Table 2.
Partial clinical trials of ICIs involving patients with TNBC
| Pathway | NCT | Phase | Results | Treatment | Reference | ||
|---|---|---|---|---|---|---|---|
| Group 1 | Group 2 | Group 1 | Group 2 | ||||
| ICIs (Anti PD-1) | NCT03125902 | III |
mPFS: 6.0 months mOS: 22.1 months ORR: 63% (95% CI, 56%-70%) |
mPFS: 5.7 months mOS: 28.3 months ORR: 55% (95% CI, 45%-65%) |
Paclitaxel + Atezolizumab | Paclitaxel + Placebo | [154] |
| ICIs (Anti PD-1) | NCT03197935 | III |
pCR: 58% treatment-related serious adverse events: 23% |
pCR: 41% treatment-related serious adverse events: 16% |
Atezolizumab + Chemotherapy (nab-paclitaxel + doxorubicin + cyclophosphamide) | Placebo + Chemotherapy (nab-paclitaxel + doxorubicin + cyclophosphamide) | [155] |
| ICIs (Anti PD-1) | NCT03036488 | II |
pCR: 64.8% (95% CI, 59.9%- 69.5%) incidence of treatment-related adverse events of grade 3 or higher: 78.0% |
pCR:51.2%(95%CI,44.1%-58.3%) incidence of treatment-related adverse events of grade 3 or higher: 73.0% |
Pembrolizumab + Chemotherapy (paclitaxel + carboplatin) | Placebo + Chemotherapy (paclitaxel + carboplatin) | [156] |
| ICIs (Anti PD-1) | NCT02622074 | I | pCR: 60% (95% CI 49%-71%) | Pembrolizumab + Chemotherapy | [157] | ||
|
ICIs (Anti PD-1) AXL inhibitor |
NCT03184558 | I |
PFS: 13.1 months (95% CI, 12.4–18.3) OS: 32.0 months (95% CI,13.6–37.1) DCR: 3.4% |
Pembrolizumab + Bemcentinib | |||
|
ICIs (Anti PD-1) IDO1 inhibitor |
NCT02178722 | I/II | ORR: 11.1% | MK-3475 + INCB024360 | |||
|
ICIs (Anti PD-1) IDO1 inhibitor GITR inhibitor |
NCT03277352 | I/II |
ORR: 30% DCR: 70% OS: 25.59 months |
Pembrolizumab + Epacadostat + INCAGN01876 | |||
| ICIs (Anti PD-1) | NCT01848834 | I | ORR: 18.5% | Pembrolizumab | [158] | ||
| ICIs (Anti PD-L1) | NCT01375842 | I |
ORR in first-line: 24% ORR in second-line: 6% |
Atezolizumab | [159] | ||
| ICIs (Anti PD-1) | NCT02838823 | I |
ORR: 5% mPFS: 1.8 months (95% CI, 1.4 -4.6) |
Humanized anti-PD-1 monoclonal antibody | [160] | ||
| ICIs (Anti PD-L1) |
(Group A) |
II |
mPFS: 2.0 months (95% CI,1.9–2.0) mOS: 9.0 months (95% CI, 7.6–11.2) |
Pembrolizumab | [161] | ||
| ICIs (Anti PD-L1) |
(Group B) |
II | ORR: 21.4% (95% CI 13.9–31.4) | Pembrolizumab | [162] | ||
| ICIs (Anti PD-1) | NCT02499367 | II |
ORR: 20.0%; mPFS: 1.9 months |
Nivolumab | [163] | ||
| ICIs (Anti PD-L1) | NCT02555657 | III | mOS: 12.7 months (95% CI, 9.9–16.3) | mOS: 11.6 months (95% CI, 8.3–13.7) | Pembrolizumab | Chemotherapy | [164] |
Clinicaltrials.gov, accessed on November 1, 2021