Agendia NV

New data published in JNCI Cancer Spectrum suggest Agendia's MammaPrint assay could help spare many women with HR+/HER2- early breast cancer from unnecessary chemotherapy, while identifying those most likely to benefit, the company said Tuesday.  The findings, based on real-world data from the ongoing FLEX Registry, back up earlier trial results and add evidence for using the test to help steer treatment decisions. MammaPrint is a genomic test that looks at 70 genes linked to the risk of breast cancer returning, with results usually ready in under a week. Providers use it to help decide on treatment before or after surgery, and it can be added into routine diagnostic testing.  Results from the earlier MINDACT trial showed that patients with Low Risk scores on the test were unlikely to benefit from chemotherapy, supporting its role in helping to avoid overtreatment. This led researchers to investigate whether the test can also identify patients most likely to see a meaningful improvement in outcomes from chemotherapy. For the study, researchers looked at 1002 patients with HR+/HER2- early breast cancer who were treated with either endocrine therapy alone or alongside chemotherapy. After matching the groups for factors like tumour stage and nodal status, they found the MammaPrint Index (MPI) was a strong predictor of five-year distant recurrence-free interval in both sets of patients. Patients with MammaPrint High Risk 2 tumours saw the greatest absolute chemotherapy benefit, averaging 10.9% and reaching as high as 14.2%. High Risk 1 patients had an average 5.5% benefit, while those in the Low or UltraLow Risk categories experienced little or no improvement. Statistical modelling showed that the link between MPI score and chemotherapy benefit held true regardless of a patient’s age, tumour stage, nodal status or grade. The FLEX Registry has enrolled over 20,000 breast cancer patients, gathering detailed genomic data alongside clinical outcomes. Agendia said this kind of large, real-world dataset can help sharpen how precision oncology is applied to individual patients, potentially improving treatment choices and long-term outcomes.

IRVINE, Calif. & AMSTERDAM--(BUSINESS WIRE)--Agendia®, Inc., a leader in precision oncology for breast cancer, today announced the presentation of four major abstracts in collaboration with independent investigators at the 2025 American Society of Clinical Oncology (ASCO®) Annual Meeting, taking place May 29th- June 3rd, 2025, in Chicago, Illinois. The research provides new follow-up data from the ongoing FLEX Study (NCT03053193), the largest real-world data early-stage breast cancer (EBC) trial that has recently reached a 20,000 of 30,000 patient enrollment milestone. This real-world evidence study is providing critical insights into how genomic testing can address disparities in early-stage breast cancer care and optimize treatment selection across diverse patient populations. Since its launch in April 2017, the FLEX Study has enrolled patients across 100 sites in the U.S. and around the world, including 16 NCI-designated cancer centers, and has conducted over 40 sub-studies in several topics. In the first poster, titled “Association of MammaPrint and clinical outcomes by race among 5000 individuals with HR+HER2- early-stage breast cancer enrolled in FLEX,” Erin Cobain MD, Associate Professor in the Division of Hematology/Oncology at the University of Michigan Medical School, Ann Arbor and co-Principal Investigator of the SWOG S2206 Trial, examined genomic risk and 4-year distant recurrence-free interval (DRFI) outcomes in patients with HR+HER2- EBC stratified by self-reported race. Black patients were more than twice as likely to present the highest genomic risk EBC (MammaPrint High 2: 18.3% and BluePrint Basal-Type: 9.3%) compared to White patients (High 2: 7.4%; Basal: 9.3%; p<0.001). Despite this, Black patients with MammaPrint High Risk disease were less likely to receive neo/adjuvant chemotherapy, highlighting a potential gap in real-world practice where Black patients may be undertreated. Notably, for MammaPrint Low Risk EBC, excellent 4-year DRFI was observed among both Black (98.3%) and White (97.9%) patients, suggesting equivalent prognostic performance of MammaPrint regardless of race. The following posters will also highlight new data on the importance of understanding how patients’ intrinsic tumor subtype and their age may impact breast care management decisions: Association of ImPrintTN signature with survival outcomes by race in Basal-Type Triple Negative Breast Cancer (TNBC) [Sharma, P., et al] - These are the first data to examine the long-term prognostic performance of the newly developed immune classifier signature, ImPrintTN, in patients with TNBC stratified by race. Results revealed that 56.6% of tumors were ImPrintTN+, with no significant differences among Black or White patients. ImPrintTN+ tumors were significantly associated with higher pathological complete response (pCR) to neoadjuvant therapy (39.3% vs. 22.0%; p=0.039) and improved 3-year recurrence-free survival (RFS) (87.9% vs. 77.5%; p=0.01). The positive prognostic benefit of ImPrintTN+ status was equivalent across racial groups, however, a nonsignificant negative prognostic impact of ImPrintTN- appeared more pronounced among Black patients, compared to White, highlighting the need for exploring biological differences within the ImPrintTN- subgroup by race. Molecular Insights into HR+/HER2+ Early-Stage Breast Cancer: Neoadjuvant Therapy Responses by MammaPrint and BluePrint genomic subtypes [Samijan, L., et al.] - The data show significant heterogeneity among 720 patients with HR+HER2+ tumors enrolled in FLEX. Among these patients, 61.4% had tumors genomically reclassified with non-HER2 molecular subtypes by BluePrint. A higher accuracy in predicting pCR was observed when stratified by BluePrint with a pCR rate of 61.2% for HER2 compared to only 26.5% for Luminal subtypes (p<0.001). These findings highlight the limitations of treatment planning among patients with conventionally classified HR+HER2+ disease and support use of genomic assays to help more accurately predict therapy response. Real-World Evidence from FLEX: Utility of MammaPrint in guiding treatment planning for patients aged 70 and older with early-stage breast cancer [Mahtani, R., et al.] - The data reveal that patients aged ≥70 with MammaPrint High Risk tumors were less likely to receive chemotherapy. However, older women with MammaPrint High 2 risk tumors who received chemotherapy vs. Those who didn’t had an 11% improvement in 3-year recurrence-free interval (RFI), suggesting chemotherapy should be considered in older populations with genomically high risk tumors. “These new data presented at ASCO further reinforce the power of genomic testing to guide precise and consistent treatment decisions within distinct patient populations,” said William Audeh, MD, MS, Chief Medical Officer at Agendia. “Whether identifying treatment-responsive subgroups in TNBC, guiding therapy in older women, or ensuring consistent outcomes regardless of race, MammaPrint, BluePrint, and Agendia’s growing suite of genomic signatures for early-stage breast cancer continue to demonstrate comprehensive utility in real-world clinical practice.” About Agendia Agendia is a leading provider of innovative solutions in the field of precision oncology. With a focus on early-stage breast cancer, Agendia offers reliable biological insights that inform personalized treatment decisions for patients and their care teams. Their advanced genomic assays, MammaPrint® + BluePrint®, enable clinicians to quickly identify the most effective treatment plan, minimizing the risk of both under- and over-treatment. Agendia was founded in 2003 with headquarters in Amsterdam and a state-of-the-art laboratory facility located in Irvine, CA. Led by world-renowned scientists and oncologists, Agendia is committed to advancing genomic insights through ongoing research. This includes the notable FLEX Study– the world’s largest whole transcriptome Real-World Evidence-based Breast Cancer database which aims to revolutionize precision in breast cancer management. With cutting-edge technology, research and innovation, Agendia strives to shape the future of precision oncology and make a significant impact in the fight against breast cancer. About MammaPrint MammaPrint® is a gene expression profiling test that reveals the distinct underlying biology of an early-stage tumor to determine its risk of spreading. As the only FDA-cleared gene expression profiling test to assess a woman’s risk of distant metastasis, MammaPrint® provides critical answers that help inform the future of her treatment plan at the point of diagnosis, including the timing and benefit to chemotherapy and endocrine therapy. MammaPrint® listens to the signals from 70 key genes in a woman’s tumor to stratify the risk of recurrence within four distinct categories – ranging from UltraLow, Low, High 1, and High 2– to fuel a right-sized care plan tailored to her biology and her life’s plans. About BluePrint BluePrint® is a gene expression profiling test that reveals the driving forces behind a tumor’s growth at the earliest stage possible in a woman’s breast cancer care journey to help optimize and personalize treatment planning. As the only molecular subtyping test available in the U.S., BluePrint® goes where pathology cannot, offers critical insights that providers may otherwise have not known to act on, and gives women the best chance to return to a life not defined by cancer. BluePrint® measures the activity of 80 key genes that are involved in a tumor’s growth to classify a tumor as Luminal-type, HER2-type, or Basal-type, each of which warrant distinct treatment pathways. By revealing the distinct underlying biology of a woman’s tumor, BluePrint® can catch often misclassified, yet highly aggressive, Basal tumors, so women can be prescribed the most appropriate treatment from the start.

IRVINE, Calif. & AMSTERDAM--(BUSINESS WIRE)--Agendia®, Inc., today announced that new data from its ongoing FLEX Study will be presented at the upcoming ESMO Breast Cancer 2025 congress taking place May 14-17 in both Munich, Germany and virtually. The FLEX Study (NCT03053193) is a prospective real-world evidence, observational breast cancer study designed to correlate whole transcriptome gene expression in early-stage breast cancer with clinical outcomes, and to evaluate how genomic insights can inform treatment decisions in early-stage breast cancer. In this analysis, researchers examined the impact of BluePrint, Agendia’s 80-gene molecular subtyping assay, on pathological complete response (pCR) rates and chemotherapy (CT) decision-making in patients with hormone receptor-positive (HR+), HER2-negative tumors classified as High Risk by MammaPrint. BluePrint further stratified these tumors into Basal or Luminal B subtypes, offering a more nuanced view of tumor biology and potential treatment response. The poster presentation, titled “The Impact of the 80-gene signature on pCR and chemotherapy treatment decisions in Early-Stage Breast Cancer: A FLEX Analysis [70P],” (A.M. Brufsky, et al.), highlights findings from the analysis of two cohorts from the FLEX Study: one consisting of patients who underwent genomic analysis on pre-operative core needle biopsy, and received neoadjuvant chemotherapy with available pCR data and another cohort with documented physician chemotherapy recommendations. The analysis found that patients with MammaPrint High Risk, HR+ HER2- Basal-type tumors were more likely to achieve a pCR following neoadjuvant chemotherapy compared to those with Luminal B tumors. The analysis also showed that these Basal-type tumors were more frequently recommended for chemotherapy overall, more often treated with neoadjuvant chemotherapy specifically, and received more intensive regimens compared to Luminal B tumors. These results suggest that BluePrint provides actionable molecular insights that physicians are using to inform real-world treatment decisions, even among patients already eligible for chemotherapy based on MammaPrint High Risk status. “These results reinforce the value of BluePrint in helping physicians personalize treatment plans for early-stage breast cancer,” said Adam Brufsky, MD, PhD, Professor and Associate Chief of Hematology and Oncology at UPMC Hillman Cancer Center. “By identifying Basal-type tumors that are more likely to respond to chemotherapy, BluePrint can guide decisions about treatment intensity and timing that align with each patient’s individual tumor biology.” Poster Presentation Details: Title: The Impact of the 80-gene signature on pCR and chemotherapy treatment decisions in Early-Stage Breast Cancer: A FLEX Analysis [70P] Date and Time : Thursday, May 15, 12:00 PM CEST Location : ICM – International Congress Center of the Munich Messe, Hall B0 About Agendia Agendia is a leading provider of innovative solutions in the field of precision oncology. With a focus on early-stage breast cancer, Agendia offers reliable biological insights that inform personalized treatment decisions for patients and their care teams. Their advanced genomic assays, MammaPrint® + BluePrint®, enable clinicians to quickly identify the most effective treatment plan, minimizing the risk of both under- and over-treatment. Agendia was founded in 2003 and is headquartered in Amsterdam with its state-of-the-art laboratory facility located in Irvine, CA. Led by world-renowned scientists and oncologists, Agendia is committed to advancing genomic insights through ongoing research. This includes the notable FLEX Study – the world’s largest whole transcriptome Real-World Evidence-based Breast Cancer database which aims to revolutionize precision in breast cancer management. With cutting-edge technology, research and innovation, Agendia strives to shape the future of precision oncology and make a significant impact in the fight against breast cancer. About BluePrint BluePrint® is a gene expression profiling test that reveals the driving forces behind a tumor’s growth at the earliest stage possible in a woman’s breast cancer care journey to help optimize and personalize treatment planning. As the only molecular subtyping test available in the U.S., BluePrint® goes where pathology cannot, offers critical insights that providers may otherwise have not known to act on, and gives women the best chance to return to a life not defined by cancer. BluePrint® measures the activity of 80 key genes that are involved in a tumor’s growth to classify a tumor as Luminal-type, HER2-type, or Basal-type, each of which warrant distinct treatment pathways. By revealing the distinct underlying biology of a woman’s tumor, BluePrint® can catch often misclassified, yet highly aggressive, Basal tumors, so women can be prescribed the most appropriate treatment from the start.