Table 2

Treatment-related AEs*†

All treated patients, N=50Progressed on prior anti-PD-1 therapy, n=33No prior anti-PD-1 therapy, n=17
Treatment-related AEs47 (94)30 (91)17 (100)
 Grade ≥3 V937-related AEs000
 Grade 3 or 4 ipilimumab-related AEs‡§7 (14)4 (12)3 (18)
Treatment-related AEs occurring in ≥10% of all treated patientsAny gradeGrade 3 or 4Any gradeGrade 3 or 4Any gradeGrade 3 or 4
 Pruritus25 (50)1 (2)17 (52)08 (47)1 (6)
 Fatigue22 (44)1 (2)15 (45)07 (41)1 (6)
 Diarrhea16 (32)2 (4)13 (39)2 (6)3 (18)0
 Nausea11 (22)09 (27)02 (12)0
 Rash10 (20)05 (15)05 (29)0
 Pyrexia8 (16)05 (15)03 (18)0
 Chills7 (14)06 (18)01 (6)0
 Influenza-like illness7 (14)06 (18)01 (6)0
 Decreased appetite6 (12)05 (15)01 (6)0
 Injection site reaction6 (12)03 (9)03 (18)0
 Transaminase increase6 (12)05 (15)01 (6)0
 Headache5 (10)05 (15)000
 Injection site pain5 (10)02 (6)03 (18)0
  • *Data are presented as n (%).

  • †Treatment-related AEs were those events with a V937 or ipilimumab relationship of possibly, probably, or definitely.

  • ‡There were no grade 5 treatment-related AEs.

  • §The most common grade 3 and 4 treatment-related AEs were dehydration, diarrhea, and hepatotoxicity (two patients (4%) each).

  • AE, adverse event; anti-PD-1, antiprogrammed death 1.