On September 7, 2021 Natera, Inc. (NASDAQ: NTRA) a leader in transforming care through genetic and cell-free DNA testing, reported an agreement with NRG Oncology, a National Cancer Institute (NCI)-funded group, to use the Signatera personalized molecular residual disease (MRD) test in NRG-GI008: Colon Adjuvant Chemotherapy based on Evaluation of Residual Disease (CIRCULATE-US), a prospective, multi-center, randomized clinical trial to investigate MRD-guided treatment strategies for patients with early stage colon cancer (Press release, NRG Oncology, SEP 7, 2021, View Source [SID1234587356]).
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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 (SOC) adjuvant chemotherapy or observation unless circulating tumor DNA (ctDNA) is subsequently detected during surveillance. Patients identified as MRD-positive will be randomized to receive SOC chemotherapy or an intensified regimen with mFOLFIRINOX. The study’s primary endpoint is to compare disease-free survival in (1) MRD-negative patients between immediate vs. delayed adjuvant chemotherapy, and (2) MRD-positive patients between SOC vs. intensified adjuvant chemotherapy.
The CIRCULATE-US study is part of an international collaboration announced at the ESMO (Free ESMO Whitepaper) 2019 conference to tailor adjuvant chemotherapy using emerging ctDNA technologies. CIRCULATE-Japan, which also uses Signatera to drive adjuvant treatment escalation and de-escalation in patients with resected colon cancer, has already reported promising data1,2 at the ASCO (Free ASCO Whitepaper) and ESMO (Free ESMO Whitepaper) GI conferences this year.
"Current standard-of-care guidelines recommend adjuvant chemotherapy for all stage III and high-risk stage II patients, when in reality, only 20%-25%3 of these patients receive any benefit, while everyone is at risk of having side effects,” said Arvind Dasari, M.D., M.S., principal study investigator and associate professor, MD Anderson Cancer Center. "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."
"We are proud to partner with NRG Oncology on this innovative study that is unlikely to be repeated in the U.S.," said Alexey Aleshin, M.D., Natera’s VP of medical affairs, oncology. "We believe the CIRCULATE-US study could provide definitive evidence to further strengthen Signatera as a potentially predictive biomarker for the management of early stage colon cancer and, in the process, improve outcomes for tens of thousands of patients in this country."
About Signatera
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 quantify how much cancer is left in the body, to detect recurrence earlier and to help optimize treatment decisions.
Signatera test performance has been clinically validated in multiple cancer types including colorectal, non-small cell lung, breast, and bladder cancers. Signatera has been developed and its performance characteristics determined by Natera, the CLIA-certified laboratory performing the test. The test has not been cleared or approved by the US Food and Drug Administration (FDA). CAP accredited, ISO 13485 certified, and CLIA certified.