Table 3.
Treatment-related adverse events reported in ≥3 patients or Grade ≥3 in the same dose cohorts (dose escalation + cohort expansion) for each combination treatment.
Adverse event | No. of patients (%) |
|||
---|---|---|---|---|
Mogamulizumab 1 mg/kg + durvalumab 10 mg/kg (n = 19) |
Mogamulizumab 1 mg/kg + tremelimumab 10 mg/kg (n = 19) |
|||
Any Grade | Grade ≥3 | Any Grade | Grade ≥3 | |
Rash maculopapular | 7 (36.8) | 4 (21.1) | 5 (26.3) | 2 (10.5) |
Fatigue | 6 (31.6) | 1 (5.3) | 3 (15.8) | 0 |
Pruritis | 5 (26.3) | 0 | 3 (15.8) | 1 (5.5) |
Infusion-related reactions | 4 (21.1) | 0 | 7 (36.8) | 0 |
Diarrhea | 4 (21.1) | 0 | 4 (21.1) | 0 |
Hypothyroidism | 3 (15.8) | 0 | 0 | 0 |
Stomatitis | 1 (5.3) | 1 (5.3) | 4 (21.1) | 0 |
Rash | 1 (5.3) | 0 | 3 (15.8) | 1 (5.3) |
Colitis | 1 (5.3) | 1 (5.3) | 3 (15.8) | 1 (5.3) |
Decreased lymphocytes | 1 (5.3) | 0 | 1 (5.3) | 1 (5.3) |
Transaminases increased | 1 (5.3) | 0 | 1 (5.3) | 1 (5.3) |
Autoimmune hepatitis | 1 (5.3) | 0 | 1 (5.3) | 1 (5.3) |
Gastritis | 1 (5.3) | 1 (5.3) | 0 | 0 |
Blood CPK increased | 1 (5.3) | 1 (5.3) | 0 | 0 |
Hyperglycemia | 1 (5.3) | 1 (5.3) | 0 | 0 |
Vomiting | 0 | 0 | 1 (5.3) | 1 (5.3) |
Abnormal liver function test | 0 | 0 | 1 (5.3) | 1 (5.3) |
Hypertension | 0 | 0 | 1 (5.3) | 1 (5.3) |
CPK, creatine phosphokinase.