Summary of demographic, baseline, and pretreatment disease characteristics (umbralisib safety population)
| Parameter/statistic . | FL (n = 147) . | MZL (n = 82) . | DLBCL/MCL (n = 74) . | CLL/SLL (n = 43) . | Other (n = 25) . | Total (N = 371) . |
|---|---|---|---|---|---|---|
| Age, median (range), y | 65 (29-87) | 68 (34-88) | 72 (41-95) | 64 (43-86) | 62 (22-85) | 67 (22-95) |
| Sex, n (%) | ||||||
| Female | 56 (38.1) | 43 (52.4) | 36 (48.6) | 16 (37.2) | 11 (44.0) | 162 (43.7) |
| Male | 91 (61.9) | 39 (47.6) | 38 (51.4) | 27 (62.8) | 14 (56.0) | 209 (56.3) |
| Race, n (%) | ||||||
| White | 120 (81.6) | 67 (81.7) | 68 (91.9) | 35 (81.4) | 17 (68.0) | 307 (82.7) |
| Non-White | 13 (8.8) | 10 (12.2) | 4 (5.4) | 7 (16.3) | 6 (24.0) | 40 (10.8) |
| Unknown | 1 (0.7) | 0 | 0 | 0 | 2 (8.0) | 3 (0.8) |
| Not reported | 13 (8.8) | 5 (6.1) | 2 (2.7) | 1 (2.3) | 0 | 21 (5.7) |
| ECOG performance status score, n (%) | ||||||
| 0 | 80 (54.4) | 42 (51.2) | 29 (39.2) | 22 (51.2) | 4 (16.0) | 177 (47.7) |
| 1 | 63 (42.9) | 38 (46.3) | 37 (50.0) | 21 (48.8) | 20 (80.0) | 179 (48.2) |
| 2 | 4 (2.7) | 2 (2.4) | 8 (10.8) | 0 | 1 (4.0) | 15 (4.0) |
| Time since initial diagnosis (mo) | ||||||
| Median (min, max) | 69.6 (4.1, 374.9) | 70.7 (4.9, 340.7) | 43.4 (3.6, 446.5) | 63.8 (6.0, 184.3) | 65.2 (7.3, 193.3) | 63.8 (3.6, 446.5) |
| Stage of disease at screening or most recent, n (%)* | ||||||
| I | 14 (9.5) | 5 (6.1) | 2 (2.7) | 1 (2.3) | 0 | 22 (5.9) |
| II | 18 (12.2) | 7 (8.5) | 4 (5.4) | 1 (2.3) | 0 | 30 (8.1) |
| III | 43 (29.3) | 13 (15.9) | 18 (24.3) | 6 (14.0) | 0 | 80 (21.6) |
| IV | 55 (37.4) | 47 (57.3) | 27 (36.5) | 13 (30.2) | 3 (12.0) | 145 (39.1) |
| Unknown | 1 (0.7) | 5 (6.1) | 2 (2.7) | 1 (2.3) | 7 (28.0) | 16 (4.3) |
| No. of prior systemic therapies | ||||||
| Median (min, max) | 3 (1, 10) | 2 (1, 7) | 3 (1, 10) | 2 (1, 8) | 4 (1, 14) | 2 (1, 14) |
| No. of prior lines of therapy, n (%) | ||||||
| <2 | 21 (14.3) | 38 (46.3) | 14 (18.9) | 11 (25.6) | 3 (12.0) | 87 (23.5) |
| ≥2 | 126 (85.7) | 44 (53.7) | 60 (81.1) | 32 (74.4) | 22 (88.0) | 284 (76.5) |
| Select prior systemic therapy, n (%) | ||||||
| Anti-CD20 antibody | 147 (100.0) | 82 (100.0) | 74 (100.0) | 43 (100.0) | 13 (52.0) | 359 (96.8) |
| Anti-CD20 monotherapy only | 3 (2.0) | 18 (22.0) | 0 | 3 (7.0) | 2 (8.0) | 26 (7.0) |
| Anti-CD20–based chemoimmunotherapy | 144 (98.0) | 61 (74.4) | 74 (100.0) | 40 (93.0) | 6 (24.0) | 325 (87.6) |
| Lenalidomide (monotherapy or in combination) | 20 (13.6) | 5 (6.1) | 11 (14.9) | 2 (4.7) | 6 (24.0) | 44 (11.9) |
| Lenalidomide + anti-CD20 antibody | 16 (10.9) | 4 (4.9) | 8 (10.8) | 1 (2.3) | 0 | 29 (7.8) |
| BTK inhibitor | 12 (8.2) | 5 (6.1) | 22 (29.7) | 6 (14.0) | 9 (36.0) | 54 (14.6) |
| Prior treatment relapsed/refractory status, n (%) | ||||||
| Relapsed | 92 (62.6) | 54 (65.9) | 34 (45.9) | 23 (53.5) | 4 (16.0) | 207 (55.8) |
| Refractory† | 55 (37.4) | 20 (24.4) | 40 (54.1) | 19 (44.2) | 11 (44.0) | 145 (39.1) |
| Prior CD20 treatment relapsed/refractory status, n (%) | ||||||
| Relapsed | 80 (54.4) | 52 (63.4) | 29 (39.2) | 11 (25.6) | 0 | 172 (46.4) |
| Refractory† | 41 (27.9) | 15 (18.3) | 16 (21.6) | 7 (16.3) | 0 | 79 (21.3) |
| Not applicable | 10 (6.8) | 2 (2.4) | 8 (10.8) | 4 (9.3) | 0 | 24 (6.5) |
| Time since most recent progression, median (mo) | ||||||
| Median (min, max) | 2.0 (0.4, 235.8) | 1.8 (0.3, 176.1) | 1.7 (0.3, 447.4) | 10.9 (0.6, 182.4) | 15.8 (0.3, 194.3) | 2.1 (0.3, 447.4) |
| Parameter/statistic . | FL (n = 147) . | MZL (n = 82) . | DLBCL/MCL (n = 74) . | CLL/SLL (n = 43) . | Other (n = 25) . | Total (N = 371) . |
|---|---|---|---|---|---|---|
| Age, median (range), y | 65 (29-87) | 68 (34-88) | 72 (41-95) | 64 (43-86) | 62 (22-85) | 67 (22-95) |
| Sex, n (%) | ||||||
| Female | 56 (38.1) | 43 (52.4) | 36 (48.6) | 16 (37.2) | 11 (44.0) | 162 (43.7) |
| Male | 91 (61.9) | 39 (47.6) | 38 (51.4) | 27 (62.8) | 14 (56.0) | 209 (56.3) |
| Race, n (%) | ||||||
| White | 120 (81.6) | 67 (81.7) | 68 (91.9) | 35 (81.4) | 17 (68.0) | 307 (82.7) |
| Non-White | 13 (8.8) | 10 (12.2) | 4 (5.4) | 7 (16.3) | 6 (24.0) | 40 (10.8) |
| Unknown | 1 (0.7) | 0 | 0 | 0 | 2 (8.0) | 3 (0.8) |
| Not reported | 13 (8.8) | 5 (6.1) | 2 (2.7) | 1 (2.3) | 0 | 21 (5.7) |
| ECOG performance status score, n (%) | ||||||
| 0 | 80 (54.4) | 42 (51.2) | 29 (39.2) | 22 (51.2) | 4 (16.0) | 177 (47.7) |
| 1 | 63 (42.9) | 38 (46.3) | 37 (50.0) | 21 (48.8) | 20 (80.0) | 179 (48.2) |
| 2 | 4 (2.7) | 2 (2.4) | 8 (10.8) | 0 | 1 (4.0) | 15 (4.0) |
| Time since initial diagnosis (mo) | ||||||
| Median (min, max) | 69.6 (4.1, 374.9) | 70.7 (4.9, 340.7) | 43.4 (3.6, 446.5) | 63.8 (6.0, 184.3) | 65.2 (7.3, 193.3) | 63.8 (3.6, 446.5) |
| Stage of disease at screening or most recent, n (%)* | ||||||
| I | 14 (9.5) | 5 (6.1) | 2 (2.7) | 1 (2.3) | 0 | 22 (5.9) |
| II | 18 (12.2) | 7 (8.5) | 4 (5.4) | 1 (2.3) | 0 | 30 (8.1) |
| III | 43 (29.3) | 13 (15.9) | 18 (24.3) | 6 (14.0) | 0 | 80 (21.6) |
| IV | 55 (37.4) | 47 (57.3) | 27 (36.5) | 13 (30.2) | 3 (12.0) | 145 (39.1) |
| Unknown | 1 (0.7) | 5 (6.1) | 2 (2.7) | 1 (2.3) | 7 (28.0) | 16 (4.3) |
| No. of prior systemic therapies | ||||||
| Median (min, max) | 3 (1, 10) | 2 (1, 7) | 3 (1, 10) | 2 (1, 8) | 4 (1, 14) | 2 (1, 14) |
| No. of prior lines of therapy, n (%) | ||||||
| <2 | 21 (14.3) | 38 (46.3) | 14 (18.9) | 11 (25.6) | 3 (12.0) | 87 (23.5) |
| ≥2 | 126 (85.7) | 44 (53.7) | 60 (81.1) | 32 (74.4) | 22 (88.0) | 284 (76.5) |
| Select prior systemic therapy, n (%) | ||||||
| Anti-CD20 antibody | 147 (100.0) | 82 (100.0) | 74 (100.0) | 43 (100.0) | 13 (52.0) | 359 (96.8) |
| Anti-CD20 monotherapy only | 3 (2.0) | 18 (22.0) | 0 | 3 (7.0) | 2 (8.0) | 26 (7.0) |
| Anti-CD20–based chemoimmunotherapy | 144 (98.0) | 61 (74.4) | 74 (100.0) | 40 (93.0) | 6 (24.0) | 325 (87.6) |
| Lenalidomide (monotherapy or in combination) | 20 (13.6) | 5 (6.1) | 11 (14.9) | 2 (4.7) | 6 (24.0) | 44 (11.9) |
| Lenalidomide + anti-CD20 antibody | 16 (10.9) | 4 (4.9) | 8 (10.8) | 1 (2.3) | 0 | 29 (7.8) |
| BTK inhibitor | 12 (8.2) | 5 (6.1) | 22 (29.7) | 6 (14.0) | 9 (36.0) | 54 (14.6) |
| Prior treatment relapsed/refractory status, n (%) | ||||||
| Relapsed | 92 (62.6) | 54 (65.9) | 34 (45.9) | 23 (53.5) | 4 (16.0) | 207 (55.8) |
| Refractory† | 55 (37.4) | 20 (24.4) | 40 (54.1) | 19 (44.2) | 11 (44.0) | 145 (39.1) |
| Prior CD20 treatment relapsed/refractory status, n (%) | ||||||
| Relapsed | 80 (54.4) | 52 (63.4) | 29 (39.2) | 11 (25.6) | 0 | 172 (46.4) |
| Refractory† | 41 (27.9) | 15 (18.3) | 16 (21.6) | 7 (16.3) | 0 | 79 (21.3) |
| Not applicable | 10 (6.8) | 2 (2.4) | 8 (10.8) | 4 (9.3) | 0 | 24 (6.5) |
| Time since most recent progression, median (mo) | ||||||
| Median (min, max) | 2.0 (0.4, 235.8) | 1.8 (0.3, 176.1) | 1.7 (0.3, 447.4) | 10.9 (0.6, 182.4) | 15.8 (0.3, 194.3) | 2.1 (0.3, 447.4) |
ECOG, Eastern Cooperative Oncology Group; FL, follicular lymphoma; max, maximum; MCL, mantle cell lymphoma; min, minimum.
Patients with NHL were staged by using the Ann Arbor staging system; patients with CLL were staged by using the Rai staging system.
Defined as progression during or within 6 months of completing immediate prior therapy.