Dr Bellmunt Discusses ctDNA Usage for Bladder Cancer in the Community

In an interview with Targeted Oncology, Joaquim Bellmunt, MD, PhD, Dana-Farber Cancer Institute, discusses the use and barriers of circulating tumor DNA (ctDNA) in the phase 3 IMvigor11 trial (NCT04660344).

The trial, presented at the 2025 European Society for Medical Oncology (ESMO) Congress, demonstrated that adjuvant atezolizumab (Tecentriq) significantly improved disease-free survival (DFS) and overall survival (OS) compared with placebo in patients with muscle-invasive bladder cancer (MIBC) who tested positive for ctDNA after radical cystectomy. This ctDNA-guided approach addresses the high unmet need for better treatment options, as disease recurrence is common and associated with a poor prognosis after standard surgery.

At a median follow-up of 16.1 months, ctDNA-positive patients (n = 167) treated with atezolizumab achieved a median DFS of 9.9 months compared with 4.8 months for those on placebo (n=83), representing a 36% reduction in the risk of recurrence or death (HR, 0.64; P =.0047). The benefit extended to OS, with the atezolizumab arm reaching a median of 32.8 months vs 21.1 months with placebo (HR, 0.59; P =.0131). This confirms an exploratory analysis from the prior negative IMvigor10 trial, which suggested that only ctDNA-positive patients benefit from this therapy.

In the presentation, lead study author Thomas Powles, MD, highlighted that serial ctDNA testing is a "novel approach" that may be more accurate than traditional radiology. The study design allocated ctDNA-positive patients (with no radiographic recurrence) to treatment or placebo, while ctDNA-negative patients entered surveillance without treatment. This strategy successfully identified a high-risk population benefiting from atezolizumab while sparing unnecessary treatment for those with ctDNA-negative disease, who showed excellent long-term outcomes with surveillance alone. The results strongly support using ctDNA to guide adjuvant treatment in MIBC.

REFERENCE:

Powles T, Kann AG, Castellano D, et al. IMvigor011: a phase 3 trial of circulating tumour (ct)DNA-guided adjuvant atezolizumab vs placebo in muscle-invasive bladder cancer. Presented at: 2025 ESMO Congress; October 17-21, 2025; Berlin, Germany. Abstract LBA8.