– Highlights the use of Invitae's personalized
cancer monitoring (PCM) technology to correlate clinical outcomes
with minimal residual disease (MRD) presence –
– The analysis demonstrates the utility of ctDNA
as a highly sensitive and specific biomarker for cancer recurrence
–
– Study validates the need for MRD assays; the
company to continue to leverage its differentiated PCM technology
in pursuing opportunities across multiple indications in the
clinical oncology market –
SAN
FRANCISCO, April 13, 2023 /PRNewswire/
-- Invitae (NYSE: NVTA), a leading medical genetics company,
today announced new research published in Nature describing the
first use of the company's personalized cancer monitoring (PCM)
platform to demonstrate the utility of ctDNA as a biomarker for
cancer recurrence in a large cohort of patients with stage I-III
non-small-cell lung cancer (NSCLC) followed for up to five
years.
The research technology used in the study leverages a
patient-specific panel developed to identify variants from a
patient's own tumor rather than a static gene panel. This study
leveraged Invitae's PCM platform to assess panels of up to 200
variants, a size unique to this platform at the time the study was
conducted, and was optimized for maximum performance. Since then,
Invitae has commercialized its laboratory developed test utilizing
panel sizes of up to 50 variants. In this publication, sensitivity
and specificity of >99.9% was achieved at 0.008% variant allele
frequency (AF) with 60ng cfDNA input and 0.03% variant AF with 10ng
cfDNA input using a 50 variant patient-specific panel.
"The use of our PCM platform in this large study shows the value
of our technology which providers can use to identify early
detection of residual disease and cancer recurrence through a
liquid biopsy and improve their patient's overall cancer journey,"
said Robert Daber, Ph.D. DABMG,
chief science officer at Invitae. "These results validate the need
for products like PCM that create a data-driven treatment process
for patients and physicians alike through ongoing cancer
monitoring."
Patients enrolled in the study had plasma analyses performed
before surgery and 141/197 patients (including 75 with NSCLC
recurrence) had repeated postoperative plasma analyses performed
with a median of six time points. Using new phylogenetic tracking
technologies including patient specific anchored-multiplex PCR
(AMP), these tumor-specific clonal and subclonal mutations were
identified in combination with a novel tool (ECLIPSE) to extract
clonal composition in the context of the low ctDNA levels in
patients with recurrent NSCLC. The versatility of the AMP
technology permitted the study of patient plasma samples across a
range of individual panel sizes (72 to 201, median 200).
Landmark MRD analyses were performed on 108 patients (analyses
of plasma samples collected within 120 days of surgery). Of the 51
patients experiencing lung cancer relapse, results showed that
ctDNA was detected in nearly half of the patients. Utilizing the
early landmark analysis window to forecast eventual relapse
demonstrated a positive predictive value of 93% and a negative
predictive value of 68%. These results are further improved by
continued surveillance beyond the landmark period. Specifically,
20% of patients who had landmark negative results were identified
with impending disease relapse based on monitoring samples
collected periodically for up to five years, which demonstrates the
importance of longitudinal ctDNA surveillance. ctDNA was detected
in relapsing patients prior to standard clinical diagnosis via
imaging by a median time of almost four months (119 days, range 0
to 1137 days).
Clinical sensitivity and specificity were also assessed in this
study. Clinical specificity was assessed in 61 patients without
evidence of disease in whom ctDNA was not expected to be
detectable. This group of 61 patients included 42 recurrence-free
patients and 19 patients who were disease-free at the time the
ctDNA was assessed but subsequently developed new primary cancers
during follow-up. The study reports a specificity of 95%, but after
removing a patient with known anomalies, 58 out of 60 patients were
negative for ctDNA, giving a specificity of 96.7% (95CI
88.64-99.08%). Clinical sensitivity was assessed in 70 patients
expected to be ctDNA positive including 66 patients with recurrent
cancer and four patients with incomplete resections. The paper
reports a minimum sensitivity of 84%. Additional filtering of
qualifying samples (including requiring ctDNA sampling within 100
days of relapse) yields 59 samples having positive ctDNA results
out of a total of 63 patients, for a sensitivity of 93.6% (95CI
84.8-97.5%).
The findings suggest that future management strategies for
early-stage adenocarcinomas should take tumor-informed ctDNA
detection into account to reduce disease recurrence rates in
patients identified to be at high risk.
About the TRACERx clinical study
TRACERx (TRAcking non-small cell lung Cancer Evolution through
Therapy [Rx]) (NCT01888601) is a multi-center, prospective study of
patients with primary non-small cell lung cancer (NSCLC) within the
UK National Health Service that aims to define the trajectories of
lung cancer through multiregional and longitudinal tumor sampling
and genetic analysis. One goal was to determine whether circulating
tumor DNA (ctDNA) could serve as a phylogenetic biomarker in
early-stage NSCLC. High-resolution ctDNA methods were applied to
track a median of 200 tumor-specific mutations from 1,069 plasma
samples from 197 patients enrolled in the study. Analyses of plasma
samples collected within 120 days post-surgery revealed ctDNA
detection in 25% of patients, including 49% of all patients who
experienced clinical relapse. A landmark positive status associated
with early-NSCLC relapse within the first postoperative year and
three to six monthly ctDNA surveillance of patients (for up to five
years) identified impending disease relapse in 20% of landmark
negative patients.
About PCM™
Invitae's Personalized Cancer Monitoring (PCM™) assay is
designed to detect minimal residual disease (MRD) in patients. The
oncology product uses a novel set of personalized assays based on a
patient's tumor to detect circulating tumor DNA (ctDNA) in blood,
assisting with risk stratification, assessing response to treatment
and detecting residual disease and cancer recurrence.
About Invitae
Invitae (NYSE: NVTA) is a leading medical genetics company
trusted by millions of patients and their providers to deliver
timely genetic information simplified by digital technology. With
accurate and actionable answers to strengthen medical
decision-making, Invitae gives individuals and their families
powerful, personalized insights that could improve and extend their
lives. Invitae's genetics experts apply a rigorous approach to data
and research, serving as the foundation of their mission to bring
comprehensive genetic information into mainstream medicine to
improve healthcare for billions of people.
To learn more, visit invitae.com and follow for updates
on Twitter, Instagram, Facebook and LinkedIn
@Invitae.
Safe Harbor Statement
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995, including statements relating to the company's beliefs
regarding the new study findings; the company's beliefs that the
new study demonstrates the utility of ctDNA, MRD assays and the
company's PCM technology; the company's plans with respect to its
PCM technology; and the company's belief that the study results
validate the need for products like PCM. Forward-looking statements
are subject to risks and uncertainties that could cause actual
results to differ materially, and reported results should not be
considered as an indication of future performance. These risks and
uncertainties include, but are not limited to: the impact of
inflation and the current economic environment on the company's
business; the company's ability to grow its business in a
cost-efficient manner; the company's history of losses; the
company's ability to maintain important customer relationships; the
company's ability to compete; the company's need to scale its
infrastructure in advance of demand for its tests and to increase
demand for its tests; the risk that the company may not obtain or
maintain sufficient levels of reimbursement for its tests; the
applicability of clinical results to actual outcomes; risks
associated with litigation; the company's ability to use rapidly
changing genetic data to interpret test results accurately and
consistently; security breaches, loss of data and other
disruptions; laws and regulations applicable to the company's
business; and the other risks set forth in the company's filings
with the Securities and Exchange Commission, including the risks
set forth in the company's Annual Report on Form 10-K for the year
ended December 31, 2022. These
forward-looking statements speak only as of the date hereof, and
Invitae Corporation disclaims any obligation to update these
forward-looking statements.
Invitae PR contact:
Amanda McQuery
pr@invitae.com
(628) 213-3283
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