NEW YORK – Natera said on Tuesday that it has signed an agreement with the National Cancer Institute-funded group NRG Oncology to use the company's Signatera personalized molecular residual disease test to investigate MRD-guided treatment strategies for early-stage colon cancer patients in the NRG-GI008: Colon Adjuvant Chemotherapy based on Evaluation of Residual Disease (CIRCULATE-US) prospective, multicenter, randomized clinical trial.
The study will enroll approximately 2,000 patients with stage II or III colon cancer after resection. Patients identified as MRD-negative by Signatera will be randomized to receive either standard-of-care adjuvant chemotherapy or observation, unless circulating tumor DNA is subsequently detected during surveillance. Patients identified as MRD-positive will be randomized to receive standard-of-care chemotherapy or an intensified chemo regimen with mFOLFIRINOX.
The study's primary endpoint is to compare disease-free survival in MRD-negative patients who receive immediate adjuvant chemotherapy with those who receive delayed adjuvant chemotherapy, Natera said. The researchers are also aiming to compare disease-free survival in MRD-positive patients who receive the standard-of-care treatment with those who receive the intensified adjuvant chemotherapy.
Signatera is a ctDNA test for treatment monitoring and MRD assessment in cancer patients. It is personalized and tumor-informed, providing each patient with a customized blood test tailored to fit the signature of clonal mutations found in their tumor, Natera said. The test's performance has been clinically validated in multiple cancer types including colorectal, non-small cell lung, breast, and bladder cancers.
"Current standard-of-care guidelines recommend adjuvant chemotherapy for all stage III and high-risk stage II patients, when in reality, only 20 percent to 25 percent of these patients receive any benefit, while everyone is at risk of having side effects," Arvind Dasari, principal study investigator and associate professor at the MD Anderson Cancer Center, said in a statement. "We are pleased to have selected Natera for this study based on the strength and quality of their evidence. We believe Signatera will help us expand the role of ctDNA in identifying patients who are likely to benefit from chemotherapy and those who can be spared."