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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.
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
pembrolizumab plus SoC (n=425) vs. placebo plus SoC (n=211)
randomized controlled trial
Pembrolizumab plus chemotherapy
200 mg of pembrolizumab every 3 weeks in combination with one of three chemotherapy options for up to 35 cycles plus chemotherapy for up to 35 cycles plus chemotherapy ((nab-paclitaxel 100 mg/m2 on days 1, 8, and 15, every 28 days; paclitaxel 90 mg/m2 on days 1, 8, and 15, every 28 days; or gemcitabine 1000 mg/m2 plus carboplatin area under the curve 2 on days 1 and 8, every 21 days).
placebo plus chemotherapy
placebo plus chemotherapy for up to 35 cycles plus chemotherapy ((nab-paclitaxel 100 mg/m2 on days 1, 8, and 15, every 28 days; paclitaxel 90 mg/m2 on days 1, 8, and 15, every 28 days; or gemcitabine 1000 mg/m2 plus carboplatin area under the curve 2 on days 1 and 8, every 21 days). nab-paclitaxel (35%) paclitaxel (10%) gemcitabine/carboplatine (55%)
Crossover between treatment groups was not permitted. nab-paclitaxel (38.8%) paclitaxel (13.2%) gemcitabine/carboplatine (54.7%)
mBC - TNBC - L1 - PDL1 positive
PD-L1 status by immunohistochemistry at a central laboratory (an archival tumour sample was used with permission from the study
Double blind
209 sites in 29 countries in Europe, North America, Asia, Australia and New Zealand, and Latin Ameri
P3/ one sided (0.025) and two interim analysis (stopped). Split between progression- free survival (0·005), overall survival (0·018), and objective response rate (0·002) endpoints. Hierachical testing strategy for PFS : CPS of 10 or more > CPS of 1 or more > ITT population.
Pembrolizumab–chemotherapy showed a significant and clinically meaningful improvement in progression-free survival versus placebo–chemotherapy among patients with metastatic triple-negative breast cancer with CPS of 10 or more.
pembrolizumab plus SoC (n=220) vs. placebo plus SoC (n=103)
randomized controlled trial
Pembrolizumab plus chemotherapy
200 mg of pembrolizumab every 3 weeks in combination with one of three chemotherapy options for up to 35 cycles plus chemotherapy ((nab-paclitaxel 100 mg/m2 on days 1, 8, and 15, every 28 days; paclitaxel 90 mg/m2 on days 1, 8, and 15, every 28 days; or gemcitabine 1000 mg/m2 plus carboplatin area under the curve 2 on days 1 and 8, every 21 days).
placebo plus chemotherapy
placebo plus chemotherapy for up to 35 cycles plus chemotherapy ((nab-paclitaxel 100 mg/m2 on days 1, 8, and 15, every 28 days; paclitaxel 90 mg/m2 on days 1, 8, and 15, every 28 days; or gemcitabine 1000 mg/m2 plus carboplatin area under the curve 2 on days 1 and 8, every 21 days). nab-paclitaxel (29%) paclitaxel (15%) gemcitabine/carboplatine (56%)
Crossover between treatment groups was not permitted. nab-paclitaxel (30.7%) paclitaxel (13.6%) gemcitabine/carboplatine (55.7%)
mBC - TNBC - L1 - PDL1 positive
PD-L1 status by immunohistochemistry at a central laboratory (an archival tumour sample was used with permission from the study
Double blind
209 sites in 29 countries in Europe, North America, Asia, Australia and New Zealand, and Latin Ameri
P3/ one sided (0.025) and two interim analysis (stopped). Split between progression- free survival (0·005), overall survival (0·018), and objective response rate (0·002) endpoints. Hierachical testing strategy for PFS : CPS of 10 or more > CPS of 1 or more > ITT population.
Pembrolizumab–chemotherapy showed a significant and clinically meaningful improvement in progression-free survival versus placebo–chemotherapy among patients with metastatic triple-negative breast cancer with CPS of 10 or more.
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