Genentech, part of the Roche Group, has reported promising results from its Phase III IMvigor011 trial, evaluating Tecentriq (atezolizumab) as an adjuvant therapy for patients with muscle-invasive bladder cancer (MIBC) who have undergone surgery and show signs of recurrence based on circulating tumor DNA (ctDNA) testing. In this precision-based approach, Tecentriq demonstrated significant benefits, reducing the risk of death by 41 percent and lowering the chance of disease returning or progressing by 36 percent when compared to a placebo group.
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The trial used Natera’s Signatera ctDNA test to identify patients with molecular residual disease, helping guide treatment decisions. Patients with no detectable ctDNA after surgery were not given unnecessary therapy, avoiding potential side effects. These results are being presented at the European Society for Medical Oncology (ESMO) Congress 2025 during its Presidential Symposium and will be shared with global regulatory agencies, including the U.S. FDA.
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Dr. Levi Garraway, Chief Medical Officer and Head of Global Product Development at Genentech, noted that the findings demonstrate a clear survival advantage for patients receiving Tecentriq. He also emphasized that this trial shows how combining a targeted diagnostic tool like ctDNA with immunotherapy may represent a new frontier in personalized cancer care.
Dr. Thomas Powles, lead investigator of the study and Chair of Barts Cancer Centre in London, explained that most people diagnosed with MIBC endure not only surgery but also the strain of additional treatment. He said this study highlights how ctDNA testing can help identify which patients are at high risk of recurrence and likely to benefit from further therapy, while sparing low-risk patients from overtreatment. According to him, this represents an important step toward more personalized and thoughtful care in bladder cancer.
In the IMvigor011 trial, which had a median follow-up period of just over 16 months, patients treated with Tecentriq had a median disease-free survival of 9.9 months compared to 4.8 months for those receiving placebo. The median overall survival was 32.8 months for the Tecentriq group versus 21.1 months in the placebo group. Importantly, those who consistently tested negative for ctDNA had a much lower risk of recurrence, reinforcing the utility of this biomarker in guiding treatment.
Every year, over 150,000 people globally are diagnosed with muscle-invasive bladder cancer, which is known for its aggressive nature and limited long-term treatment success. Despite its severity, bladder cancer has lagged behind other cancer types in the adoption of precision medicine. These findings could change that, offering new hope for more accurate treatment strategies. By using ctDNA as a tool to tailor therapy, healthcare professionals may soon be able to offer more effective, individualized care while reducing unnecessary exposure to drugs and their side effects.
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