Roche Pharmaceutical Development and Sales Overview
Tecentriq (atezolizumab, RG7446)
Anti-PD-L1 cancer immunotherapy - breast cancer
Indication
Neoadjuvant triple negative breast cancer (TNBC)
Adjuvant triple negative breast cancer (TNBC)
Phase/study
# of patients
Design
Primary endpoint
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Status
CT Identifier
Phase III
IMpassion031
N=333
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ARM A: Tecentriq plus nab-paclitaxel
ARM B: Placebo plus nab-paclitaxel
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• Percentage of participants with pathologic complete response
FPI Q3 2017
Recruitment completed Q2 2018
Study met primary endpoint Q2 2020
Data presented at ESMO 2020
Data published in Lancet 2020;396 (10257):1090-1100
Filed in EU Q4 2020 - application withdrawn Q3 2021
NCT03197935
PD-L1-Programmed cell death-ligand 1; ESMO-European Society for Medical Oncology
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Roche
Phase III
IMpassion030
N=2,300
ARM A: Tecentriq plus paclitaxel followed by Tecentriq plus AC, followed
by Tecentriq maintenance
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ARM B: Placebo plus paclitaxel followed by AC followed by placebo
Invasive disease-free survival
FPI Q3 2018
NCT03498716
74
14
OncologyView entire presentation