Half-Year 2022 Financial and Clinical Trials Update
Tecentriq
Anti-PD-L1 cancer immunotherapy - breast cancer
Indication
Phase/study
# of patients
Design
Phase III
IMpassion 130
N=902
ARM A: Tecentriq plus nab-paclitaxel
ARM B: Placebo plus nab-paclitaxel
Previously untreated metastatic
triple negative breast cancer (TNBC)
Phase III
IMpassion 132
N=572
ARM A: Tecentriq plus capecitabine or carbo/gem
ARM B: Placebo plus capecitabine or carbo/gem
Primary endpoint
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
■ Overall survival
FPI Q1 2018
"
Primary PFS and interim OS data presented at ESMO 2018 and ASCO 2019
Data published in NEJM 2018; 379:2108-2121
Status
US accelerated approval Q1 2019 - US indication voluntarily withdrawn Q3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
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
24
94
OncologyView entire presentation