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Roche’s Tecentriq showed significant overall and disease-free survival benefits in bladder cancer with ctDNA-guided treatment
Globenewswire· 2025-10-20 05:05
Core Insights - Roche announced positive results from the phase III IMvigor011 study, showing that Tecentriq significantly improves overall survival and disease-free survival in muscle-invasive bladder cancer patients at risk of recurrence after surgery [1][3][6] Study Results - Tecentriq reduced the risk of death by 41% and the risk of disease recurrence or death by 36% compared to placebo [1][6] - At a median follow-up of 16.1 months, median disease-free survival (DFS) was 9.9 months for the Tecentriq group versus 4.8 months for the placebo group, with a stratified hazard ratio of 0.64 [3][4] - Median overall survival (OS) was 32.8 months for the Tecentriq group compared to 21.1 months for the placebo group, with a hazard ratio of 0.59 [3][4] Study Design - The IMvigor011 study was a global phase III, randomized, placebo-controlled, double-blind trial involving 761 participants, focusing on those with detectable circulating tumor DNA (ctDNA) [4] - The study utilized Natera's Signatera ctDNA test to guide treatment decisions, currently under FDA review as a companion diagnostic [4] Clinical Implications - The results indicate that ctDNA-guided treatment can help identify patients who would benefit from adjuvant therapy, potentially leading to more personalized treatment approaches [3][4] - More than 150,000 people are diagnosed with muscle-invasive bladder cancer annually, highlighting the need for effective treatment strategies [3]