Roche has announced positive phase III results from its IMvigor011 study, showing that Tecentriq® (atezolizumab) significantly improves survival outcomes in patients with muscle-invasive bladder cancer (MIBC) when guided by a circulating tumour DNA (ctDNA)-based approach.
The trial demonstrated that Tecentriq, used as an adjuvant therapy in patients with detectable ctDNA after surgery (cystectomy), reduced the risk of death by 41% and the risk of disease recurrence or death by 36% compared to placebo. The results are being presented at the Presidential Symposium of the European Society for Medical Oncology (ESMO) Congress 2025.
“This study shows that Tecentriq helped people with muscle-invasive bladder cancer live longer and without disease recurrence,” said Dr. Levi Garraway, Roche’s Chief Medical Officer and Head of Global Product Development. “By pairing immunotherapy with precision diagnostics like serial ctDNA testing, we’re paving the way for a new, more targeted standard of care.”
The study used Natera’s Signatera™ ctDNA Molecular Residual Disease (MRD) test to identify patients most at risk of recurrence. Patients who were ctDNA-positive post-surgery were treated with Tecentriq, while those without detectable ctDNA avoided unnecessary treatment, reducing potential side effects.
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 with placebo. Median overall survival (OS) reached 32.8 months with Tecentriq compared to 21.1 months with placebo.
“These findings suggest we can better personalise treatment by identifying those who truly need adjuvant therapy,” said Professor Thomas Powles, principal investigator of the IMvigor011 study. “Using ctDNA, we can help patients avoid overtreatment while still targeting those most at risk.”
MIBC is an aggressive cancer that affects over 150,000 people globally each year. Current treatment options are limited and often non-personalised. The use of ctDNA to guide immunotherapy represents a promising shift toward precision oncology in bladder cancer.
Roche plans to engage with regulatory bodies, including the U.S. FDA, to discuss next steps for approval based on these findings.