Table 3.
Summary of AEs
| n (%) | Patients (n = 40) |
|---|---|
| Patients with at least one AE | 40 (100.0) |
| Mosunetuzumab-related AE | 40 (100.0) |
| SAE, not including grade 5 disease progression | 20 (50.0) |
| Mosunetuzumab-related SAE | 12 (30.0) |
| Grade 5 AE | 2 (5.0)∗ |
| AE leading to mosunetuzumab discontinuation | 4 (10.0) |
| Treatment-related AE leading to mosunetuzumab discontinuation | 1 (2.5) |
| Any-grade AEs (≥20% of patients) or grade ≥3 AEs (≥5% of patients) based on preferred term | Any grade | Grade ≥3 |
|---|---|---|
| Neutropenia/neutrophil count decreased | 28 (70.0) | 26 (65.0) |
| CRS | 24 (60.0) | 0 |
| Nausea | 22 (55.0) | 1 (2.5) |
| Fatigue | 19 (47.5) | 4 (10.0) |
| Anemia/hemoglobin decreased | 17 (42.5) | 12 (30.0) |
| Decreased appetite | 15 (37.5) | 3 (7.5) |
| Constipation | 15 (37.5) | 1 (2.5) |
| Hypokalemia | 13 (32.5) | 3 (7.5) |
| Peripheral neuropathy | 13 (32.5) | 1 (2.5) |
| Diarrhea | 13 (32.5) | 1 (2.5) |
| Alopecia | 12 (30.0) | 0 |
| Vomiting | 12 (30.0) | 1 (2.5) |
| Thrombocytopenia/platelet count decreased | 10 (25.0) | 7 (17.5) |
| Headache | 10 (25.0) | 1 (2.5) |
| Dizziness | 10 (25.0) | 0 |
| Hypotension | 9 (22.5) | 1 (2.5) |
| Febrile neutropenia | 8 (20.0) | 8 (20.0) |
| Abdominal pain | 8 (20.0) | 1 (2.5) |
| Peripheral edema | 8 (20.0) | 0 |
| Pyrexia | 8 (20.0) | 0 |
| Dyspnea | 7 (17.5) | 2 (5.0) |
| Hypophosphatemia | 7 (17.5) | 2 (5.0) |
| Hypoalbuminemia | 6 (15.0) | 2 (5.0) |
| Alanine aminotransferase increased | 6 (15.0) | 2 (5.0) |
| Aspartate transaminase increased | 5 (12.5) | 2 (5.0) |
| Lymphopenia/lymphocyte count decreased | 5 (12.5) | 4 (10.0) |
| Dehydration | 5 (12.5) | 2 (5.0) |
| Leukopenia/white blood cell decreased | 4 (10.0) | 3 (7.5) |
| Pneumonia | 4 (10.0) | 3 (7.5) |
| Colitis | 3 (7.5) | 2 (5.0) |
| Syncope | 2 (5.0) | 2 (5.0) |
| SAEs (≥5% of patients) based on preferred term | Any grade | Grade ≥3 |
|---|---|---|
| Febrile neutropenia | 6 (15.0) | 6 (15.0) |
| Neutropenia/neutrophil count decreased | 3 (7.5) | 3 (7.5) |
| Pneumonia | 3 (7.5) | 3 (7.5) |
| Colitis | 2 (5.0) | 2 (5.0) |
| Nausea | 2 (5.0) | 1 (2.5) |
AE, adverse event; SAE, serious adverse event
∗
One case of pneumonia unrelated to mosunetuzumab but related to chemotherapy and 1 case of malignant disease progression.