Patient characteristics and disposition (primary study, unless otherwise indicated)
| . | Idela + R (n = 32) . | Idela + B (n = 33) . | Idela + BR (n = 14) . | All patients (n = 79) . |
|---|---|---|---|---|
| Age, median (range), y | 65 (40-84) | 59 (37-80) | 56 (48-76) | 61 (37-84) |
| Sex, male, n (%) | 22 (69) | 22 (67) | 8 (57) | 52 (66) |
| Disease subtype, n (%) | ||||
| FL | 23 (72) | 25 (76) | 11 (79) | 59 (75) |
| SLL | 7 (22) | 6 (18) | 2 (14) | 15 (19) |
| MZL | 2 (6) | 2 (6) | 1 (7) | 5 (6) |
| Prognostic factors, n (%) | ||||
| Performance status ≥1 | 12 (37) | 17 (52) | 4 (29) | 33 (41) |
| Stage IV | 20 (63) | 17 (52) | 8 (57) | 46 (57) |
| Bulky adenopathy (>5 cm) | 16 (50) | 18 (54) | 5 (36) | 39 (48) |
| Bone marrow involvement | 14 (44) | 14 (42) | 4 (29) | 32 (41) |
| β2 microglobulin (>ULN) | 18 (56) | 22 (67) | 7 (50) | 47 (59) |
| LDH (>ULN) | 9 (28) | 9 (27) | 4 (29) | 22 (28) |
| FLIPI score (FL patients) | ||||
| 0/1 | 2 (9) | 5 (20) | 4 (36) | 11 (19) |
| 2 | 10 (43) | 11 (44) | 2 (18) | 23 (39) |
| ≥3 | 8 (35) | 7 (28) | 5 (46) | 20 (34) |
| Missing | 3 (13) | 2 (8) | 0 | 5 (8) |
| Prior therapies, median, n (range) | 3 (1-9) | 3 (1-10) | 3 (1-8) | 3 (1-11) |
| Rituximab-containing regimen, % | 93 | 100 | 100 | 97 |
| Rituximab monotherapy as only prior treatment, % | 0 | 6 | 14 | 5 |
| Rituximab monotherapy as last prior treatment, % | 16 | 39 | 29 | 28 |
| Alkylating agent, % | 90 | 82 | 86 | 86 |
| Anthracycline, % | 50 | 49 | 57 | 51 |
| Bendamustine, % | 40 | 21 | 29 | 32 |
| Purine analog, % | 20 | 33 | 14 | 25 |
| Platinum agent, % | 16 | 18 | 7 | 15 |
| ASCT, % | 9 | 6 | 7 | 8 |
| Disease status, n (%) | ||||
| Relapsed | 19 (59) | 19 (58) | 5 (36) | 43 (56) |
| Refractory* | 13 (41) | 14 (42) | 9 (64) | 36 (46) |
| Idela dose received, n (%) | ||||
| 100 mg twice daily | 8 (25) | 8 (24) | 0 | 16 (20) |
| 150 mg twice daily | 24 (75) | 25 (76) | 14 (100) | 64 (81) |
| Duration of Idela therapy, median (range), mo | ||||
| Primary + extension study | 10.0 (0.5-33) | 9.9 (0.6-32.3) | 11.4 (0.9-25.3) | 10.1 (0.5-33) |
| Treatment disposition, n (%) | ||||
| Received study drug | 32 (100) | 33 (100) | 14 (100) | 79 (100) |
| Completed cycle 2 | 32 (100) | 32 (97) | 11 (79) | 75 (95) |
| Discontinued from primary study | 16 (50) | 18 (54) | 8 (57) | 42 (53) |
| Enrolled in extension study | 14 (44) | 15 (45) | 6 (43) | 35 (44) |
| Discontinued from extension study | 8 (57) | 7 (47) | 3 (50) | 18 (51) |
| Reasons for early discontinuation, primary study, n (%) | ||||
| AE | 6 (19) | 6 (18) | 4 (29) | 16 (20) |
| Disease progression | 4 (12) | 4 (12) | 1 (7) | 9 (11) |
| Patient/investigator request | 1 (3) | 4 (12) | 1 (7) | 6 (8) |
| Withdrew consent | 1 (3) | 1 (3) | 2 (14) | 4 (5) |
| Worsening disease/symptoms | 2 (6) | 1 (3) | 0 | 3 (4) |
| Death | 1 (3) | 1 (3) | 0 | 2 (3) |
| SCT | 1 (3) | 0 | 0 | 1 (1) |
| Reasons for discontinuation, extension study, n (%) | ||||
| Disease progression | 5 (36) | 2 (13) | 1 (17) | 8 (23) |
| AE | 2 (14) | 1 (7) | 2 (33) | 5 (14) |
| Death | 0 | 2 (13) | 0 | 2 (6) |
| Investigator request | 0 | 1 (7) | 0 | 1 (3) |
| SCT | 0 | 1 (7) | 0 | 1 (3) |
| Withdrew consent | 1 (7) | 0 | 0 | 1 (3) |
| . | Idela + R (n = 32) . | Idela + B (n = 33) . | Idela + BR (n = 14) . | All patients (n = 79) . |
|---|---|---|---|---|
| Age, median (range), y | 65 (40-84) | 59 (37-80) | 56 (48-76) | 61 (37-84) |
| Sex, male, n (%) | 22 (69) | 22 (67) | 8 (57) | 52 (66) |
| Disease subtype, n (%) | ||||
| FL | 23 (72) | 25 (76) | 11 (79) | 59 (75) |
| SLL | 7 (22) | 6 (18) | 2 (14) | 15 (19) |
| MZL | 2 (6) | 2 (6) | 1 (7) | 5 (6) |
| Prognostic factors, n (%) | ||||
| Performance status ≥1 | 12 (37) | 17 (52) | 4 (29) | 33 (41) |
| Stage IV | 20 (63) | 17 (52) | 8 (57) | 46 (57) |
| Bulky adenopathy (>5 cm) | 16 (50) | 18 (54) | 5 (36) | 39 (48) |
| Bone marrow involvement | 14 (44) | 14 (42) | 4 (29) | 32 (41) |
| β2 microglobulin (>ULN) | 18 (56) | 22 (67) | 7 (50) | 47 (59) |
| LDH (>ULN) | 9 (28) | 9 (27) | 4 (29) | 22 (28) |
| FLIPI score (FL patients) | ||||
| 0/1 | 2 (9) | 5 (20) | 4 (36) | 11 (19) |
| 2 | 10 (43) | 11 (44) | 2 (18) | 23 (39) |
| ≥3 | 8 (35) | 7 (28) | 5 (46) | 20 (34) |
| Missing | 3 (13) | 2 (8) | 0 | 5 (8) |
| Prior therapies, median, n (range) | 3 (1-9) | 3 (1-10) | 3 (1-8) | 3 (1-11) |
| Rituximab-containing regimen, % | 93 | 100 | 100 | 97 |
| Rituximab monotherapy as only prior treatment, % | 0 | 6 | 14 | 5 |
| Rituximab monotherapy as last prior treatment, % | 16 | 39 | 29 | 28 |
| Alkylating agent, % | 90 | 82 | 86 | 86 |
| Anthracycline, % | 50 | 49 | 57 | 51 |
| Bendamustine, % | 40 | 21 | 29 | 32 |
| Purine analog, % | 20 | 33 | 14 | 25 |
| Platinum agent, % | 16 | 18 | 7 | 15 |
| ASCT, % | 9 | 6 | 7 | 8 |
| Disease status, n (%) | ||||
| Relapsed | 19 (59) | 19 (58) | 5 (36) | 43 (56) |
| Refractory* | 13 (41) | 14 (42) | 9 (64) | 36 (46) |
| Idela dose received, n (%) | ||||
| 100 mg twice daily | 8 (25) | 8 (24) | 0 | 16 (20) |
| 150 mg twice daily | 24 (75) | 25 (76) | 14 (100) | 64 (81) |
| Duration of Idela therapy, median (range), mo | ||||
| Primary + extension study | 10.0 (0.5-33) | 9.9 (0.6-32.3) | 11.4 (0.9-25.3) | 10.1 (0.5-33) |
| Treatment disposition, n (%) | ||||
| Received study drug | 32 (100) | 33 (100) | 14 (100) | 79 (100) |
| Completed cycle 2 | 32 (100) | 32 (97) | 11 (79) | 75 (95) |
| Discontinued from primary study | 16 (50) | 18 (54) | 8 (57) | 42 (53) |
| Enrolled in extension study | 14 (44) | 15 (45) | 6 (43) | 35 (44) |
| Discontinued from extension study | 8 (57) | 7 (47) | 3 (50) | 18 (51) |
| Reasons for early discontinuation, primary study, n (%) | ||||
| AE | 6 (19) | 6 (18) | 4 (29) | 16 (20) |
| Disease progression | 4 (12) | 4 (12) | 1 (7) | 9 (11) |
| Patient/investigator request | 1 (3) | 4 (12) | 1 (7) | 6 (8) |
| Withdrew consent | 1 (3) | 1 (3) | 2 (14) | 4 (5) |
| Worsening disease/symptoms | 2 (6) | 1 (3) | 0 | 3 (4) |
| Death | 1 (3) | 1 (3) | 0 | 2 (3) |
| SCT | 1 (3) | 0 | 0 | 1 (1) |
| Reasons for discontinuation, extension study, n (%) | ||||
| Disease progression | 5 (36) | 2 (13) | 1 (17) | 8 (23) |
| AE | 2 (14) | 1 (7) | 2 (33) | 5 (14) |
| Death | 0 | 2 (13) | 0 | 2 (6) |
| Investigator request | 0 | 1 (7) | 0 | 1 (3) |
| SCT | 0 | 1 (7) | 0 | 1 (3) |
| Withdrew consent | 1 (7) | 0 | 0 | 1 (3) |
ASCT, allogeneic stem cell transplantation; FLIPI, Follicular Lymphoma International Prognostic Index; LDH, lactate dehydrogenase.
Refractory is defined as a lack of response or progression within 6 mo of completion of last therapy.