Table 2.
Treatment-related adverse events by cohort (parts A and B)
| Treatment-related AE, n (%) of patients |
Part A (V937 monotherapy) | Part B (V937+pembrolizumab) | ||||
| Cohort 1 1×108 TCID50 (n=3) |
Cohort 2 3×108 TCID50 (n=3) |
Cohort 3 1×109 TCID50 (n=12) |
Cohort 1 1×108 TCID50+200 mg (n=3) |
Cohort 2 3×108 TCID50+200 mg (n=4) |
Cohort 3 1×109 TCID50+200 mg (n=78) |
|
| Any grade | 2 (67) | 2 (67) | 7 (58) | 3 (100) | 2 (50) | 63 (81) |
| Grade 3* | 0 | 0 | 0 | 0 | 1 (25)† | 9 (12)‡ |
| Led to discontinuation of study drug(s) | 0 | 0 | 0 | 0 | 0 | 5 (6) |
| Led to dose modification(s) | 0 | 0 | 2 (17) | 0 | 1 (25) | 10 (13) |
| Led to death | 0 | 0 | 0 | 0 | 0 | 0 |
| Most common (>2 patients in any cohort in either part A or B) | ||||||
| Fatigue | 0 | 1 (33) | 4 (33) | 1 (33) | 1 (25) | 29 (37) |
| Pyrexia | 1 (33) | 1 (33) | 3 (25) | 1 (33) | 1 (25) | 9 (12) |
| Pruritus | 0 | 0 | 0 | 0 | 0 | 15 (19) |
| Influenza-like illness | 0 | 1 (33) | 2 (17) | 0 | 1 (25) | 9 (12) |
| Myalgia | 0 | 0 | 1 (8) | 1 (33) | 1 (25) | 10 (13) |
| Diarrhea | 1 (33) | 0 | 0 | 0 | 1 (25) | 10 (13) |
| Nausea | 0 | 0 | 1 (8) | 2 (67) | 1 (25) | 7 (9) |
| Decreased appetite | 0 | 0 | 0 | 1 (33) | 0 | 8 (10) |
| Rash | 0 | 0 | 0 | 0 | 0 | 9 (12) |
| Chills | 0 | 0 | 0 | 1 (33) | 0 | 7 (9) |
| Arthralgia | 0 | 0 | 1 (8) | 0 | 0 | 6 (8) |
| Cough | 0 | 0 | 0 | 0 | 0 | 6 (8) |
| Headache | 0 | 0 | 1 (8) | 1 (33) | 1 (25) | 3 (4) |
| Oropharyngeal pain | 0 | 0 | 0 | 1 (33) | 0 | 5 (6) |
| Vomiting | 0 | 0 | 0 | 0 | 1 (25) | 5 (6) |
| Hypothyroidism | 0 | 0 | 0 | 0 | 0 | 5 (6) |
| Lethargy | 0 | 0 | 3 (25) | 0 | 0 | 2 (3) |
| Malaise | 0 | 0 | 0 | 1 (33) | 0 | 4 (5) |
| Rhinorrhea | 0 | 0 | 0 | 0 | 0 | 5 (6) |
| Nasal congestion | 0 | 0 | 0 | 0 | 0 | 4 (5) |
| Productive cough | 0 | 0 | 0 | 0 | 0 | 4 (5) |
| Blood CPK increased | 0 | 0 | 0 | 0 | 0 | 3 (4) |
| Dry skin | 0 | 0 | 0 | 0 | 0 | 3 (4) |
| Dyspnea | 0 | 0 | 0 | 0 | 0 | 3 (4) |
| Respiratory tract congestion | 0 | 0 | 0 | 0 | 0 | 3 (4) |
*There were no grade 4 or 5 treatment-related AEs.
†Hyponatremia (n=1) considered related to V937.
‡Lymphocyte count decreased (n=1) considered related to V937; arthralgia/myalgia (n=1), blood creatine phosphokinase increased (n=1), brain edema (n=1), colitis/fatigue (n=1), colitis/pneumonitis (n=1), diarrhea (n=1), immune-mediated pneumonitis (n=1), and acute myocardial infarction/hypoxia/myocarditis/tachypnea/troponin T increased (n=1) considered related to pembrolizumab.
AE, adverse event; CPK, creatine phosphokinase; TCID50, 50% tissue culture infectious dose.