- Tecentriq reduced death risk by 41% and recurrence by 36% in bladder cancer.
- IMvigor011 is the first global phase III study using ctDNA-guided treatment for bladder cancer.
- Median disease-free survival was 9.9 months with Tecentriq vs. 4.8 months with placebo.
- Median overall survival was 32.8 months with Tecentriq vs. 21.1 months with placebo.
Study Overview
Roche's phase III IMvigor011 study evaluated Tecentriq as an adjuvant treatment for muscle-invasive bladder cancer (MIBC) patients with detectable circulating tumor DNA (ctDNA) post-surgery. The study is the first global phase III trial to use a ctDNA-guided approach for this cancer type.
Key Findings
Tecentriq reduced the risk of death by 41% and the risk of disease recurrence or death by 36% compared to placebo. Median disease-free survival was 9.9 months for Tecentriq versus 4.8 months for placebo, while median overall survival was 32.8 months versus 21.1 months, respectively.
Clinical Implications
The ctDNA-guided approach, using Natera’s Signatera test, helps identify patients at risk of recurrence who could benefit from Tecentriq, sparing low-risk patients from unnecessary treatment. This method combines precision diagnostics with cancer immunotherapy, potentially advancing bladder cancer treatment.
Presentation and Future Steps
Results were presented at the ESMO Congress 2025 and will be discussed with health authorities, including the FDA. The study involved 761 participants, with 250 entering the treatment phase based on positive Signatera tests.
