Patient demographic and baseline clinical characteristics
| ITT . | Randomized . | Extension cohort, pola + BR (n = 106) . | Pooled, pola + BR (N = 152) . | |
|---|---|---|---|---|
| BR (n = 40) . | pola + BR (n = 40) . | |||
| Median (range) age, y | 71 (30-84) | 67 (33-86) | 70 (24-94) | 69 (24-94) |
| Age ≥65 y | 26 (65) | 23 (58) | 77 (73) | 103 (68) |
| Male sex | 25 (63) | 28 (70) | 52 (49) | 84 (55) |
| ECOG PS score | ||||
| 0 | 17 (43) | 12 (30) | 30 (28) | 44 (29) |
| 1 | 14 (35) | 21 (53) | 62 (59) | 87 (57) |
| 2 | 8 (20) | 6 (15) | 14 (13) | 20 (13) |
| Ann Arbor stage III/IV | 36 (90) | 34 (85) | 84 (79) | 122 (80) |
| Bulky disease | 14 (35.0) | 10 (25) | 28 (26) | 39 (26) |
| IPI score 3-5 at enrollment | 29 (73) | 22 (55) | 70 (66) | 94 (62) |
| Median no. of prior therapies (range) | 2 (1-5) | 2 (1-7) | 2 (1-7) | 2 (1-7) |
| 1 line | 12 (30) | 11 (28) | 37 (35) | 50 (33) |
| 2 lines | 9 (23) | 11 (28) | 27 (26) | 42 (28) |
| ≥3 lines | 19 (48) | 18 (45) | 42 (40) | 60 (39) |
| WHO 2016 classification (central pathology review)* | 40 | 40 | 104 | 150 |
| DLBCL NOS | 40 (100) | 38 (95) | 98 (94) | 142 (95) |
| ABC | 20 (50) | 19 (48) | 50 (48) | 73 (49) |
| GCB | 17 (43) | 15 (38) | 42 (40) | 58 (39) |
| Follicular lymphoma | 0 | 1 (3) | 0 | 1 (1) |
| Burkitt lymphoma | 0 | 1 (3) | 0 | 1 (1) |
| T-cell/histiocyte-rich large B-cell lymphoma | 0 | 0 | 1 (1) | 1 (1) |
| High-grade B-cell lymphoma with MYC and BCL2, and/or BCL6 rearrangements (DLBCL morphology) | 0 | 0 | 5 (5) | 5 (3) |
| Prior SCT | 6 (15) | 10 (25) | 17 (16) | 27 (18) |
| Prior CAR T-cell therapy | 0 | 0 | 1 (1) | 1 (1) |
| DOR of last treatment ≤12 mo | 34 (85) | 32 (80) | 92 (87) | 129 (85) |
| Median (range) time from last treatment, mo | 2.7 (1-97) | 4.3 (1-386) | 3.2 (1-232) | 3.4 (1-386) |
| Primary refractory† | 28 (70) | 21 (53) | 73 (69) | 97 (64) |
| Refractory to last prior therapy‡ | 33 (83) | 30 (75) | 81 (76) | 116 (76) |
| ITT . | Randomized . | Extension cohort, pola + BR (n = 106) . | Pooled, pola + BR (N = 152) . | |
|---|---|---|---|---|
| BR (n = 40) . | pola + BR (n = 40) . | |||
| Median (range) age, y | 71 (30-84) | 67 (33-86) | 70 (24-94) | 69 (24-94) |
| Age ≥65 y | 26 (65) | 23 (58) | 77 (73) | 103 (68) |
| Male sex | 25 (63) | 28 (70) | 52 (49) | 84 (55) |
| ECOG PS score | ||||
| 0 | 17 (43) | 12 (30) | 30 (28) | 44 (29) |
| 1 | 14 (35) | 21 (53) | 62 (59) | 87 (57) |
| 2 | 8 (20) | 6 (15) | 14 (13) | 20 (13) |
| Ann Arbor stage III/IV | 36 (90) | 34 (85) | 84 (79) | 122 (80) |
| Bulky disease | 14 (35.0) | 10 (25) | 28 (26) | 39 (26) |
| IPI score 3-5 at enrollment | 29 (73) | 22 (55) | 70 (66) | 94 (62) |
| Median no. of prior therapies (range) | 2 (1-5) | 2 (1-7) | 2 (1-7) | 2 (1-7) |
| 1 line | 12 (30) | 11 (28) | 37 (35) | 50 (33) |
| 2 lines | 9 (23) | 11 (28) | 27 (26) | 42 (28) |
| ≥3 lines | 19 (48) | 18 (45) | 42 (40) | 60 (39) |
| WHO 2016 classification (central pathology review)* | 40 | 40 | 104 | 150 |
| DLBCL NOS | 40 (100) | 38 (95) | 98 (94) | 142 (95) |
| ABC | 20 (50) | 19 (48) | 50 (48) | 73 (49) |
| GCB | 17 (43) | 15 (38) | 42 (40) | 58 (39) |
| Follicular lymphoma | 0 | 1 (3) | 0 | 1 (1) |
| Burkitt lymphoma | 0 | 1 (3) | 0 | 1 (1) |
| T-cell/histiocyte-rich large B-cell lymphoma | 0 | 0 | 1 (1) | 1 (1) |
| High-grade B-cell lymphoma with MYC and BCL2, and/or BCL6 rearrangements (DLBCL morphology) | 0 | 0 | 5 (5) | 5 (3) |
| Prior SCT | 6 (15) | 10 (25) | 17 (16) | 27 (18) |
| Prior CAR T-cell therapy | 0 | 0 | 1 (1) | 1 (1) |
| DOR of last treatment ≤12 mo | 34 (85) | 32 (80) | 92 (87) | 129 (85) |
| Median (range) time from last treatment, mo | 2.7 (1-97) | 4.3 (1-386) | 3.2 (1-232) | 3.4 (1-386) |
| Primary refractory† | 28 (70) | 21 (53) | 73 (69) | 97 (64) |
| Refractory to last prior therapy‡ | 33 (83) | 30 (75) | 81 (76) | 116 (76) |
Data are presented as n (%) unless otherwise specified. Pooled pola + BR cohort includes patients from the phase 1b safety run-in (n = 6), phase 2 randomized arm (n = 40), and phase 2 extension cohort (n = 106). ABC, activated B-cell; ECOG PS, Eastern Cooperative Oncology Group performance status; GCB, germinal center B-cell; IPI, International Prognostic Index; ITT, intention-to-treat; NOS, not otherwise specified; WHO, World Health Organization.
Initial diagnosis unknown for some patients.
Defined as no response or progression or relapse within 6 months of first antilymphoma therapy end date.
Defined as no response or progression or relapse within 6 months of last antilymphoma therapy end date.