Inivata and Collaborators Publish Positive Results from Prospective Clinical Study of RaDaRTM in Head and Neck Squamous Cell Carcinoma
RaDaR demonstrated 100% specificity in patients with no recurrence and 100% sensitivity in patients with clinical recurrence
Research Triangle Park, NC, USA and Cambridge, UK, 11 February 2022 — Inivata, a leader in liquid biopsy, today announced clinical validation data for its RaDaRTM liquid biopsy test in head and neck squamous cell carcinoma (HNSCC). The data from the Liquid BIOpsy for MiNimal RESidual DiSease Detection in Head and Neck Squamous Cell Carcinoma (LIONESS) study have been published in the British Journal of Cancer and can be viewed here. The study was in collaboration with the Department of Otorhinolaryngology, Head and Neck Surgery (ORL-HNS), LMU Klinikum, and Institute of Pathology, Faculty of Medicine, LMU Munich.
In the LIONESS study, blood samples taken from 17 patients with stage III-IVB, p16-negative HNSCC who received curative-intent primary surgical treatment were tested using RaDaR to detect circulating tumor DNA (ctDNA) as evidence of minimal residual disease (MRD) and recurrence pre- and post-surgery. All patients had detectable ctDNA prior to surgery (100% clinical detection). In longitudinal monitoring after surgery, ctDNA was detected in five patients at levels as low as 0.0006% VAF (6 parts per million), consistent with previous studies utilizing RaDaR in breast and lung cancer.
Importantly, ctDNA was detected prior to progression in all five patients with clinical recurrence to date (clinical sensitivity of 100%), with lead times ahead of clinical confirmation ranging from 108 to 253 days. In the remaining 12 patients there was no recurrence detected, indicating a 100% clinical specificity of the RaDaR assay and confirming post-operative tumor clearance.
David Eberhard MD, PhD, Chief Medical Officer, Inivata said: “These data further highlight the clinical utility of our RaDaR assay in the detection of minimal residual disease across tumor types. The assay showed exceptionally high sensitivity, detecting ctDNA in every HNSCC patient who went on to recur, which along with its specificity demonstrates the potential of RaDaR to identify HNSCC patients at an increased risk of relapse, enabling earlier intervention and personalized therapy planning.”
Professor Philipp Baumeister, ORL-HNS, LMU commented: “The exciting data from this study highlight the potential of ctDNA as a reliable biomarker to facilitate monitoring and treatment of disease in HNSCC patients. Importantly, this method may spare our patients many unnecessary invasive examinations and imaging studies, and can guide our treatment recommendations in terms of de-escalation or intensification if needed.”
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 molecular 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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