atezolizumab plus paclitaxel (n=191) vs. Standard of Care (SoC) (n=101)
randomized controlled trial
Atezolizumab plus paclitaxel
atezolizumab at a dose of 840 mg on days 1 and 15 of every 28-day treatment cycle plus paclitaxel : 90 mg/m2 of paclitaxel on days 1, 8, and 15 of every 28-day cycle,
placebo plus paclitaxel
paclitaxel : 90 mg/m2 of paclitaxel on days 1, 8, and 15 of every 28-day cycle,
Patients received dexamethasone at least the first two infusions of paclitaxel (8-10mg or less).
mBC - TNBC - L1 - PDL1 positive
double blind
multicenter, 150 sites in Europe, North and South America, Asia and Africa
P3 / all tests were performed at 2-sided with alpha at 0.05 with testing for secondary endpoints conducted hierarchically, using a fixed sequence testing approach. Each hypothesis was tested if all previous were rejected, order : PFS (PD-L1 pos pop) > PFS (ITT pop) > OS ((PD-L1 pos pop) > OS (ITT pop) > ORR (PD-L1 pos response evaluable pop) > ORR (response evaluable pop) / interim analysis for OS at the data cut off of the PFS (alpha level : 0.012 for OS interim analysis, and 0.046 for OS final analysis)
Atezolizumab plus paclitaxel did not significantly reduce the risk of cancer progression and death, when compared with paclitaxel plus placebo