improve our ability to predict response to neoadjuvant therapy in HER2-positive early-stage breast cancer and may be hypothesis-generating for chemotherapy de-escalation studies," said William Audeh, M.D., Chief Medical Officer of Agendia. "Both the HRD and HER2+ studies highlight the utility of MammaPrint and BluePrint and emerging signatures for identifying clinically relevant breast cancer biology. Drawing on insights from the FLEX Study, which captures real-world treatment patterns as they evolve, we can address challenging clinical questions in a timely and relevant manner."
ImPrint was developed to be used in the clinic to predict the likelihood of patients responding to immunotherapies by looking at the biology of the patient's tumor. Agendia currently holds a U.S. Food and Drug Administration Investigational Device Exempt status for the ImPrint signature, allowing for its use in the I-SPY2 trial and for other ongoing research with collaborators.
About Agendia
Agendia is a global leader in precision oncology focused on early-stage breast cancer. The company's genomic assays, MammaPrint BluePrint, deliver essential biological insights to inform personalized treatment decisions for patients and their care teams. With operations in Amsterdam and Irvine, Agendia partners with academic and community oncology centers worldwide to generate real-world evidence through the landmark FLEX Study (NCT03053193), the largest whole-transcriptome registry of early-stage breast cancer.
About MammaPrint
MammaPrint is a gene expression profiling test that assesses a woman's risk of distant metastasis in early-stage breast cancer. By analyzing 70 key genes in a tumor, it stratifies risk into four categories UltraLow Risk, Low Risk, High Risk 1, and High Risk 2 to help guide personalized treatment planning, including chemotherapy benefit and de-escalation decisions.
About BluePrint
BluePrint is an 80-gene molecular subtyping assay that reveals the functional biology driving tumor growth, classifying tumors as Luminal-type, HER2-type, or Basal-type. By defining intrinsic subtypes beyond traditional immunohistochemistry, BluePrint provides critical insights to optimize treatment selection and improve outcomes.
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