First of its kind study in muscle-invasive
urothelial cancer, with both escalation and de-escalation arms
Approximately 1,000 patients will be enrolled
at more than 300 sites
Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA
testing, and the Alliance for Clinical Trials in Oncology, which is
part of the National Clinical Trials Network (NCTN) funded by the
National Cancer Institute (NCI), part of National Institutes of
Health, today announced the launch of Alliance A032103 (MODERN), a
randomized, phase II/III, biomarker-integrated trial. Alliance
A032103 (MODERN) will utilize Signatera™, Natera’s personalized and
tumor-informed molecular residual disease (MRD) test, to help guide
personalized treatment based on molecular status in patients
diagnosed with muscle-invasive urothelial cancer (MIUC) after
radical cystectomy.
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Urothelial cancer is the most common urinary cancer diagnosed in
the United States, and approximately 35,000 patients per year are
diagnosed with localized and locally advanced urothelial cancer.1
Approximately 50% of patients treated with cystectomy will develop
metastatic recurrence within 2-3 years.2,3
In the Alliance A032103 (MODERN) trial, approximately 1,000
patients will be enrolled at more than 300 sites in North America.
Patients will be divided into two cohorts based on an initial
assessment of MRD status. Patients who are Signatera MRD-positive
will have treatment randomized to either nivolumab, a PD-1
antibody, or escalation with nivolumab, a PD-1 antibody plus
relatlimab, a LAG-3 antibody; LAG-3 and PD-1 are distinct
inhibitory immune checkpoints. Patients who are Signatera
MRD-negative will be randomized to either nivolumab, a standard of
care therapy, or de-escalation to surveillance, with the surveilled
patients receiving treatment only upon future conversion to
MRD-positive status based on serial testing.
This trial was made possible by results of the pivotal CheckMate
274 trial,4 which established the safety and efficacy of adjuvant
nivolumab in MIUC, and is now the only FDA-approved therapy in this
disease setting.5 Additionally, data published in the journal
Nature in 2021 from the IMvigor010 trial showed that 63% of
patients with MIUC tested Signatera MRD-negative after surgery, and
those patients received no significant benefit from adjuvant
immunotherapy (atezolizumab) versus observation.6
“The MODERN trial represents a step towards precision medicine
in bladder cancer treatment,” said Matthew Galsky, MD, professor of
medicine (hematology and medical oncology), director of
genitourinary medical oncology, co-director of the Center of
Excellence for Bladder Cancer and associate director for
translational research at the Tisch Cancer Institute. “By using
Signatera to measure residual cancer after surgery, the Alliance
A032103 (MODERN) trial may ultimately help to tailor the use of
immunotherapy after surgery and optimize the care of individual
patients.”
“MODERN, like the CIRCULATE clinical trials in colorectal
cancer, is a pivotal study that examines how Signatera-guided
escalation and de-escalation pathways can potentially improve
patient outcomes,” said Minetta Liu, MD, chief medical officer of
oncology at Natera. “We are grateful to collaborate with the
Alliance on this important study.”
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.
About Alliance for Clinical Trials in Oncology
The Alliance for Clinical Trials in Oncology develops and
conducts clinical trials with promising new cancer therapies, and
utilizes the best science to develop optimal treatment and
prevention strategies for cancer, as well as research methods to
alleviate side effects of cancer and cancer treatments. The
Alliance is part of the National Clinical Trials Network (NCTN)
funded by the National Cancer Institute (NCI) and serves as a
research base for the NCI Community Research Oncology Program
(NCORP). The Alliance comprises nearly 10,000 cancer specialists at
hospitals, medical centers, and community clinics across the United
States and Canada. To learn more, visit
www.AllianceforClinicalTrialsinOncology.org.
Forward-Looking Statements (Natera)
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.
References
- Source: Kantar Health (Cerner Enviza) estimate.
- Stein JP, Lieskovsky G, Cote R, et al. Radical cystectomy in
the treatment of invasive bladder cancer: long-term results in
1,054 patients. J Clin Oncol. 2001;19(3):666-75.
- Tian J, Sun J, Fu G, et al. Population-based outcome of
muscle-invasive bladder cancer following radical cystectomy: who
can benefit from adjuvant chemotherapy? Transl Androl Urol.
2021;10(1):356-373.
- Bajorin D, Witjes JA, Gschwend JE, et al. Adjuvant atezolizumab
versus observation in muscle-invasive urothelial carcinoma
(IMvigor010): a multicentre, open-label, randomised, phase 3 trial.
N Engl J Med. 2021;384(22):2102-2114.
- Nivolumab Package Insert.
https://packageinserts.bms.com/pi/pi_opdivo.pdf
- Powles T, Assaf ZJ, Davarpanah N, et al. ctDNA guiding adjuvant
immunotherapy in urothelial carcinoma. Nature.
2021;595(7867):432-437.
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version on businesswire.com: https://www.businesswire.com/news/home/20240401420903/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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