On March 18, 2024 Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing, reported 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 (Press release, Natera, MAR 18, 2024, View Source [SID1234641247]).

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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.