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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.
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
pembrolizumab alone (n=74) vs. Standard of Care (SoC) (n=90)
randomized controlled trial
pembrolizumab
pembrolizumab at dose of 200 mg every 3 weeks
chemotherapy (ICC)
investigator's choice of chemotherapy with paclitaxel, docetaxel, or vinflunine : paclitaxel (at a dose of 175 mg per square meter of body-surface area), docetaxel (at a dose of 75 mg per square meter), or vinflunine (at a dose of 320 mg per square meter), all administered intravenously every 3 weeks.(no % for this sub-population)
There was no planned crossover on disease progression.
mUC - L2 - PDL1 positive
open-label
120 sites in 29 countries
P3 / one sided and two interim analysis. Repartition and hierachical testing procedure between coprimary endpoints
Pembrolizumab was associated with significantly longer overall survival (by approximately3 months) and with a lower rate of treatment-related adverse events than chemotherapyas second-line therapy for platinum-refractory advanced urothelial carcinoma.
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