Demographics and baseline disease characteristics for all patients in part 1, cohort 2a, and patients with CLL/SLL in part 2
| Parameter . | Dose escalation* . | CLL/SLL† . |
|---|---|---|
| Part 1: n = 17; and cohort 2a, part 2: n = 39 . | Part 2: n = 94 . | |
| Age, median (range), y | 67 (41-85) | 69 (24-87) |
| Sex | ||
| Male | 42 (75.0) | 73 (77.7) |
| Female | 14 (25.0) | 21 (22.3) |
| Race | ||
| White | 45 (80.4) | 86 (91.5) |
| Black or African American | 0 | 1 (1.1) |
| Asian | 9 (16.1) | 4 (4.3) |
| Other | 2 (3.6) | 3 (3.2) |
| ECOG performance status | ||
| 0 | 27 (48.2) | 47 (50.0) |
| 1 | 24 (42.9) | 42 (44.7) |
| 2 | 5 (8.9) | 5 (5.3) |
| Prior treatment status | ||
| Treatment-naive | 1 (1.8) | 22 (23.4) |
| Relapsed or refractory | 55 (98.2) | 72 (76.6) |
| No. of prior therapies, median (range)‡ | 2 (0-7) | 2 (1-9)§ |
| Cytogenetics, n/N evaluable|| | ||
| del(17p) or TP53 mutation | — | 18/94 (19.1) |
| del(11q) | — | 17/73 (23.3) |
| Unmutated IgHV | — | 14/21 (66.7) |
| Bulky disease, >10 cm | 0 | 5 (5.3) |
| Parameter . | Dose escalation* . | CLL/SLL† . |
|---|---|---|
| Part 1: n = 17; and cohort 2a, part 2: n = 39 . | Part 2: n = 94 . | |
| Age, median (range), y | 67 (41-85) | 69 (24-87) |
| Sex | ||
| Male | 42 (75.0) | 73 (77.7) |
| Female | 14 (25.0) | 21 (22.3) |
| Race | ||
| White | 45 (80.4) | 86 (91.5) |
| Black or African American | 0 | 1 (1.1) |
| Asian | 9 (16.1) | 4 (4.3) |
| Other | 2 (3.6) | 3 (3.2) |
| ECOG performance status | ||
| 0 | 27 (48.2) | 47 (50.0) |
| 1 | 24 (42.9) | 42 (44.7) |
| 2 | 5 (8.9) | 5 (5.3) |
| Prior treatment status | ||
| Treatment-naive | 1 (1.8) | 22 (23.4) |
| Relapsed or refractory | 55 (98.2) | 72 (76.6) |
| No. of prior therapies, median (range)‡ | 2 (0-7) | 2 (1-9)§ |
| Cytogenetics, n/N evaluable|| | ||
| del(17p) or TP53 mutation | — | 18/94 (19.1) |
| del(11q) | — | 17/73 (23.3) |
| Unmutated IgHV | — | 14/21 (66.7) |
| Bulky disease, >10 cm | 0 | 5 (5.3) |
Values shown are n (%) unless otherwise indicated.
—, data not available; ECOG, Eastern Cooperative Oncology Group; IgHV, immunoglobulin variable-region heavy chain.
Includes the following B-cell malignancy histologies: CLL/SLL (n = 4), WM (n = 4), MCL (n = 6), diffuse large B-cell lymphoma (n = 2), and hairy cell leukemia (n = 1).
Includes 6 patients also included in cohort 2a.
Prior therapies included purine nucleoside analogs (fludarabine and pentostatin), alkylating agents (cyclophosphamide and chlorambucil), anti-CD20 antibodies (rituximab, ofatumumab, and obinutuzumab) and bendamustine either alone or in combination; anthracycline-based regimens (eg, cyclophosphamide, doxorubicin, vincristine, prednisone [CHOP]) and/or cyclophosphamide, vincristine, and prednisone [CVP]; alemtuzumab; and lenalidomide. Three patients had prior exposure to a BCL-2 inhibitor (venetoclax or navitoclax) and 2 patients received prior therapy with a phosphoinositide 3-kinase inhibitor (idelalisib or duvelisib).
Relapsed or refractory patients only.
Denominators are the number of patients with valid assessments.