Table 1:
Baseline Patient Characteristics
| Characteristic | Phase Ib | Phase II | All DLBCL (N=50) |
All Patients (N=60) |
|---|---|---|---|---|
| DL1-DL4 (N=20) |
DLBCL Cohort (N=40) |
|||
| Median (range) age – yr. | 58 (34-76) | 59 (29-77) | 61 (29-77) | 58 (29-77) |
| Male sex – no. (%) | 13 (65%) | 26 (65%) | 33 (66%) | 39 (65%) |
| Race and ethnicity – no. (%) | ||||
| Caucasian | 15 (75%) | 25 (63%) | 33 (66%) | 40 (67%) |
| African American | 3 (15%) | 10 (25%) | 11 (22%) | 13 (22%) |
| Asian | 2 (10%) | 1 (3%) | 2 (4%) | 3 (5%) |
| Hispanic | 0 (0%) | 4 (10%) | 4 (8%) | 4 (7%) |
| Disease histology – no. (%) | ||||
| Non-GCB DLBCL, NOS | 4 (20%) | 9 (23%) | 13 (26%) | 13 (22%) |
| HGBCL-DH-BCL6 | 0 (0%) | 3 (8%) | 3 (6%) | 3 (5%) |
| THRLBCL | 0 (0%) | 5 (13%) | 5 (10%) | 5 (8%) |
| GCB DLBCL, NOS | 4 (20%) | 8 (20%) | 12 (24%) | 12 (20%) |
| HGBCL-DH-BCL2 | 2 (10%) | 15 (38%) | 17 (34%) | 17 (28%) |
| FL | 8 (40%) | 0 (0%) | 0 (0%) | 8 (13%) |
| MZL | 2 (10%) | 0 (0%) | 0 (0%) | 2 (3%) |
| Transformed lymphoma – no. (%) a, b | 4 (40%) | 13 (33%) | 17 (34%) | -- |
| ECOG ≥2 – no. (%) | 3 (15%) | 4 (10%) | 7 (14%) | 7 (12%) |
| Stage III/IV – no. (%) | 18 (90%) | 37 (93%) | 46 (92%) | 55 (92%) |
| Elevated LDH – no. (%) | 13 (65%) | 35 (88%) | 43 (86%) | 48 (80%) |
| Extranodal sites ≥2 – no. (%) | 12 (60%) | 22 (55%) | 28 (56%) | 34 (57%) |
| IPI ≥3 – no. (%) a | 7 (70%) | 27 (68%) | 34 (68%) | -- |
| Median (range) prior therapies | 3 (1-7) | 3 (1-9) | 3 (1-9) | 3 (1-9) |
| Prior therapies- no. (%) | ||||
| One prior study agentc | 6 (30%) | 14 (35%) | 18 (36%) | 20 (33%) |
| ASCT | 4 (20%) | 3 (8%) | 5 (10%) | 7 (12%) |
| Allo-HSCT | 1 (5%) | 0 (0%) | 1 (2%) | 1 (2%) |
| CAR-T | 3 (15%) | 17 (43%) | 20 (40%) | 20 (33%) |
| Refractory status - no. (%) | ||||
| Primary refractory | 9 (45%) | 27 (68%) | 30 (60%) | 36 (60%) |
| Refractory per SCHOLAR-1a | 6 (60%) | 23 (58%) | 29 (58%) | -- |
Aggressive B-cell lymphoma patients only (N=50);
Seventeen patients had transformed DLBCL from an underlying indolent lymphoma, 15 from follicular lymphoma and 2 from marginal zone lymphoma, including 9 who transformed to HGBCL-DH-BCL2, 5 to GCB DLBCL, NOS, and 3 to non-GCB DLBCL, NOS;
Includes 12 patients who received prior lenalidomide, 7 patients who received prior ibrutinib or acalabrutinib, and 1 patient who received prior venetoclax;
Abbreviations: Non-GCB DLBCL, NOS, non-germinal center B-cell diffuse large B-cell lymphoma, not otherwise specified; HGBCL-DH-BCL6, high-grade B-cell lymphoma, double-hit, with MYC and BCL6 rearrangements; THRLBCL, T-cell/histiocyte-rich large B-cell lymphoma; GCB DLBCL, NOS, germinal center B-cell diffuse large B-cell lymphoma, not otherwise specified; HGBCL-DH-BCL2, high-grade B-cell lymphoma, double-hit, with MYC and BCL2 rearrangements; FL, follicular lymphoma; MZL, marginal zone lymphoma; ECOG, Eastern Cooperative Oncology Group performance score; LDH, lactate dehydrogenase; IPI, international prognostic index; ASCT, autologous stem cell transplantation; Allo-HSCT, allogeneic hematopoietic stem cell transplantation; CAR-T, chimeric antigen receptor T-cell therapy; DL, dose level.