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| Disease setting | Trial | Phase | Drug | Line | Number of patients | PD-L1 status | Endpoints |
|
| Advanced PD-L1+ TNBC | KEYNOTE-012, NCT01848834 | Ib | Pembrolizumab | ≥1 | 27 | PD-L1 expression in stroma or ≥1% of tumor cells | ORR: 18.5%
6-month PFS: 24.4%
mPFS: 1.9 months
mOS: 11.2 months
24-month OS: 22% |
| Cohort A: advanced, previously treated, any PD-L1 TNBC | KEYNOTE-086, NCT02447003 | II | Pembrolizumab | Cohort A: >1 | Cohort A: 170 | Cohort A: — | Cohort A:
ORR: 5.3%
mPFS: 2 months
mOS: 8.9 months |
| Cohort B: advanced, untreated PD-L1+ TNBC | | | | Cohort B: 1 | Cohort B: 84 | Cohort B: | Cohort B:
ORR: 21.4%
mPFS: 2.1 months
mOS: 18 months |
| Advanced TNBC unselected for PD-L1 | ENHANCE-1, NCT02513472 | Ib/II | Pembrolizumab+eribulin mesylate | ≥1 | 82 | — | ORR: 25.6%
mPFS: 4.1 months
mOS: NE |
| Metastatic, previously treated, PD-L1+ TNBC | KEYNOTE-119, NCT02555657 | III | Pembrolizumab vs. chemotherapy | >1 | 622 | | : mOS: 10.7 vs. 10.2 months ()
: mOS: 12.7 vs. 11.6 months () |
| Previously untreated, locally recurrent, inoperable TNBC | KEYNOTE-355, NCT02819518 | III | Pembrolizumab+chemotherapy vs. placebo chemotherapy | 1 | 847 | — | : mPFS: 9.7 vs. 5.6 months ()
: mPFS: 7.6 vs. 5.6 months ()
ITT: mPFS: 7.5 vs. 5.6 months |
| Metastatic TNBC after induction treatment | TONIC, NCT02499367 | II | Nivolumab | >3 |
Cohort 1 (no induction): 12
Cohort 2 (radiotherapy): 12
Cohort 3 (cyclophosphamide): 12
Cohort 4 (cisplatin): 13
Cohort 5 (doxorubicin): 17 | — | ORR:
Overall: 20%
Cohort 1: 17%
Cohort 2: 8%
Cohort 3: 8%
Cohort 4: 23%
Cohort 5: 35% |
| Advanced TNBC unselected for PD-L1 | NCT01375842 | I | Atezolizumab | ≥1 | 115
| — | ORR: 10% (, 12.7% in PD-L1+)
mPFS: 1.4 months by RECIST, 1.9 by irRECIST
mOS: 8.9 months () |
| Advanced, untreated TNBC unselected for PD-L1 | IMpassion130, NCT02425891 | III | Atezolizumab+nab-paclitaxel vs. placebo+nab-paclitaxel | 1 | 902 (1 : 1) | | ITT: mPFS: 7.2 vs. 5.5 months ()
mOS: 21.3 vs. 17.6 months ()
: mPFS: 7.5 vs. 5 months ()
mOS: 25 vs. 15.5 months |
| Metastatic TNBC unselected for PD-L1 | JAVELIN, NCT01772004 | I | Avelumab | >1 | 168 (58 TNBC) | — | ORR: 5.2% (PD-L1+: 22.2% vs. PD-L1-: 2.6%)
mPFS: 1.5 months
mOS: 9.2 months |
| Neoadjuvant TNBC | I-SPAY 2, NCT01042379 | II | Pembrolizumab+paclitaxel vs. paclitaxel | — | 250 randomized: 69 experimental arms (29 TNBC) and 181 control arms | — | pCR: 60% vs. 20% |
| Neoadjuvant TNBC | KEYNOTE-522, NCT03036488 | III | Pembrolizumab+chemotherapy vs. placebo+chemotherapy | — | 1174 randomized: 784 experimental arms and 390 control arms | — | pCR: 64.8% vs. 51.2% () |
| Neoadjuvant TNBC | GeparNuevo, NCT02685059 | II | Durvalumab+nab-paclitaxel vs. placebo+nab-paclitaxel | — | 174 | — | pCR: 53.4% vs. 44.2% |
| Neoadjuvant TNBC | NeoTRIP, NCT02620280 | III | Atezolizumab+carboplatin+nab-paclitaxel vs. carboplatin+nab-paclitaxel | — | 280 | — | pCR: 43.5% vs. 40.8% () |
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