Inivata to provide ctDNA liquid biopsy using its InVisionFirst®-Lung test to analyze resistance in patients treated with lorlatinib
Study is being funded by Pfizer
Research Triangle Park, NC, USA and Cambridge, UK, October 29, 2019 -- Inivata, a leader in liquid biopsy, and the European Organisation for Research and Treatment of Cancer (EORTC) have today announced a collaboration in which Inivata’s InVisionFirst-Lung liquid biopsy test will be used in a Phase II trial to screen and monitor ALK positive non-small cell lung cancer (NSCLC) patients initiating treatment with third generation ALK inhibitor therapy lorlatinib.
Although ALK positive NSCLC cancer patients are known to respond well to ALK inhibition therapies, such as lorlatinib, this has been limited in time by the emergence of drug resistance. Furthermore, the impact of acquired resistance on response to sequential therapies is unknown. The study has been designed to better understand resistance mechanisms and to analyze the correlation between ALK resistance mutational profile and response to lorlatinib.
Inivata’s InVisionFirst-Lung ctDNA test will be used initially to provide ‘real-time’ data for the pretrial selection of patients through the detection of molecular resistance. The liquid biopsy test will also be used to provide data on ALK mutational profile in relation to each patient’s response to lorlatinib treatment at the point of disease progression and throughout the course of the study for those patients in whom new ALK mutations are detected.
Eighty-four patients will be involved in this Phase II study across 30 participating EORTC sites in Belgium, France, Italy, The Netherlands, Norway, Spain and the United Kingdom. EORTC, an independent, non-profit research organization in cancer, is the trial sponsor. The trial is being funded by Pfizer Inc., the marketing authorization holder of lorlatinib.
Clive Morris, Chief Executive Officer at Inivata, said: “This pharmaceutical company-backed collaboration highlights the value of our InVision platform in providing rapid and repeatable genomic profiling to enable new analyses of disease and benefit patient treatment. EORTC is a highly regarded leader in translation research and we look forward to working with them on this important study.”
Dr Denis Lacombe, EORTC Director General, said: “Understanding the patterns of resistance and relapse is one of the most burning challenges in oncology. EORTC’s scientific strategy, being primarily patient centered, has developed, over the years, a specific focus on programs which address the entire course of the disease taking forward the challenges that patients face at recurrence. We are, therefore, particularly excited with this partnership which brings together the capacity of our organization and new technologies to address the applicability of liquid biopsy for longitudinal studies on this critical question. Better understanding of resistance will not only provide insight on how to design the next generation of treatment, but could also potentially suggest combination treatment to prevent the development of resistance.
“I would also like to add that this trial protocol was developed in the Methods in Clinical Research workshop (MCCR). This is a workshop to educate early career investigators on how to develop good clinical trial designs and we are delighted that we have been able to implement this protocol.”
InVisionFirst-Lung is a ctDNA next generation sequencing liquid biopsy capable of testing 36 genes, including ALK, relevant to the care of patients with advanced NSCLC. The test is available world-wide for both commercial and research use. In the US, InVisionFirst-Lung is covered for Medicare patients with advanced (Stage IIIB/IV) NSCLC who meet specific clinical criteria. 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 EORTC (European Organisation for Research and Treatment of Cancer) European Organisation for Research and Treatment of Cancer conducts clinical research in cancer, defining new standards of practice for better treatment and care of cancer patients. EORTC network comprises more than 5300 multidisciplinary collaborators in more than 930 hospitals and institutions in 37 countries. For more information, visit www.eortc.org.
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