Inivata publishes positive clinical validation results and real-world utility for its InVisionFirst®-Lung liquid biopsy test

InVisionFirst®-Lung demonstrated excellent concordance with tissue profiling and detected 26% more actionable alterations than
standard-of-care testing

Data from two prospective U.S. trials published in Journal Clinical Oncology – Precision Oncology

Research Triangle Park, NC and Cambridge, UK, April 26, 2019 -- Inivata, a leader in liquid biopsy, today published the clinical validation results and real-world utility of its InVisionFirst-Lung liquid biopsy test for use in advanced non-small cell lung cancer (NSCLC). Inivata conducted two prospective, multi-center studies in collaboration with 41 key institutions across the United States. The data, published in JCO Precision Oncology[i], highlights the potential of Inivata’s first Medicare-reimbursed commercial test to improve delivery of comprehensive tumor genomic profiling. The publication follows the presentation of these data at the World Conference on Lung Cancer in September 2018.

The studies recruited 264 advanced NSCLC patients and compared the genomic profiling performance of InVisionFirst-Lung versus standard-of-care tissue testing. The studies showed that Inivata’s liquid biopsy test demonstrated excellent concordance with tissue profiling, with a high level of sensitivity and specificity. Notably, the InVisionFirst-Lung liquid biopsy test was able to detect 26% more actionable alterations versus standard-of-care tissue testing. More comprehensive testing with InVisionFirst-Lung could lead to more accurate patient stratification and potentially to improved outcomes based on more personalized therapy.

Clive Morris, Chief Executive Officer at Inivata, said: “We are delighted to publish compelling data that highlights the robust clinical validation for InVisionFirst-Lung in patients with advanced non-small cell lung cancer. The data demonstrate the potential of our liquid biopsy technology to help clinicians make more informed treatment decisions for patients with advanced NSCLC. Advanced liquid biopsy technologies like our InVision platform are becoming increasingly important for helping to refine and improve the treatment of cancer, particularly in cases where tissue testing is not achievable.”

Dr Ramaswamy Govindan, Professor of Medicine, Washington University School of Medicine, said: “In this multi-centered prospective study, the InVisionFirst-Lung test showed excellent concordance with tissue profiling. The detection of an increased percentage of patients with actionable mutations using liquid biopsy demonstrates how this technology can help ensure patients with lung cancer receive the appropriate therapies. Using liquid biopsies enables us to make informed treatment decisions in the absence of comprehensive tissue testing, ensuring more NSCLC patients can be treated with the appropriate therapy, improving their chances of durable response and survival.”

Study Details

Two prospective multi-center clinical validation and utility studies were conducted enrolling 264 advanced untreated NSCLC patients. Tumor tissue-based genotyping was available in 178 patients for comparison to plasma profiling. The remaining 86 patients were included to compare ctDNA profiles across patients with and without tissue for profiling.

Study Results:

• Considering specific alterations in the 8 clinically relevant genes that most influence patient management in advanced NSCLC, sensitivity was 73.9% with 99.8% specificity; 97.8% PPV and 97.1% NPV.
• Overall concordance of InVisionFirst-Lung with matched tissue profiling was 97.8%, 70.6% sensitivity and 99.2% specificity with 82.9% PPV, 98.5% NPV.
• The studies support the hypothesis that InVisionFirst-Lung has clinical utility in over 50% of patients in untreated advanced stage NSCLC, based on detection of clinically relevant mutations in 53.8% of the enrolled patients.
• Across the enrolled population, 48 patients with actionable alterations were identified by ctDNA testing compared to only 38 by tissue testing; InVisionFirst-Lung identified 26% more actionable alterations.

The data and list of authors can be viewed on the JCO Precision Oncology website.

For more details on the studies:  INI-001 [NCT02906852] & GRN-ALV [NCT03116633]).