Table 4.
Completed phase II/III neoadjuvant immunotherapy trials for early-stage breast cancer
| Trial name Trial identifier |
Phase | Subtype | Control and immunotherapy arms | pCR rate (95% CI) (investigational vs control) |
|
I-SPY 2* NCT01042379 |
II | HER2– | Control (n=201): paclitaxel × 4 → doxorubicin+cyclophosphamide × 4 → surgery Investigational (n=69): paclitaxel+pembrolizumab × 4 → doxorubicin plus cyclophosphamide × 4 → surgery |
HR+/HER2– 30% (17% to 43%) vs 13% (7% to 19%) |
| TNBC 60% (44% to 75%) vs 22% (13% to 30%) | ||||
| HER2– | Control (n=295): paclitaxel × 4 → doxorubicin+cyclophosphamide × 4 → surgery Investigational (n=73): paclitaxel+pembrolizumab × 4 → pembrolizumab × 4 → surgery |
HR+/HER2– 15% (1% to 29%) vs 15% (9% to 20%) |
||
| TNBC 27% (9% to 45%) vs 27% (19% to 35%) | ||||
| HER2– | Control (n=299): paclitaxel × 4 → doxorubicin+cyclophosphamide × 4 → surgery Investigational (n=74): olaparib+durvalumab+paclitaxel × 4 → doxorubicin+cyclophosphamide × 4 → surgery |
HR+/HER2– 28% (18% to 38%) vs 14% (9% to 19%) |
||
| TNBC: 47% (29% to 64%) vs 27% (20% to 34%) | ||||
|
GeparNuevo NCT02685059 |
II | TNBC | Control (n=86): nab-paclitaxel × 4 →epirubicin+cyclophosphamide × 4 → surgery Investigational (n=88): nab-paclitaxel+durvalumab × 4 → EC+durvalumab × 4 → surgery |
ITT 53.4% (42.5% to 61.4%) vs 44.2% (33.5% to 55.3%) |
| Window cohort 61% (NR) vs 41.4% (NR) | ||||
|
KEYNOTE-522 NCT03036488 |
III | TNBC | Control (n=390): paclitaxel+carboplatin+placebo → doxorubicin+cyclophosphamide/epirubicin+cyclophosphamide+placebo × 4 → surgery → placebo Investigational (n=784): paclitaxel+carboplatin+pembrolizumab → doxorubicin+cyclophosphamide/epirubicin+cyclophosphamide+pembrolizumab × 4 → surgery → pembrolizumab |
ITT 63% (59.5% to 66.4%) vs 55.6% (50.6% to 60.6%) |
| PD-L1-positive 68.9% vs 54.9% | ||||
| PD-L1-negative 45.3% vs 30.3% | ||||
| LN-negative 64.9% (NR) vs 58.6% (NR) | ||||
| LN-positive 64.8% (NR) vs 44.1 (NR) | ||||
|
NeoTRIPaPDL1 NCT02620280 |
III | TNBC | Control (n=142): nab-paclitaxel+carboplatin × 8 → surgery → doxorubicin+cyclophosphamide/epirubicin+cyclophosphamide/5 FU+epirubicin+cyclophosphamide × 4 Investigational (n=138): nab-paclitaxel+carboplatin+atezolizumab × 8 → surgery → doxorubicin+cyclophosphamide/epirubicin+cyclophosphamide/5 FU+epirubicin+cyclophosphamide × 4 |
ITT 43.5% (35.1% to 52.2%) vs 40.8% (32.7% to 49.4%) |
| PD-L1-negative 32.2% (NR) vs 32.3% (NR) | ||||
| PD-L1-positive 51.9% (NR) vs 48% (NR) | ||||
|
IMpassion031 NCT03197935 |
III | TNBC | Control (n=165): placebo × 6+nab-paclitaxel × 12 → placebo+doxorubicin+cyclophosphamide × 4 → surgery → monitoring Investigational (n=168): atezolizumab × 6+nab-paclitaxel × 12 → atezolizumab+doxorubicin+cyclophosphamide × 4 → surgery →atezolizumab |
ITT 58% (50% to 65%) vs 41% (34% to 49%) |
| PD-L1-positive 69% (57% to 79%) vs 49% (38% to 61%) |
*pCR rate in I-SPY 2 trial is estimated due to adaptive clinical trial design.
EC, epirubicin/cyclophosphamide; HER2, human epidermal growth factor receptor 2; HR, hormone receptor; ITT, intent-to-treat; LN, lymph node; NR, not reported; pCR, pathologic complete response; PD-L1, programmed death-ligand 1; TNBC, triple-negative breast cancer.