N (%) | Pacmilimab ≤1 mg/kg (n=21) | Pacmilimab 3 mg/kg (n=13) | Pacmilimab 10 mg/kg (n=16) | Pacmilimab 30 mg/kg (n=3) | Total (n=53) |
Treatment-emergent AEs in ≥10% of patients (all severity grades) | |||||
Fatigue | 6 (29) | 4 (31) | 6 (38) | 0 | 16 (30) |
Decreased appetite | 8 (38) | 3 (23) | 4 (25) | 0 | 15 (28) |
Nausea | 5 (24) | 5 (38) | 4 (25) | 0 | 14 (26) |
Cough | 4 (19) | 4 (31) | 4 (25) | 1 (33) | 13 (25) |
Constipation | 6 (29) | 4 (31) | 2 (13) | 0 | 12 (23) |
Anemia | 2 (10) | 4 (31) | 4 (25) | 2 (67) | 12 (23) |
Infusion-related reaction | 5 (24) | 3 (23) | 3 (19) | 0 | 11 (21) |
Back pain | 3 (14) | 3 (23) | 3 (19) | 1 (33) | 10 (19) |
Dyspnea | 1 (5) | 4 (31) | 4 (25) | 0 | 9 (17) |
Arthralgia | 2 (10) | 2 (15) | 2 (13) | 2 (67) | 8 (15) |
Fever | 3 (14) | 1 (8) | 3 (19) | 1 (33) | 8 (15) |
Diarrhea | 1 (5) | 1 (8) | 4 (25) | 1 (33) | 7 (13) |
Headache | 3 (14) | 1 (8) | 3 (19) | 0 | 7 (13) |
Increased blood alkaline phosphatase | 2 (10) | 0 | 3 (19) | 1 (33) | 6 (11) |
Dizziness | 2 (10) | 2 (15) | 2 (13) | 0 | 6 (11) |
Hyponatremia | 3 (14) | 1 (8) | 2 (13) | 0 | 6 (11) |
Pain in extremity | 2 (10) | 2 (15) | 2 (13) | 0 | 6 (11) |
Pruritus | 3 (14) | 0 | 2 (13) | 1 (33) | 6 (11) |
Treatment-related AEs in ≥5% of patients (all severity grades) | |||||
Patients with at least 1 | 10 (48) | 8 (62) | 11 (69) | 3 (100) | 32 (60) |
Infusion-related reaction | 5 (24) | 3 (23) | 3 (19) | 0 | 11 (21) |
Fatigue | 3 (14) | 1 (8) | 4 (25) | 0 | 8 (15) |
Arthralgia | 0 | 1 (8) | 2 (13) | 2 (67) | 5 (9) |
Myalgia | 1 (5) | 0 | 2 (13) | 1 (33) | 4 (8) |
Pruritus | 2 (10) | 0 | 1 (6) | 0 | 3 (6) |
Fever | 1 (5) | 0 | 1 (6) | 1 (33) | 3 (6) |
Immune-related AEs in ≥1 patient (all severity grades) | |||||
Patients with at least 1 irAE | 2 (10) | 2 (15) | 1 (6) | 1 (33) | 6 (11) |
Hypothyroidism | 1 (5) | 0 | 1 (6) | 0 | 2 (4) |
Febrile neutropenia | 0 | 1 (8) | 0 | 0 | 1 (2) |
Thrombocytopenia | 0 | 1 (8) | 0 | 0 | 1 (2) |
Alanine aminotransferase increased | 0 | 0 | 0 | 1 (33) | 1 (2) |
Aspartate aminotransferase increased | 0 | 0 | 0 | 1 (33) | 1 (2) |
Pneumonitis | 0 | 1 (8) | 0 | 0 | 1 (2) |
Serious AEs in >1 patient (all severity grades) | |||||
Diarrhea | 0 | 0 | 2 (13) | 0 | 2 (4) |
Infusion-related reaction | 1 (5) | 0 | 1 (6) | 0 | 2 (4) |
Lower respiratory tract infection | 1 (5) | 1 (8) | 0 | 0 | 2 (4) |
Grade 3–4 treatment-related AEs | |||||
Patients with at least 1 | 1 (5) | 4 (31) | 2 (13) | 1 (33) | 8 (15) |
Alanine aminotransferase increased | 0 | 0 | 0 | 1 (33) | 1 (2) |
Anemia | 0 | 1 (8) | 0 | 0 | 1 (2) |
Aspartate aminotransferase increased | 0 | 0 | 0 | 1 (33) | 1 (2) |
Thrombocytopenia | 0 | 1 (8) | 0 | 0 | 1 (2) |
Amylase increased | 0 | 1 (8) | 0 | 0 | 1 (2) |
Epistaxis | 0 | 0 | 1 (6) | 0 | 1 (2) |
Febrile neutropenia | 0 | 1 (8) | 0 | 0 | 1 (2) |
ɣ-glutamyltransferase increased | 0 | 0 | 1 (6) | 0 | 1 (2) |
Infusion-related reaction | 1 (5) | 0 | 0 | 0 | 1 (2) |
Pneumonitis | 0 | 1 (8) | 0 | 0 | 1 (2) |
Stress cardiomyopathy | 1 (5) | 0 | 0 | 0 | 1 (2) |
AE, adverse event; irAE, immune-related adverse events.