Table 4 Anti-myeloma activity of BMS-986354.
Part A - Dose Escalation | Part B- Dose Expansion | RP2D (Parts A + B) | Total | |||
|---|---|---|---|---|---|---|
DL1 | DL2 | DL3 | DL2 | DL2 | ||
N = 7 | N = 24 | N = 11 | N = 23 | N = 47 | N = 65 | |
Treatment best response (IMWG category) | ||||||
SD | 0 (0%) | 1 (4%) | 0 (0%) | 1 (4%) | 2 (4%) | 2 (3%) |
MR | 0 (0%) | 0 (0%) | 0 (0%) | 1 (4%) | 1 (2%) | 1 (2%) |
PR | 1 (14%) | 9 (38%) | 1 (9%) | 5 (22%) | 14 (30%) | 16 (25%) |
VGPR | 1 (14%) | 4 (17%) | 3 (27%) | 8 (35%) | 12 (26%) | 16 (25%) |
CR | 0 (0%) | 0 (0%) | 2 (18%) | 0 (0%) | 0 (0%) | 2 (3%) |
sCR | 5 (71%) | 10 (42%) | 5 (46%) | 8 (35%) | 18 (38%) | 28 (43%) |
≥CR | 5 (71%) | 10 (42%) | 7 (64%) | 8 (35%) | 18 (38%) | 30 (46%) |
≥PR | 7 (100%) | 23 (96%) | 11 (100%) | 21 (91%) | 44 (94%) | 62 (95%) |
Median time to response in mo. (range) | 1.0 (0.9–1.0) | 1.0 (0.9–4.1) | 1.0 (0.9–2.9) | 1.0 (1.0–3.1) | 1.0 (0.9–4.1) | 1.0 (0.9–4.1) |
Median DOR for patients with ≥ PR in months (95% C.I.) | 10.6 (2.1–15.1) | 11.0 (8.3–17.1) | NE (10.3–NE) | NE (5.1–NE) | 10.9 (8.2–17.1) | 11.3 (10.6–17.1) |
Median DOR for patients with ≥CR in months (95% C.I.) | 15.0 (6.9–NE) | 18.2 (13.8–NE) | NE (NE-NE) | NE (4.9–NE) | 17.1 (10.8–NE) | 15.1 (11.0–NE) |
Median PFS in months (95% C.I.) | 11.6 (3.1–16.0) | 11.9 (9.7–18.0) | NE (11.3-NE) | NE (5.9–NE) | 11.9 (9.2–18.0) | 12.3 (11.3–16.0) |
