Most frequently reported TEAEs, all grades (occurring in 10% or more of patients overall) and grade 3 or higher (occurring in 5% or more of patients overall) (safety population)
| n (%) . | Mezagitamab cohort . | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 45 mg (n = 4) . | 135 mg (n = 3) . | 300 mg (n = 12) . | 600 mg (n = 22) . | 1200 mg (n = 3) . | PomDex (n = 6) . | Total (N = 50) . | ||||||||
| Any grade . | Grade ≥3 . | Any grade . | Grade ≥3 . | Any grade . | Grade ≥3 . | Any grade . | Grade ≥3 . | Any grade . | Grade ≥3 . | Any grade . | Grade ≥3 . | Any grade . | Grade ≥3 . | |
| Any TEAEs | 4 (100) | 2 (50) | 3 (100) | 1 (33) | 12 (100) | 3 (25) | 22 (100) | 12 (55) | 3 (100) | 1 (33) | 6 (100) | 6 (100) | 50 (100) | 25 (50) |
| Hematologic | ||||||||||||||
| Anemia | 0 | 0 | 1 (33) | 0 | 3 (25) | 1 (8) | 4 (18) | 2 (9) | 0 | 0 | 0 | 0 | 8 (16) | 3 (6) |
| Neutropenia∗ | 1 (25) | 0 | 0 | 0 | 1 (8) | 0 | 2 (9) | 1 (5) | 1 (33) | 0 | 3 (50) | 2 (33) | 8 (16) | 3 (6) |
| Neutrophil count decreased∗ | 1 (25) | 1 (25) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 3 (50) | 3 (50) | 4 (8) | 4 (8) |
| Nonhematologic | ||||||||||||||
| Fatigue | 1 (25) | 0 | 1 (33) | 0 | 4 (33) | 0 | 5 (23) | 0 | 2 (67) | 0 | 2 (33) | 1 (17) | 15 (30) | 1 (2) |
| URT infection | 0 | 0 | 1 (33) | 0 | 2 (17) | 0 | 7 (32) | 0 | 1 (33) | 0 | 2 (33) | 0 | 13 (26) | 0 |
| Insomnia | 0 | 0 | 1 (33) | 1 (33) | 3 (25) | 0 | 5 (23) | 0 | 0 | 0 | 1 (17) | 0 | 10 (20) | 1 (2) |
| Back pain | 0 | 0 | 0 | 0 | 4 (33) | 0 | 6 (27) | 1 (5) | 0 | 0 | 0 | 0 | 10 (20) | 1 (2) |
| Arthralgia | 3 (75) | 0 | 1 (33) | 0 | 3 (25) | 0 | 2 (9) | 1 (5) | 0 | 0 | 0 | 0 | 9 (18) | 1 (2) |
| Headache | 0 | 0 | 1 (33) | 0 | 4 (33) | 0 | 2 (9) | 0 | 0 | 0 | 1 (17) | 0 | 8 (16) | 0 |
| Diarrhea | 1 (25) | 0 | 1 (33) | 0 | 1 (8) | 0 | 3 (14) | 0 | 1 (33) | 0 | 1 (17) | 0 | 8 (16) | 0 |
| Nausea | 1 (25) | 0 | 0 | 0 | 3 (25) | 0 | 3 (14) | 0 | 0 | 0 | 1 (17) | 0 | 8 (16) | 0 |
| Hypertension | 1 (25) | 0 | 1 (33) | 0 | 0 | 0 | 4 (18) | 3 (14) | 0 | 0 | 0 | 0 | 6 (12) | 3 (6) |
| Pneumonia | 0 | 0 | 0 | 0 | 0 | 0 | 4 (18) | 2 (9) | 0 | 0 | 1 (17) | 0 | 5 (10) | 2 (4) |
| Abdominal pain | 1 (25) | 0 | 0 | 0 | 0 | 0 | 2 (9) | 1 (5) | 1 (33) | 0 | 1 (17) | 0 | 5 (10) | 1 (2) |
| Abdominal distension | 0 | 0 | 1 (33) | 0 | 1 (8) | 0 | 2 (9) | 0 | 1 (33) | 0 | 0 | 0 | 5 (10) | 0 |
| Myalgia | 0 | 0 | 2 (67) | 0 | 1 (8) | 0 | 1 (5) | 0 | 0 | 0 | 1 (17) | 0 | 5 (10) | 0 |
| n (%) . | Mezagitamab cohort . | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 45 mg (n = 4) . | 135 mg (n = 3) . | 300 mg (n = 12) . | 600 mg (n = 22) . | 1200 mg (n = 3) . | PomDex (n = 6) . | Total (N = 50) . | ||||||||
| Any grade . | Grade ≥3 . | Any grade . | Grade ≥3 . | Any grade . | Grade ≥3 . | Any grade . | Grade ≥3 . | Any grade . | Grade ≥3 . | Any grade . | Grade ≥3 . | Any grade . | Grade ≥3 . | |
| Any TEAEs | 4 (100) | 2 (50) | 3 (100) | 1 (33) | 12 (100) | 3 (25) | 22 (100) | 12 (55) | 3 (100) | 1 (33) | 6 (100) | 6 (100) | 50 (100) | 25 (50) |
| Hematologic | ||||||||||||||
| Anemia | 0 | 0 | 1 (33) | 0 | 3 (25) | 1 (8) | 4 (18) | 2 (9) | 0 | 0 | 0 | 0 | 8 (16) | 3 (6) |
| Neutropenia∗ | 1 (25) | 0 | 0 | 0 | 1 (8) | 0 | 2 (9) | 1 (5) | 1 (33) | 0 | 3 (50) | 2 (33) | 8 (16) | 3 (6) |
| Neutrophil count decreased∗ | 1 (25) | 1 (25) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 3 (50) | 3 (50) | 4 (8) | 4 (8) |
| Nonhematologic | ||||||||||||||
| Fatigue | 1 (25) | 0 | 1 (33) | 0 | 4 (33) | 0 | 5 (23) | 0 | 2 (67) | 0 | 2 (33) | 1 (17) | 15 (30) | 1 (2) |
| URT infection | 0 | 0 | 1 (33) | 0 | 2 (17) | 0 | 7 (32) | 0 | 1 (33) | 0 | 2 (33) | 0 | 13 (26) | 0 |
| Insomnia | 0 | 0 | 1 (33) | 1 (33) | 3 (25) | 0 | 5 (23) | 0 | 0 | 0 | 1 (17) | 0 | 10 (20) | 1 (2) |
| Back pain | 0 | 0 | 0 | 0 | 4 (33) | 0 | 6 (27) | 1 (5) | 0 | 0 | 0 | 0 | 10 (20) | 1 (2) |
| Arthralgia | 3 (75) | 0 | 1 (33) | 0 | 3 (25) | 0 | 2 (9) | 1 (5) | 0 | 0 | 0 | 0 | 9 (18) | 1 (2) |
| Headache | 0 | 0 | 1 (33) | 0 | 4 (33) | 0 | 2 (9) | 0 | 0 | 0 | 1 (17) | 0 | 8 (16) | 0 |
| Diarrhea | 1 (25) | 0 | 1 (33) | 0 | 1 (8) | 0 | 3 (14) | 0 | 1 (33) | 0 | 1 (17) | 0 | 8 (16) | 0 |
| Nausea | 1 (25) | 0 | 0 | 0 | 3 (25) | 0 | 3 (14) | 0 | 0 | 0 | 1 (17) | 0 | 8 (16) | 0 |
| Hypertension | 1 (25) | 0 | 1 (33) | 0 | 0 | 0 | 4 (18) | 3 (14) | 0 | 0 | 0 | 0 | 6 (12) | 3 (6) |
| Pneumonia | 0 | 0 | 0 | 0 | 0 | 0 | 4 (18) | 2 (9) | 0 | 0 | 1 (17) | 0 | 5 (10) | 2 (4) |
| Abdominal pain | 1 (25) | 0 | 0 | 0 | 0 | 0 | 2 (9) | 1 (5) | 1 (33) | 0 | 1 (17) | 0 | 5 (10) | 1 (2) |
| Abdominal distension | 0 | 0 | 1 (33) | 0 | 1 (8) | 0 | 2 (9) | 0 | 1 (33) | 0 | 0 | 0 | 5 (10) | 0 |
| Myalgia | 0 | 0 | 2 (67) | 0 | 1 (8) | 0 | 1 (5) | 0 | 0 | 0 | 1 (17) | 0 | 5 (10) | 0 |
PomDex was given in combination with mezagitamab 300 mg (administered per the product label).
URT, upper respiratory tract.
Numbers for these preferred terms were pooled as neutropenia in the manuscript text.