Table 2.
All treated patients, N=50 | Progressed on prior anti-PD-1 therapy, n=33 | No prior anti-PD-1 therapy, n=17 | |
Treatment-related AEs | 47 (94) | 30 (91) | 17 (100) |
Grade ≥3 V937-related AEs | 0 | 0 | 0 |
Grade 3 or 4 ipilimumab-related AEs‡§ | 7 (14) | 4 (12) | 3 (18) |
Treatment-related AEs occurring in ≥10% of all treated patients | Any grade | Grade 3 or 4 | Any grade | Grade 3 or 4 | Any grade | Grade 3 or 4 |
Pruritus | 25 (50) | 1 (2) | 17 (52) | 0 | 8 (47) | 1 (6) |
Fatigue | 22 (44) | 1 (2) | 15 (45) | 0 | 7 (41) | 1 (6) |
Diarrhea | 16 (32) | 2 (4) | 13 (39) | 2 (6) | 3 (18) | 0 |
Nausea | 11 (22) | 0 | 9 (27) | 0 | 2 (12) | 0 |
Rash | 10 (20) | 0 | 5 (15) | 0 | 5 (29) | 0 |
Pyrexia | 8 (16) | 0 | 5 (15) | 0 | 3 (18) | 0 |
Chills | 7 (14) | 0 | 6 (18) | 0 | 1 (6) | 0 |
Influenza-like illness | 7 (14) | 0 | 6 (18) | 0 | 1 (6) | 0 |
Decreased appetite | 6 (12) | 0 | 5 (15) | 0 | 1 (6) | 0 |
Injection site reaction | 6 (12) | 0 | 3 (9) | 0 | 3 (18) | 0 |
Transaminase increase | 6 (12) | 0 | 5 (15) | 0 | 1 (6) | 0 |
Headache | 5 (10) | 0 | 5 (15) | 0 | 0 | 0 |
Injection site pain | 5 (10) | 0 | 2 (6) | 0 | 3 (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.