Inivata Launches US Clinical Trial of Innovative ctDNA Liquid Biopsy Analysis in Lung Cancer
Large-Scale, Prospective Clinical Validation Study to be Conducted with Vector Oncology
Inivata, a global clinical cancer genomics company employing a revolutionary approach to circulating tumor DNA (ctDNA) analysis to improve personalized healthcare in oncology, today announces the launch of its US clinical validation study (INI-001) in non-small cell lung cancer (NSCLC).
INI-001 will be conducted at more than 30 centers in the US and led by co-principal investigators Ramaswamy Govindan, MD, Anheuser-Busch Endowed Chair in Medical Oncology, Director, Section of Oncology, Washington University School of Medicine and Ed Kim, MD, Chairman, Solid Tumor Oncology and Investigational Therapeutics at Levine Cancer Institute. It is expected to recruit several hundred patients. It is a prospective study to evaluate the performance of Inivata’s targeted molecular profiling liquid biopsy platform in comparison to tissue based molecular profiling in patients with advanced NSCLC.
Lee Schwartzberg, MD, President and Chief Medical Officer of Vector Oncology, said:
“Tissue biopsies are highly invasive, particularly in lung cancer, and can fail as a result of lack of tissue availability. The launch of this trial is an exciting step in establishing the clinical utility of liquid biopsies in a disease which remains a significant cause of cancer-related mortality.”
“Tissue biopsies are highly invasive, particularly in lung cancer, and can fail as a result of lack of tissue availability. The launch of this trial is an exciting step in establishing the clinical utility of liquid biopsies in a disease which remains a significant cause of cancer-related mortality,” said Dr. Govindan. Dr. Kim added, “I am excited to see Inivata take this important step to begin to establish a robust clinical evidence base for their novel approach to ctDNA analysis. The potential of ctDNA to unlock real time genomic information to help us treat lung cancer patients more effectively has transformative potential, and I am eager to work with the strong scientific and medical teams at Inivata to demonstrate the clinical utility of these approaches over time.”
Inivata is currently involved with a number of clinical studies with leading cancer centers globally, but this is Inivata’s first prospective clinical validation study. Clive Morris, MD, Inivata’s Chief Medical Officer said, “We are thrilled to partner with outstanding national cancer centers across the US to launch our INI-001 study, which will correlate our highly sensitive ctDNA analysis from a simple blood draw with standard of care tissue biopsies. These data will be a key part of the evidence to support the use of Inivata’s proprietary platform in helping physicians improve the clinical outcomes of their cancer patients.”
The INI-001 (NCT02906852) trial is expected to complete in July 2017. The primary outcome measure is concordance in the detection of molecular abnormalities using Inivata’s liquid biopsy panel with detection using standard of care tissue biopsy analysis. Secondary outcome measures include sensitivity and specificity comparisons, and an analysis of the proportion of NSCLC patients eligible for targeted therapy compared to standard of care alone. More details can be seen at ClinicalTrials.gov (https://clinicaltrials.gov/ct2/show/NCT02906852?term=inivata&rank=1).
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 and offers best-in-class 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. 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. For more information, please go to www.inivata.com. Follow us on Twitter @Inivata.