Natera Announces Activation Of NRG Oncology Trial, ARCHER, Randomized, Phase III Study In Muscle-Invasive Bladder Cancer

Randomized study aims to reduce treatment burden for patients and utilizes Signatera to monitor for disease recurrence

Natera, 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.

MIBC accounts for approximately one-quarter of all bladder cancer cases in the United States and typically requires aggressive treatment. 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.

The 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.

The launch of ARCHER will expand Natera's breadth of MIBC clinical evidence, where data has proven how ctDNA testing can benefit patients. That includes the recent read-out of positive topline results from the randomized phase III IMVigor011 trial, which demonstrated Signatera's ability to predict adjuvant immunotherapy benefit in patients post-cystectomy.