Research Triangle Park, NC, USA and Cambridge, UK, 10 April 2021 -- Inivata, a leader in liquid biopsy, today unveils new data at the American Association for Cancer Research (AACR) Virtual Annual Meeting in support of the capabilities and application of the Company’s liquid biopsy technologies, particularly the RaDaR® assay for the detection of molecular residual disease (MRD) and recurrence.

In two studies, RaDaR demonstrated excellent specificity (100%) and sensitivity (100%) in detecting MRD in patient cohorts with head and neck cancer and early-stage breast cancer. The data are available in ePosters to view today by AACR attendees in the conference’s Liquid Biopsies: Circulating DNA session, from 8:30 AM – 12:00 PM ET.

In a retrospective, multi-center, proof-of-principle study of early-stage breast cancer, personalized RaDaR assays were carried out on samples from 22 patients who had undergone surgery with curative intent, from whom 147 plasma samples were analyzed for circulating tumor DNA (ctDNA) across multiple timepoints. MRD was identified by RaDaR in 100% of the relapsed patients (17/17) and in none of the patients that did not relapse. This included patients with brain only metastasis, which was not previously achievable with single mutation dPCR MRD-detection assays. Detection of ctDNA levels ranged from 0.0007% estimated variant allele fraction (VAF) to 1.3% VAF. Median lead-time from ctDNA detection to clinical relapse (in patients where relapse occurred outside of the brain) was 12.89 months, with a maximum lead-time of over two years. The study was run in collaboration with The Institute of Cancer Research, London and The Royal Marsden NHS Foundation Trust and the abstract can be viewed here.

RaDaR is also being used in the LIONESS study (Liquid BIOpsy for MiNimal RESidual DiSease Detection) in head and neck squamous cell carcinoma (HNSCC). In this ongoing single-center prospective experimental evidence-generating study, patients who had received primary surgical treatment with curative intent are monitored for MRD and recurrence using RaDaR. Preliminary data from patients recruited shows 100% ctDNA detection in baseline samples taken prior to surgery. In all patients (4/4) who have gone on to relapse, ctDNA was detected ahead of clinical progression, with a lead time of 108-248 days. In these post-surgery samples, ctDNA could be detected at levels as low as 0.0006% VAF. The study abstract can be viewed here. The study is being conducted in collaboration with the Department of Otorhinolaryngology, Head and Neck Surgery (ORL-HNS), LMU Klinikum, and Institute of Pathology, Faculty of Medicine, LMU Munich.​

Posters can be viewed during on the AACR website by registered attendees and will be available on the Inivata website after today’s session.

These results provide growing evidence in support of RaDaR’s capabilities in different cancer types, building on data previously reported in non-small cell lung cancer (NSCLC), where RaDaR detected ctDNA 6-12 months ahead of clinical progression in the majority of cases and predicted lower progression free survival.

Professor Philipp Baumeister, ORL-HNS, LMU commented: “Despite improvements in treatment, survival rates for patients with head and neck cancers remain low. These early data from the ongoing LIONESS study are encouraging, as the findings could help to guide clinical responses to potential relapse. Detecting MRD in a patient sooner using ctDNA technology has the potential to inform clinicians on the appropriate next steps, such as the use of adjuvant therapy, close monitoring through further biopsy or repeat resection. This would represent a significant step towards more personalized, effective care for individuals with head and neck cancers.”

Clive Morris, CEO of Inivata, commented: “While these are relatively small-scale studies, we are hugely encouraged to see RaDaR continue to deliver exceptionally sensitive detection of ctDNA in MRD settings across multiple tumor types. Within both studies RaDaR was able to detect ctDNA in every patient who went on to recur. We believe this high level of sensitivity, coupled with excellent specificity, has the potential to allow for earlier detection of residual disease and recurrence, providing a window for intervention and informing clinicians on the appropriate next steps for their patients.”

New data were also shared at the conference showcasing Inivata’s InVisionFirst®-Lung liquid biopsy for use in BRAF-mutant NSCLC. The study abstract can be viewed here. The data supports the use of liquid biopsy analysis to help assess resistance to certain drug treatments with this form of NSCLC, and help to guide precision care for patients.

About Inivata

Inivata is a leader in liquid biopsy. Its InVision® 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. Its lead product, InVisionFirst®-Lung is commercially available internationally and through NeoGenomics in the US. It offers competitive sensitivity and turnaround, providing molecular insights that enable clinicians to make more informed treatment decisions for advanced NSCLC patients. Inivata has also launched the personalized RaDaR® assay – allowing the highly sensitive detection of residual disease and recurrence – which has been granted Breakthrough Device Designation by the US FDA. Inivata is partnering with pharmaceutical, biotechnology companies and commercial partners in a range of early and late-stage cancer development programs. The Company has a CLIA certified, CAP accredited laboratory in Research Triangle Park, NC and R&D laboratories in Cambridge, UK.

About RaDaR®

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.

About InVisionFirst®-Lung

InVisionFirst-Lung is Inivata’s 37 gene liquid biopsy test relevant to the care of patients with advanced NSCLC. InVisionFirst-Lung offers competitive sensitivity and a rapid turnaround time with results being delivered within seven calendar days from blood draw. The test has received reimbursement for US Medicare patients with advanced non-small cell lung cancer (NSCLC) and is available for both commercial and research use. InVisionFirst-Lung is being commercialized in the US by NeoGenomics as part of a strategic collaboration with Inivata.