Efficacy outcomes
| . | TN (n = 24) . | R/R (n = 49) . | Total (N = 73) . |
|---|---|---|---|
| Duration of follow-up, median, mo | 23.5 | 35.8 | 30.3 |
| Best overall response, n (%) | |||
| CR | 0 | 1 (2.0) | 1 (1.4) |
| VGPR | 8 (33.3) | 24 (49.0) | 32 (43.8) |
| PR | 13 (54.2) | 14 (28.6) | 27 (37.0) |
| MR | 3 (12.5) | 7 (14.3) | 10 (13.7) |
| SD | 0 | 3 (6.1) | 3 (4.1) |
| PD | 0 | 0 | 0 |
| VGPR/CR rate, % (95% CI) | 33.3 (15.6-55.3) | 51.0 (36.3-65.6) | 45.2 (33.5-57.3) |
| VGPR/CR rate by genotype, % (95% CI) | |||
| MYD88L265P/CXCR4WT (n = 39) | 59.0 (42.1-74.4) | ||
| MYD88L265P/CXCR4WHIM (n = 11) | 27.3 (6.0-61.0) | ||
| MYD88L265P/CXCR4FS (n = 6) | 33.3 (4.3-77.7) | ||
| MYD88L265P/CXCR4NS (n = 5) | 20.0 (0.5-71.6) | ||
| MYD88WT (n = 8) | 25.0 (3.2-65.1) | ||
| ORR (MR or better), % (95% CI) | 100.0 (85.8-100.0) | 93.9 (83.1-98.7) | 95.9 (88.5-99.1) |
| MRR (PR or better), % (95% CI) | 87.5 (67.6-97.3) | 79.6 (65.7-89.8) | 82.2 (71.5-90.2) |
| PFS estimate at 24 mo, % (95% CI) | 91.5 (70.0-97.8) | 76.2 (60.9-86.2)* | 80.5 (68.5-88.3) |
| OS estimated at 24 mo, % (95% CI) | 100 (NE-NE) | 91.5 (78.8-96.7)* | 94.1 (84.9-97.7) |
| . | TN (n = 24) . | R/R (n = 49) . | Total (N = 73) . |
|---|---|---|---|
| Duration of follow-up, median, mo | 23.5 | 35.8 | 30.3 |
| Best overall response, n (%) | |||
| CR | 0 | 1 (2.0) | 1 (1.4) |
| VGPR | 8 (33.3) | 24 (49.0) | 32 (43.8) |
| PR | 13 (54.2) | 14 (28.6) | 27 (37.0) |
| MR | 3 (12.5) | 7 (14.3) | 10 (13.7) |
| SD | 0 | 3 (6.1) | 3 (4.1) |
| PD | 0 | 0 | 0 |
| VGPR/CR rate, % (95% CI) | 33.3 (15.6-55.3) | 51.0 (36.3-65.6) | 45.2 (33.5-57.3) |
| VGPR/CR rate by genotype, % (95% CI) | |||
| MYD88L265P/CXCR4WT (n = 39) | 59.0 (42.1-74.4) | ||
| MYD88L265P/CXCR4WHIM (n = 11) | 27.3 (6.0-61.0) | ||
| MYD88L265P/CXCR4FS (n = 6) | 33.3 (4.3-77.7) | ||
| MYD88L265P/CXCR4NS (n = 5) | 20.0 (0.5-71.6) | ||
| MYD88WT (n = 8) | 25.0 (3.2-65.1) | ||
| ORR (MR or better), % (95% CI) | 100.0 (85.8-100.0) | 93.9 (83.1-98.7) | 95.9 (88.5-99.1) |
| MRR (PR or better), % (95% CI) | 87.5 (67.6-97.3) | 79.6 (65.7-89.8) | 82.2 (71.5-90.2) |
| PFS estimate at 24 mo, % (95% CI) | 91.5 (70.0-97.8) | 76.2 (60.9-86.2)* | 80.5 (68.5-88.3) |
| OS estimated at 24 mo, % (95% CI) | 100 (NE-NE) | 91.5 (78.8-96.7)* | 94.1 (84.9-97.7) |
Percentages are based on N, the number of patients who received ≥1 dose of zanubrutinib and had baseline IgM or M-paraprotein ≥5 g/L.
MR, minimal response; NE, not evaluable; PR, partial response; SD, stable disease.
For patients with R/R WM, 36-month PFS estimate was 76.2% (95% CI, 60.9-86.2) and 36-month OS estimate was 80.2 (63.8-89.7).