Natera, Inc. announced positive topline results from the randomized, phase III IMvigor011 clinical trial in muscle-invasive bladder cancer (MIBC), sponsored by Genentech. The trial demonstrated that Signatera-positive patients treated with atezolizumab (Tecentriq®) achieved statistically significant and clinically meaningful improvements in disease-free survival and overall survival.
IMvigor011 is the first prospective phase III study in MIBC to utilize a personalized, circulating tumor DNA (ctDNA) molecular residual disease (MRD)-guided approach. This landmark trial highlights Signatera's ability to detect MRD after surgery and predict which patients will benefit from adjuvant immunotherapy.
Natera expects to finalize its premarket approval application to the U.S. Food and Drug Administration for Signatera as a companion diagnostic for the selection of MIBC patients to be treated with atezolizumab. A preliminary analysis also showed that Signatera-negative patients had excellent outcomes without adjuvant treatment, with 100% overall survival at 12 months and 98% at 18 months.
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