Best clinical responses in the BR-ibrutinib cohort: primary study (PCYC-1108) and primary study with extension
| Variable . | Primary study (N = 30) . | Primary study and extension period (N = 30) . |
|---|---|---|
| ORR (CR, CRi, nPR, or PR), n (%), (95% CI) | 28 (93.3), (77.9-99.2) | 28 (93.3), (77.9-99.2) |
| ORR + PR with lymphocytosis, n (%), (95% CI) | 29 (96.7), (82.8-99.9) | 29 (96.7), (82.8-99.9) |
| Response categories, n (%) | ||
| CR | 5 (16.7) | 12 (40.0) |
| CRi | 0 (0.0) | 0 (0.0) |
| nPR | 3 (10.0) | 2 (6.7) |
| PR | 20 (66.7) | 14 (46.7) |
| PR with lymphocytosis | 1 (3.3) | 1 (3.3) |
| Progressive disease | 1 (3.3) | 1 (3.3) |
| Sustained hematologic improvement,* n (%) | ||
| Neutropenia (n = 8) | 5 (62.5) | — |
| Anemia (n = 7) | 5 (71.4) | — |
| Thrombocytopenia (n = 14) | 8 (57.1) | — |
| Median duration of response, mo (range)† | Not reached (2.14+ to 16.1+) | Not reached (0.03+ to 38.3+) |
| Estimated rate of duration of response,† (%) | ||
| 6 mo (95% CI) | 88.9 (69.4-96.3) | 92.3 (72.6-98.0) |
| 12 mo (95% CI) | 81.3 (60.8-91.8) | 84.4 (63.7-93.9) |
| 15 mo (95% CI) | 77.2 (56.1-89.1) | — |
| 24 mo (95% CI) | — | 80.4 (59.1-91.4) |
| 36 mo (95% CI) | — | 72.2 (50.2-85.7) |
| 42 mo (95% CI) | — | 72.2 (50.2-85.7) |
| Variable . | Primary study (N = 30) . | Primary study and extension period (N = 30) . |
|---|---|---|
| ORR (CR, CRi, nPR, or PR), n (%), (95% CI) | 28 (93.3), (77.9-99.2) | 28 (93.3), (77.9-99.2) |
| ORR + PR with lymphocytosis, n (%), (95% CI) | 29 (96.7), (82.8-99.9) | 29 (96.7), (82.8-99.9) |
| Response categories, n (%) | ||
| CR | 5 (16.7) | 12 (40.0) |
| CRi | 0 (0.0) | 0 (0.0) |
| nPR | 3 (10.0) | 2 (6.7) |
| PR | 20 (66.7) | 14 (46.7) |
| PR with lymphocytosis | 1 (3.3) | 1 (3.3) |
| Progressive disease | 1 (3.3) | 1 (3.3) |
| Sustained hematologic improvement,* n (%) | ||
| Neutropenia (n = 8) | 5 (62.5) | — |
| Anemia (n = 7) | 5 (71.4) | — |
| Thrombocytopenia (n = 14) | 8 (57.1) | — |
| Median duration of response, mo (range)† | Not reached (2.14+ to 16.1+) | Not reached (0.03+ to 38.3+) |
| Estimated rate of duration of response,† (%) | ||
| 6 mo (95% CI) | 88.9 (69.4-96.3) | 92.3 (72.6-98.0) |
| 12 mo (95% CI) | 81.3 (60.8-91.8) | 84.4 (63.7-93.9) |
| 15 mo (95% CI) | 77.2 (56.1-89.1) | — |
| 24 mo (95% CI) | — | 80.4 (59.1-91.4) |
| 36 mo (95% CI) | — | 72.2 (50.2-85.7) |
| 42 mo (95% CI) | — | 72.2 (50.2-85.7) |
Dashes represent data not obtained. Neutropenia was defined as baseline ANC ≤1500/μL, anemia was defined as baseline hemoglobin ≤11.0 g/dL, and thrombocytopenia was defined as baseline platelet count ≤100 000/μL.
CI, confidence interval.
Hematologic improvement is calculated based on the number of patients with the respective cytopenia at baseline.
N = 28. Duration of response defined as the number of months from first documented PR with lymphocytosis or better to disease progression or death or to date of last adequate disease assessment for subjects who achieved PR or better.