Press release
Signatera™ Test Selected for NRG-Sponsored Phase III ARCHER Trial in Bladder Cancer
Randomized study aims to reduce treatment burden for patients and utilizes Signatera to monitor for disease recurrence AUSTIN, Texas--(BUSINESS WIRE)--
About this update from Natera, Inc.
[{"type":"text","content":"\nRandomized study aims to reduce treatment burden for patients and utilizes Signatera to monitor for disease recurrence\n\n\n AUSTIN, Texas--(BUSINESS WIRE)--\nNatera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, today announced the activation of the NRG Oncology trial, ARCHER (NRG-GU015), a randomized, phase III study in muscle-invasive bladder cancer (MIBC). The study is evaluating whether a shorter course of radiation can achieve outcomes comparable to the current standard of care. It prospectively incorporates Signatera, Natera’s personalized, tumor-informed molecular residual disease (MRD) test, as a pre-specified secondary endpoint.\n\n\nMIBC accounts for approximately one-quarter of all bladder cancer cases in the United States and typically requires aggressive treatment.1 Bladder-sparing treatment options are increasing in patient care, and there is a high interest in identifying therapeutic approaches that can achieve promising clinical outcomes while maximizing patient quality of life.2\n\n\nThe ARCHER trial is sponsored by NRG Oncology through the National Cancer Institute’s National Clinical Trials Network. It is expected to have enrollment from more than 100 sites across the U.S. and Canada. Signatera will be collected and reported to investigators during treatment and follow-up at defined timepoints. The test will enable investigators to evaluate real-time circulating-tumor DNA (ctDNA) clearance patterns in each treatment arm as a predictive marker of treatment response and recurrence. Natera will also assess urine tumor DNA as an exploratory endpoint. Signatera has been clinically validated in MIBC to detect recurrence months before standard imaging and to independently predict recurrence risk following curative-intent therapy.3\n\n\n“With Signatera as a key assessment in the ARCHER trial, we aim to evaluate ctDNA dynamics to detect early molecular signs of disease recurrence in real time and refine our clinical surveillance toolbox beyond imaging and cystoscopy,” said Catherine Spina, M.D., Ph.D., co-chair of translational science for the study. “By utilizing ctDNA to monitor treatment response and recurrence, we hope to improve clinical outcomes for patients with MIBC.”\n\n\n“By exploring whether we can safely reduce the intensity and duration of therapy without compromising out...