Natera Announces DECIPHER: A Phase II, Single-Arm Adjuvant Trial in Gastroesophageal Cancer
27 Junio 2024 - 6:00AM
Business Wire
First-of-its-kind study in gastroesophageal
adenocarcinoma using Signatera to guide treatment and assess the
efficacy of a novel HER2-directed adjuvant treatment
Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA
(cfDNA) and genetic testing, today announced a new gastroesophageal
cancer trial, DECIPHER, that will utilize the company’s
personalized and tumor-informed molecular residual disease (MRD)
test, Signatera™, to guide patient selection and assess the rate of
MRD clearance in patients being treated for gastroesophageal
cancer.
DECIPHER (Developing ctDNA Guided Adjuvant Therapy for
Gastroesophageal Cancer) is a single-arm, open-label phase II
trial, and the first trial to evaluate the efficacy of a
HER2-directed antibody-drug conjugate in gastroesophageal
adenocarcinoma (EGC) patients in the adjuvant setting. The study
plans to enroll 25 patients from more than 10 sites across the
United Kingdom. Patients who are Signatera-positive following
neoadjuvant chemotherapy and surgery will forgo standard-of-care
adjuvant chemotherapy and receive the investigational therapy for a
maximum of eight cycles. Signatera will be used to measure
MRD-positivity following surgery and serially thereafter, with MRD
clearance serving as the primary endpoint.
“With an adaptive approach aimed at eliminating MRD, DECIPHER is
designed to offer patients a second chance at a cure when they have
not responded to standard of care therapies,” said Dr. Elizabeth
Smyth, M.D., consultant in medical oncology at Oxford University
Hospitals NHS Foundation Trust l and chief investigator of the
trial. “Signatera’s personalized, tumor-informed approach, which
has demonstrated high sensitivity across several different cancer
types including EGC, will be a key component of this study.”
This launch of DECIPHER follows data from the PLAGAST study
presented last month at the 2024 American Society of Clinical
Oncology (ASCO) Annual Meeting. The data showed that EGC patients
who were Signatera-positive following neoadjuvant FLOT
(fluorouracil, leucovorin, oxaliplatin and docetaxel) chemotherapy
and surgical resection were at an extremely high risk of disease
progression by 12 months, despite standard of care adjuvant
treatment, and had a 24-month overall survival rate of zero.1
Gastroesophageal cancer is a common global cancer that has
sustained a nearly 2.5-fold increase in incidence over the last two
decades.1 Patients with early-stage disease are typically treated
with neoadjuvant chemotherapy, followed by surgery and adjuvant
chemotherapy. Despite this aggressive and multimodal approach,
treatment is curative in less than 50 percent of patients.2
“We are pleased to work with leading investigators in the UK on
the first interventional trial for Signatera in gastroesophageal
cancer,” said Adham Jurdi, M.D., senior medical director of
oncology at Natera. “With DECIPHER, we aim to demonstrate how the
pairing of Signatera with innovative therapies can potentially
enable new personalized treatment options and ultimately improve
outcomes for EGC patients.”
DECIPHER will be featured today, June 27, 2024, in a poster at
the European Society for Medical Oncology Gastrointestinal Cancers
(ESMO GI) Congress 2024 in Munich, Germany. The poster is entitled,
“A single arm phase II trial of trastuzumab deruxtecan in patients
with gastro-oesophageal adenocarcinoma cancer who are ctDNA and
HER2 positive: DECIPHER”.
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 60 peer-reviewed papers.
About Natera
NateraTM is a global leader in cell-free DNA and genetic
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 200 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, or our expectations 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
- Zannan et. al. Longitudinal circulating tumor DNA (ctDNA)
analysis during treatment (Tx) of locally advanced resectable (LAR)
gastric or gastroesophageal junction(G/GEJ) adenocarcinoma
(ADENOCA): the PLAGAST prospective biomarker study. 2024 ASCO
Annual Meeting. Poster #4028
- https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9148370/
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version on businesswire.com: https://www.businesswire.com/news/home/20240627607646/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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