Data demonstrate Research Use Only ImPrint test’s ability to identify patients with high risk early breast cancer who may benefit from PD-1/PD-L1 checkpoint inhibition

Agendia, Inc., a commercial-stage company focused on improving outcomes for breast cancer patients worldwide by providing physicians and patients with next-generation diagnostic and information solutions to inform optimized treatment decision-making, today announced it will share findings in a poster discussion debuting initial data from its ImPrint test, a 53-gene signature in development, at the American Society of Clinical Oncology Annual Meeting (ASCO) 2022.

The poster discussion, titled The ImPrint immune signature identifies high risk early breast cancer patients who may benefit from PD1 checkpoint inhibition in I-SPY2 [Kuilman, M., et al.], draws from the neoadjuvant biomarker-rich I-SPY2 trial, which established a new benchmark for the efficacy of Phase 2 clinical trials and is widely regarded as the pioneer of the platform trial. In this study, whole transcriptome data collected by Agendia was assessed from patients who had high risk early breast cancer who received immunotherapy (IO). The goal was to migrate the I-SPY2 findings into a robust clinical-grade signature – a biomarker that had not previously existed in early stage breast cancer – to predict sensitivity to IO drugs that target PD-1/PDL-1, a cell pathway that, when overexpressed, allows many breast tumors to escape destruction by the immune system.

Importantly, results showed that in the development phase, the gene-expression biomarker ImPrint met this task and had the potential to predict pathologic complete response (pCR) to PD-1/PDL-1 checkpoint inhibitors with high sensitivity and specificity, especially in ER+ breast cancer which represents a large population of women who may benefit.

“We are incredibly encouraged by the data we are sharing with regard to the ImPrint Test, which is currently in development,” said Annuska Glas, Senior Vice President Research and Development and Innovation at Agendia. “ImPrint appears very effective in identifying a subset of HR+HER2- patients who could benefit from IO. We are also interested in the signature’s ability to identify tumors with an immune active phenotype denoted by the enrichment of several immune-related pathways. This kind of information is not currently available to a broad range of patients with breast cancer, and while we are in the research use only stage, we look forward to continuing validation to ensure ImPrint is in physicians’ hands as soon as possible.”

The effect of these findings on patients is potentially significant, ultimately having the potential to impact outcomes. The data shared at ASCO 2022 point to the RUO ImPrint Test’s ability to find those who will benefit from a PD-1/PDL-1 treatment as initial therapy, regardless of receptor subtype, providing the information needed to define more specific treatment planning soon after diagnosis.

“There has been a substantial increase of novel IO drugs in many types of diseases, which are astoundingly effective in some cases but not a panacea for all. This had led to the urgent need for biomarkers to identify which patients may benefit from them,” said Midas M. Kuilman, Research and Development, Agendia NV, Amsterdam and first author on the poster. “We see this signature as addressing an unmet need as various predictive biomarkers have been developed, but none have consistently predicted efficacy. Here, we see that ImPrint appears to predict with high sensitivity and specificity in both discovery and validation sets – it’s an incredibly promising set of data and we look forward to validating it in the I-SPY 2.2 trial.”

Redefining Breast Cancer Care in Post-Neoadjuvant Settings

Another poster, presented by Agendia in partnership with investigators from Cedars-Sinai Medical Center, Los Angeles, looks at matched tumors pre- and post-neoadjuvant chemotherapy analyzed by both MammaPrint^® and BluePrint^® to report differential gene expression and pathway analyses in the tumors that may help distinguish different responses. The poster, titled Identification of transcriptional changes with MammaPrint and BluePrint in early-stage breast cancer after neoadjuvant chemotherapy [Chung, A., et al.], found a more robust transcriptional change in tumors that remain MammaPrint High Risk between pre- and post-neoadjuvant chemotherapy. While these tumors remained High Risk, they also had many changes in gene expression pre- and post-neoadjuvant chemotherapy, unlocking clues to resistance and inspiring further research.

The study also found that tumors which changed from MammaPrint High Risk to MammaPrint Low Risk post-therapy had an activated immune response that may be a biomarker for therapy response and improved outcomes based on it.

Taken together, these posters represent Agendia’s continuous dedication to producing and evolving products that lead to insights across the breast cancer care continuum, from initial diagnosis to tailored treatment guidance.

In addition, Agendia will be presenting six posters and a second poster discussion centered on its revolutionary FLEX Trial, which is accelerating impactful data generation aimed at redefining cancer care. Its patient-centric design and national network of participating sites is backed by Agendia’s infrastructure, allowing its investigator-initiated sub-studies to produce important results that have the potential to drive science forward.

Agendia will be sharing updates throughout the conference on its Twitter, Facebook and LinkedIn pages.

About Agendia

Agendia is a mission-driven, commercial stage company focused on enabling optimized decision-making by providing physicians with next-generation diagnostic and information solutions that can be used to help improve outcomes 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 the biology underlying 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 www.agendia.com.

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