Table 1.
Main studies with immune-checkpoint inhibitors in monotherapy for the treatment of advanced triple-negative breast cancer.
| Study Name | Phase | Line of Therapy and Population | TNBC (=N) | Treatment | Findings |
|---|---|---|---|---|---|
|
KEYNOTE-012 [16] |
Ib | mTNBC All lines (first in 15.6%) |
32 | Pembrolizumab | ORR: 18.5% mPFS: 1.9 mo OS: 11.2 mo |
|
JAVELIN [23] |
I | mTNBC All lines (first or second line in 50% of patients) |
58 | Avelumab | ORR (TNBC cohort): 5.2% ORR (PD-L1 positive): 22.2% ORR (PD-L1 negative): 2.6% |
|
KEYNOTE-086 (cohort A) [17] |
II | mTNBC Second or later lines (second in 31%) |
170 | Pembrolizumab | ORR (ITT): 5.3% ORR (PD-L1 positive): 5.7% ORR (PD-L1 negative): 4.7% |
|
KEYNOTE-086 (cohort B) [18] |
II | mTNBC First line |
84 | Pembrolizumab | ORR: 21.4% mPFS: 2.1 mom OS: 18 mo |
|
TAPUR [22] |
II | mBC with HTMB Second or later lines (≥3 in 93%) |
28 | Pembrolizumab | ORR: 21% DCR: 37% mPFS: 10.6 weeks mOS: 30.6 weeks |
|
ENCORE 602/TRIO025 [24] |
II | mTNBC Second or later lines (second in 69%) |
41 | Atezolizumab | ORR: 2.0% mPFS: 1.51 mo mOS: 12.4 mo |
|
TONIC [25] |
II | mTNBC First to fourth lines (first in 24%) |
67 | Nivolumab with (1) no induction or (2) irradiation or (3) cyclophosphamide or (4) cisplatin or (5) doxorubicin | ORR (overall cohort): 20% ORR (cisplatin cohor): 23% ORR (doxorubicin cohort): 35% ORR (TNBC cohort): 5% |
|
SAFIR02-BREAST IMMUNO [26] |
II | mBC First or second lines (second in 52%) |
82 | Durvalumab vs. chemotherapy | HR for OS (ITT): 0.84, 95 Cl: 0.54–1.29; p = 0.423. HR for OS (TNBC cohort): 0.54, 95% CI 0.30–0.97, p = 0.0377 HR for OS (TNBC PD-L1 positive) 0.37, 95% CI 0.12–1.13 |
|
KEYNOTE-119 [19] |
III | mTNBC Second or third lines (second in 60%) |
622 | Pembrolizumab vs. chemotherapy | mOS (PD-L1 CPS > 1): 10.7 vs. 10.2 mo (HR 0.86, 95%CI 0.69–1.06) mOS (PD-L1 CPS > 10): 12.7 vs. 11.6 mo (HR 0.78, 95%CI 0.57–1.06) OS (ITT): 9.9 vs. 10.8 mo (HR 0.97, 95%CI 0.82–1.15) PFS (ITT): 2.1 vs. 3.3 mo (HR 1.60, 95%CI 1.33–1.92) |
Abbreviations: CI: Confidence interval; CPS: Combined positive score; HR: Hazard ratio; HTMB: High tumor mutational burden; ITT: Intention to treat; mBC: Metastatic breast cancer; mo: Months; mOS: Median overall survival; mPFS: Median progression free survival; mTNBC: Metastatic triple negative breast cancer; ORR: Objective response rate; OS: Overall survival; PD-L1: Programmed death ligand 1; PFS: Progression free survival; TNBC: Triple negative breast cancer.