n (%) | Dose-escalation phase (n=16) | TNBC (n=14) | Anal SCC (n=14) | cSCC (n=14) | UPS (n=20) | SBA (n=14) | TET (n=8) | hTMB (n=14) | Pacmilimab 10 mg/kg Total (n=114) |
Treatment-emergent AEs in ≥10% of patients (all severity grades) | |||||||||
Fatigue | 6 (38) | 4 (29) | 3 (21) | 7 (50) | 5 (25) | 6 (43) | 3 (38) | 4 (29) | 38 (33) |
Diarrhea | 4 (25) | 3 (21) | 1 (7) | 6 (43) | 6 (30) | 4 (29) | 1 (13) | 5 (36) | 30 (26) |
Anemia | 4 (25) | 1 (7) | 4 (29) | 3 (21) | 7 (35) | 3 (21) | 3 (38) | 3 (21) | 28 (25) |
Decreased appetite | 4 (25) | 1 (7) | 3 (21) | 7 (50) | 4 (20) | 3 (21) | 2 (25) | 4 (29) | 28 (25) |
Nausea | 4 (25) | 6 (43) | 1 (7) | 4 (29) | 1 (5) | 4 (29) | 1 (13) | 6 (43) | 27 (24) |
AST increased | 0 | 5 (36) | 5 (36) | 1 (7) | 3 (15) | 4 (29) | 1 (13) | 4 (29) | 23 (20) |
Vomiting | 3 (19) | 2 (14) | 2 (14) | 3 (21) | 3 (15) | 3 (21) | 1 (13) | 5 (36) | 22 (19) |
Cough | 4 (25) | 4 (29) | 1 (7) | 1 (7) | 4 (20) | 2 (14) | 4 (50) | 0 | 20 (18) |
Dyspnea | 4 (25) | 2 (14) | 2 (14) | 1 (7) | 4 (20) | 1 (7) | 2 (25) | 3 (21) | 19 (17) |
Arthralgia | 2 (13) | 4 (29) | 0 | 4 (29) | 3 (15) | 1 (7) | 0 | 2 (14) | 16 (14) |
Constipation | 2 (13) | 0 | 3 (21) | 2 (14) | 2 (10) | 2 (14) | 2 (25) | 3 (21) | 16 (14) |
ALT increased | 1 (6) | 1 (7) | 3 (21) | 1 (7) | 3 (15) | 3 (21) | 1 (13) | 2 (14) | 15 (13) |
Fever | 3 (19) | 4 (29) | 0 | 1 (7) | 3 (15) | 1 (7) | 1 (13) | 2 (14) | 15 (13) |
Headache | 3 (19) | 3 (21) | 0 | 2 (14) | 4 (20) | 0 | 0 | 2 (14) | 14 (12) |
Back pain | 3 (19) | 3 (21) | 2 (14) | 2 (14) | 1 (5) | 0 | 1 (13) | 2 (14) | 14 (12) |
Rash | 1 (6) | 2 (14) | 0 | 2 (14) | 1 (5) | 2 (14) | 1 (13) | 5 (36) | 14 (12) |
Blood alkaline phosphatase increased | 3 (19) | 0 | 3 (21) | 0 | 3 (15) | 1 (7) | 2 (25) | 1 (7) | 13 (11) |
Weight decreased | 1 (6) | 1 (7) | 1 (7) | 2 (14) | 2 (10) | 2 (14) | 1 (13) | 3 (21) | 13 (11) |
Upper respiratory tract infection | 2 (13) | 1 (7) | 1 (7) | 1 (7) | 1 (5) | 1 (7) | 3 (38) | 2 (14) | 12 (11) |
Urinary tract infection | 1 (6) | 2 (14) | 1 (7) | 1 (7) | 2 (10) | 2 (14) | 0 | 2 (14) | 11 (10) |
Treatment-related AEs in ≥5% of patients (all severity grades) | |||||||||
Patients with at least 1 | 11 (69) | 10 (71) | 8 (57) | 9 (64) | 5 (25) | 5 (36) | 6 (75) | 12 (86) | 66 (58) |
Fatigue | 4 (25) | 2 (14) | 1 (7) | 5 (36) | 1 (5) | 3 (21) | 2 (25) | 0 | 18 (16) |
AST increased | 0 | 2 (14) | 4 (29) | 1 (7) | 2 (10) | 2 (14) | 1 (13) | 3 (21) | 15 (13) |
ALT increased | 0 | 1 (7) | 3 (21) | 1 (7) | 2 (10) | 2 (14) | 1 (13) | 2 (14) | 12 (11) |
Infusion-related reaction | 3 (19) | 1 (7) | 2 (14) | 2 (14) | 0 | 0 | 0 | 1 (7) | 9 (8) |
Rash | 1 (6) | 1 (7) | 0 | 1 (7) | 1 (5) | 1 (7) | 0 | 4 (29) | 9 (8) |
Arthralgia | 2 (13) | 2 (14) | 0 | 1 (7) | 0 | 1 (7) | 0 | 2 (14) | 8 (7) |
Decreased appetite | 2 (13) | 0 | 1 (7) | 4 (29) | 0 | 1 (7) | 0 | 0 | 8 (7) |
Myalgia | 2 (13) | 1 (7) | 0 | 0 | 1 (5) | 1 (7) | 0 | 2 (14) | 7 (6) |
Diarrhea | 0 | 1 (7) | 0 | 2 (14) | 1 (5) | 0 | 0 | 2 (14) | 6 (5) |
Vomiting | 0 | 1 (7) | 0 | 2 (14) | 0 | 1 (7) | 0 | 2 (14) | 6 (5) |
Immune-related AEs in ≥1 patient (all severity grades) | |||||||||
Patients with at least 1 | 1 (6) | 3 (21) | 1 (7) | 2 (14) | 2 (10) | 3 (21) | 1 (13) | 4 (29) | 17 (15) |
AST increased | 0 | 1 (7) | 0 | 1 (7) | 0 | 2 (14) | 0 | 1 (7) | 5 (4) |
Hypothyroidism | 1 (6) | 0 | 1 (7) | 0 | 1 (5) | 1 (7) | 0 | 1 (7) | 5 (4) |
ALT increased | 0 | 0 | 0 | 1 (7) | 0 | 2 (14) | 0 | 1 (7) | 4 (4) |
Rash | 0 | 0 | 0 | 1 (7) | 0 | 1 (7) | 0 | 1 (7) | 3 (3) |
Maculopapular rash | 0 | 2 (14) | 0 | 0 | 0 | 0 | 0 | 0 | 2 (2) |
Acute thyroiditis | 0 | 0 | 0 | 0 | 1 (5) | 0 | 0 | 0 | 1 (1) |
Arthralgia | 0 | 1 (7) | 0 | 0 | 0 | 0 | 0 | 0 | 1 (1) |
Hyperthyroidism | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (7) | 1 (1) |
Myocarditis | 0 | 0 | 0 | 0 | 0 | 0 | 1 (13) | 0 | 1 (1) |
Grade 3–4 treatment-related AEs in >1 patient | |||||||||
Patients with at least 1 | 2 (13) | 2 (14) | 0 | 0 | 0 | 2 (14) | 3 (38) | 1 (7) | 10 (9) |
ɣ-glutamyltransferase increased | 1 (6) | 1 (7) | 0 | 0 | 0 | 0 | 0 | 0 | 2 (2) |
Lipase increased | 0 | 0 | 0 | 0 | 0 | 0 | 2 (25) | 0 | 2 (2) |
AST increased | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (7) | 1 (1) |
Enterocutaneous fistula | 1 (6) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (1) |
Fatigue | 0 | 0 | 0 | 0 | 0 | 1 (7) | 0 | 0 | 1 (1) |
Hypertension | 0 | 0 | 0 | 0 | 0 | 1 (7) | 0 | 0 | 1 (1) |
Maculopapular rash | 0 | 1 (7) | 0 | 0 | 0 | 0 | 0 | 0 | 1 (1) |
Myocarditis | 0 | 0 | 0 | 0 | 0 | 0 | 1 (13) | 0 | 1 (1) |
AE, adverse event; ALT, alanine aminotransferase; AST, aspartate aminotransferase; cSCC, cutaneous squamous cell carcinoma; hTMB, high tumor mutational burden; SBA, small bowel adenocarcinoma; SCC, squamous cell carcinoma; TET, thymic epithelial tumor; TNBC, triple-negative breast cancer; UPS, undifferentiated pleiomorphic sarcoma.