The Absolute Effect / Evidence / IMvigor010
Bladder Cancer · Medical Oncology · Adjuvant
IMvigor010
Clinical question
Does adjuvant atezolizumab improve outcomes after surgery for high-risk muscle-invasive urothelial carcinoma?
Trial context
Population
809 patients with high-risk muscle-invasive urothelial carcinoma after radical surgery
Intervention
Adjuvant atezolizumab vs observation
Key endpoint
Disease-free survival
Time horizon / follow-up
Median follow-up 21.9 months
Absolute Effect
What changes for patients?
Atezolizumab did not improve DFS: median 19.4 vs 16.6 months, HR 0.89, P=.24. This negative phase III trial is important because it shows that adjuvant checkpoint inhibition cannot be assumed to work across all settings. NNT is not applicable because benefit was not demonstrated.
NNT: Not applicable; no significant benefit demonstrated
Treatment burden / harm
Grade 3–4 treatment-related adverse events
NNH: Not applicable as a comparative NNH because treatment-related grade 3–4 events were not reported for the observation arm
Relative effect
HR: 0.89
95% CI 0.74–1.08; P=.24
Clinical interpretation
IMvigor010 was negative for disease-free survival in an unselected postoperative population; the later ctDNA-guided IMvigor011 strategy is a distinct biomarker-selected approach.
Primary publication
- Bellmunt J, et al. Lancet Oncol. 2021;22:525–537.
- Primary publication / source