IP : Inivata Ltd - Inivata announces launch of clinical trial to evaluate impact of InVisionFirst®-Lung liquid biopsy test on time to appropriate treatment in advanced lung cancer

Prospective, interventional study sponsored by Centre Léon Bérard cancer center will compare use of InVisionFirst-Lung versus standard of care tissue biopsy

Primary end point is a reduction in time to treatment in patients with suspected metastatic non-small cell lung cancer

Inivata, a leader in liquid biopsy, and the Centre Léon Bérard cancer center in Lyon, France, today announce the start of a randomized phase III clinical trial to evaluate time to appropriate treatment in patients with suspected metastatic lung cancer, using Inivata's InVisionFirst®-Lung liquid biopsy test compared to standard of care tissue biopsy. This is the first interventional study for Inivata's InVisionFirst-Lung liquid biopsy test.

The 'Liquid Biopsy for the Early detection of LUng cancer LEsion' ('LIBELULE') study will enroll approximately 286 patients across 17 clinical sites in France (more details available here). The trial will demonstrate if Inivata's liquid biopsy test could be used in routine clinical practice to reduce the time to appropriate treatment for targeted lung cancer therapies, whilst assessing whether it has the potential to be complementary to tissue profiling for other therapeutic selection.

The primary end point of the study is a reduction in time to treatment of more than 20% in the overall population of patients with suspected metastatic lung cancer. The study will also evaluate clinical outcomes, including progression-free-survival.

Maurice Pérol, Department of Medical Oncology, Centre Léon Bérard, said: 'Treatment of advanced lung cancer today needs to take into consideration many different parameters, including the genomic characteristics of the tumour, in order to deliver as personalized a treatment as possible. Using standard methods, the time required to obtain the results of the genomic characterization of a tumour from tissue biopsy is substantial and may delay initiation of treatment. In the LIBELULE clinical trial, we are testing whether the use of liquid biopsy can shorten this time before clinicians gain critical genetic insights into an individual patient's cancer and therefore start the most appropriate treatment earlier.'

Pierre Saintigny, Department of Translational Research and Innovation, Centre Léon Bérard, said: 'Working with a robust and validated test will allow us to evaluate, in a real-life study, whether liquid biopsy may bring important benefits for patients with suspected advanced lung cancer through earlier access to appropriate therapy and also guide treatment for those for whom tissue biopsy is not available. We look forward to working with Inivata and our clinical colleagues across France on this important study.'

Clive Morris, Chief Executive Officer at Inivata, said: 'We are committed to continuing to build a highly robust body of evidence around the use of our liquid biopsy tests and are excited to be starting this real-life, interventional study which we believe to be the first of its type in the liquid biopsy field.

'We have already published the strong clinical validation results that underpinned our positive Medicare reimbursement decision, and are proud to be working with high-quality teams around the world to develop a deeper understanding of the impact InVisionFirst-Lung can have on treatment.'

The LIBELULE study

LIBELULE is a multicenter, randomized (1:1 ratio), comparative, open-label Phase III study and will take place in across 17 sites in France with 286 patients expected to be enlisted. Recruitment is anticipated to be completed in 18 months.

The primary objective is to evaluate in patients with suspected metastatic non-small cell lung cancer the impact of genomic characterization using plasma cell-free DNA, with InVisionFirst-Lung, at the time of the first evaluation by a lung cancer specialist on time-to-appropriate treatment initiation. The study involves two comparative arms: experimental where patients will be stratified to treatment according to Inivata's InVisionFirst-Lung liquid biopsy test results, compared to a control arm where treatment is determined based on tissue biopsy profiling only. In the experimental arm, where InVisionFirst-Lung results are not clinically informative, treatment will be initiated on tissue biopsy genomic profiling. Clinicians will initiate the appropriate therapy according to standard of care. The primary end point is a reduction of time to treatment initiation (TTI) of 21% in the overall population with suspicious metastatic lung cancer, including a 50% and 40% reduction in TTI for EGFR/ALK/ROS1/BRAF V600E sub groups and KRAS/LKB1/ERBB2/c-MET/BRAF non V600E sub groups, respectively.

LIBELULE is a multicenter, randomized (1:1 ratio), comparative, open-label Phase III study and will take place in across 17 sites in France with 286 patients with suspected metastatic non-small cell lung cancer expected to be enrolled. Recruitment is anticipated to be completed in 18 months.

The primary objective is to evaluate the impact of genomic characterization on time-to-appropriate treatment initiation using plasma cell-free DNA with InVisionFirst-Lung at the time of the first evaluation by a lung cancer specialist. The study involves two comparative arms: experimental where patients will be stratified to treatment according to Inivata's InVisionFirst-Lung liquid biopsy test results, compared to a control arm where treatment is determined based on tissue biopsy profiling only. In the experimental arm, where InVisionFirst-Lung results are not clinically informative, treatment will be initiated on tissue biopsy genomic profiling. Clinicians will initiate the appropriate therapy according to standard of care. The primary end point is a reduction of time to treatment initiation (TTI) of 21% in the overall population with suspicious metastatic lung cancer, including a 50% and 40% reduction in TTI for EGFR/ALK/ROS1/BRAF V600E sub groups and KRAS/LKB1/ERBB2/c-MET/BRAF non V600E sub groups, respectively.

About Inivata

Inivata is a leader in liquid biopsy. Its InVision® platform unlocks essential genomic information from a simple blood draw to transform the care of cancer patients. The Company's technology is based on pioneering research from the Cancer Research UK Cambridge Institute, University of Cambridge and reinforced by multiple high calibre publications. Its lead product, InVisionFirst®-Lung, is commercially available and provides molecular insights that enable clinicians to make more informed treatment decisions for advanced NSCLC patients. Inivata is partnering with pharmaceutical and biotechnology companies on InVisionFirst-Lung and its wider platform, which is applicable to a range of cancer types. The Company has a CLIA certified, CAP accredited laboratory in Research Triangle Park, NC and laboratories in Cambridge, UK. For more information, please go to www.inivata.com. Follow us on Twitter @Inivata.

About Centre Léon Bérard

The Centre Léon Bérard (CLB) is part of the twenty French Comprehensive Cancer Centres in France, providing a global management of cancer patients on a unique area, from diagnosis to treatment and beyond. The Centre is a regional, national and international recognized reference cancer Centre assigned with three essential missions: Care, Research and Education and is willing to continuously improve the quality and accessibility of care for cancer patients.

More than 37,000 patients are received each year, on consultations or exams and 11,000 new cancer cases are diagnosed. The CLB has technical and treatment facilities (operating room, radiation therapy centre, medical imaging departments, pathology and nuclear medicine departments).

The bench-to-bedside process is one of the strengths of the Centre Léon Bérard

The Centre Léon Bérard develops an excellence and multidisciplinary research, in association with the cares carried out on site and institutional and private partners. The foundations of this development lay in the medical and scientific project. The CLB aims to reinforce the bench-to-bedside process by facilitating translational research to help innovation and speed-up its access to patients for diagnoses and therapies. Clinical research has been certified ISO 9001 since 2013 and is thus one of the strength of the Centre.As a result, more than 18,5% of patients were included in clinical trials in 2018.At the Centre Léon Bérard 1,700 persons work in cares, research, education and supportive care (200 physicians, 500 researchers, 600 caregivers).

InVisionFirst®-Lung

InVisionFirst®-Lung is a clinical diagnostic laboratory-developed test (LDT) validated for the accurate identification of genomic alterations in 36 genes, including genes that are relevant to advanced NSCLC. Results from this ctDNA liquid biopsy help inform physicians' prognostic and therapeutic decisions for patients diagnosed with advanced NSCLC. InVisionFirst®-Lung received a final Local Coverage Determination from Palmetto GBA, supporting its use in aiding the management of US Medicare patients with advanced NSCLC that meet certain eligibility criteria.

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