Table 4.
Best overall responses by study phase and dose
n (%) | Phase 1 | Phase 2 | All‐treated | |
---|---|---|---|---|
10 mg/kg QW/Q2W (n = 3) | 20 mg/kg QW/Q2W (n = 5) | 20 mg/kg QW/Q2W (n = 28) | 20 mg/kg QW/Q2W (n = 33) | |
ORR (≥PR) | 2 (67) | 3 (60) | 9 (32) | 12 (36.4) (95% CI: 20.4‐54.9, P < 0.0001) |
CBR (≥MR) | 2 (67) | 3 (60) | 15 (54) | 18 (54.5) (95% CI: 36.4‐71.9) |
sCR | 0 | 0 | 0 | 0 |
CR | 0 | 1 (20) | 1 (4) | 2 (6) |
VGPR | 1 (33) | 1 (20) | 3 (11) | 4 (12) |
PR | 1 (33) | 1 (20) | 5 (18) | 6 (18) |
MR | 0 | 0 | 6 (21) | 6 (18) |
SD | 0 | 0 | 7 (25) | 7 (21) |
PD | 0 | 1 (20) | 3 (11) | 4 (12) |
Unconfirmed PD | 1 (33) | 0 | 2 (7) | 2 (6) |
NE | 0 | 1 (20) | 1 (4) | 2 (6) |
Abbreviations: CBR, clinical benefit rate; CI, confidence interval; CR, complete response; MR, minimal response; NE, not evaluable; ORR, overall response rate; PD, progressive disease; PR, partial response; Q2W, every 2 weeks; QW, every week; sCR, stringent complete response; SD, stable disease; VGPR, very good partial response.