Roche announced positive results from the Phase III IMvigor011 study evaluating Tecentriq® (atezolizumab) as an adjuvant treatment for muscle-invasive bladder cancer (MIBC) in patients at risk of recurrence after surgery who have detectable circulating tumor DNA (ctDNA).
In this ctDNA-guided setting, Tecentriq reduced the risk of death by 41% and the risk of disease recurrence or death by 36% compared with placebo. The study used Natera’s Signatera™ ctDNA Molecular Residual Disease (MRD) test to identify patients most likely to benefit, sparing those at low risk from unnecessary treatment and side effects. The safety profile was consistent with previous Tecentriq studies.
Dr. Levi Garraway, Roche’s Chief Medical Officer, said, “These clinically meaningful results show that Tecentriq helped people with muscle-invasive bladder cancer live longer and without their disease returning. The use of serial ctDNA testing may advance bladder cancer treatment by combining a precision diagnostic with immunotherapy.”
Professor Thomas Powles, lead investigator of IMvigor011, added, “Even after surgery, most people with MIBC face further treatment burdens. Signatera ctDNA testing may allow us to identify those at risk of recurrence who could benefit from adjuvant Tecentriq, while sparing others unnecessary therapy, paving the way for more personalized treatment.”
At a median follow-up of 16.1 months, median disease-free survival (DFS) was 9.9 months in the Tecentriq arm versus 4.8 months in the placebo arm (HR=0.64). Median overall survival (OS) was 32.8 months versus 21.1 months (HR=0.59). Patients without detectable ctDNA had a low risk of recurrence.
MIBC affects over 150,000 people globally each year and is aggressive, with poor long-term outcomes and high treatment burden. ctDNA-guided therapy represents a precision medicine approach that could improve clinical outcomes while reducing unnecessary interventions.
The results are being presented at the European Society for Medical Oncology (ESMO) Congress 2025 and will be discussed with health authorities, including the U.S. FDA.