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. 2019 Sep;7(18):435. doi: 10.21037/atm.2019.09.08

Table 3. Efficacy in patients with advanced TNBC treated with JS001.

Variable 1 mg/kg (n=6) 3 mg/kg (n=8) 10 mg/kg (n=6) Total (n=20) PD-L1 ≥1% (n=9) PD-L1 <1% (n=11)
CR 0 0 0 0 0 0
PR 0 0 1 (16.7) 1 (5.0) 1 (11.1) 0
SD 2 (33.3) 2 (25.0) 2 (33.3) 6 (30.0) 1 (11.1) 5 (45.5)
PD 4 (66.7) 6 (75.0) 3 (50.0) 13 (65.0) 7 (77.8) 6 (54.5)
ORR (%) (95% CI) 0 (NE to NE) 0 (NE to NE) 16.7 (0.4 to 64.1) 5.0 (0.1 to 24.9) 11.1 (0.3 to 48.2) 0 (NE to NE)
DCR (%) (95% CI) 33.3 (4.3 to 77.7) 25.0 (3.2 to 65.1) 50.0 (11.8 to 88.2) 35.0 (15.4 to 59.2) 22.2 (2.8 to 60.0) 45.5 (16.7 to 76.6)
Median PFS (95% CI, months)* 2.1 (0.9 to 5.5) 1.7 (1.0 to NE) 2.7 (1.8 to NE) 1.8 (1.4 to 4.6) 1.8 (1.0 to 3.7) 2.9 (1.0 to NE)
6-month PFS rate (%) (95% CI) 0.0 (NE to NE) 25.0 (3.7 to 55.8) 33.3 (4.6 to 67.6) 18.0 (4.8 to 38.0) 11.1 (0.6 to 38.8) 22.7 (3.8 to 51.1)

*, group PD-L1 ≥1% vs. group PD-L1 <1%, P=0.327, HR =1.64 (0.6 to 4.46).