Table 3

AEs at pacmilimab 10 mg/kg in dose-escalation and expansion phases

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)
 Fatigue6 (38)4 (29)3 (21)7 (50)5 (25)6 (43)3 (38)4 (29)38 (33)
 Diarrhea4 (25)3 (21)1 (7)6 (43)6 (30)4 (29)1 (13)5 (36)30 (26)
 Anemia4 (25)1 (7)4 (29)3 (21)7 (35)3 (21)3 (38)3 (21)28 (25)
 Decreased appetite4 (25)1 (7)3 (21)7 (50)4 (20)3 (21)2 (25)4 (29)28 (25)
 Nausea4 (25)6 (43)1 (7)4 (29)1 (5)4 (29)1 (13)6 (43)27 (24)
 AST increased05 (36)5 (36)1 (7)3 (15)4 (29)1 (13)4 (29)23 (20)
 Vomiting3 (19)2 (14)2 (14)3 (21)3 (15)3 (21)1 (13)5 (36)22 (19)
 Cough4 (25)4 (29)1 (7)1 (7)4 (20)2 (14)4 (50)020 (18)
 Dyspnea4 (25)2 (14)2 (14)1 (7)4 (20)1 (7)2 (25)3 (21)19 (17)
 Arthralgia2 (13)4 (29)04 (29)3 (15)1 (7)02 (14)16 (14)
 Constipation2 (13)03 (21)2 (14)2 (10)2 (14)2 (25)3 (21)16 (14)
 ALT increased1 (6)1 (7)3 (21)1 (7)3 (15)3 (21)1 (13)2 (14)15 (13)
 Fever3 (19)4 (29)01 (7)3 (15)1 (7)1 (13)2 (14)15 (13)
 Headache3 (19)3 (21)02 (14)4 (20)002 (14)14 (12)
 Back pain3 (19)3 (21)2 (14)2 (14)1 (5)01 (13)2 (14)14 (12)
 Rash1 (6)2 (14)02 (14)1 (5)2 (14)1 (13)5 (36)14 (12)
 Blood alkaline phosphatase increased3 (19)03 (21)03 (15)1 (7)2 (25)1 (7)13 (11)
 Weight decreased1 (6)1 (7)1 (7)2 (14)2 (10)2 (14)1 (13)3 (21)13 (11)
 Upper respiratory tract infection2 (13)1 (7)1 (7)1 (7)1 (5)1 (7)3 (38)2 (14)12 (11)
 Urinary tract infection1 (6)2 (14)1 (7)1 (7)2 (10)2 (14)02 (14)11 (10)
Treatment-related AEs in ≥5% of patients (all severity grades)
 Patients with at least 111 (69)10 (71)8 (57)9 (64)5 (25)5 (36)6 (75)12 (86)66 (58)
 Fatigue4 (25)2 (14)1 (7)5 (36)1 (5)3 (21)2 (25)018 (16)
 AST increased02 (14)4 (29)1 (7)2 (10)2 (14)1 (13)3 (21)15 (13)
 ALT increased01 (7)3 (21)1 (7)2 (10)2 (14)1 (13)2 (14)12 (11)
 Infusion-related reaction3 (19)1 (7)2 (14)2 (14)0001 (7)9 (8)
 Rash1 (6)1 (7)01 (7)1 (5)1 (7)04 (29)9 (8)
 Arthralgia2 (13)2 (14)01 (7)01 (7)02 (14)8 (7)
 Decreased appetite2 (13)01 (7)4 (29)01 (7)008 (7)
 Myalgia2 (13)1 (7)001 (5)1 (7)02 (14)7 (6)
 Diarrhea01 (7)02 (14)1 (5)002 (14)6 (5)
 Vomiting01 (7)02 (14)01 (7)02 (14)6 (5)
Immune-related AEs in ≥1 patient (all severity grades)
 Patients with at least 11 (6)3 (21)1 (7)2 (14)2 (10)3 (21)1 (13)4 (29)17 (15)
 AST increased01 (7)01 (7)02 (14)01 (7)5 (4)
 Hypothyroidism1 (6)01 (7)01 (5)1 (7)01 (7)5 (4)
 ALT increased0001 (7)02 (14)01 (7)4 (4)
 Rash0001 (7)01 (7)01 (7)3 (3)
 Maculopapular rash02 (14)0000002 (2)
 Acute thyroiditis00001 (5)0001 (1)
 Arthralgia01 (7)0000001 (1)
 Hyperthyroidism00000001 (7)1 (1)
 Myocarditis0000001 (13)01 (1)
Grade 3–4 treatment-related AEs in >1 patient
 Patients with at least 12 (13)2 (14)0002 (14)3 (38)1 (7)10 (9)
 ɣ-glutamyltransferase increased1 (6)1 (7)0000002 (2)
 Lipase increased0000002 (25)02 (2)
 AST increased00000001 (7)1 (1)
 Enterocutaneous fistula1 (6)00000001 (1)
 Fatigue000001 (7)001 (1)
 Hypertension000001 (7)001 (1)
 Maculopapular rash01 (7)0000001 (1)
 Myocarditis0000001 (13)01 (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.