Table 2 Most common TEAEs (≥20% patients), grade ≥3 TEAEs (≥5% patients), and hematologic abnormalities (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) | ||||||
All grades | Grade 3/4 | All grades | Grade 3/4 | All grades | Grade 3/4 | All grades | Grade 3/4 | All grades | Grade 3/4 | |
TEAEs, n (%) | 22 (95.7) | 17 (73.9) | 25 (100) | 15 (60.0) | 24 (100) | 19 (79.2) | 25 (100) | 15 (60.0) | 96 (99.0) | 66 (68.0) |
Nausea | 6 (26.1) | 0 | 11 (44.0) | 0 | 9 (37.5) | 0 | 7 (28.0) | 0 | 33 (34.0) | 0 |
Fatigue | 5 (21.7) | 0 | 11 (44.0) | 0 | 6 (25.0) | 0 | 9 (36.0) | 0 | 31 (32.0) | 0 |
URTI | 6 (26.1) | 2 (8.7) | 9 (36.0) | 0 | 7 (29.2) | 0 | 6 (24.0) | 1 (4.0) | 28 (28.9) | 3 (3.1) |
Diarrhea | 5 (21.7) | 0 | 9 (36.0) | 1 (4.0) | 7 (29.2) | 0 | 5 (20.0) | 1 (4.0) | 26 (26.8) | 2 (2.1) |
Cough | 2 (8.7%) | 0 | 7 (28.0) | 0 | 9 (37.5) | 0 | 8 (32.0) | 0 | 26 (26.8) | 0 |
Headache | 4 (17.4) | 0 | 8 (32.0) | 0 | 4 (16.7) | 0 | 7 (28.0) | 0 | 23 (23.7) | 0 |
Dyspnea | 5 (21.7) | 0 | 8 (32.0) | 1 (4.0) | 5 (20.8) | 1 (4.2) | 4 (16.0) | 0 | 22 (22.7) | 2 (2.1) |
Pneumonia | 2 (8.7) | 1 (4.3) | 2 (8.0) | 2 (8.0) | 4 (16.7) | 4 (16.7) | 0 | 0 | 8 (8.2) | 7 (7.2) |
Progressive disease | 4 (17.4) | 4 (17.4) | 1 (4.0) | 1 (4.0) | 0 | 0 | 1 (4.0) | 1 (4.0) | 6 (6.2) | 6 (6.2) |
Sepsis | 4 (17.4) | 4 (17.4) | 0 | 0 | 1 (4.2) | 1 (4.2) | 0 | 0 | 5 (5.2) | 5 (5.2) |
Hematologic abnormalities, n/n (%)a | ||||||||||
Anemia | 22/22 (100) | 7/22 (31.8) | 23/24 (95.8) | 9/24 (37.5) | 21/22 (95.5) | 4/22 (18.2) | 25/25 (100) | 3/25 (12.0) | 91/93 (97.8) | 23/93 (24.7) |
White blood cell decreased | 14/22 (63.6) | 2/22 (9.1) | 18/24 (75.0) | 0 | 15/22 (68.2) | 5/22 (22.7) | 24/25 (96.0) | 4/25 (16.0) | 71/93 (76.3) | 11/93 (11.8) |
Lymphocyte count decreased | 12/22 (54.5) | 5/22 (22.7) | 17/24 (70.8) | 7/24 (29.2) | 19/22 (86.4) | 7/22 (31.8) | 21/25 (84.0) | 8/25 (32.0) | 69/93 (74.2) | 27/93 (29.0) |
Platelet count decreased | 14/22 (63.6) | 5/22 (22.7) | 14/24 (58.3) | 2/24 (8.3) | 11/22 (50.0) | 2/22 (9.1) | 20/25 (80.0) | 6/25 (24.0) | 59/93 (63.4) | 15/93 (16.1) |
Neutrophil count decreased | 8/22 (36.4) | 5/22 (22.7) | 7/24 (29.2) | 1/24 (4.2) | 8/22 (36.4) | 6/22 (27.3) | 15/25 (60.0) | 6/25 (24.0) | 38/93 (40.9) | 18/93 (19.4) |
Adverse events of special interest | ||||||||||
Infusion reaction | 8 (34.8) | 0 | 14 (56.0) | 0 | 14 (58.3) | 2 (8.3) | 14 (56.0) | 0 | 50 (51.5) | 2 (2.1) |
