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Table 6 Selected phase III clinical trials assessing immune checkpoint inhibitors in the metastatic, neoadjuvant and adjuvant settings of triple negative breast cancer

From: Heterogeneity of triple negative breast cancer: Current advances in subtyping and treatment implications

Trial Target Treatment vs. control arm Phase Setting Key results
(Treatment vs. control)
Targeting the immune microenvironment – Metastatic setting
IMpassion130 [10, 165] PDL1 inhibition
(atezolizumab)
Atezolizumab + 
nab-paclitaxel
vs
Placebo + 
nab-paclitaxel
III Previously untreated
TNBC
ITT population
PFS 7.2 vs. 5.5 months
HR 0.80 (95% CI 0.69- 0.92; P = 0.002)
PDL1-positive population
PFS 7.5 vs. 5 months
HR 0.62 (95%CI 0.49–0.78; P < 0.001)
KEYNOTE-355 [12] PD1 inhibition
(pembrolizumab)
Pembrolizumab
 + chemotherapy (investigator’s choice)
vs
Placebo + chemotherapy (investigator’s choice)
III Previously untreated
TNBC
Combined positive score ≥ 10 population
PFS 9.7 vs 5.6 months
HR 0.65 (95%CI 0.49–0.86; P = 0.001)
Targeting the immune microenvironment – Neoadjuvant setting
KEYNOTE-522 [168, 169] PD1 inhibition
(pembrolizumab)
Chemotherapy + pembrolizumab
surgery
pembrolizumab
vs
Chemotherapy + placebo
surgery
placebo
III TNBC ITT population pCR 63% vs. 55.6%
PDL1-positive population pCR 68.9% vs. 54.9%
PDL1-negative population pCR 45.3% vs. 30.3%
Lymph node negative
64.8% vs. 44.1%
Lymph node negative
64.9% vs 58.6%
Event free survival at 36 months 84.5% vs. 76.8%
HR 0.63 (95%CI 0.48–0.82; P < 0.001)
IMpassion031 [171] PDL1 inhibition
(atezolizumab)
Chemotherapy + atezolizumab
surgery
atezolizumab
vs
Chemotherapy + placebo
surgery
monitoring
III TNBC ITT population
pCR 58% vs. 41%
PDL1-positive population
pCR 69% vs. 49%
NeoTRIPaPDL1 [174] PDL1 inhibition
(atezolizumab)
Chemotherapy + atezolizumab
surgery
chemotherapy
vs
Chemotherapy
surgery
chemotherapy
III TNBC ITT population
pCR 43.5% vs. 40.8%
PDL1-positive population
pCR 51.9% vs 48%
Event free survival primary endpoint results—pending
Targeting the immune microenvironment – Adjuvant setting
ALEXANDRA/
IMpassion030
(NCT03498716)
PDL1 inhibition
(atezolizumab)
Chemotherapy + atezolizumab
vs
Chemotherapy alone
III TNBC Ongoing
Primary endpoint is iDFS
Secondary endpoints include iDFS by PDL1 status, lymph node status and OS
SWOG S1418
(NCT02954874)
PD1 inhibition
(pembrolizumab)
Pembrolizumab
vs
Observation
III TNBC with
residual disease measuring at least 1 cm in the breast and/or lymph node
Ongoing
Primary endpoint is iDFS
Secondary endpoints include OS and DFS
A-BRAVE
(NCT02926196)
PDL1 inhibition
(avelumab)
Avelumab
vs
Observation
III TNBC Ongoing
Stratum A: surgery of the primary tumor followed by adjuvant chemotherapy
Stratum B: residual disease after surgery of the primary tumor
Primary endpoint is DFS
Secondary endpoints include OS
  1. Abbreviations: ITT intention-to-treat, PFS progression free survival, HR hazard ratio, CI confidence interval, pCR pathologic complete response, DFS disease-free survival, iDFS invasive disease-free survival, OS overall survival, TNBC triple negative breast cancer