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atezolizumab plus SoC (n=651) vs. placebo plus SoC (n=650)
randomized controlled trial
atezolizumab plus paclitaxel carboplatin and bevacizumalb
atezolizumab 1,200 mg on day 1 of cycles 1-22, combined with paclitaxel175 mg/m2 and carboplatin area under the curve 6 on day 1during cycles 1-6, and bevacizumab 15 mg/kg on day 1during cycles 2-22.placebo on day 1 of cycles 1-22, combined with paclitaxel
placeb plus paclitaxel carboplatin and bevacizumalb
placebo on day 1 of cycles 1-22, combined with paclitaxel175 mg/m2 and carboplatin area under the curve 6 on day 1during cycles 1-6, and bevacizumab 15 mg/kg on day 1during cycles 2-22.placebo on day 1 of cycles 1-22, combined with paclitaxel
neoadjuvant cohort,were randomly assigned before starting studytherapy to receive either atezolizumab 1,200 mg or placebo on day 1 of cycles 1-22, both combined with paclitaxel andcarboplatin during cycles 1-6 as above.
mOC - L1 - all population
double-blind
269 study location in North and South America, Europe, Asia, and Australia
P3/ two sided and one OS IA. PFS was tested in parallel in the PD-L1–positive and ITTpopulations (two-sided P 5 .002); OS was tested hierarchically(with the actual alpha spent dependent on the PFSresults) first in the PD-L1–positive population; if statisticalsignificance was reached, OS was tested further in the ITTpopulation.
Current evidence does not support the use of immune checkpoint inhibitors in newly diagnosedOC. This trial fails to meet its primary endpoint
atezolizumab plus SoC (n=391) vs. placebo plus SoC (n=393)
randomized controlled trial
atezolizumab plus paclitaxel carboplatin and bevacizumalb
atezolizumab 1,200 mg on day 1 of cycles 1-22, combined with paclitaxel175 mg/m2 and carboplatin area under the curve 6 on day 1during cycles 1-6, and bevacizumab 15 mg/kg on day 1during cycles 2-22.placebo on day 1 of cycles 1-22, combined with paclitaxel
placeb plus paclitaxel carboplatin and bevacizumalb
placebo on day 1 of cycles 1-22, combined with paclitaxel175 mg/m2 and carboplatin area under the curve 6 on day 1during cycles 1-6, and bevacizumab 15 mg/kg on day 1during cycles 2-22.placebo on day 1 of cycles 1-22, combined with paclitaxel
neoadjuvant cohort,were randomly assigned before starting studytherapy to receive either atezolizumab 1,200 mg or placebo on day 1 of cycles 1-22, both combined with paclitaxel andcarboplatin during cycles 1-6 as above.
mOC - L1 - PDL1 positive
PDL1–positive (IC > 1%) populations.
double-blind
269 study location in North and South America, Europe, Asia, and Australia
P3/ two sided and one OS IA. PFS was tested in parallel in the PD-L1–positive and ITTpopulations (two-sided P 5 .002); OS was tested hierarchically(with the actual alpha spent dependent on the PFSresults) first in the PD-L1–positive population; if statisticalsignificance was reached, OS was tested further in the ITTpopulation.
Current evidence does not support the use of immune checkpoint inhibitors in newly diagnosed OC. This trial fails to meet its primary endpoint
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