Table 1.
Impassion130 and Impassion131 trials
| IMpassion130 (n=902) | IMpassion131 (n=651) | |||
| Disease setting | 1st line metastatic TNBC | 1st line metastatic TNBC | ||
| Trial design | Phase III, randomised (1:1), placebo controlled | Phase III, randomised (2:1), placebo controlled | ||
| PD-L1 testing | SP142 | SP142 | ||
| Intervention | Atezolizumab or placebo combined with nab-paclitaxel | Atezolizumab or placebo combined with paclitaxel | ||
| Primary endpoint | PFS and OS ITT and PD-L1+ (hierarchical) | PFS PD-L1+ and ITT (hierarchical) | ||
| PFS PD-L1+ (intervention vs control) |
7.5 vs 5.0 months (HR: 0.62; 95% CI 0.49 to 0.78) |
6.0 vs 5.7 months (HR: 0.82; 95% CI 0.60-1-12 p=0.20) |
||
| PFS ITT (intervention vs control) |
7.2 vs 5.5 months (HR 0.80; 95% CI 0.69 to 0.92) |
5.7 vs 5.6 months (HR: 0.86; 95% CI 0.70 to 1.05) |
||
| OS PD-L1+ (intervention vs control) |
25.4 vs 17.9 months (HR: 0.67; 95% CI 0.53 to 0.86) |
22.1 vs 28.3 months (HR: 1.12; 95% CI 0.76 to 1.65) |
||
| OS ITT (intervention vs control) |
21.0 vs 18.7 months (HR: 0.87; 95% CI 0.75 to 1.02) |
19.2 vs 22.8 months (HR 1.11; 95% CI 0.87 to 1.42) |
||
| Study population (reported) | ||||
| Trial arms (ITT) | Atezolizumab | Placebo | Atezolizumab | Placebo |
| Median age | 55 (20–82) | 56 (26–86) | 54 (22–85) | 53 (25–81) |
| PD-L1+ | 41% | 41% | 44% | 46% |
| Liver metastases | 28% | 26% | 27% | 28% |
| >3 metastatic sites | 26% | 24% | 24% | 22% |
| Prior taxane | 51% | 51% | 48% | 49% |
| Prior anthracycline | 54% | 54% | 49% | 50% |
| De novo metastatic TNBC | 37% | 37% | 30% | 31% |
| Use of concomitant steroids | Not required | 8–10 mg dexamethasone or equivalent for at least the first two infusions | ||
CI, Confidence interval; HR, Hazard ratio; ITT, Intention-to-treat; ITT, intention to treat; OS, Overall survival; PD-L1, programme death ligand 1; PFS, Progression-free survival; TILs, tumour-infiltrating lymphocytes; TNBC, triple-negative breast cancer.