A recent study from the phase 3 IMvigor011 trial has revealed that circulating tumor DNA (ctDNA) status serves as a crucial biomarker in predicting the effectiveness of adjuvant atezolizumab (Tecentriq) in patients with muscle-invasive bladder cancer (MIBC). Conducted by Dr. Joaquim Bellmunt and colleagues, the trial demonstrated improved outcomes for patients who tested positive for ctDNA.
In an interview at the 2025 ESMO Congress, Bellmunt emphasized the trial”s significance, stating, “This trial is telling us that ctDNA is driving who is going to benefit from receiving adjuvant immunotherapy.” The IMvigor011 trial aimed to assess ctDNA-guided treatment strategies for MIBC patients, comparing the efficacy of atezolizumab versus a placebo.
Following previous trials that explored the role of immunotherapy in high-risk muscle-invasive disease, including those involving nivolumab and pembrolizumab, the IMvigor011 study was specifically designed to focus on ctDNA status. The study involved screening approximately 756 patients, among whom 379 were found to be ctDNA positive after surgery.
Patients with ctDNA positivity were randomized to receive either atezolizumab or a placebo, resulting in a total of 250 eligible participants. The primary endpoint was investigator-assessed disease-free survival (DFS), with overall survival (OS) assessed as a secondary endpoint. The results indicated that patients receiving atezolizumab experienced superior DFS, with a hazard ratio of 0.64, suggesting a significant delay in disease recurrence compared to the placebo group.
Moreover, the trial also observed an OS benefit for patients receiving atezolizumab, marking a notable first in adjuvant immunotherapy for this patient population. Patients who tested negative for ctDNA at one year had an 88.4% likelihood of remaining disease-free at 24 months, highlighting the potential to avoid unnecessary treatments.
Interestingly, the trial tracked patients who were initially ctDNA negative but later became ctDNA positive. These patients also showed similar benefits from atezolizumab, indicating that delaying treatment based on ctDNA status could still be effective in managing disease recurrence.
While the trial noted adverse effects related to the immunotherapy, they remained within expected limits, with only 4.8% of patients experiencing adverse events. No life-threatening complications were reported among those receiving atezolizumab.
