Natera Achieves Milestone of Enrolling First 1,000 Patients in its BESPOKE CRC Study
Clinical utility study in stage I-IV colorectal cancer (CRC) evaluates how adjuvant treatment decisions are impacted by using the Signatera™ MRD test
AUSTIN, Texas, March 11, 2022 /PRNewswire/ — Natera, Inc. (NASDAQ: NTRA) a global leader in cell-free DNA testing, today announced a milestone with over 100 sites initiated and 1,000 patients enrolled across the U.S. in its BESPOKE CRC study, a prospective, multi-center trial to measure the clinical impact of serial testing with Signatera in resectable CRC.
Since its initial launch in January 2020, interest in the outcome of this trial has grown among oncologists nationwide, with a current target to enroll over 2,000 CRC patients across different stages of disease and to follow them for up to 5 years post surgery. The primary objectives of the study are to quantify the real-world impact of Signatera testing on both adjuvant treatment decisions and clinical outcomes, compared to a historical control group. The investigators plan to conduct an interim analysis later in 2022, for presentation at a future scientific congress.
"After the positive interim results from the CIRCULATE-Japan trial, we are eagerly awaiting results from BESPOKE CRC," said Scott Kopetz, M.D., Ph.D., FACP, chair of the Colon Cancer Task Force at the National Cancer Institute, deputy department chair at the M.D. Anderson Cancer Center and coordinating investigator in the BESPOKE CRC trial. "This study will give us important real-world insight into the implementation and utility of personalized MRD assessment in clinical practice."
"We are pleased to reach this milestone as patient recruitment continues to accelerate," said Adham Jurdi, M.D., medical director of oncology at Natera. "This momentum speaks to the growing interest of Signatera among the oncology community, as a highly accurate tool to inform decision-making in the adjuvant and surveillance settings."
BESPOKE CRC is one among dozens of clinical trials evaluating the clinical utility of Signatera to inform treatment decisions across a range of solid tumors. In CRC specifically, this complements the CIRCULATE-Japan and CIRCULATE-US trials, both prospective, randomized, multi-center trials investigating whether MRD-negative CRC patients benefit from adjuvant chemotherapy. Interim results were recently presented from the CIRCULATE-Japan trial, showing that Signatera is predictive of treatment benefit in early-stage CRC.
Signatera is a custom-built circulating tumor DNA (ctDNA) test for treatment monitoring and molecular residual disease (MRD) assessment in patients previously diagnosed with cancer. The test is available for both clinical and research use, and has been granted three Breakthrough Device Designations by the FDA for multiple cancer types and indications. The Signatera test is personalized and tumor-informed, providing each individual with a customized blood test tailored to fit the unique signature of clonal mutations found in that individual’s tumor. This maximizes Signatera’s accuracy for detecting the presence or absence of residual disease in a blood sample, even at levels down to a single tumor molecule in a tube of blood. Signatera is intended to detect and assess how much cancer is left in the body, to identify recurrence earlier and to help optimize treatment decisions.
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 enable earlier, more targeted interventions that help lead to longer, healthier lives. Natera’s tests are validated by more than 100 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.
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 our efforts to develop and commercialize new product offerings, 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.
Investor Relations: Mike Brophy, CFO, Natera, Inc., 510-826-2350
Media: Kate Stabrawa, Communications, Natera, Inc., firstname.lastname@example.org
SOURCE Natera, Inc.