TABLE 1.
Patient baseline characteristics
| Arm A | Arm B | Arm C | Arm D | ||
|---|---|---|---|---|---|
| Characteristic | Avadomide + CC‐223 ± R (n = 34) | Avadomide + CC‐292 ± R (n = 28) | CC‐292 + CC‐223 ± R (n = 14) | Avadomide + R (n = 30) | Overall (N = 106) |
| Median age, years (range) | 63 (28–84) | 57 (24–84) | 68 (25–80) | 66 (28–84) | 65 (24–84) |
| Age > 65 years, n (%) a | 13 (38.2) | 8 (28.6) | 9 (64.3) | 15 (50.0) | 45 (42.5) |
| Male, n (%) a | 19 (55.9) | 17 (60.7) | 8 (57.1) | 19 (63.3) | 63 (59.4) |
| ECOG PS, n (%) a | |||||
| 0 | 14 (41.2) | 18 (64.3) | 6 (42.9) | 11 (36.7) | 49 (46.2) |
| 1 | 17 (50.0) | 9 (32.1) | 8 (57.1) | 19 (63.3) | 53 (50.0) |
| Missing | 3 (8.8) | 1 (3.6) | 0 | 0 | 4 (3.8) |
| Disease stage, n (%) | |||||
| I | 1 (3.2) | 0 | 0 | 0 | 1 (1.0) |
| II | 6 (17.6) | 3 (10.7) | 1 (7.1) | 4 (13.3) | 14 (13.2) |
| III | 8 (23.5) | 6 (21.4) | 4 (28.6) | 6 (20.0) | 24 (22.6) |
| IV | 15 (44.1) | 16 (57.1) | 9 (64.3) | 20 (66.7) | 60 (56.6) |
| Missing | 1 (3.2) | 2 (7.4) | 0 | 0 | 3 (2.9) |
| Transformed DLBCL, n (%) | 11 (35.5) | 9 (33.3) | 4 (28.6) | 8 (26.7) | 32 (31.4) |
| Double‐hit, n (%) b | 5 (16.1) | 5 (18.5) | 1 (7.1) | 4 (13.3) | 15 (14.7) |
| Bone marrow involvement, n (%) | 5 (16.1) | 3 (11.1) | 2 (14.2) | 4 (13.3) | 14 (13.7) |
| Median no. prior systemic anticancer regimens (range) | 3 (2‐8) | 3 (1–7) | 3 (1–5) | 3 (2–10) | 3 (1–10) |
| 1 | 0 | 3 (11.1) | 2 (14.3) | 0 | 5 (4.9) |
| 2 | 7 (22.6) | 6 (22.2) | 4 (28.6) | 8 (26.7) | 25 (24.5) |
| >2 | 24 (77.4) | 18 (66.7) | 8 (57.1) | 22 (73.3) | 72 (70.6) |
| Prior rituximab, n (%) | 29 (93.5) | 27 (100) | 13 (92.9) | 30 (100) | 99 (97.1) |
| Prior ASCT, n (%) | 11 (35.5) | 9 (33.3) | 3 (21.4) | 8 (26.7) | 31 (30.4) |
| POD12, n (%) | 5 (14.7) | 2 (7.1) | 0 | 1 (3.3) | 8 (7.5) |
| Median time since last recurrence (range), months | 1.0 (‐1.0–5.7) | 0.5 (0–4.9) | 1.1 (0.3–10.6) | 0.9 (‐0.1–3.8) | 0.9 (‐1.0–10.6) |
Abbreviations: ASCT, autologous stem cell transplant; DLBCL, diffuse large B‐cell lymphoma; ECOG PS, Eastern Cooperative Oncology Group performance status; POD12, progression of disease within 12 months of diagnosis; R, rituximab.
a
Data in the enrolled population shown; all other results are in the safety population.
b
Rearrangement or overexpression of both BCL2 and MYC.