Table 1.
Summary of trial designs.
CO40151 | IPATunity130, Cohort C | IPATunity170 | |
---|---|---|---|
Design | Phase Ib | Open-label single-arm cohort within phase III | Two-cohort placebo-controlled randomized phase III |
Geographic locations | Australia, France, Spain, UK, USA | Europe, North and South America, Asia | Europe, Asia, Australia, North and South America |
Taxane backbone | Paclitaxel or nab-paclitaxel | Paclitaxel | Paclitaxel |
Comparator arms | None | None | PD-L1–positive cohort: atezolizumab + paclitaxel |
PD-L1–negative/unknown cohort: paclitaxel alone or paclitaxel + ipatasertib | |||
PIK3CA/AKT1/PTEN mutation status | Unselected | Not altered | Unselected |
Known BRCA1/2 mutation eligible | Yes | Yes | No (unless ineligible for PARP inhibitor) |
Primary endpoint | Confirmed ORR and DoR | PFS | PFS and OS |
Secondary efficacy endpoints | PFS, confirmed CBR, OS | Confirmed ORR (RECIST version 1.1), DoR, CBR, OS, 1-year PFS rate, 1-year OS rate | All nonprimary predefined endpoints were exploratory |
Abbreviations: CBR, clinical benefit rate (stable disease for ≥24 weeks or confirmed complete/partial response); DoR, duration of response (interval between confirmed complete/partial response and disease progression or death).