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Natera Stock Spikes on Results From Bladder Cancer Phase III Surveillance Trial

NEW YORK – Natera's stock rose approximately 6 percent on Friday following the news that muscle-invasive bladder cancer (MIBC) patients who tested serially negative with Signatera after surgery in the Phase III IMvigor011 trial had 100 percent overall survival after 12 months, suggesting they may not need adjuvant therapy .

The study results were announced at this year's European Association of Urology Congress in Paris, France.

High-risk MIBC patients in the trial were serially tested with Signatera for up to 12 months after surgery to remove part or all of their bladder. Those who tested positive for minimal residual disease (MRD) by Signatera were randomized to receive either Genentech's Tecentriq (atezolizumab) or a placebo, while Signatera-negative patients received no treatment and continued undergoing radiographic surveillance imaging after 12 months.

In all, 171 patients remained MRD-negative throughout the surveillance window. Among these, the overall survival rate was 100 percent at 12 months and 98 percent at 18 months, with disease-free survival rates of 92 percent at 12 months and 88 percent at 18 months.

"We believe the results of this trial will further demonstrate how Signatera can help personalize treatment decisions and improve outcomes for bladder cancer patients," John Simmons, VP of BioPharma at Natera, said in a statement. "We look forward to the full trial read-out which could serve as the basis of Natera’s first FDA companion diagnostic submission for Signatera."

Last year, Austin, Texas-based Natera submitted the first module of a premarket approval application to the US Food and Drug Administration for Signatera as a companion diagnostic for patients with MIBC.

Also in the bladder cancer diagnostics space, Vesica Health recently published a study showing that its PCR-based AssureDx assay has the potential to reduce the use of bladder surgeries in patients who have had radiation treatment for MIBC.

Shares of Natera were trading up approximately 5 percent, at $97.29 per share, late Friday afternoon on the Nasdaq.