IMvigor211
Atezolizumab versus chemotherapy in patients with platinum-treated locally advanced or metastatic urothelial carcinoma (IMvigor211)
Phase 3N = 931NCT02302807
- Population
- Metastatic urothelial carcinoma that progressed after platinum-based chemotherapy
- Design
- Multicentre, open-label phase 3 randomised trial; 1:1 to atezolizumab 1200 mg or physician's choice of vinflunine, paclitaxel or docetaxel every 3 weeks, stratified by PD-L1 expression on immune cells, chemotherapy type, liver metastases and number of prognostic factors. Primary endpoint overall survival, tested hierarchically in the IC2/3 population, then IC1/2/3, then the intention-to-treat population.
- Primary endpoint
- OS
- Arms
- Atezolizumab (experimental, n = 467): Atezolizumab 1200 mg every 3 weeks
- Chemotherapy (control, n = 464): Vinflunine 320 mg/m2, paclitaxel 175 mg/m2 or docetaxel 75 mg/m2 every 3 weeks
- People
- Powles T
OSHR 0.87 (95% CI 0.63–1.21)Δ median OS+0.5 monthsΔ ORR+1 pointsDORHR 0.57 (95% CI 0.26–1.26)Δ median DOR+7.6 months
Show the numbers
| Endpoint | Analysis | Atezolizumab | Chemotherapy | Effect |
|---|---|---|---|---|
| OSPD-L1 on immune cells 5% or more (IC2/3; n = 234) | primaryPowles 2018 | median 11.1 months (8.6–15.5) | median 10.6 months (8.4–12.2) | HR 0.87 (95% CI 0.63–1.21)P=0.41Not significant; the abstract states this precluded further formal statistical analysis in the hierarchy. |
| ORRIC2/3, evaluable patients | primaryPowles 2018 | 23% | 22% | — |
| DORIC2/3, responders | exploratoryPowles 2018 | median 15.9 months | median 8.3 months (5.6–13.2) | HR 0.57 (95% CI 0.26–1.26)Described as numerically longer; the atezolizumab confidence interval is 10.4 months to not estimable. Recorded as exploratory because the abstract says the non-significant IC2/3 OS result precluded further formal statistical analysis; the abstract does not label this analysis itself. |
| Endpoint | Analysis | Atezolizumab | Chemotherapy | Effect |
|---|---|---|---|---|
| OSPD-L1 on immune cells 5% or more (IC2/3; n = 234) | primaryPowles 2018 | median 11.1 months (8.6–15.5) | median 10.6 months (8.4–12.2) | HR 0.87 (95% CI 0.63–1.21)P=0.41Not significant; the abstract states this precluded further formal statistical analysis in the hierarchy. |
| ORRIC2/3, evaluable patients | primaryPowles 2018 | 23% | 22% | — |
| DORIC2/3, responders | exploratoryPowles 2018 | median 15.9 months | median 8.3 months (5.6–13.2) | HR 0.57 (95% CI 0.26–1.26)Described as numerically longer; the atezolizumab confidence interval is 10.4 months to not estimable. Recorded as exploratory because the abstract says the non-significant IC2/3 OS result precluded further formal statistical analysis; the abstract does not label this analysis itself. |
Data table
| Endpoint | HR | 95% CI |
|---|---|---|
| OS | 0.87 | 0.63–1.21 |
| DOR | 0.57 | 0.26–1.26 |
- Atezolizumab (experimental)
- Chemotherapy (control)
Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.
Data table (modelled values)
| Months | Atezolizumab | Chemotherapy |
|---|---|---|
| 0 | 100.0% | 100.0% |
| 7 | 64.6% | 63.3% |
| 14 | 41.7% | 40.0% |
| 21 | 26.9% | 25.3% |
| 28 | 17.4% | 16.0% |
- Atezolizumab (experimental)
- Chemotherapy (control)
Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.
Data table (modelled values)
| Months | Atezolizumab | Chemotherapy |
|---|---|---|
| 0 | 100.0% | 100.0% |
| 10 | 64.7% | 43.4% |
| 20 | 41.8% | 18.8% |
| 30 | 27.0% | 8.2% |
| 40 | 17.5% | 3.5% |
Appears in
Sources
Powles T, Durán I, van der Heijden MS, Loriot Y, Vogelzang NJ, De Giorgi U, et al. Atezolizumab versus chemotherapy in patients with platinum-treated locally advanced or metastatic urothelial carcinoma (IMvigor211): a multicentre, open-label, phase 3 randomised controlled trial. Lancet. 2018;391(10122):748-757.