Natera Announces Positive Surveillance Analysis from the Randomized Phase III IMvigor011 Trial in Muscle-Invasive Bladder Cancer
April 05 2024 - 7:00AM
Business Wire
Data demonstrates that MIBC patients who remain
Signatera MRD-negative after surgery may be spared from adjuvant
treatment, with 100% overall survival at 12 months
Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA
testing, today announced an analysis from the IMvigor011 study that
was presented at the European Association of Urology (EAU) Congress
2024 in Paris, France. The analysis evaluates outcomes in
muscle-invasive bladder cancer (MIBC) patients who tested serially
negative with Signatera™, Natera’s personalized and tumor-informed
molecular residual disease (MRD) test.
Sponsored by Genentech, a member of the Roche group, IMvigor011
is a global, double-blind, randomized, Phase III trial, in which
high-risk MIBC patients are serially tested with Signatera for up
to 12 months post cystectomy. Patients who test Signatera
MRD-positive at any point during the 12-month surveillance window
are randomized to the anti-PDL1 atezolizumab (Tecentriq®) vs.
placebo. Patients who remain Signatera-negative at completion of
the testing window are not randomized but continue to undergo
radiographic imaging thereafter.
The analysis presented at the EAU Congress evaluated clinical
outcomes in 171 high-risk MIBC patients who entered screening for
IMvigor011 and remained MRD-negative during the surveillance
window. Key takeaways from the presentation include:
- Overall survival (OS) rates of 100% at 12 months and 98% at 18
months, in patients who remained serially MRD-negative.
- Disease-free survival (DFS) rates of 92% at 12 months and 88%
at 18 months, in patients who remained serially MRD-negative.
- Concludes that patients who remain MRD-negative on serial
testing may be spared from adjuvant treatment.
“IMvigor011 is an important randomized study that is designed to
address a critical unmet need for the more than 35,000 patients a
year diagnosed with muscle-invasive bladder cancer,” said John
Simmons, vice president, BioPharma at Natera. “We believe the
results of this trial will further demonstrate how Signatera can
help personalize treatment decisions and improve outcomes for
bladder cancer patients. Together with Professor Powles and our
collaborators at Genentech, we look forward to the full trial
read-out which could serve as the basis of Natera’s first FDA
companion diagnostic submission for Signatera.”
This presentation follows a study published in Nature based on
the phase III randomized IMvigor010 trial, which showed that
patients who tested Signatera MRD-positive after radical cystectomy
received significant benefit from adjuvant immunotherapy with
atezolizumab, while Signatera-negative patients derived no
significant benefit from adjuvant therapy.
As previously announced in October 2023, Natera submitted the
first module of its premarket approval application to the U.S. Food
and Drug Administration (FDA) for Signatera as a companion
diagnostic (CDx) assay for patients with MIBC.
Note: Tecentriq® (atezolizumab) is a registered trademark of
Genentech, a member of the Roche Group.
About Signatera Signatera is a personalized,
tumor-informed, molecular residual disease test for patients
previously diagnosed with cancer. Custom-built for each individual,
Signatera uses circulating tumor DNA to detect and quantify cancer
left in the body, identify recurrence earlier than standard of care
tools, and help optimize treatment decisions. The test is available
for clinical and research use and is covered by Medicare for
patients with colorectal cancer, breast cancer, ovarian cancer and
muscle-invasive bladder cancer, as well as for immunotherapy
monitoring of any solid tumor. Signatera has been clinically
validated across multiple cancer types and indications, with
published evidence in more than 50 peer-reviewed papers.
About Natera Natera™ is a global leader in cell-free DNA
testing, dedicated to oncology, women’s health, and organ health.
We aim to make personalized genetic testing and diagnostics part of
the standard of care to protect health, and inform earlier, more
targeted interventions that help lead to longer, healthier lives.
Natera’s tests are validated by more than 180 peer-reviewed
publications that demonstrate high accuracy. Natera operates ISO
13485-certified and CAP-accredited laboratories certified under the
Clinical Laboratory Improvement Amendments (CLIA) in Austin, Texas
and San Carlos, California. For more information, visit
www.natera.com.
Forward-Looking Statements All statements other than
statements of historical facts contained in this press release are
forward-looking statements and are not a representation that
Natera’s plans, estimates, or expectations will be achieved. These
forward-looking statements represent Natera’s expectations as of
the date of this press release, and Natera disclaims any obligation
to update the forward-looking statements. These forward-looking
statements are subject to known and unknown risks and uncertainties
that may cause actual results to differ materially, including with
respect to whether the results of clinical or other studies will
support the use of our product offerings, the impact of results of
such studies, our expectations of the reliability, accuracy and
performance of our tests, or of the benefits of our tests and
product offerings to patients, providers and payers. Additional
risks and uncertainties are discussed in greater detail in "Risk
Factors" in Natera’s recent filings on Forms 10-K and 10-Q and in
other filings Natera makes with the SEC from time to time. These
documents are available at www.natera.com/investors and
www.sec.gov.
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version on businesswire.com: https://www.businesswire.com/news/home/20240404630656/en/
Investor Relations: Mike Brophy, CFO, Natera, Inc.,
510-826-2350, investor@natera.com Media: Lesley Bogdanow, VP of
Corporate Communications, Natera, Inc., pr@natera.com
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