AUSTIN, Texas--(BUSINESS WIRE)--Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and genetic testing, today announced that it will present new SignateraTM data at the San Antonio Breast Cancer Symposium (SABCS), taking place Dec. 10-13 in San Antonio, TX. Natera and its collaborators will present a total of six abstracts.
“We are proud to share this new data on Signatera at SABCS that underscores our commitment to generating evidence on the clinical utility of Signatera for patients with breast cancer,” said Angel Rodriguez, M.D., senior medical director at Natera.
The full list of abstracts with selected highlights are as follows:
ZEST Clinical Trial
Oral Presentation #GS3-01 | Dec. 13 | Presenter: Nicholas Turner, MD, PhD, FRCP, FMedSci
Circulating tumor DNA surveillance in ZEST, a randomized, phase 3, double-blind study of niraparib or placebo in patients with triple-negative breast cancer or HR+ HER2− BRCA-mutated breast cancer with molecular residual disease after definitive therapy
ZEST was a randomized, phase III, double-blind trial, sponsored by GSK, that evaluated whether niraparib can enhance disease-free survival in patients with breast cancer who are ctDNA-positive after completion of curative intent therapy and without evidence of radiographic recurrence. A total of 2,746 patients were pre-screened. Of patients who were ctDNA-positive, 40 were enrolled and randomized (niraparib, 18; placebo, 22); 36 patients (90%) had Triple Negative Breast Cancer (TNBC), and 4 patients (10%) had BRCA-mutated HR+ disease. An analysis of outcomes among randomized patients showed a median disease-free survival of 11.4 months in the niraparib arm versus 5.4 months in the placebo group (hazard ratio, 0.64; 95% CI, 0.30–1.39).
Clinical Genomics Database Experience
Poster Spotlight #PS9-01 | Dec. 12 | Presenter: Marla Lipsyc-Sharf, MD
Actionable Genomic Alterations in Localized Hormone Receptor Positive (HR+) Breast Cancer and Impact on Clinical Outcomes: Results from Comprehensive Whole Exome Sequencing (WES) and Tumor-Informed circulating tumor DNA (ctDNA) analysis
This real-world analysis evaluated the association of targetable tumor genomic alterations with ctDNA detection and distant recurrence-free survival (DRFS) in early-stage breast cancer. In the study, 44% of patients (127/287) who were Signatera-positive had at least one targetable genomic alternation, including 34.5% with the PIK3CA mutation. In addition, of patients with ctDNA-positivity within 2 years, those with mutated PIK3CA had an inferior DRFS (HR: 36.9), compared to patients with wild-type PIK3CA (HR=16.3).
Patient-Reported Outcomes
Four abstracts to be presented at SABCS evaluated patient reported outcomes when testing for circulating tumor DNA (ctDNA). The data indicates that ctDNA testing can provide valuable information for treatment planning while not causing increased anxiety in patients.
Poster #P2-03-21 | Dec. 11 | Presenter: Neil Carleton
Longitudinal Monitoring of ctDNA to Facilitate Surgical De-Escalation and Disease Surveillance in Older Women with ER+ Breast Cancer on Primary Endocrine Therapy: A Prospective, Pragmatic, Hybrid-Decentralized Trial with Correlative Analyses
Poster #P4-03-29 | Dec. 12 | Presenter: Devora Isseroff, MD
Patient (Pt) reported anxiety levels during ctDNA surveillance in early-stage triple negative (TNBC) and hormone receptor positive (HR+) breast cancer (BC)
Poster #P3-01-22 | Dec. 12 | Presenter: Mrinalini Ramesh, DO
Pilot feasibility study of ctDNA testing in breast cancer and its association with pain, stress and anxiety
Poster #P5-12-19 | Dec. 13 | Presenter: Mridula George, MD
Patient-reported outcomes from the CIPHER 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 100 peer-reviewed papers.
About Natera
Natera™ 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 250 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.
