Table 1.
Demographics and baseline characteristics by cohort (parts A and B)
| Characteristic | 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) |
|
| Median age (range), years | 69.8 (55–81) | 53.6 (51–67) | 66.7 (32–81) | 67.0 (57–73) | 72.0 (62–81) | 66.0 (40–83) |
| Male, n (%) | 3 (100) | 3 (100) | 7 (58) | 3 (100) | 2 (50) | 55 (71) |
| ECOG performance status, n (%) | ||||||
| 0 | 1 (33) | 3 (100) | 3 (25) | 2 (67) | 1 (25) | 36 (46) |
| 1 | 2 (67) | 0 | 6 (50) | 1 (33) | 3 (75) | 42 (54) |
| 2 | 0 | 0 | 3 (25) | 0 | 0 | 0 |
| Diagnosis, n (%) | ||||||
| NSCLC | 1 (33) | 1 (33) | 3 (25) | 1 (33) | 2 (50) | 43 (55) |
| Urothelial cancer | 1 (33) | 1 (33) | 3 (25) | 2 (67) | 2 (50) | 35 (45) |
| CRPC | 0 | 1 (33) | 3 (25) | 0 | 0 | 0 |
| Melanoma | 1 (33) | 0 | 3 (25) | 0 | 0 | 0 |
| Median time since diagnosis (range), months | 71.6 (34–196) | 19.1 (14–130) | 47.5 (12–94) | 67.9 (13–175) | 37.5 (17–66) | 18.3 (1–125) |
| Prior therapy, n (%) | ||||||
| Chemotherapy | 3 (100) | 3 (100) | 12 (100) | 3 (100) | 4 (100) | 63 (81) |
| Surgery | 3 (100) | 1 (33) | 7 (58) | 3 (100) | 3 (75) | 58 (74) |
| Radiation therapy | 3 (100) | 3 (100) | 12 (100) | 2 (67) | 3 (75) | 26 (33) |
| Immunotherapy | 3 (100) | 2 (67) | 12 (100) | 1 (33) | 3 (75) | 25 (32) |
| Hormone therapy | 3 (100) | 3 (100) | 12 (100) | 0 | 0 | 0 |
| Other | 0 | 0 | 0 | 0 | 0 | 7 (9)* |
| Median no. of prior treatments (range) | 6 (2–7) | 3 (2–10) | 4 (2–5) | 15 (14–20) | 10 (4–40) | 5 (1–22) |
*Tyrosine kinase inhibitor (n=3), EGFR inhibitor (n=2), kinase inhibitor (n=1), and investigational (n=1); patients may have received ≥1 of the treatments.
CRPC, castration-resistant prostate cancer; ECOG, Eastern Cooperative Oncology Group; EGFR, epidermal growth factor receptor; NSCLC, non-small cell lung cancer; TCID50, 50% tissue culture infectious dose.