Patient demographics and baseline characteristics for the R/R and 1L populations (efficacy population)
| Characteristic . | R/R, N = 43 . | 1L, N = 32 . |
|---|---|---|
| Median age (range), y | 61 (42-80) | 63 (47-73) |
| Male, n (%) | 30 (70) | 20 (63) |
| ECOG PS, n (%) | ||
| 0 | 22 (51) | 16 (50) |
| 1 | 21 (49) | 16 (50) |
| 2 | 0 | 0 |
| Rai stage at screening, n (%) | ||
| 0 | 0 | 0 |
| I/II | 13 (30) | 9 (28) |
| III/IV | 28 (65) | 18 (56) |
| Unknown | 2 (5) | 5 (16) |
| Creatinine clearance, n/N (%) | ||
| <70 mL/min | 19 (44) | 9/31 (29) |
| ≥70 mL/min | 24 (56) | 22/31 (71) |
| Pretreatment TLS risk, n (%)* | ||
| Low | 10 (23) | 2 (6) |
| Medium | 19 (44) | 22 (69) |
| High | 14 (33) | 8 (25) |
| Cytogenetics, n/N (%)† | ||
| del(17p)/TP53 mut‡ | 23/42 (55) | 5/29 (17) |
| del(11q) | 8/42 (19) | 6/29 (21) |
| Trisomy 12 | 2/42 (5) | 6/29 (21) |
| No abnormalities | 3/42 (7) | 1/29 (3) |
| del(13q) | 6/42 (14) | 11/29 (38) |
| TP53 mutation, n/N (%)§ | 18/40 (45) | 5/26 (19) |
| IGHV unmutated, n/N (%) | 26/34 (77) | 16/28 (57) |
| Serum β-2 microglobulin, n (%) | ||
| ≥3.5 mg/mL | 28 (65) | 19 (59) |
| CD38+, n/N (%)|| | 19/33 (58) | 12/25 (48) |
| Median previous therapies, n (range) | 2 (1-6) | NA |
| Prior therapies received, n (%) | ||
| Fludarabine-based treatment | 34 (79) | NA |
| Bendamustine or BR | 12 (28) | NA |
| BTKi | 9 (21) | NA |
| PI3Ki | 6 (14) | NA |
| Characteristic . | R/R, N = 43 . | 1L, N = 32 . |
|---|---|---|
| Median age (range), y | 61 (42-80) | 63 (47-73) |
| Male, n (%) | 30 (70) | 20 (63) |
| ECOG PS, n (%) | ||
| 0 | 22 (51) | 16 (50) |
| 1 | 21 (49) | 16 (50) |
| 2 | 0 | 0 |
| Rai stage at screening, n (%) | ||
| 0 | 0 | 0 |
| I/II | 13 (30) | 9 (28) |
| III/IV | 28 (65) | 18 (56) |
| Unknown | 2 (5) | 5 (16) |
| Creatinine clearance, n/N (%) | ||
| <70 mL/min | 19 (44) | 9/31 (29) |
| ≥70 mL/min | 24 (56) | 22/31 (71) |
| Pretreatment TLS risk, n (%)* | ||
| Low | 10 (23) | 2 (6) |
| Medium | 19 (44) | 22 (69) |
| High | 14 (33) | 8 (25) |
| Cytogenetics, n/N (%)† | ||
| del(17p)/TP53 mut‡ | 23/42 (55) | 5/29 (17) |
| del(11q) | 8/42 (19) | 6/29 (21) |
| Trisomy 12 | 2/42 (5) | 6/29 (21) |
| No abnormalities | 3/42 (7) | 1/29 (3) |
| del(13q) | 6/42 (14) | 11/29 (38) |
| TP53 mutation, n/N (%)§ | 18/40 (45) | 5/26 (19) |
| IGHV unmutated, n/N (%) | 26/34 (77) | 16/28 (57) |
| Serum β-2 microglobulin, n (%) | ||
| ≥3.5 mg/mL | 28 (65) | 19 (59) |
| CD38+, n/N (%)|| | 19/33 (58) | 12/25 (48) |
| Median previous therapies, n (range) | 2 (1-6) | NA |
| Prior therapies received, n (%) | ||
| Fludarabine-based treatment | 34 (79) | NA |
| Bendamustine or BR | 12 (28) | NA |
| BTKi | 9 (21) | NA |
| PI3Ki | 6 (14) | NA |
BTKi, Bruton tyrosine kinase inhibitor; mut, mutated; NA, not applicable; PI3Ki, phosphoinositide 3-kinase inhibitor.
Low risk if largest node <5 cm diameter and absolute lymphocyte count (ALC) <25 × 109/L, medium risk if ALC ≥25 × 109/L or largest nodes ≥5 cm and <10 cm diameter, or high risk if ALC ≥25 × 109/L and largest node ≥5 cm diameter or largest node ≥10 cm diameter.
Fluorescence in situ hybridization (FISH) cutoffs for positivity: del17p >7%; del11q >6%; del13q >5.5%; trisomy 12 >2.5%.
A modified hierarchical model was used to maximize identification of the higher-risk population due to missing samples for cytogenetic assessment. The del(17p)/TP53 mutated subgroup included patients with a 17p deletion by FISH and/or TP53 mutation by next-generation sequencing (NGS).
By NGS. Cutoff for positivity >5%.
Cutoff for positivity >30%.