Table 3.

Adverse event (AE) summary

n (%)	Pacmilimab+ipilimumab dose (mg/kg)					All patients (N=27)
	0.3+3 (n=6)	1+3 (n=3)	3+3 (n=3)	10+3 (n=8)	10+6/10+10 (n=7)	All grade	Grade 3–4
Treatment-emergent AEs in ≥15% of patients (all-grade by dose group)
Nausea	4 (67)	3 (100)	0	1 (13)	5 (71)	13 (48)	0
Pruritus	1 (17)	0	1 (33)	4 (50)	4 (57)	10 (37)	0
Decreased appetite	2 (33)	1 (33)	1 (33)	2 (25)	2 (29)	8 (30)	0
Fatigue	3 (50)	2 (67)	0	2 (25)	1 (14)	8 (30)	0
Abdominal pain	2 (33)	0	0	3 (38)	2 (29)	7 (26)	3 (11)
Diarrhea	2 (33)	1 (33)	1 (33)	1 (13)	2 (29)	7 (26)	1 (4)
Vomiting	3 (50)	1 (33)	1 (33)	1 (13)	1 (14)	7 (26)	0
Anemia	1 (17)	1 (33)	0	2 (25)	2 (29)	6 (22)	4 (15)
Headache	0	2 (67)	0	2 (25)	2 (29)	6 (22)	0
Increased AST	1 (17)	1 (33)	1 (33)	1 (13)	2 (29)	6 (22)	1 (4)
Constipation	2 (33)	1 (33)	1 (33)	0	1 (14)	5 (19)	0
Increased ALT	1 (17)	1 (33)	2 (67)	0	1 (14)	5 (19)	1 (4)
Rash	0	1 (33)	2 (67)	1 (13)	1 (14)	5 (19)	0
Treatment-related AEs in ≥10% of patients (all-grade by dose group)
Patients with ≥1	5 (83)	3 (100)	1 (33)	6 (75)	6 (86)	23 (85)	9 (33)
Pruritus	1 (17)	0	1 (33)	4 (50)	4 (57)	10 (37)	0
Nausea	1 (17)	2 (67)	0	1 (13)	5 (71)	9 (33)	0
Increased AST	1 (17)	1 (33)	1 (33)	1 (13)	2 (29)	6 (22)	1 (4)
Fatigue	1 (17)	2 (67)	0	1 (13)	1 (14)	5 (19)	0
Increased ALT	1 (17)	1 (33)	2 (67)	0	1 (14)	5 (19)	1 (4)
Increased amylase	0	0	1 (33)	1 (13)	2 (29)	4 (15)	1 (4)
Infusion-related reaction	1 (17)	0	0	2 (25)	1 (14)	4 (15)	1 (4)
Maculopapular rash	0	0	0	3 (38)	1 (14)	4 (15)	0
Dyspnea	1 (17)	0	0	2 (25)	0	3 (11)	1 (4)
Headache	0	2 (67)	0	1 (13)	0	3 (11)	0
Immune-related AEs in ≥1 patient (all grade by dose group)
Patients with least 1	3 (50)	1 (33)	1 (33)	6 (75)	5 (71)	16 (59)	6 (22)
Pruritus	0	0	0	3 (38)	2 (29)	5 (19)	0
Maculopapular rash	0	0	0	3 (38)	1 (14)	4 (15)	0
Rash	0	1 (33)	1 (33)	1 (33)	0	3 (11)	0
Colitis	1 (17)	0	0	0	1 (14)	2 (7)	2 (7)
Diarrhea	0	0	0	0	2 (29)	2 (7)	1 (4)
Hyperthyroidism	0	0	0	2 (25)	0	2 (7)	0
Hypothyroidism	0	0	0	2 (25)	0	2 (7)	0
Autoimmune hypothyroidism	0	0	0	0	1 (14)	1 (4)	0
Guillain-Barre syndrome	0	0	0	0	1 (14)	1 (4)	1 (4)
Hypophysitis	0	1 (33)	0	0	0	1 (4)	0
Immune-mediated hepatitis	0	0	0	0	1 (14)	1 (4)	0
Increased AST	1 (17)	0	0	0	0	1 (4)	1 (4)
Increased hepatic transaminases	0	0	0	1 (13)	0	1 (4)	1 (4)
Macular rash	1 (17)	0	0	0	0	1 (4)	0
Neutropenia	0	0	0	0	1 (14)	1 (4)	1 (4)
Pneumonitis	1 (17)	0	0	0	0	1 (4)	1 (4)
Serious AEs in ≥1 patient (all grade by dose group)
Patients with least one serious AE	3 (50)	3 (100)	0	4 (50)	3 (43)	13 (48)	11 (41)
Abdominal pain	1 (17)	0	0	1 (13)	0	2 (7)	2 (7)
Anemia	0	1 (33)	0	0	1 (14)	2 (7)	2 (7)
Colitis	1 (17)	0	0	0	1 (14)	2 (7)	2 (7)

ALT, alanine aminotransferase; AST, aspartate aminotransferase.