Inivata and Collaborators Publish New Data on RaDaR™ MRD Assay at AACR 2022
Data demonstrates potential of RaDaR to predict clinical response in stage III urothelial cancer
Research Triangle Park, NC, USA and Cambridge, UK, 11 April 2022 — Inivata, a leader in liquid biopsy, today unveils new data at the American Association for Cancer Research (AACR) Annual Meeting further demonstrating the potential of its RaDaR assay for the detection of minimal residual disease (MRD) and recurrence. The data being presented is from the NABUCCO study, which was run in collaboration with the Netherlands Cancer Institute.
Inivata is presenting data from a retrospective analysis based on 24 patients from the NABUCCO phase Ib trial in which high-risk resectable urothelial cancer patients received preoperative neo-adjuvant (NeoAdj) treatment of two immune checkpoint inhibitors (ipilimumab and nivolumab). In the study, RaDaR was used to analyze circulating tumor DNA (ctDNA) to determine whether post-treatment ctDNA levels correlated with treatment response and outcome.
The study found that following the NeoAdj treatment and prior to surgery, ctDNA was detected in only 7% of patients with pathological complete response to treatment compared to 60% of non-responders (p=0.0088). Of the 17 patients with undetected ctDNA following NeoAdj treatment and before surgery, 13 (76%) had pathological complete response and, importantly, 16 (94%) remained recurrence-free after a median follow-up of 34 months. These results suggest that plasma ctDNA changes after neoadjuvant treatment are associated with pathological response and have the potential to predict clinical outcomes.
David Eberhard MD PhD, Chief Medical Officer of Inivata said: “These latest data further demonstrate the potential for RaDaR to be informative in a variety of clinical settings across different tumor types. Along with continuing to generate clinical validation data, we will proceed with the regulatory pathway as we move towards commercialization of the assay.”
Michiel van der Heijden MD PhD, Medical Oncologist at the Netherlands Cancer Institute and Principal Investigator of the NABUCCO study, commented: “The results of this study highlight the potential of Inivata’s RaDaR ctDNA assay to predict clinical response to neoadjuvant treatment using a plasma sample before surgery takes place. This could ultimately help to guide clinical decisions in urothelial cancer, which is especially relevant in the context of selecting patients for the bladder-sparing strategies that are currently in development.”
Inivata is the liquid biopsy focused subsidiary of the NeoGenomics, Inc (NASDAQ: NEO) Group. Inivata’s InVision® liquid biopsy platform unlocks essential genomic information from a simple blood draw to guide and personalize cancer treatment, monitor response and detect relapse. Inivata’s technology is based on pioneering research from the Cancer Research UK Cambridge Institute, University of Cambridge. The personalized RaDaR™ assay allows the highly sensitive detection of residual disease and recurrence and has been granted Breakthrough Device Designation by the US FDA. The commercially available InVisionFirst®-Lung test offers best-in-class sensitivity and turnaround and provides molecular insights that enable clinicians to make more informed treatment decisions for advanced NSCLC patients. Inivata is partnering with pharmaceutical, biotechnology companies and commercial partners in a range of early and late-stage cancer development programs across a range of cancer types. Inivata has a CLIA certified, CAP accredited laboratory in Research Triangle Park, NC and R&D laboratories in Cambridge, UK.
RaDaR is Inivata’s assay for the detection of minimal residual disease (MRD) and recurrence. Built on Inivata’s proven InVision® liquid biopsy platform technology, RaDaR is a highly sensitive personalized assay that tracks a set of up to 48 tumor-specific variants in a patient using a liquid biopsy, allowing both detection of residual disease following curative intent or definitive treatment and early detection of relapse. RaDaR has been granted Breakthrough Device Designation by the US FDA.
Consilium Strategic Communications
Chris Gardner/Angela Gray/Genevieve Wilson
Alix Floyd (US)
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