Table 2.
Main phase III studies with immune-checkpoint inhibitors in the first line for advanced TNBC.
| Study Name | IMpassion130 [28,29,30] | IMpassion131 [31] | KEYNOTE-355 [34,35,36] | |
|---|---|---|---|---|
| Population | mTNBC (=902) | mTNBC (=651) | mTNBC (=847) | |
| Random | 1:1 | 2:1 | 2:1 | |
| ICI | Atezolizumab | Atezolizumab | Pembrolizumab | |
| Chemotherapy | Nab-paclitaxel | Paclitaxel | Nab-paclitaxel Paclitaxel Carboplatin and gemcitabine |
|
| Primary endpoint | PFS and OS in ITT and PD-L1 positive (hierarchical) | PFS in PD-L1 positive and ITT (hierarchical) | PFS and OS in PD-L1 CPS score ≥10, ≥1, and ITT (hierarchical) | |
| PD-L1 definition | IC > 1 | IC > 1 | CPS > 1 and CPS > 10 | |
| Assay | SP142 | SP142 | 22C3 | |
| Findings | PFS | ITT: 7.2 vs. 5.5 mo (HR 0.80, 95% CI 0.69–0.92, p = 0.002) PD-L1: 7.5 vs. 5.3 mo (HR 0.63, 95% CI 0.50–0.80) |
ITT: 5.7 vs. 5.6 mo (HR 0.86, 95% CI 0.70–1.05) PD-L1: 6.0 vs. 5.7 mo (HR 0.82, 95% CI 0.60–1.12; p = 0.20) |
ITT: 7.5 mos vs. 5.6 (HR 0.82, 95%CI 0.70–0.98) PD-L1 CPS ≥ 10: 9.7 vs. 5.6 (HR 0.66, 95%CI 0.50–0.88) PD-L1 CPS ≥ 1: 7.5 vs. 5.6 (HR 0.75, 95%CI 0.62–0.91) |
| OS | ITT: 21.0 vs. 18.7 mo (HR 0.87, 95% CI 0.75–1.02, p = 0.08) PD-L1: 25.4 vs. 17.9 mo (HR 0.67, 95%CI 0.53–0.86) |
ITT: 19.2 vs. 22.8 mo (HR 1.12, 95% CI 0.88–1.43) PD-L1: 22.1 vs. 28.3 mo (HR 1.11, 95% CI 0.76–1.64) |
ITT: 17.2 mos vs. 15.5 (HR 0.89, 95%CI 0.76–1.05) PD-L1 CPS ≥ 10: 23.0 vs. 16.1 (HR 0.73, 95%CI 0.55–0.95, p = 0.0093) PD-L1 CPS ≥ 1: 17.6 vs. 16.0 (HR 0.86, 95%CI 0.72–1.04, p = 9.0563) |
|
Abbreviations: CI: Confidence interval; CPS: Combined positive score; HR: Hazard ratio; IC: Immune cell score; ICI: Immune checkpoint inhibitor: ITT: Intention to treat; mo: Months; mTNBC: Metastatic triple negative breast cancer; OS: Overall survival; PD-L1: Programmed death ligand 1; PFS: Progression free survival.