Table 1 Patient demographics, disease characteristics, and treatment history (all treated population, N = 97).
Isatuximab dose and schedule | |||||
|---|---|---|---|---|---|
3 mg/kg Q2W n = 23 | 10 mg/kg Q2W/Q4W n = 25 | 10 mg/kg Q2W n = 24 | 20 mg/kg QW/Q2W n = 25 | Total N = 97 | |
Age in years, median (range) | 63 (44–80) | 59 (49–81) | 66 (38–83) | 59 (48–85) | 62 (38–85) |
Male, n (%) | 12 (52.2) | 18 (72.0) | 13 (54.2) | 12 (48.0) | 55 (56.7) |
Race, n (%) | |||||
White | 21 (91.3) | 19 (76.0) | 19 (79.2) | 21 (84.0) | 80 (82.5) |
Black or African American | 1 (4.3) | 4 (16.0) | 2 (8.3) | 3 (12.0) | 10 (10.3) |
Asian | 0 | 0 | 0 | 1 (4.0) | 1 (1.0) |
Other | 1 (4.3) | 2 (8.3) | 3 (12.5) | 0 | 6 (6.2) |
Ethnicity, n (%)a | |||||
Hispanic or Latino | 0 | 1 (4.0) | 2 (8.3) | 2 (8.0) | 5 (5.2) |
Not Hispanic or Latino | 22 (95.7) | 23 (9.0) | 22 (91.7) | 23 (92.0) | 90 (92.8) |
ECOG score (Karnofsky PS), n (%) | |||||
0 (100%) | 7 (30.4) | 1 (4.0) | 0 | 8 (32.0) | 16 (16.5) |
1 (80–90%) | 11 (47.8) | 22 (88.0) | 22 (91.7) | 14 (56.0) | 69 (71.1) |
2 (60–70%) | 5 (21.7) | 2 (8.0) | 2 (8.3) | 3 (12.0) | 12 (12.4) |
Creatinine clearance <60 ml/min, n (%) | 9 (39.1) | 8 (32.0) | 10 (41.7) | 6 (24.0) | 33 (34.0) |
Years since initial diagnosis, median (range) | 5.8 (2.2–11.0) | 5.5 (1.2–12.7) | 7.1 (3.4–24.1) | 6.1 (1.8–14.3) | 5.8 (1.2–24.1) |
Measurable paraprotein, n (%)b | |||||
Serum M-protein | 17 (73.9) | 20 (80.0) | 17 (70.8) | 17 (68.0) | 71 (73.2) |
Urine M-protein | 1 (4.3) | 4 (16.0) | 5 (20.8) | 5 (20.0) | 15 (15.5) |
κ light chain | 3 (13.0) | 0 | 1 (4.2) | 3 (12.0) | 7 (7.2) |
λ light chain | 1 (4.3) | 1 (4.0) | 1 (4.2) | 0 | 3 (3.1) |
ISS stage at baseline, n (%)b | |||||
I | 5 (21.7) | 8 (32.0) | 6 (25.0) | 11 (44.0) | 30 (30.9) |
II | 8 (34.8) | 5 (20.0) | 10 (41.7) | 7 (28.0) | 30 (30.9) |
III | 9 (39.1) | 12 (48.0) | 8 (33.3) | 7 (28.0) | 36 (37.1) |
Bone marrow plasma cells, median % (range) | 45.0 (1.4–95.0) | 24.6 (1.0–97.0) | 17.0 (0.0–81.8) | 25.5 (1.4–90.0) | 24.6 (0.0–97.0) |
Extramedullary plasmacytoma at baseline, n (%) | 4 (17.4) | 7 (28.0) | 4 (16.7) | 2 (8.0) | 17 (17.5) |
High-risk cytogeneticsc, n (%) | 6 (26.1) | 5 (20.0) | 7 (29.2) | 10 (40.0) | 28 (28.9) |
del(17p) | 2 (8.7) | 3 (12.0) | 5 (20.8) | 7 (28.0) | 17 (17.5) |
t(4:14) | 5 (21.7) | 2 (8.0) | 3 (12.5) | 5 (20.0) | 15 (15.5) |
Median prior lines of therapy, n (range) | 5 (2–12) | 5 (3–14) | 6 (2–13) | 5 (2–10) | 5 (2–14) |
≥1 prior stem cell transplant, n (%) | 20 (87.0) | 23 (92.0) | 21 (87.5) | 22 (88.0) | 86 (88.7) |
Refractory to an immunomodulatory drug, n (%)d | 21 (91.3) | 23 (92.0) | 22 (91.7) | 23 (92.0) | 89 (91.8) |
Refractory to lenalidomide, n (%) | 19 (82.6) | 20 (80.0) | 20 (83.3) | 22 (88.0) | 81 (83.5) |
Refractory to pomalidomide, n (%) | 17 (73.9) | 16 (64.0) | 16 (66.7) | 13 (52.0) | 62 (63.9) |
Refractory to a proteasome inhibitor, n (%)d | 19 (82.6) | 23 (92.0) | 22 (91.7) | 23 (92.0) | 87 (89.7) |
Refractory to bortezomib, n (%) | 17 (73.9) | 22 (88.0) | 16 (66.7) | 17 (68.0) | 72 (74.2) |
Refractory to carfilzomib, n (%) | 12 (52.2) | 17 (68.0) | 14 (58.3) | 16 (64.0) | 59 (60.8) |
Refractory to alkylating agent, n (%) | 15 (65.2) | 15 (60.0) | 17 (70.8) | 14 (56.0) | 61 (62.9) |
Double refractory, n (%)e | 18 (78.3) | 22 (88.0) | 20 (83.3) | 22 (88.0) | 82 (84.5) |
Refractory to pomalidomide and carfilzomib | 11 (47.8) | 14 (56.0) | 12 (50.0) | 9 (36.0) | 46 (47.4) |
Quadruple refractory, n (%)f | 9 (39.1) | 11 (44.0) | 7 (29.2) | 5 (20.0) | 32 (33.0) |
