Natera Announces Phase III Randomized CIRCULATE Trial in France, Evaluating Signatera™ in Stage II Colorectal Cancer

Rhea-AI Summary

Natera, Inc. collaborates with French organizations on a phase III clinical trial for colorectal cancer, evaluating the benefits of adjuvant chemotherapy based on circulating tumor DNA detection. The study aims to impact treatment decisions for stage II CRC patients, potentially setting a new standard of care in France.

Insights

Oncology Doctor

Colorectal cancer (CRC) is a major health concern and the adoption of molecular residual disease (MRD)-guided adjuvant treatment represents a significant advancement in personalized medicine. The use of circulating tumor DNA (ctDNA) as a biomarker for assessing the presence of cancer post-surgery is gaining traction. The ability to detect ctDNA can potentially alter the treatment landscape by identifying which stage II CRC patients might benefit from additional chemotherapy, which is traditionally offered based on clinical and pathological criteria.

The CIRCULATE-PRODIGE-70 study's focus on MRD-guided treatment in stage II CRC patients could lead to more targeted and efficient use of adjuvant chemotherapy, sparing some patients from unnecessary treatment and its associated side effects. This tailored approach aligns with the ongoing shift towards precision oncology, where treatments are adapted to the individual characteristics of each patient's cancer. If the study confirms the benefit of using ctDNA levels to guide treatment decisions, it could result in a paradigm shift in how stage II CRC patients are managed, potentially leading to improved survival rates and quality of life.

Medical Research Analyst

The collaboration between Natera and the French cancer organizations in the CIRCULATE-PRODIGE-70 study is a strategic move to validate the clinical utility of the Signatera MRD test. The study's design, which includes approximately 1,600 patients, provides a robust sample size for evaluating the efficacy of MRD-guided treatment. The prospective randomized nature of the trial enhances the validity of the results.

From a research perspective, the addition of Natera's Signatera test after the initial use of a different ctDNA assay indicates a search for improved sensitivity and specificity in MRD detection. The success of this trial could establish Signatera as a standard tool in the management of stage II CRC in France, potentially influencing treatment guidelines and reimbursement policies. The expected readout in 2025 will be a highly anticipated event for stakeholders, as it may confirm the clinical and economic benefits of personalized MRD testing.

Health Economist

The economic implications of adopting MRD-guided adjuvant treatment in stage II CRC are multifaceted. On one hand, the targeted use of chemotherapy based on ctDNA detection could lead to cost savings by avoiding overtreatment and reducing the incidence of adverse events associated with chemotherapy. On the other hand, the initial investment in MRD testing technologies such as Signatera could increase short-term healthcare costs.

However, if the study results in 2025 demonstrate that MRD-guided treatment improves survival and reduces recurrence rates, the long-term economic benefits could outweigh the initial costs. Health systems could experience reduced expenditures related to metastatic CRC treatment, which is often more intensive and expensive than adjuvant treatment. Additionally, the potential for Signatera's adoption and reimbursement in France hinges on the demonstration of cost-effectiveness, which would be a key consideration for healthcare payers and policymakers.

AUSTIN, Texas--(BUSINESS WIRE)-- Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing, today announced a collaboration with the Fédération Francophone de Cancérologie Digestive and CHU Dijon Bourgogne on the CIRCULATE-PRODIGE-70 study, a randomized, multicenter, prospective phase III clinical trial in France investigating molecular residual disease (MRD)-guided adjuvant treatment in stage II colorectal cancer (CRC) patients.

The study’s main objective is to determine the benefit of adjuvant chemotherapy (ACT) in stage II CRC patients with detectable circulating tumor DNA (ctDNA) post-surgery. Patients who are Signatera MRD-positive will be randomized to receive ACT (FOLFOX 6m) or pursue observation (no chemotherapy). Patients who are Signatera MRD-negative will be treated according to the standard of care (observation). Approximately 1,600 patients will be tested with Signatera, and a successful study result is expected to pave the way for the adoption and reimbursement of Signatera in France. The initial readout is expected in 2025.

CIRCULATE-France is complementary to the CIRCULATE-Japan and CIRCULATE-US trials. While the Japanese and U.S. trials evaluate the benefit of MRD-guided treatment in stage III and high-risk stage II CRC patients, the French trial is focused on stage II CRC.

“With more than 44,000 people in France affected by CRC, there is a significant need for more accurate tools to identify those who will benefit from adjuvant systemic therapy and those who can be treated with surgery alone,” said Julien Taieb, MD, PhD, head of the gastroenterology and gastrointestinal oncology department at the Université Paris-Cité and principal investigator of the study. “We believe this randomized study could establish a new standard of MRD-guided care in stage II colorectal cancer, potentially improving treatment decisions for thousands of patients.”

Natera has joined the study in progress. A separate methylation-based tumor-naive ctDNA assay, developed in-house by UMR-1138 Centre de Recherche des Cordeliers, was used to screen the first 800 patients for eligibility. The principal investigators elected to add Signatera, Natera’s personalized and tumor-informed MRD test, to enhance MRD detection.

“We are pleased to have been selected to support this pivotal trial, which underscores the value of personalized MRD testing across various clinical settings in colorectal cancer,” said Adham Jurdi, MD, senior medical director of oncology at Natera. “We are encouraged by the early momentum of this study and look forward to partnering with the Fédération Francophone de Cancérologie Digestive to improve survival and outcomes for colorectal cancer patients in France.”

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.

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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240318920785/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

Source: Natera, Inc.

FAQ

What is Natera, Inc. collaborating on in France?

Natera, Inc. is collaborating on the CIRCULATE-PRODIGE-70 study, a phase III clinical trial for colorectal cancer.

What is the main objective of the CIRCULATE-PRODIGE-70 study?

The main objective is to determine the benefit of adjuvant chemotherapy in stage II CRC patients with detectable circulating tumor DNA post-surgery.

How many patients will be tested with Signatera in the study?

Approximately 1,600 patients will be tested with Signatera in the CIRCULATE-PRODIGE-70 study.

When is the initial readout of the study expected?

The initial readout of the study is expected in 2025.

Who is the principal investigator of the study?

Julien Taieb, MD, PhD, head of the gastroenterology and gastrointestinal oncology department at the Université Paris-Cité, is the principal investigator of the study.