Roche has gained fresh momentum in bladder cancer after an earlier trial setback, with new results highlighting the value of a precision medicine approach.
In the phase 3 IMvigor011 trial, Roche’s PD-L1 inhibitor Tecentriq (atezolizumab) significantly improved both disease-free survival (DFS) and overall survival compared with placebo in patients with muscle-invasive bladder cancer (MIBC) who tested positive for molecular residual disease (MRD) following surgery. The therapy also helped prevent recurrence, metastasis, or death, meeting its primary endpoint.
The trial enrolled patients who showed no visible cancer on imaging but tested positive for MRD within 12 months after surgery. MRD was detected using Natera’s circulating tumor DNA (ctDNA) test, Signatera.
Natera announced the positive outcome, and Roche confirmed that the data will be submitted to the FDA and presented at an upcoming medical meeting. Roche previously indicated Tecentriq in ctDNA-positive high-risk MIBC as a planned regulatory submission in 2025.
“This result is very significant, opening the door for a new treatment paradigm for bladder cancer patients who are positive for recurrence on a molecular level but have no evidence of disease on imaging,” said Thomas Powles, M.D., Barts Cancer Institute, lead investigator of the study.
The readout stands in contrast to the earlier IMvigor010 trial, which tested Tecentriq broadly in MIBC patients regardless of MRD status and failed to meet its primary endpoint.
The MIBC treatment landscape has shifted rapidly. In March, the FDA approved AstraZeneca’s Imfinzi as the first immunotherapy for MIBC in a perioperative setting, showing a 25% reduction in death risk in the Niagara trial. More recently, Pfizer/Astellas’ Padcev plus Merck’s Keytruda also demonstrated strong perioperative outcomes in cisplatin-ineligible MIBC patients.