Baseline patient characteristics
| Characteristic . | ESCAL . | EXP . | ESCAL+EXP . | |
|---|---|---|---|---|
| Overall (n = 33) . | RP2D 300 mg (n = 26) . | RP2D 300 mg (n = 40) . | Overall (N = 59) . | |
| Median (range) age, y | 65 (25, 80) | 71 (55, 80) | 67 (30, 80) | 66 (25, 80) |
| Age > 60 y, n (%) | 22 (66.7) | 23 (88.5) | 31 (77.5) | 45 (76.3) |
| Male, n (%) | 18 (54.5) | 17 (65.4) | 25 (62.5) | 35 (59.3) |
| ECOG PS, n (%) | ||||
| 0 | 17 (51.5) | 12 (46.2) | 21 (52.5) | 29 (49.2) |
| 1 | 14 (42.4) | 13 (50.0) | 18 (45.0) | 27 (45.8) |
| Ann Arbor disease stage, n (%) | ||||
| II | 2 (6.1) | 2 (7.7) | 2 (5.0) | 4 (6.8) |
| III | 10 (30.3) | 8 (30.8) | 13 (32.5) | 18 (30.5) |
| IV | 21 (63.6) | 16 (61.5) | 25 (62.5) | 37 (62.7) |
| Median time between first diagnosis and first dose (range), d | 28 (7, 380) | 27 (3, 103) | 28 (3, 380) | 28 (3, 380) |
| DLBCL* | 27 (9, 61) | 25 (3, 103) | 24 (3, 103) | 26 (3, 103) |
| IPI score, n (%) | ||||
| Low/low-intermediate (= 2)† | 15 (45.5) | 9 (34.6) | 18 (45.0) | 24 (40.6) |
| High-intermediate/high (≥ 3) | 18 (54.5) | 17 (65.4) | 22 (55.0) | 35 (59.3) |
| Transformed DLBCL, n (%) | 5 (15.2) | 5 (19.2) | 8 (20.0) | 10 (16.9) |
| Cell of origin, n (%)‡ | ||||
| GCB | 13 (39.4) | 12 (46.2) | 16 (40.0) | 25 (42.4) |
| Non-GCB | 9 (27.3) | 9 (34.6) | 14 (35.0) | 18 (30.5) |
| Undetermined | 11 (33.3) | 5 (19.2) | 10 (25.0) | 16 (27.1) |
| Overexpression of BCL2 and/or MYC, n (%) | ||||
| Yes§ | 19/29 (65.5) | 23/25 (92.0) | 32/38 (84.2) | 42/54 (77.8) |
| BCL2 | 9 (31.0) | 8 (32.0) | 13 (34.2) | 17 (31.5) |
| MYC | 7 (24.1) | 5 (20.0) | 9 (23.7) | 12 (22.2) |
| Double expressor | 4 (13.8) | 3 (12.0) | 5 (13.2) | 7 (13.0) |
| Unknown | 4 (12.1) | 1 (3.8) | 2 (5.0) | 5 (8.5) |
| Molecular abnormalities, n (%) | ||||
| Yes‖ | 14/31 (45.2) | 13/23 (56.5) | 21/37 (56.8) | 27/54 (50.0) |
| Double hit | 1 (3.2) | 1 (4.3) | 2 (5.4) | 2 (3.7) |
| Triple hit | 0 | 1 (4.3) | 1 (2.7) | 1 (1.9) |
| Missing | 2 (6.1) | 3 (11.5) | 3 (7.5) | 5 (8.5) |
| Characteristic . | ESCAL . | EXP . | ESCAL+EXP . | |
|---|---|---|---|---|
| Overall (n = 33) . | RP2D 300 mg (n = 26) . | RP2D 300 mg (n = 40) . | Overall (N = 59) . | |
| Median (range) age, y | 65 (25, 80) | 71 (55, 80) | 67 (30, 80) | 66 (25, 80) |
| Age > 60 y, n (%) | 22 (66.7) | 23 (88.5) | 31 (77.5) | 45 (76.3) |
| Male, n (%) | 18 (54.5) | 17 (65.4) | 25 (62.5) | 35 (59.3) |
| ECOG PS, n (%) | ||||
| 0 | 17 (51.5) | 12 (46.2) | 21 (52.5) | 29 (49.2) |
| 1 | 14 (42.4) | 13 (50.0) | 18 (45.0) | 27 (45.8) |
| Ann Arbor disease stage, n (%) | ||||
| II | 2 (6.1) | 2 (7.7) | 2 (5.0) | 4 (6.8) |
| III | 10 (30.3) | 8 (30.8) | 13 (32.5) | 18 (30.5) |
| IV | 21 (63.6) | 16 (61.5) | 25 (62.5) | 37 (62.7) |
| Median time between first diagnosis and first dose (range), d | 28 (7, 380) | 27 (3, 103) | 28 (3, 380) | 28 (3, 380) |
| DLBCL* | 27 (9, 61) | 25 (3, 103) | 24 (3, 103) | 26 (3, 103) |
| IPI score, n (%) | ||||
| Low/low-intermediate (= 2)† | 15 (45.5) | 9 (34.6) | 18 (45.0) | 24 (40.6) |
| High-intermediate/high (≥ 3) | 18 (54.5) | 17 (65.4) | 22 (55.0) | 35 (59.3) |
| Transformed DLBCL, n (%) | 5 (15.2) | 5 (19.2) | 8 (20.0) | 10 (16.9) |
| Cell of origin, n (%)‡ | ||||
| GCB | 13 (39.4) | 12 (46.2) | 16 (40.0) | 25 (42.4) |
| Non-GCB | 9 (27.3) | 9 (34.6) | 14 (35.0) | 18 (30.5) |
| Undetermined | 11 (33.3) | 5 (19.2) | 10 (25.0) | 16 (27.1) |
| Overexpression of BCL2 and/or MYC, n (%) | ||||
| Yes§ | 19/29 (65.5) | 23/25 (92.0) | 32/38 (84.2) | 42/54 (77.8) |
| BCL2 | 9 (31.0) | 8 (32.0) | 13 (34.2) | 17 (31.5) |
| MYC | 7 (24.1) | 5 (20.0) | 9 (23.7) | 12 (22.2) |
| Double expressor | 4 (13.8) | 3 (12.0) | 5 (13.2) | 7 (13.0) |
| Unknown | 4 (12.1) | 1 (3.8) | 2 (5.0) | 5 (8.5) |
| Molecular abnormalities, n (%) | ||||
| Yes‖ | 14/31 (45.2) | 13/23 (56.5) | 21/37 (56.8) | 27/54 (50.0) |
| Double hit | 1 (3.2) | 1 (4.3) | 2 (5.4) | 2 (3.7) |
| Triple hit | 0 | 1 (4.3) | 1 (2.7) | 1 (1.9) |
| Missing | 2 (6.1) | 3 (11.5) | 3 (7.5) | 5 (8.5) |
ESCAL, dose-escalation phase; EXP, expansion phase; DLBCL, diffuse large B-cell lymphoma; ECOG PS, Eastern Cooperative Oncology Group performance status; GCB, germinal center B cell; IPI, International Prognostic Index; RP2D, recommended phase 2 dose.
Total number of patients with DLBCL (not transformed follicular lymphoma) was 49 (ESCAL, n = 28; EXP, n = 21; RP2D 300 mg, n = 32).
Includes 1 patient with an IPI score of 0/1 (low) and 23 patients with an IPI score of 2 (low-intermediate).
By Hans algorithm.
Overexpression of BCL2 (≥30%) or MYC (≥40%) was determined by immunohistochemistry based on local pathology laboratory assessment. Double expressors have increased expression of BCL2 and MYC. The denominators are the total number of patients with known expression levels.
Includes all patients with BCL2, BCL6, and/or MYC rearrangements. Double-hit are BCL2 or BCL6 and MYC rearrangements, and triple-hit are BCL2, BCL6, and MYC rearrangements. The denominators are the total number of patients with no missing data.