On March 20, 2024 Agendia, Inc. reported new data from the I-SPY 2 trial showcasing its ImPrint signature for patients with triple negative (TN) breast cancer, shared by I-SPY 2 researchers in an oral presentation at the 14th European Breast Cancer Conference in Milan, Italy (Press release, Agendia, MAR 20, 2024, View Source [SID1234641310]). Agendia has been in partnership with Quantum Leap Healthcare Collaborative, the sponsors of the neoadjuvant biomarker-rich I-SPY 2 trial, since 2010. I-SPY 2 established a new benchmark for the efficacy of Phase 2 clinical trials and is widely regarded as the pioneer of the platform trial.
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The presentation, titled Immune subtyping in the Response Predictive Subtypes (RPS) identifies a subset of triple negative (TN) early-stage breast cancer patients with a very low likelihood of response to neoadjuvant immunotherapy (IO): results from 5 IO arms of the I-SPY 2 TRIAL (van ’t Veer, L, J., et al.), investigates the utility of a refined version of ImPrint, called ImPrintTN, designed to provide more accurate predictions to response to common immunotherapy (IO) regimens for TN patients. The study, examining the responses of patients who received a variety of IO regimens in the I-SPY 2 trial, showed that ImPrintTN predicts both response and non-response, suggesting that the test may help inform prioritization of IO versus other treatments for TN patients to best balance likely benefit versus the risk of the serious adverse effects that often accompany IO.
"Many immunotherapy treatments can have difficult, severe adverse side effects on patients that can outweigh the benefit of the treatment. It is imperative to understand what a patient’s response will be to these therapies prior to using them," said Laura van ‘t Veer, Professor of Laboratory Medicine, Co-leader of the Breast Oncology Program and Director of Applied Genomics at the Helen Diller Family Comprehensive Cancer Center, University of California, and Co-Founder of Agendia, Inc. "The data we are presenting at the European Breast Cancer Conference demonstrates ImPrintTN’s predictive ability to help patients with triple negative breast cancer avoid immunotherapy if they are not likely to benefit – these insights are critical and can be used to inform alternative treatment strategies and customize our approach to meet the needs of each patient’s cancer diagnosis."
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 an FDA Investigational Device Exempt status for the ImPrint signature, allowing for its use in the I-SPY 2 trial and for other ongoing research with collaborators.
About the I-SPY TRIALs
The I-SPY TRIAL (Investigation of Serial studies to Predict Your Therapeutic Response with Imaging And moLecular analysis 2) (I-SPY 2 TRIAL) was designed to rapidly screen promising experimental treatments and identify those most effective in specific patient subgroups based on molecular characteristics (biomarker signatures). The trial is a unique collaborative effort by a consortium that includes the Food and Drug Administration (FDA), industry, patient advocates, philanthropic sponsors, and clinicians from over 40 major U.S. cancer research centers. Under the terms of the collaboration agreement, Quantum Leap Healthcare Collaborative is the trial sponsor and manages all study operations. For more information, visit www.ispytrials.org.