Natera has announced positive results from the Phase III IMvigor011 clinical trial for muscle-invasive bladder cancer (MIBC).
The trial revealed that testing involving personalised blood assay Signatura can guide the use of adjuvant atezolizumab (Tecentriq), leading to improvements in overall survival (OS) and disease-free survival (DFS).
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These findings were presented at the European Society for Medical Oncology Congress (ESMO).
The trial prospectively assessed atezolizumab compared to placebo in participants with MIBC who were identified as Signatera-positive through serial testing conducted up to seven times during the first year following cystectomy.
A total of 761 participants were enrolled in the surveillance phase, with 50% testing positive on Signatera. Of these, 250 were randomised to receive atezolizumab against a placebo.
Participants who tested positive for Signatera and received atezolizumab experienced more than double the median disease-free survival compared to those who received a placebo.
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By GlobalDataThe median DFS for participants treated with atezolizumab was 9.9 months, compared to just 4.8 months for the placebo group.
Additionally, these participants demonstrated a significant improvement in overall survival, with a median survival of 32.8 months compared to 21.1 months for those on placebo.
Patients who tested negative on Signatera exhibited outstanding outcomes without the need for adjuvant immunotherapy.
Those who remained persistently negative during surveillance experienced a remarkably low risk of recurrence, achieving a DFS rate of 95.4% at one year and 88.4% at two years.
Natera oncology general manager and corporate chief medical officer Alexey Aleshin said: “This is the first study to demonstrate that the adjuvant treatment decision window can be safely extended to one year post-surgery, minimising overtreatment and allowing therapy to be precisely guided by Signatera results.
“These findings can redefine the standard of care in muscle-invasive bladder cancer and also underscore the broader potential for Signatera-guided management across multiple tumour types.”
