atezolizumab alone (n=116) vs. Standard of Care (SoC) (n=118)
randomized controlled trial
atezolizumab
atezolizumab 1200 mg intravenously every 3 weeks
chemotherapy
chemotherapy (vinflunine 320 mg/m², paclitaxel 175 mg/m², or docetaxel 75 mg/m²) intravenously every 3 weeks (no % for this sub-population)
No prespecified crossover was planned per protocol.
mUC - L2 - PDL1 positive
IC2/3 patients as planned as step 1 of the hierarchical testing
open label
217 academic medical centres and community (results from 198 sites)
P3/two sided no AI planned. Tested with a hierarchical fixed-sequence procedure based on a stratified log-rank test at a two-sided level of 5% significance
The sponsor has revealed that its phase III IMVigor 211 failed to meet the primary endpoint of extending overall survival compared with chemotherapy.Roche withdraws Atezolizumab in platinum refractory UC after FDA discussions.
IMvigor-211 (PDL1>1%), 2018 NCT02302807
atezolizumab alone (n=316) vs. Standard of Care (SoC) (n=309)
randomized controlled trial
atezolizumab
atezolizumab 1200 mg intravenously every 3 weeks
chemotherapy
chemotherapy (vinflunine 320 mg/m², paclitaxel 175 mg/m², or docetaxel 75 mg/m²) intravenously every 3 weeks (no % for this sub-population)
No prespecified crossover was planned per protocol.
mUC - L2 - PDL1 positive
IC1/2/3 patients as planned as step 1 of the hierarchical testing
open label
217 academic medical centres and community (results from 198 sites)
P3/two sided no AI planned. Tested with a hierarchical fixed-sequence procedure based on a stratified log-rank test at a two-sided level of 5% significance
The sponsor has revealed that its phase III IMVigor 211 failed to meet the primary endpoint of extending overall survival compared with chemotherapy.Roche withdraws Atezolizumab in platinum refractory UC after FDA discussions