Research Triangle Park, NC, USA and Cambridge, UK, and Lyon, France,  July 18, 2019 -- 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.