Table 3.
Summary of the most relevant studies with immunotherapy in the different subtypes of breast cancer.
| Clinical Trial | Breast Cancer Subtype and Stage | Number of Patients Included | PD-L1 Expression | Antibody Clone | Immunotherapy Drug | Associated Drugs | Response Rates |
|---|---|---|---|---|---|---|---|
| GIADA | Early luminal B | 43 | Any expression | 28-8 (DAKO PharmDx) | Nivolumab | Anthracyclines plus endocrine therapy | 16.3% pCR |
| JAVELIN Solid Tumor | Pretreated and metastatic BC | 168 | Any expression | 73–10 (DAKO PharmDx) | Avelumab | No other drugs | ORR 2.8% in luminal, 0% in HER2+ and 5.2% in TNBC |
| KEYNOTE-028 | Pretreated and advanced luminal BC | 25 | CPS ≥ 1 | 22C3 (DAKO PharmDx) | Pembrolizumab | No other drugs | ORR 12% |
| KATE2 | Pretreated and advanced HER2-positive BC | 202 | Any expression | SP142 (VENTANA) | Atezolizumab | T-DM1 | Unknown ORR |
| PANACEA | Pretreated and advanced HER2-positive BC | 58 | Any expression | 22C3 (DAKO PharmDx) | Pembrolizumab | Trastuzumab | ORR 15% in PD-L1+, no ORR in PD-L1- |
| GeparNuevo | Early TNBC | 174 | Any expression | SP263 (VENTANA) | Durvalumab vs. placebo | Nab-paclitaxel, + epirubicin and CP | 53.4% of pCR in durvalumab arm vs. 44.2% in placebo arm |
| KEYNOTE-522 | Early TNBC | 602 | Any expression | 22C3 (DAKO PharmDx) | Pembrolizumab vs. placebo | Paclitaxel and carboplatin + anthracyclines and CP | 64.8% of pCR in pembrolizumab arm vs. 51.2% in placebo arm |
| NeoTRIP | Early TNBC | 280 | Any expression | SP142 (VENTANA) | Atezolizumab | Nab-paclitaxel + carboplatin | 43.5% of pCR in atezolizumab arm vs. 40.8% in placebo arm |
| IMpassion 031 | Early TNBC | 333 | Any expression | SP142 (VENTANA) | Atezolizumab | Nab-paclitaxel + doxorubicin and CP | 57.6% of pCR in atezolizumab arm vs. 41% in placebo arm |
| KEYNOTE-012 | Pretreated and advanced TNBC | 111 | ≥1% of TCs and IC by IHC | 22C3 (DAKO PharmDx) | Pembrolizumab | No other drugs | ORR 18.5% |
| KEYNOTE-119 | Pretreated and advanced TNBC | 622 | Any expression. Stratified by PD-L1 | 22C3 (DAKO PharmDx) | Pembrolizumab vs. single-drug CT | No other drugs | ORR (~9% in both arms) |
| KEYNOTE-355 | Advanced TNBC | 847 | Any expression. Stratified by PD-L1 | 22C3 (DAKO PharmDx) | Pembrolizumab vs. placebo | Chemotherapy | ORR 41% in combination arm and 35.9% in CT arm |
| IMpassion 130 | Advanced TNBC | 902 | Any expression. Stratified by PD-L1 | SP142 (VENTANA) | Atezolizumab vs. placebo | Nab-paclitaxel | ORR 56% in combination arm and 45.9% in CT arm |
| IMpassion 131 | Advanced TNBC | 651 | Any expression. Stratified by PD-L1 | SP142 (VENTANA) | Atezolizumab vs. placebo | Paclitaxel | ORR 53.6% in combination arm and 47.5% in CT arm |
Legend: BC, breast cancer; CP, cyclophosphamide; pCR, pathological complete response; ORR, Overall Response Rate; CT, chemotherapy.