Roche Pharmaceutical Development and Sales Overview
Tecentriq (atezolizumab, RG7446)
Anti-PD-L1 cancer immunotherapy - urothelial carcinoma
Indication
1L metastatic urothelial carcinoma (UC)
High-risk non-muscle-invasive
bladder cancer (MIBC)
ctDNA+, high-risk muscle-invasive
bladder cancer (MIBC)
Phase/study
# of patients
Design
■
Primary endpoint
"
"
Status
☐
CT Identifier
"
Phase III
IMvigor 130
N=1,200
ARM A: Tecentriq plus gemcitabine and
carboplatin or cisplatin
ARM B: Tecentriq monotherapy
ARM C: Placebo plus gemcitabine and
carboplatin or cisplatin
Progression-free survival, overall survival and
safety
FPI Q3 2016
FPI for arm B (amended study) Q1 2017
Recruitment completed Q3 2018
Study met co-primary endpoint of PFS Q3 2019
Data presented at ESMO 2019 and AACR 2021
Data published in Lancet 2020 May
16;395(10236):1547-1557
NCT02807636
Phase III
ALBAN
N=516
ARM A: BCG induction and maintenance
ARM B: Tecentriq plus BCG induction and
maintenance
"
Recurrence-free survival
FPI Q4 2018
NCT03799835
Phase III
IMvigor011
N=495
ARM A: Tecentriq monotherapy
"
ARM B: Placebo
Recurrence-free survival
◉
FPI Q2 2021
NCT04660344
BCG-Bacille Calmette-Guérin; PD-L1-Programmed cell death-ligand 1; PFS-Progression-free survival; AACR-American Association for Cancer Research; ESMO-European Society for Medical Oncology
Roche
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OncologyView entire presentation