Overview of TEAEs (safety population)
| Patients, 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 TEAE | 4 (100) | 3 (100) | 12 (100) | 22 (100) | 3 (100) | 6 (100) | 50 (100) |
| Grade ≥3 TEAE | 2 (50) | 1 (33) | 3 (25) | 12 (55) | 1 (33) | 6 (100) | 25 (50) |
| Drug-related TEAE | 2 (50) | 2 (67) | 5 (42) | 12 (55) | 2 (67) | 4 (67) | 27 (54) |
| Drug-related grade ≥3 TEAE | 1 (25) | 0 | 1 (8) | 3 (14) | 0 | 3 (50) | 8 (16) |
| Serious TEAE | 0 | 0 | 1 (8) | 8 (36) | 1 (33) | 2 (33) | 12 (24) |
| Drug-related serious TEAE | 0 | 0 | 0 | 1 (5)∗ | 0 | 0 | 1 (2) |
| TEAE resulting in study drug dose modification | 1 (25) | 1 (33) | 1 (8) | 11 (50) | 1 (33) | 6 (100) | 21 (42) |
| TEAE resulting in study drug dose reduction | 0 | 1 (33) | 1 (8) | 6 (27) | 0 | 6 (100) | 14 (28) |
| TEAE resulting in study drug discontinuation | 0 | 0 | 0 | 2 (9)† | 0 | 3 (50) | 5 (10) |
| TEAE resulting in discontinuation from all study drugs | 0 | 0 | 0 | 2 (9) | 0 | 1 (17) | 3 (6) |
| On-study deaths | 0 | 0 | 0 | 1 (5) | 0 | 1 (17) | 2 (4) |
| Patients, 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 TEAE | 4 (100) | 3 (100) | 12 (100) | 22 (100) | 3 (100) | 6 (100) | 50 (100) |
| Grade ≥3 TEAE | 2 (50) | 1 (33) | 3 (25) | 12 (55) | 1 (33) | 6 (100) | 25 (50) |
| Drug-related TEAE | 2 (50) | 2 (67) | 5 (42) | 12 (55) | 2 (67) | 4 (67) | 27 (54) |
| Drug-related grade ≥3 TEAE | 1 (25) | 0 | 1 (8) | 3 (14) | 0 | 3 (50) | 8 (16) |
| Serious TEAE | 0 | 0 | 1 (8) | 8 (36) | 1 (33) | 2 (33) | 12 (24) |
| Drug-related serious TEAE | 0 | 0 | 0 | 1 (5)∗ | 0 | 0 | 1 (2) |
| TEAE resulting in study drug dose modification | 1 (25) | 1 (33) | 1 (8) | 11 (50) | 1 (33) | 6 (100) | 21 (42) |
| TEAE resulting in study drug dose reduction | 0 | 1 (33) | 1 (8) | 6 (27) | 0 | 6 (100) | 14 (28) |
| TEAE resulting in study drug discontinuation | 0 | 0 | 0 | 2 (9)† | 0 | 3 (50) | 5 (10) |
| TEAE resulting in discontinuation from all study drugs | 0 | 0 | 0 | 2 (9) | 0 | 1 (17) | 3 (6) |
| On-study deaths | 0 | 0 | 0 | 1 (5) | 0 | 1 (17) | 2 (4) |
PomDex was given in combination with mezagitamab 300 mg (administered per the product label).
A patient with a past medical history of diverticulitis was hospitalized for diverticulitis.
A patient discontinued therapy and died after 1 dose of mezagitamab due to respiratory failure secondary to Haemophilus influenzae sepsis related to complications for underlying progressing myeloma. The second patient contracted severe acute respiratory syndrome coronavirus 2 and died of COVID-19.