Atezolizumab: Clinical Development
IRF, independent review facility. ClinicalTrials.gov ID: NCT02108652
a
PD-L1 prospectively assessed by a central laboratory, with patients and investigators blinded
b
Cockcroft-Gault formula
Loriot et al. ESMO 2016
Co-primary endpoints
•
ORR
(confirmed) per RECIST v.1.1 (
central
independent review
)
•
Investigator-assessed ORR per modified
RECIST
•
Primary endpoints met if null hypothesis
(ORR of 10%) rejected at significance level
(α) of 5%
Key secondary endpoints
•
PFS, DOR,
OS
, safety
Cohort 2 (N=310)
:
Platinum-treated mUC
Atezolizumab 1,200mg IV q3w
until loss of clinical benefit
Cohort 2-specific inclusion criteria
•
Locally advanced or metastatic cancer of the bladder, renal pelvis,
ureter or urethra
•
Predominant transitional cell histology
•
Progression
during or following platinum
–
No restriction on number of prior lines of therapy
•
Creatinine clearance ≥30mL/min
•
ECOG PS 0–1
•
Tumour tissue evaluable for PD-L1 testing
Cohort 1
(N=119):
1L cisplatin ineligible
Atezolizumab 1,200mg IV q3w
until RECIST v1.1 progression
IMVIGOR 210
•
Inoperable locally advanced or
metastatic urothelial carcinoma
•
Predominantly UC histology
•
Tumour tissue evaluable for
PD-L1 testing
a
