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Signatera™ Test Selected for NRG-Sponsored Phase III ARCHER Trial in Bladder Cancer
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Natera a leader in cell-free DNA and precision medicine, has announced the start of a new clinical trial called ARCHER (NRG-GU015), a randomized phase III study for muscle-invasive bladder cancer (MIBC). This trial, sponsored by NRG Oncology, will assess if a shorter course of radiation treatment can be as effective as the current standard of care. The study aims to improve patient quality of life by potentially reducing the intensity and duration of therapy without compromising outcomes. The trial is expected to enroll patients from over 100 sites across the U.S. and Canada.

A key component of the ARCHER trial is the prospective use of Natera’s personalized, tumor-informed molecular residual disease (MRD) test, Signatera, as a pre-specified secondary endpoint. Signatera will be used to evaluate circulating-tumor DNA (ctDNA) clearance patterns in real time during treatment and follow-up. This will allow investigators to assess whether ctDNA can serve as a predictive marker for treatment response and disease recurrence.

The clinical validation of Signatera in MIBC has already shown its ability to detect cancer recurrence months earlier than standard imaging and independently predict the risk of recurrence after curative treatment.

The integration of Signatera into the ARCHER trial is a significant step toward using MRD insights to guide more precise patient management. According to Dr. Catherine Spina, a co-chair of translational science for the study, the goal is to use ctDNA dynamics to detect early signs of recurrence and refine the clinical surveillance toolbox beyond traditional methods like imaging and cystoscopy. Dr. Minetta Liu, Natera’s chief medical officer of oncology, emphasized that the trial has the potential to reduce patient burden. The ARCHER trial will add to Natera’s existing body of clinical evidence in MIBC, which includes data from the recent IMVigor011 trial that demonstrated Signatera's ability to predict the benefit of adjuvant immunotherapy for patients post-cystectomy. This ongoing research underscores the potential of Natera’s technology to inform more targeted and effective interventions, ultimately contributing to longer, healthier lives for patients.

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