Dr Bellmunt on Efficacy Findings With ctDNA-Guided Adjuvant Atezolizumab in MIBC

“This was the first time we have seen an OS benefit in patients receiving an adjuvant immunotherapy.”

Joaquim Bellmunt, MD, PhD, the director of the Bladder Cancer Center and a senior physician at Dana-Farber Cancer Institute, as well as an associate professor of medicine at Harvard Medical School, discussed findings from the phase 3 IMvigor011 trial (NCT04660344) of circulating tumor DNA (ctDNA)–guided adjuvant atezolizumab (Tecentriq) for the treatment of patients with muscle-invasive bladder cancer (MIBC), which were presented during the 2025 ESMO Congress.

At a median follow-up of 16.1 months, patients who were ctDNA-positive and received atezolizumab (n = 167) achieved a median investigator-assessed disease-free survival (DFS) of 9.9 months (95% CI, 7.2-12.7) compared with 4.8 months (95% CI, 4.1-8.3) among those who received placebo (n = 83). These findings were statistically significant and translated to a HR for DFS of 0.64 (95% CI, 0.47-0.87; P = .0047), Bellmunt noted. The 12- and 24-month DFS rates in the investigational arm were 44.7% and 28.0%, respectively. These respective rates in the placebo arm were 30.0% and 12.1%.

Patients who received adjuvant atezolizumab also experienced a benefit vs placebo in terms of overall survival (OS), Bellmunt added. The median OS in the investigational arm was 32.8 months (95% CI, 27.7-not evaluable [NE]) compared with 21.1 months (95% CI, 14.7-NE) in the placebo group. Treatment with atezolizumab reduced the risk of death by 41% vs placebo (HR, 0.59; 95% CI, 0.39-0.90; P = .0131). This was the first time that an OS benefit has been reported among patients with MIBC receiving an adjuvant immunotherapy, he emphasized.

These findings indicate that ctDNA status is a good indicator of which patients will benefit from receiving adjuvant therapy, Bellmunt explained. He added that for patients who are ctDNA negative, additional therapy could potentially be avoided, thus sparing them of toxic and expensive further treatment.