Table 2.
Clinical trials with immune checkpoint inhibitors in triple-negative breast cancer.
| Study | Phase | Stage | Patients (N) | Treatment | Primary end-point | Secondary end-points |
| KEYNOTE-119 | III | Metastatic | 622 | Pembrolizumab vs. TPCa | OS CPS≥10 12.7 vs.11.6 mos (not significant) |
PFS 2.1 vs. 3.3 mos (HR 1.6, 1.33–1.92) Severe AEs 14 % vs. 36 % |
| NCT02555657 | ||||||
| KEYNOTE-355 | III | Metastatic | 847 | Pembrolizumab + TPCb vs. placebo + TPC | PFS CPS≥ 10 9.7 vs. 5.6 mos (1-sided p = 0.0012) |
OS (CPS≥ 10) 23.0 vs. 16.1 mos (HR 0.54, 0.28–1.04) |
| NCT02819518 | ||||||
| KEYNOTE-522 | III | EBC | 1174 | Taxane/carboplatin and anthracycline plus either pembrolizumab or placebo followed by adjuvant pembrolizumab or placebo | pCR 64.8 % vs. 51.2 % (p < 0.001) |
EFS 84.3 % vs. 76.8 % (HR 0.63, p < 0.001) |
| NCT03036488 | ||||||
| IMPassion130 | III | Metastatic | 902 | nab-paclitaxel plus either atezolizumab or placebo | PFS in PD-L1+ 7.5 vs. 5.0 mos (p < 0.001) |
OS in ITT 21.3 vs. 17.6 mos (p = 0.08) OS in PD-L1+ 25.4 vs. 17.9 mos (HR 0.62, 0.45–0.86) |
| NCT02425891 | ||||||
| IMPassio031 | III | EBC | 333 | nab-paclitaxel, doxorubicin/cyclophosphamide plus either atezolizumab or placebo followed by adjuvant atezolizumabc | pCR 58 % vs. 41 % (1-sided p = 0.004) |
pCR in PD-L1+ 69 % vs. 49 % (not significant) |
| NCT03197935 | ||||||
| TONIC | II | Metastatic | 67 | Nivolumab after induction doxorubicin or cisplatin | ORR 35 % doxorubicin 23 % cisplatin |
Up-regulation of PD-1/PD-L1 and T cell cytotoxicity |
| NCT02499367 | ||||||
| DART SWOG S1609 | II | Metaplastic Metastatic |
33 | Nivolumab + ipilimumab | ORR 18 % | mPFS 2 mos mOS 12 mos irAEs, 47 % |
| NCT02834013 | ||||||
| GeparNuevo | II | EBC | 174 | Neoadjuvant nab-paclitaxel, epirubicin and cyclophosphamide plus either durvalumab or placebo | pCR 53.4 % vs. 44.2 % (not significant) |
iDFS 85.6 % vs. 77.2 %, DDFS 91.7 % vs. 78.4 % OS 95.2 % vs. 83.5 % (all significant) |
| NCT02685059 | ||||||
| SAFIR02-BREAST IMMUNO NCT02299999 | II | Metastatic | 199 | Durvalumab vs. chemotherapyd | PFS 4.5 vs. 6.2 mos (not significant) |
OS benefit in PD-L1+ and PD-L1- TNBC (exploratory analysis) |
Abbreviations: AE, adverse event; irAE, immune-related adverse event; CPS, combined positive score; pCR, pathological complete response; DDFS, distant disease-free survival; iDFS, invasive disease-free survival; ITT, intention to treat; ORR, overall response rate; OS, overall survival; PFS, progression-free survival; a TPC: capecitabine, eribulin, gemcitabine or vinorelbine. bTPC: nab-paclitaxel, paclitaxel or carboplatin plus gemcitabine. c After surgery, patients and study personnel were unmasked to treatment assignment: patients in the experimental arm continued to receive adjuvant atezolizumab, whereas patients in the control arm were monitored. dDurvalumab or chemotherapy were given as maintenance.