Table 2.
TEAEs and grade 3 or higher TEAEs (occurring in ≥5% of all patients by preferred term) and hematologic abnormalities (safety population)
| System organ class | Isatuximab (n = 109) | Isatuximab + dexamethasone (n = 55) | ||
|---|---|---|---|---|
| Preferred term | All grades | Grade 3 or higher | All grades | Grade 3 or higher |
| TEAEs, n (%) | 100 (91.7) | 53 (48.6) | 51 (92.7) | 33 (60.0) |
| Injury, poisoning, and procedural complications | 46 (42.2) | 7 (6.4) | 26 (47.3) | 3 (5.5) |
| IRs* | 44 (40.4) | 5 (4.6) | 22 (40.0) | 2 (3.6) |
| Infections and infestations | 65 (59.6) | 24 (22.0) | 33 (60.0) | 12 (21.8) |
| URTI | 14 (12.8) | 1 (0.9) | 8 (14.5) | 1 (1.8) |
| Pneumonia | 10 (9.2) | 7 (6.4) | 6 (10.9) | 3 (5.5) |
| Bronchitis | 7 (6.4) | 1 (0.9) | 4 (7.3) | 3 (5.5) |
| Nasopharyngitis | 4 (3.7) | 0 | 7 (12.7) | 0 |
| Respiratory tract infection | 5 (4.6) | 3 (2.8) | 4 (7.3) | 1 (1.8) |
| Urinary tract infection | 8 (7.3) | 1 (0.9) | 1 (1.8) | 0 |
| Respiratory, thoracic, and mediastinal disorders | 50 (45.9) | 11 (10.1) | 23 (41.8) | 2 (3.6) |
| Cough | 19 (17.4) | 0 | 9 (16.4) | 0 |
| Dyspnea | 19 (17.4) | 2 (1.8) | 8 (14.5) | 0 |
| Nasal congestion | 9 (8.3) | 0 | 2 (3.6) | 0 |
| Metabolism and nutrition disorders | 20 (18.3) | 3 (2.8) | 7 (12.7) | 0 |
| Decreased appetite | 12 (11.0) | 1 (0.9) | 4 (7.3) | 0 |
| Psychiatric disorders | 13 (11.9) | 0 | 17 (30.9) | 3 (5.5) |
| Insomnia | 2 (1.8) | 0 | 14 (25.5) | 1 (1.8) |
| Nervous system disorders | 37 (33.9) | 7 (6.4) | 21 (38.2) | 5 (9.1) |
| Headache | 14 (12.8) | 0 | 8 (14.5) | 0 |
| Gastrointestinal disorders | 41 (37.6) | 3 (2.8) | 27 (49.1) | 4 (7.3) |
| Diarrhea | 21 (19.3) | 0 | 11 (20.0) | 2 (3.6) |
| Nausea | 16 (14.7) | 1 (0.9) | 8 (14.5) | 0 |
| Vomiting | 14 (12.8) | 1 (0.9) | 3 (5.5) | 0 |
| Constipation | 10 (9.2) | 1 (0.9) | 3 (5.5) | 0 |
| Dyspepsia | 2 (1.8) | 0 | 4 (7.3) | 0 |
| Musculoskeletal and connective tissue disorders | 58 (53.2) | 7 (6.4) | 27 (49.1) | 4 (7.3) |
| Back pain | 22 (20.2) | 2 (1.8) | 9 (16.4) | 0 |
| Pain in extremity | 9 (8.3) | 1 (0.9) | 9 (16.4) | 2 (3.6) |
| Arthralgia | 9 (8.3) | 0 | 4 (7.3) | 0 |
| Musculoskeletal chest pain | 9 (8.3) | 0 | 4 (7.3) | 0 |
| Bone pain | 10 (9.2) | 0 | 1 (1.8) | 0 |
| Myalgia | 8 (7.3) | 0 | 3 (5.5) | 1 (1.8) |
| Musculoskeletal pain | 7 (6.4) | 2 (1.8) | 3 (5.5) | 0 |
| General disorders and administration site conditions | 45 (41.3) | 11 (10.1) | 26 (47.3) | 4 (7.3) |
| Fatigue | 19 (17.4) | 3 (2.8) | 10 (18.2) | 0 |
| Asthenia | 8 (7.3) | 1 (0.9) | 6 (10.9) | 1 (1.8) |
| Chills | 9 (8.3) | 0 | 5 (9.1) | 0 |
| Pyrexia | 5 (4.6) | 0 | 7 (12.7) | 1 (1.8) |
| Peripheral edema | 5 (4.6) | 0 | 5 (9.1) | 0 |
| Disease progression | 7 (6.4) | 7 (6.4) | 2 (3.6) | 2 (3.6) |
| Pain | 6 (5.5) | 1 (0.9) | 3 (5.5) | 0 |
| Hematologic abnormalities, n/N (%)† | ||||
| Anemia | 104/109 (95.4) | 25/109 (22.9) | 52/54 (96.3) | 8/54 (14.8) |
| Platelet count decreased | 73/109 (67.0) | 20/109 (18.3) | 32/54 (59.3) | 8/54 (14.8) |
| Neutrophil count decreased | 72/109 (66.1) | 20/109 (18.3) | 20/54 (37.0) | 7/54 (13.0) |
| Lymphocyte count decreased | 91/109 (83.5) | 30/109 (27.5) | 47/54 (87.0) | 26/54 (48.1) |
URTI, upper respiratory tract infection.
*
IRs of grade 3 or higher were prespecified as an AE of special interest.
†
Based on laboratory values measured during the on-treatment period.