Roche Pharmaceutical Development and Sales Overview
Tecentriq (atezolizumab, RG7446)
Anti-PD-L1 cancer immunotherapy - breast cancer
Indication
Previously untreated metastatic
triple negative breast cancer (TNBC)
Phase/study
# of patients
Design
Primary endpoint
Phase III
IMpassion 130
N=902
"
ARM A: Tecentriq plus nab-paclitaxel
ARM B: Placebo plus nab-paclitaxel
☐
Progression-free survival and overall survival (co-primary endpoint)
"
Study met co-primary endpoint of PFS in both PD-L1+ and ITT populations
Q3 2018
"
"
Primary PFS and interim OS data presented at ESMO 2018 and ASCO 2019
Data published in NEJM 2018; 379:2108-2121
Status
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US accelerated approval Q1 2019 - US indication voluntarily withdrawn
Q3 2021
CT Identifier
☐
Approved in EU Q3 2019
Final OS presented at ESMO Asia 2020
NCT02425891
☐
Phase III
IMpassion 132
N=572
ARM A: Tecentriq plus capecitabine or carbo/gem
ARM B: Placebo plus capecitabine or carbo/gem
Overall survival
FPI Q1 2018
NCT03371017
Carbo/gem-gemcitabine and carboplatin; ITT-Intention to treat; PD-L1-Programmed cell death-ligand 1; PFS-Progression-free survival; OS-Overall survival; ESMO-European Society for Medical Oncology; ASCO=American
Society of Clinical Oncology; NEJM=New England Journal of Medicine
Roche
73
OncologyView entire presentation