Genentech announces results from IMvigor011 study

Genentech, a member of Roche (RHHBY), announced results from the Phase III IMvigor011 study evaluating Tecentriq as an adjuvant treatment for people with muscle-invasive bladder cancer who are at risk of recurrence after surgery and have detectable circulating tumor DNA. In this ctDNA-guided setting, Tecentriq reduced the risk of death by 41% and the risk of disease recurrence or death by 36%, both compared with placebo. This ctDNA-guided approach, using Natera’s Signatera ctDNA Molecular Residual Disease test, spared people at low risk of recurrence from unnecessary treatment and side effects. The safety profile was consistent with previous studies of Tecentriq. These results are being presented as part of the Presidential Symposium at the European Society for Medical Oncology Congress 2025. They will also be discussed with health authorities, including the FDA. At median follow up of 16.1 months, median DFS was 9.9 months in the Tecentriq arm versus 4.8 months in the placebo arm. Median OS was 32.8 months in the Tecentriq arm versus 21.1 months in the placebo arm. People who persistently tested for no detectable ctDNA had low risk of recurrence. More than 150,000 people worldwide are diagnosed with MIBC each year. It is an aggressive type of cancer, with poor long-term outcomes and high treatment burden. Despite this, personalized treatment approaches lag behind other cancer types. ctDNA-guided treatment could change this, by helping healthcare professionals tailor treatment more precisely to improve clinical benefit and reduce unnecessary intervention.