Natera, Inc. (NTRA), a provider of molecular testing services, Monday announced positive topline results from Phase III IMvigor011 study in muscle-invasive bladder cancer (MIBC).
The study, sponsored by Genentech, a member of the Roche Group, utilizes Natera's Signatera ctDNA test in patients with MIBC to predict who will benefit from adjuvant treatment with Roche's cancer immunotherapy atezolizumab.
MIBC patients participated in the trial underwent serial Signatera testing for up to 12 months post surgery. They were randomized to receive either atezolizumab or placebo if they tested Signatera-positive and remained free of cancer recurrence on imaging. Topline results from the study showed a statistically significant and clinically meaningful improvement in disease-free survival and overall survival for Signatera-positive patients treated with atezolizumab.
"The results of IMvigor011 are very significant, opening the door for a new treatment paradigm for bladder cancer patients who are positive for recurrence on a molecular level but have no evidence of disease on imaging," said Professor Thomas Powles, lead principal investigator of the study, Barts Cancer Institute QMUL.
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