Patient demographics and baseline clinical characteristics
| Characteristic . | Patients who received idelalisib as the last prior BCRi . | ||
|---|---|---|---|
| Main cohort (n = 21) . | Expansion cohort (n = 15) . | All patients (N = 36) . | |
| Age, median (range), years | 68 (56-85) | 66 (57-81) | 68 (56-85) |
| Male | 15 (71) | 10 (67) | 25 (69) |
| White | 19 (91) | 14 (93) | 33 (92) |
| ECOG grade* | |||
| 0 | 5 (24) | 7 (47) | 12 (33) |
| 1 | 14 (67) | 7 (47) | 21 (58) |
| 2 | 2 (10) | 1 (7) | 3 (8) |
| Number of prior therapies, median (range) | 3 (1-11) | 2 (1-11) | 3 (1-11) |
| Rituximab/other monoclonal antibodies, n (%) | 18 (86)/16 (76) | 11 (73)/10 (67) | 29 (81)/26 (72) |
| Alkylating agents, n (%) | 12 (57) | 8 (53) | 20 (56) |
| Fludarabine, n (%) | 11 (52) | 7 (47) | 18 (50) |
| Prior idelalisib use,† n (%) | 21 (100) | 15 (100) | 36 (100) |
| Time on prior idelalisib, median (range), months | 9 (1-27) | 11 (2-45) | 9 (1-45) |
| Prior ibrutinib use, n (%) | 5 (24) | 5 (33) | 10 (28) |
| Time on prior ibrutinib, median (range), months | 6 (2-11) | 25 (3-53) | 10 (2-53) |
| Laboratory values,‡ median (range) | |||
| Creatinine clearance, mL/min | 75 (44-140) | 64 (46-91) | 72 (44-140) |
| 90 mL/min or more, n (%) | 7 (35) | 2 (13) | 9 (26) |
| Lymphocyte count, ×109/L | 14.2 (0.3-407) | 10.1 (0.9-197.4) | 12.2 (0.3-407) |
| 25 × 109/L or more, n (%) | 7 (33) | 4 (27) | 11 (31) |
| 100 × 109/L or more, n (%) | 4 (19) | 4 (27) | 8 (22) |
| Hemoglobin, g/dL | 11.9 (8.2-14.8) | 11.3 (9-15.2) | 11.7 (8.2-15.2) |
| Platelet count, ×109/L | 110 (18-452) | 102 (12-233) | 109 (18-452) |
| Neutrophil count, ×109/L | 4 (1.2-8.4) | 2.8 (1.1-7) | 3.9 (1.1-8.4) |
| Bulky nodal disease, n (%) | |||
| 5 cm or more | 11 (52) | 6 (40) | 17 (47) |
| 10 cm or more | 5 (24) | 0 | 5 (14) |
| Tumor lysis syndrome risk category§ | |||
| High | 7 (33) | 2 (13) | 9 (25) |
| Medium | 9 (43) | 8 (53) | 17 (47) |
| Low | 5 (24) | 5 (33) | 10 (28) |
| Prognostic factors¶ | |||
| Unmutated IGHV | 11/13 (85) | 11/12 (92) | 22/25 (88) |
| del(17p) | 2/21 (10) | 6/15 (40) | 8/36 (22) |
| del(11q) | 6/21 (29) | 7/15 (47) | 13/36 (36) |
| del(13q) | 10/21 (48) | 9/15 (60) | 19/36 (53) |
| 12q trisomy | 3/21 (14) | 5/15 (33) | 8/36 (22) |
| TP53 mutation | 1/20 (5) | 4/15 (27) | 5/35 (14) |
| CD-38 positive | 12/19 (63) | 5/14 (36) | 17/33 (51) |
| ZAP-70 positive | 4/16 (25) | 2/12 (17) | 6/28 (21) |
| del(17p) and/or TP53 mutation | 5/21 (24) | 6/15 (40) | 11/36 (31) |
| Characteristic . | Patients who received idelalisib as the last prior BCRi . | ||
|---|---|---|---|
| Main cohort (n = 21) . | Expansion cohort (n = 15) . | All patients (N = 36) . | |
| Age, median (range), years | 68 (56-85) | 66 (57-81) | 68 (56-85) |
| Male | 15 (71) | 10 (67) | 25 (69) |
| White | 19 (91) | 14 (93) | 33 (92) |
| ECOG grade* | |||
| 0 | 5 (24) | 7 (47) | 12 (33) |
| 1 | 14 (67) | 7 (47) | 21 (58) |
| 2 | 2 (10) | 1 (7) | 3 (8) |
| Number of prior therapies, median (range) | 3 (1-11) | 2 (1-11) | 3 (1-11) |
| Rituximab/other monoclonal antibodies, n (%) | 18 (86)/16 (76) | 11 (73)/10 (67) | 29 (81)/26 (72) |
| Alkylating agents, n (%) | 12 (57) | 8 (53) | 20 (56) |
| Fludarabine, n (%) | 11 (52) | 7 (47) | 18 (50) |
| Prior idelalisib use,† n (%) | 21 (100) | 15 (100) | 36 (100) |
| Time on prior idelalisib, median (range), months | 9 (1-27) | 11 (2-45) | 9 (1-45) |
| Prior ibrutinib use, n (%) | 5 (24) | 5 (33) | 10 (28) |
| Time on prior ibrutinib, median (range), months | 6 (2-11) | 25 (3-53) | 10 (2-53) |
| Laboratory values,‡ median (range) | |||
| Creatinine clearance, mL/min | 75 (44-140) | 64 (46-91) | 72 (44-140) |
| 90 mL/min or more, n (%) | 7 (35) | 2 (13) | 9 (26) |
| Lymphocyte count, ×109/L | 14.2 (0.3-407) | 10.1 (0.9-197.4) | 12.2 (0.3-407) |
| 25 × 109/L or more, n (%) | 7 (33) | 4 (27) | 11 (31) |
| 100 × 109/L or more, n (%) | 4 (19) | 4 (27) | 8 (22) |
| Hemoglobin, g/dL | 11.9 (8.2-14.8) | 11.3 (9-15.2) | 11.7 (8.2-15.2) |
| Platelet count, ×109/L | 110 (18-452) | 102 (12-233) | 109 (18-452) |
| Neutrophil count, ×109/L | 4 (1.2-8.4) | 2.8 (1.1-7) | 3.9 (1.1-8.4) |
| Bulky nodal disease, n (%) | |||
| 5 cm or more | 11 (52) | 6 (40) | 17 (47) |
| 10 cm or more | 5 (24) | 0 | 5 (14) |
| Tumor lysis syndrome risk category§ | |||
| High | 7 (33) | 2 (13) | 9 (25) |
| Medium | 9 (43) | 8 (53) | 17 (47) |
| Low | 5 (24) | 5 (33) | 10 (28) |
| Prognostic factors¶ | |||
| Unmutated IGHV | 11/13 (85) | 11/12 (92) | 22/25 (88) |
| del(17p) | 2/21 (10) | 6/15 (40) | 8/36 (22) |
| del(11q) | 6/21 (29) | 7/15 (47) | 13/36 (36) |
| del(13q) | 10/21 (48) | 9/15 (60) | 19/36 (53) |
| 12q trisomy | 3/21 (14) | 5/15 (33) | 8/36 (22) |
| TP53 mutation | 1/20 (5) | 4/15 (27) | 5/35 (14) |
| CD-38 positive | 12/19 (63) | 5/14 (36) | 17/33 (51) |
| ZAP-70 positive | 4/16 (25) | 2/12 (17) | 6/28 (21) |
| del(17p) and/or TP53 mutation | 5/21 (24) | 6/15 (40) | 11/36 (31) |
ECOG, Eastern Cooperative Oncology Group.
ECOG performance status ranges from 0 to 5, where higher numbers indicate greater disability.
Ten patients had received prior ibrutinib followed by idelalisib during their previous course of treatment.
Baseline values were assessed after screening but before the first dose of venetoclax was given.
Low was defined as all lymph nodes ≤5 cm with an absolute lymphocyte count <25 × 109/L. Medium was any lymph node ≥5 cm to <10 cm or an absolute lymphocyte count ≥25 ×109/L. High was any lymph node ≥10 cm or lymph node ≥5 cm and absolute lymphocyte count ≥25 ×109/L.
Site-reported data. Data are presented for all patients with available data.