Additional research from the real-world FLEX Registry focuses on age effect and lymph node status for patients with breast cancer

IRVINE, CALIF., U.S., and AMSTERDAM, NETHERLANDS – December 10, 2021 – Agendia, Inc., a world leader in precision oncology for breast cancer, announced that it will present a spotlight poster at the 2021 San Antonio Breast Cancer Symposium (SABCS 2021) which confirms the utility of BluePrint® in guiding neoadjuvant treatment decisions.

The spotlight presentation, resulting from a research collaboration between Agendia and the Netherlands Cancer Institute and titled Effect of pertuzumab plus neoadjuvant trastuzumab-based chemotherapy in early-stage HER2-positive breast cancer according to BluePrint molecularly defined breast cancer subtypes [PD15-07], evaluates the BluePrint 80-gene molecular subtyping test for predicting response to neoadjuvant trastuzumab-based chemotherapy with or without pertuzumab in a large nationwide cohort of patients from the TRAIN2 study (NCT01996267) and the Netherlands Cancer Registry.

Results showed that BluePrint reclassified 15% of the IHC/FISH HER-2+ patients in this study to a different molecular subtype. These reclassified patients typically do not respond as expected to HER2-targeted therapies, indicating a potential role for genomics in treatment planning for HER2+ patients. The data also support the pronounced benefit of adding pertuzumab to neoadjuvant trastuzumab-based chemotherapy in patients with the BluePrint-defined HER2-subtype, with other subtypes having a less pronounced benefit from pertuzumab. These new findings reinforce the heterogeneity of pathologically HER2+ breast cancer and provide support for the results of a prior translational analysis of the APHINITY trial, which also showed that BluePrint may identify subgroups of HER2+ patients with differing degrees of benefit from the addition of pertuzumab based on gene expression.

“In addition to these results reclassifying 15% of patients in this cohort, the data confirm the genomic heterogeneity of clinically HER2+ patients, and suggest that genomic information could help make more precise decisions following diagnosis,” said William Audeh, MD, Chief Medical Officer at Agendia. “HER2 is an extremely complex histological subtype of breast cancer. The results presented in this spotlight poster show again the incredible diversity of this subtype, and the importance of looking at these tumors at a genomic level in order to adjust treatment appropriately even before surgery.”

In addition, Agendia shared updates and study results from the 30,000-patient breast cancer genome project, the FLEX study:

  • [OT2-07-01] The FLEX real-world data platform explores new gene expression profiles and investigator-initiated protocols in early stage breast cancer shares data from some of the 38 investigator-initiated sub-studies approved within the FLEX Registry, the real-world, large-scale, prospective, observational breast cancer study (NCT03053193) intended to enable the discovery of novel genomic profiles to improve precision in the management of breast cancer. With purposefully-wide inclusion criteria, and more than 9,000 patients enrolled towards the 30,000-patient goal, the registry aims to enable researchers to investigate the differences and trends between breast cancer subgroups and allow focus on smaller, more diverse patient populations, which have traditionally been challenging to recruit in sufficient numbers for clinical trials.

  • [P5-07-05] Deciphering the inferior prognosis of young women with estrogen receptor-positive early-stage breast cancer through full transcriptome analysis: a FLEX database sub-study aims to better understand the biological basis for the disparity in outcomes between older and younger women with early-stage breast cancer by identifying genes that distinguish tumors in these two groups. Data demonstrated that there were relatively few gene expression changes identified by age, and that few transcriptional differences were observed between tumors from women aged 40-54 and women older than 55. These results suggest that observed chemotherapy benefit represents differences in host biology rather than intrinsic tumor biology. Additionally, these findings indicate that age is potentially a more relevant cutoff than menopausal status when observing genes to aid in treatment decisions, reinforcing the need for genomic testing to be available to all women with early stage breast cancer regardless of menopausal status.
  • [P2-08-06] Defining transcriptomic profiles of breast cancer with early lymph node metastases: a FLEX database sub-study provides a foundation for understanding the mechanisms that promote lymph node (LN) metastasis, with data indicating more biological differences between MammaPrint risk and BluePrint subtype than by pathological stage. Early LN metastasis often precedes systemic metastasis and corresponds with a 20% decrease in 10-year survival compared to patients without LN metastasis,[1] underscoring the importance of understanding biologic pathways involved in early LN metastasis to identify promising drug targets for early-stage breast cancer treatment.

“The robust variety and value of the data being collected by the FLEX project cannot be overstated,” said Cynthia X Ma, MD, PhD, oncologist and FLEX national principal investigator at Washington University School of Medicine in St. Louis. “In the data presented at SABCS 2021 alone, we see insights that can be turned into clinical actions immediately. Especially interesting is the representation of extreme MammaPrint risk groups, with over 1,100 Ultra Low Risk and over 1,200 High Risk 2 patients enrolled in the study. The insights from these analyses will guide physicians supporting the entire breast cancer community in hard-to-treat cases they may see in their practice today. This project could be one of the most impactful, inclusive studies in breast cancer research to date, and the constant learnings from it allow us to better understand biologic drivers of breast cancer and ultimately result in more personalized, precise treatment plans.”

Agendia will present six posters that were accepted to SABCS 2021, highlighting Agendia’s mission to help guide the diagnosis and personalized treatment of breast cancer for all patients throughout their treatment journey.

About Agendia

Agendia is a mission-driven company focused on enabling optimized treatment planning by providing physicians with next-generation diagnostic and information solutions that can be used to help improve outcomes and quality of life for breast cancer patients worldwide. The company currently offers two commercially-available genomic profiling tests that help surgeons, oncologists and pathologists to personalize treatment for women at critical intervention points throughout their patient journey.

MammaPrint® is a 70-gene prognostic test that, along with other clinicopathologic factors, determines a specific patient’s breast cancer recurrence risk. BluePrint® is an 80-gene molecular subtyping test that identifies the underlying biology of an individual breast cancer to provide information about its behavior, long-term prognosis and potential response to systemic therapy. Together, MammaPrint® and BluePrint® provide a holistic view of an individual patient’s breast cancer, enabling physicians to objectively select the best treatment plan.

For more information on Agendia’s assays and ongoing trials, please visit

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[1] Fisher ER, et al. Cancer. 1993;71(6)2141-2150.