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).