On October 22, 2021 Invitae (NYSE: NVTA), University College London (UCL), and the Francis Crick Institute reported new data from their TRACERx lung cancer research collaboration funded by Cancer Research UK and sponsored by UCL (Press release, Invitae, OCT 22, 2021, View Source [SID1234591778]). The data, presented by Professor Charles Swanton of UCL and the Francis Crick Institute at the International Society of Liquid Biopsy (ISLB) Congress, further validate the value of liquid biopsy as a less invasive and more comprehensive approach to guiding personalized cancer treatment in the absence of detectable disease by clinical imaging. Previously reported findings from the TRACERx cohort found that monitoring for cancer circulating tumor DNA (ctDNA) based minimal residual disease (MRD) detected relapse of non-small cell lung cancer (NSCLC) up to three years earlier than standard of care imaging surveillance in some instances.1

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Invitae’s (NVTA) mission is to bring comprehensive genetic information into mainstream medical practice to improve the quality of healthcare for billions of people. www.invitae.com (PRNewsFoto/Invitae Corporation)

The study used a new blood-based informatic tool called ECLIPSE (Extraction of CLonality from LIquid bioPSiEs) with an earlier iteration of the Invitae Personalized Cancer Monitoring (PCM) liquid biopsy assay to analyze plasma samples of patients in the TRACERx study. With this approach, data demonstrated multiplex-anchored PCR sequencing of the plasma samples enhanced MRD lead times relative to standard of care surveillance scanning and allowed holistic sampling of clonal dynamics, or tumor heterogeneity, with prognostic implications for disease progression.

"Tumours are highly heterogeneous and standard biopsies can miss important tumor traits. Our findings from applying our novel ECLIPSE software with Invitae’s multiplex-anchored PCR technology, which powers the Invitae PCM assay, are promising. They underscore the tremendous potential of PCM for providing representative tumor sampling throughout the disease course, and most importantly at an early stage or at early recurrence in the absence of disease on standard imaging, which may in the future inform clinical trial stratification and the best treatment plans for patients," said Professor Charles Swanton, Cancer Research UK’s Chief Clinician and a 2021 ISLB award recipient for outstanding scientific contribution in liquid biopsy. "Better understanding the true pathology of a patient’s tumor, including driver and passenger clonal mutations, and identifying MRD earlier, are key to unlocking personalized cancer care and changing the paradigm of cancer drug development towards earlier intervention in the adjuvant setting where cures are more readily achievable."

Invitae’s PCM is a pan-cancer, tumor-informed liquid biopsy assay that uses next-generation sequencing powered by Anchored Multiplex PCR (AMP) to monitor MRD with high sensitivity at low variant allele fractions. The service employs a combination of a tumor profile, blood tests and personalized assays based on a patient’s tumor with the goal of earlier detection of cancer recurrence through ctDNA before it is detectable by imaging or other conventional methods. ECLIPSE, developed by the Cancer Research UK TRACERx team at UCL and the Francis Crick Institute, uses a standardized algorithm that helps resolve tumor tissue-based sample bias. Coupling Invitae’s PCM assay with ECLIPSE, the researchers analyzed 972 longitudinal plasma samples from 136 TNM I-III NSCLC patients in TRACERx who had undergone multiregion whole exome sequencing of primary tumor and relapse tissue and had 364 surveillance scans. Seventy-five of these patients experienced a recurrence of their surgically resected disease.

The researchers concluded that multiplex-anchored PCR with trinucleotide specific background models improves NSCLC relapse detection compared to standard of care clinical follow up. Using ECLIPSE, plasma samples of less than 1% purity can be used to accurately profile the clonal structure of tumors at diagnosis, during treatment and at relapse, which impacts patient outcome and has the potential to guide personalized medicine.

"Determining the best treatment plan for a cancer patient depends on several factors, including the results of current disease monitoring. Unfortunately, traditional monitoring methods such as imaging and tissue biopsy are insensitive when it comes to adequately representing a tumor or detecting relapse early in a patient’s treatment cycle," said Robert Nussbaum, M.D., chief medical officer of Invitae. "These findings further validate the role of PCM in determining a therapy’s effectiveness and identifying relapses more quickly, both of which are essential to optimizing personalized treatment plans."

PCM and other liquid biopsy approaches for monitoring MRD have the potential to become a mainstay in personalized oncology. PCM could be applied in a variety of ways to help improve patient care and prolong survival outcomes, including monitoring for recurrence, monitoring a patient’s response to therapy to inform treatment decisions, and improving clinical trial designs to help get new therapies to market sooner.

About TRACERx Study

TRACERx (Tracking Cancer Evolution through therapy (Rx)) lung study is the single biggest investment in lung cancer research by Cancer Research UK. Taking place over nine years, we believe the translational research programme is the first study to look at the evolution of cancer in real time and immense detail. Researchers follow patients with lung cancer all the way from diagnosis through to either disease relapse or cure after surgery, tracking and analysing how their cancer develops. TRACERx is led by UCL (University College London) via the Cancer Research UK Lung Cancer Centre of Excellence and also supported by the National Institute for Health Research, University College London Hospitals Biomedical Research Centre, Francis Crick Institute and the Rosetrees Trust.