Adjuvant Atezolizumab Shows Minimal Impact on Functioning/QOL in MIBC

A patient-report outcome (PRO) analysis from the phase 3 IMvigor011 trial (NCT04660344) revealed that treatment with ctDNA-guided adjuvant atezolizumab (Tecentriq) provided minimal impact on functioning and quality of life (QOL) vs placebo among patients with muscle invasive bladder cancer (MIBC), according to findings presented in a poster session at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting.

Regarding time to confirmed deterioration per the European Organisation For Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30), no evidence of a difference between the atezolizumab or placebo arms emerged. The median time to deterioration in the respective arms was 25.1 months (95% CI, 18.5-not estimable [NE]) vs NE (95% CI, 19.4-NE) for physical functioning (HR, 1.25; 95% CI, 0.76-2.07); 18.5 months (95% CI, 12.2-NE) vs NE (95% CI, 19.4-NE) for role functioning (HR, 1.45; 95% CI, 0.88-2.40); and 35.4 months (95% CI, 19.3-NE) vs 16.5 months (95% CI, 10.9-NE) for global health status (GHS)/QOL (HR, 0.71; 95% CI, 0.45-1.12).

Additionally, the mean scores across the EORTC QLQ-C30 showed no significant differences–– within 10 points––throughout the course of treatment. Moreover, from cycle 1, day 1 to cycle 11, day 1 of treatment, more than 90% of patients reported little to no adverse effect (AE) burden across both arms.

Safety data revealed that among patients who tested positive for ctDNA, atezolizumab conferred a tolerable profile comparable to placebo and consistent with EORTC IL46 data on treatment burden. Specifically, data from the QLQ-C30 questionnaire showed similar rates of patient-reported constipation (10.9% vs 7.2%), diarrhea (9.1% vs 10.8%), and nausea (7.3% vs 8.4%) between the atezolizumab and placebo arms. Moreover, pain-related AEs were generally similar between each arm (21.8% vs 21.7%), in addition to fatigue-related AEs (21.2% vs 24.1%).

“Patients in IMvigor011 had high functioning and QOL and low symptom burden at initiation of treatment, and there were no clinically meaningful differences in symptoms, functioning, or GHS/QOL over time,” Joaquim Bellmunt, MD, PhD, director of the Bladder Cancer Center at Dana-Farber Cancer Institute and a professor of Medicine at Harvard Medical School, wrote in the presentation with study coinvestigators. “The vast majority of patients reported little or no [adverse] effect burden. The safety profile observed in IMvigor011 was consistent with the established [one for] atezolizumab monotherapy.”

The investigators conducted the PRO analysis to assess the QOL trajectory among patients with MIBC who were ctDNA positive and received atezolizumab or placebo, as well as for patients who persistently tested negative during surveillance. Those enrolled had histologically confirmed pT2-T4aN0M0 or pT0-T4aN+M0 MIBC with no evidence of radiographic disease. Patients were also within 6 to 24 weeks of radical cystectomy with an ECOG performance status of 0 to 2; they were permitted to have undergone neoadjuvant chemotherapy.

Those enrolled underwent monitoring for ctDNA, with 6-week ctDNA testing and 12-week radiographic imaging until 1 year after cystectomy. Those with a positive ctDNA test underwent confirmation of no evidence of disease progression before being randomly assigned 2:1 to 1680 mg of intravenous atezolizumab every 4 weeks for up to a year or placebo at the same schedule.

The PRO analysis examined time to confirmed deterioration of physical functioning, role functioning, and GHS/QOL per EORTC QLQ-C30 as secondary end points. Exploratory end points were symptoms, functioning, and GHS/QOL, as well as AE burden per EORTC IL46. In the overall study, the primary end point was investigator-assessed disease-free survival, with overall survival being a key secondary end point.

The PRO questionnaire completion rates were generally high among both treatment groups. At baseline, 95.8% of the atezolizumab arm vs 94.0% of the placebo arm had completed the QLQ-C30 questionnaire, with completion rates remaining high up to cycle 11 of treatment at 95.2% vs 87.0%, respectively. The completion rates for the EORTC IL46 questionnaire were 79.4% vs 72.3% in each respective arm at baseline and 95.2% vs 95.7% by cycle 11.

Reference

Bellmunt J, Gupta S, Durán MÁ, et al. Patient-reported outcomes from IMvigor011: a phase 3 study of circulating tumor (ct)DNA-guided adjuvant atezolizumab vs placebo in muscle-invasive bladder cancer (MIBC). J Clin Oncol. 2026;44(suppl 16):4627. doi:10.1200/JCO.2026.44.16_suppl.4627