Natera to Present New Data from the CIRCULATE-Japan and BESPOKE CRC Studies at ASCO GI 2024 Supporting Signatera’s Clinical Utility in CRC
18 Janeiro 2024 - 10:00AM
Business Wire
Oral presentations include updated 24-month DFS
analysis from GALAXY and first interim analysis from BESPOKE
CRC
Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA
testing, today announced that new data on its personalized and
tumor-informed molecular residual disease (MRD) test, Signatera™,
will be presented at the American Society of Clinical Oncology’s
2024 Gastrointestinal Cancers Symposium (ASCO GI), taking place
January 18 – 20, 2024 in San Francisco, California.
Natera and its collaborators will present 11 abstracts that
feature new Signatera data across various GI indications, including
two oral presentations. An updated analysis from the previously
published GALAXY study, the observational arm of the prospective
CIRCULATE-Japan trial, will be presented in an oral presentation at
the symposium and is also featured in ASCO GI’s press program.
GALAXY is one of the largest and most comprehensive prospective
studies of MRD testing in resectable colorectal cancer (CRC).
Additionally, the first read-out from the Natera-sponsored
BESPOKE CRC study will be presented in a rapid oral presentation.
BESPOKE CRC is the first large, prospective, US-based study in
resectable CRC, with over 130 participating sites.
Highlights from the abstracts selected for
oral presentation include:
Abstract ID: 6 | Oral Abstract Session C | CRC |
Presenter: Hiroki Yukami, MD Circulating tumor DNA (ctDNA)
dynamics in CRC patients (pts) with MRD: Updated analysis from
GALAXY study in CIRCULATE-JAPAN
This latest analysis from GALAXY included close to 3,000 stage
I-IV CRC patients. Key findings include:
- ctDNA dynamics at the six-month time point post-surgery showed
that patients who remained ctDNA-positive were >6 times more
likely to recur compared to those who cleared their ctDNA.
- ctDNA-positive patients with sustained clearance in subsequent
time points as a result of adjuvant chemotherapy (ACT) had
remarkably better outcomes compared to those with transient ctDNA
clearance (24-month DFS rate; 90.1% vs 2.3%) or no clearance
(24-month DFS rate; 90.1% vs 2%).
- In ctDNA-positive patients treated with ACT, a >50% decrease
in ctDNA MTM/mL levels at six months, including those with complete
clearances, was associated with better DFS than a <50% decrease
or increase (24-month DFS rate; 51.1% vs 29%).
Abstract ID: 9 | Rapid Oral Abstract Session C | CRC |
Presenter: Pashtoon Kasi, MD, MS ctDNA for informing
adjuvant chemotherapy (ACT) in stage II/III CRC: Interim analysis
of BESPOKE CRC study
This analysis included 689 patients with stage II/III resectable
CRC. Key findings include:
- Within the ctDNA-positive cohort, patients receiving ACT had
significantly longer DFS compared to those in the observation group
(24-month DFS rate; 42.4% vs 12.5%). No benefit of ACT was observed
in ctDNA-negative patients.
- ctDNA monitoring allowed for oligometastases-directed therapy
in 40% of patients who recurred.
- A separate poster on the BESPOKE CRC study (abstract ID: 54)
found that in 400+ patients surveyed, ≥92% valued the information
received from their Signatera results or would use Signatera to
guide their clinical care. In addition, 73% reported that Signatera
results reduced anxiety about cancer recurrence.
“These latest findings from the landmark CIRCULATE trial
underscore Signatera’s ability to identify patients who may be more
likely to benefit from adjuvant chemotherapy, showing the value of
personalized MRD testing to guide treatment decisions in CRC and
potentially spare patients from unnecessary toxicity,” said Hiroki
Yukami, MD, from the Cancer Chemotherapy Center, Osaka Medical and
Pharmaceutical University, and lead study author of the GALAXY
study. “We are encouraged by the widespread attention and
recognition this presentation has received from the oncology
community, and are optimistic that the GALAXY study, along with the
ALTAIR escalation and VEGA de-escalation arms of CIRCULATE, will
fundamentally change the way CRC is treated.”
“We are pleased to share new data from the Japanese-based GALAXY
and US-based BESPOKE CRC studies, which further demonstrate the
prognostic and predictive power of longitudinal testing with
Signatera in resectable colorectal cancer,” said Minetta C. Liu,
MD, chief medical officer of oncology at Natera. “These two
prospective clinical trials provide strong evidence supporting the
clinical utility of Signatera to inform adjuvant chemotherapy
decisions and facilitate surveillance for cancer recurrence.”
Below are the additional Natera poster
presentations at ASCO GI:
- Abstract ID: 54 | CRC | Presenter: Pashtoon Kasi, MD,
MS Patient-reported outcomes from the BESPOKE CRC study
- Abstract ID: 27 | CRC | Presenter: Giulia Maddalena,
MD INTERCEPT Program of ctDNA Testing for MRD in CRC: Results
from a Prospective Clinical Cohort
- Abstract ID: 183 | CRC | Presenter: Hidekazu
Oyoshi Prediction of postoperative recurrence by integrating
preoperative ctDNA levels and tumor metastasis volume in pts with
CRC with resectable lung or liver metastasis
- Abstract ID: 528 | Bile Duct Cancer | Presenter: Woo
Jin Choi, MD, PhD The role of pre-operative ctDNA in resectable
intrahepatic cholangiocarcinoma
- Abstract ID: 212 | Rectal Cancer | Presenter: Sakti
Chakrabarti, MD Prognostic value of ctDNA testing in rectal
cancer pts after neoadjuvant therapy (NAT) and surgery
- Abstract ID: 23 | CRC | Presenter: Masaaki Miyo, MD,
PhD Association of ctDNA MRD detection with lymph node
metastasis after local excision of pathological T1 CRC: First
results from DENEB, a CIRCULATE-Japan GALAXY substudy
- Abstract ID: 196 | CRC | Presenter: Andrew Pellatt,
MD Redefining The Prognostic Significance of RAS and BRAF V600E
Mutations on Disease Free Survival in CRC Pts in the Era of ct-DNA
Defined MRD: Results from the MD Anderson INTERCEPT Program
- Abstract ID: 695 | Pancreatic Cancer | Presenter:
Ujwal Yanala, MD Utility of ctDNA for the detection of MRD
after curative-intent therapy for pts with localized pancreatic
adenocarcinoma (PDAC): A single institution series and
meta-analysis
- Abstract ID: 214 | CRC | Presenter: Nikolas Naleid,
MD Surveillance of Resected Metastatic Colorectal Cancer
Utilizing Circulating DNA
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 (stage IIb and higher) 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/20240118279116/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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