Patient demographics and baseline characteristics among patients with higher-risk CLL
| Characteristic . | TN CLL (n = 320) . | R/R CLL (n = 488)∗ . | Total (N = 808) . |
|---|---|---|---|
| Age, median (range), y | 68 (34-88) | 66 (32-89) | 67 (32-89) |
| Male, n (%) | 206 (64) | 346 (71) | 552 (68) |
| Number of prior therapies, median (range) | 0 (0-1)† | 2 (1-10) | 1 (0-10) |
| ECOG PS, n (%) | |||
| 0-1 | 301 (94) | 451 (92) | 752 (93) |
| ≥2 | 19 (6) | 37 (8) | 56 (7) |
| Genetic status‡ , n (%) | |||
| del(17p) and/or TP53m | 64 (20) | 219 (45) | 283 (35) |
| del(17p)/TP53m alone§ | 11 (3) | 35 (7) | 46 (6) |
| del(17p)/TP53m and uIGHV | 23 (7) | 93 (19) | 116 (14) |
| del(17p)/TP53m and CK | 9 (3) | 14 (3) | 23 (3) |
| del(17p)/TP53m with uIGHV and CK | 21 (7) | 77 (16) | 98 (12) |
| del(17p)/TP53m with either uIGHV or CK | 53 (17) | 184 (38) | 237 (29) |
| uIGHV | 287 (90) | 425 (87) | 712 (88) |
| uIGHV alone‖ | 207 (65) | 200 (41) | 407 (50) |
| uIGHV and CK | 36 (11) | 55 (11) | 91 (11) |
| uIGHV and del(17p)/TP53m | 23 (7) | 93 (19) | 116 (14) |
| uIGHV with CK and del(17p)/TP53m | 21 (7) | 77 (16) | 98 (12) |
| uIGHV with either CK or del(17p)/TP53m | 80 (25) | 225 (46) | 305 (38) |
| CK (≥3 chromosomal abnormalities)¶ | 79 (25) | 160 (33) | 239 (30) |
| CK alone§ | 13 (4) | 14 (3) | 27 (3) |
| CK and uIGHV | 36 (11) | 55 (11) | 91 (11) |
| CK and del(17p)/TP53m | 9 (3) | 14 (3) | 23 (3) |
| CK with uIGHV and del(17p)/TP53m | 21 (7) | 77 (16) | 98 (12) |
| CK with either uIGHV or del(17p)/TP53m | 66 (21) | 146 (30) | 212 (26) |
| CK without del(17p) and/or TP53m | 49 (15) | 69 (14) | 118 (15) |
| Characteristic . | TN CLL (n = 320) . | R/R CLL (n = 488)∗ . | Total (N = 808) . |
|---|---|---|---|
| Age, median (range), y | 68 (34-88) | 66 (32-89) | 67 (32-89) |
| Male, n (%) | 206 (64) | 346 (71) | 552 (68) |
| Number of prior therapies, median (range) | 0 (0-1)† | 2 (1-10) | 1 (0-10) |
| ECOG PS, n (%) | |||
| 0-1 | 301 (94) | 451 (92) | 752 (93) |
| ≥2 | 19 (6) | 37 (8) | 56 (7) |
| Genetic status‡ , n (%) | |||
| del(17p) and/or TP53m | 64 (20) | 219 (45) | 283 (35) |
| del(17p)/TP53m alone§ | 11 (3) | 35 (7) | 46 (6) |
| del(17p)/TP53m and uIGHV | 23 (7) | 93 (19) | 116 (14) |
| del(17p)/TP53m and CK | 9 (3) | 14 (3) | 23 (3) |
| del(17p)/TP53m with uIGHV and CK | 21 (7) | 77 (16) | 98 (12) |
| del(17p)/TP53m with either uIGHV or CK | 53 (17) | 184 (38) | 237 (29) |
| uIGHV | 287 (90) | 425 (87) | 712 (88) |
| uIGHV alone‖ | 207 (65) | 200 (41) | 407 (50) |
| uIGHV and CK | 36 (11) | 55 (11) | 91 (11) |
| uIGHV and del(17p)/TP53m | 23 (7) | 93 (19) | 116 (14) |
| uIGHV with CK and del(17p)/TP53m | 21 (7) | 77 (16) | 98 (12) |
| uIGHV with either CK or del(17p)/TP53m | 80 (25) | 225 (46) | 305 (38) |
| CK (≥3 chromosomal abnormalities)¶ | 79 (25) | 160 (33) | 239 (30) |
| CK alone§ | 13 (4) | 14 (3) | 27 (3) |
| CK and uIGHV | 36 (11) | 55 (11) | 91 (11) |
| CK and del(17p)/TP53m | 9 (3) | 14 (3) | 23 (3) |
| CK with uIGHV and del(17p)/TP53m | 21 (7) | 77 (16) | 98 (12) |
| CK with either uIGHV or del(17p)/TP53m | 66 (21) | 146 (30) | 212 (26) |
| CK without del(17p) and/or TP53m | 49 (15) | 69 (14) | 118 (15) |
ECOG PS, Eastern Cooperative Oncology Group performance status.
R/R data set includes acalabrutinib plus obinutuzumab data from the CL-003 study in addition to the acalabrutinib monotherapy data from the CL-001, ELEVATE-R/R, and ASCEND studies.
One patient in the CL-001 study received an interrupted prior course of treatment.
Genomic categories are not mutually exclusive.
Includes patients with mIGHV, which is not considered an unfavorable genetic feature, and excludes the other high-risk genetic features.
Includes patients with uIGHV without del(17p)/TP53m or CK.
CK was defined as having ≥3 chromosomal abnormalities with ≥1 structural abnormality excluding inversion of chromosome 9.