atezolizumab plus nab-paclitaxel (n=185) vs. Standard of Care (SoC) (n=184)
randomized controlled trial
atezolizumab plus nab-paclitaxel
atezolizumab at a dose of 840 mg, administered intravenously, on days 1 and 15 and received nab-paclitaxel at a dose of 100 mg per square meter of body-sur- face area, administered intravenously, on days 1, 8, and 15 of every 28-day cycle
placebo plus nab-paclitaxel
placebo, administered intravenously, on days 1 and 15 and received nab-paclitaxel at a dose of 100 mg per square meter of body-sur- face area, administered intravenously, on days 1, 8, and 15 of every 28-day cycle
Dose reductions of atezolizumab or placebo were not permitted;No crossover is allowed.
mBC - TNBC - L1 - PDL1 positive
double blind
246 academic centres and community oncology practices in 41 countries
P3/ two sided and two interim analysis. Repartition between coprimary endpoints, and hierarchy for OS (ITT then PDL1)
Atezolizumab plus nab-paclitaxel prolonged progression-free survival among patientswith metastatic triple-negative breast cancer in both the intention-to-treat populationand the PD-L1–positive subgroup.
IMpassion-131 (PD-L1 > 1%), 2020 NCT03125902
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