IMvigor210
Atezolizumab in locally advanced or metastatic urothelial carcinoma: single-arm, two-cohort phase 2 trial (cohort 1, cisplatin-ineligible and untreated; cohort 2, after platinum-based chemotherapy)
Phase 2NCT02108652
- Population
- Locally advanced or metastatic urothelial carcinoma
- Design
- Multicentre, single-arm, two-cohort phase 2 trial; atezolizumab 1200 mg intravenously every 3 weeks. Cohort 2 enrolled patients who progressed after platinum-based chemotherapy; cohort 1 enrolled previously untreated cisplatin-ineligible patients. Co-primary endpoints in cohort 2 were independent-review RECIST v1.1 and investigator-assessed immune-modified RECIST objective response rates; PD-L1 on tumour-infiltrating immune cells (IC) assessed by immunohistochemistry.
- Primary endpoint
- ORR
- Arms
- Cohort 2: after platinum chemotherapy (experimental, n = 310): Atezolizumab 1200 mg every 3 weeks
- Cohort 1: cisplatin-ineligible, previously untreated (experimental, n = 119): Atezolizumab 1200 mg every 21 days until progression
- People
- Rosenberg JE, IMvigor210 Study Group
Show the numbers
| Endpoint | Analysis | Cohort 2: after platinum chemotherapy / Cohort 1: cisplatin-ineligible, previously untreated | Control | Effect |
|---|---|---|---|---|
| ORRCohort 2, PD-L1 IC2/3 (immune cells 5% or more) | long term-updateRosenberg 2016 | 26% (18–36%) | — | Longer-follow-up analysis (data cutoff 14 September 2015); the primary analysis (cutoff 5 May 2015) gave 27% in IC2/3. |
| ORRCohort 2, all treated patients (n = 310) | long term-updateRosenberg 2016 | 15% (11–19%) | — | Ongoing responses in 38 (84%) of 45 responders at median follow-up 11.7 months. |
| ORRCohort 1, treated patients (n = 119) | primarymedian follow-up 17.2 monthsBalar 2017 | 23% (16–31%) | — | Complete response rate 9% (n = 11); median response duration not reached. |
| OSCohort 1, treated patients (n = 119) | primarymedian follow-up 17.2 monthsBalar 2017 | median 15.9 months | — | 95% CI 10.4 months to not estimable; median PFS 2.7 months (95% CI 2.1 to 4.2). |
| Endpoint | Analysis | Cohort 2: after platinum chemotherapy / Cohort 1: cisplatin-ineligible, previously untreated | Control | Effect |
|---|---|---|---|---|
| ORRCohort 2, PD-L1 IC2/3 (immune cells 5% or more) | long term-updateRosenberg 2016 | 26% (18–36%) | — | Longer-follow-up analysis (data cutoff 14 September 2015); the primary analysis (cutoff 5 May 2015) gave 27% in IC2/3. |
| ORRCohort 2, all treated patients (n = 310) | long term-updateRosenberg 2016 | 15% (11–19%) | — | Ongoing responses in 38 (84%) of 45 responders at median follow-up 11.7 months. |
| ORRCohort 1, treated patients (n = 119) | primarymedian follow-up 17.2 monthsBalar 2017 | 23% (16–31%) | — | Complete response rate 9% (n = 11); median response duration not reached. |
| OSCohort 1, treated patients (n = 119) | primarymedian follow-up 17.2 monthsBalar 2017 | median 15.9 months | — | 95% CI 10.4 months to not estimable; median PFS 2.7 months (95% CI 2.1 to 4.2). |
- Cohort 1: cisplatin-ineligible, previously untreated (experimental)
Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.
Data table (modelled values)
| Months | Cohort 1: cisplatin-ineligible, previously untreated |
|---|---|
| 0 | 100.0% |
| 10 | 64.7% |
| 20 | 41.8% |
| 30 | 27.0% |
| 40 | 17.5% |
Appears in
Sources
Rosenberg JE, Hoffman-Censits J, Powles T, van der Heijden MS, Balar AV, Necchi A, et al. Atezolizumab in patients with locally advanced and metastatic urothelial carcinoma who have progressed following treatment with platinum-based chemotherapy: a single-arm, multicentre, phase 2 trial. Lancet. 2016;387(10031):1909-20.
Balar AV, Galsky MD, Rosenberg JE, Powles T, Petrylak DP, Bellmunt J, et al. Atezolizumab as first-line treatment in cisplatin-ineligible patients with locally advanced and metastatic urothelial carcinoma: a single-arm, multicentre, phase 2 trial. Lancet. 2017;389(10064):67-76.