urothelial carcinoma (advanced)

Description Results NMA

Atezolizumab (n=-9)

vs.

single arm study (n=-9)

Single-arm study

Sample size: -9/-9

Primary endpoint:

FU duration:

phase 2

grade 3-4 treatment-related adverse events 0.46 [0.38; 0.58]

OS 0.87 [0.63; 1.21] median 11.1 months vs. 10.6 months

ORR 1.07 [0.66; 1.73]

atezolizumab (n=467)

vs.

chemotherapy (n=464)

IC2/3 patients as planned as step 1 of the hierarchical testing

open label

Parallel groups

Sample size: 467/464

Primary endpoint: OS

FU duration:

sequential testing of IC2/3 population in first then IC1/2/3 population; and finaly all-comers population

Atezolizumab+Gemcitabine+Carboplatin/Cisplatin (n=-9)

vs.

Placebo+Gemcitabine+Carboplatin/Cisplatin (n=-9)

3rd arm with Atezolizumab Monotherapy

open-design

Sample size: -9/-9

Primary endpoint:

FU duration:

durvalumab at 10 mg/kg body weight administered as an intravenous infusion over 60 minutes every two weeks until disease progression or unacceptable toxicity (n=-9)

vs.

(n=-9)

Single-arm study

Sample size: -9/-9

Primary endpoint:

FU duration:

phase 1/2

nivolumab 3 mg/kg intravenously every 2 weeks until disease progression and clinical deterioration, unacceptable toxicity, or other protocol-defined reasons (n=270)

vs.

(n=-9)

Single-arm study

Sample size: 270/-9

Primary endpoint: ORR

FU duration:

pembrolizumab 200 mg every 3 weeks (Q3W) (n=990)

vs.

chemotherapy alone (n=0)

3 arms: pembrolizumab ± chemotherapy versus chemotherapy

Sample size: 990/0

Primary endpoint:

FU duration:

intravenous pembrolizumab 200 mg every 3 weeks (n=374)

vs.

(n=-9)

open-design

Single-arm study

Sample size: 374/-9

Primary endpoint: ORR

FU duration: 5 months (median)

phase 2, single arm

OS 0.73 [0.59; 0.91] median 10.3 months vs. 7.4 months

PFS 0.98 [0.81; 1.19]

pembrolizumab (n=270)

vs.

investigator's choice of chemotherapy with paclitaxel, docetaxel, or vinflunine (n=272)

open-label

Parallel groups

Sample size: 270/272

Primary endpoint: OS

FU duration: