Table 3.
Efficacy results by cohort (part A and B)
| 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 NSCLC 1×109 TCID50+200 mg (n=43) |
Cohort 3 Urothelial Cancer 1×109 TCID50+200 mg (n=35) |
|
| BOR, n (%) | |||||||
| Complete response | 0 | 0 | 0 | 0 | 0 | 3 (7) | 3 (9) |
| Partial response | 0 | 0 | 1 (8) | 0 | 0 | 1 (2) | 4 (11) |
| Stable disease | 2 (67) | 2 (67) | 5 (42) | 0 | 0 | 7 (16) | 11 (31) |
| Progressive disease | 1 (33) | 1 (33) | 6 (50) | 3 (100) | 4 (100) | 32 (74) | 17 (49) |
| ORR, n (%) | 0 | 0 | 1 (8) | 0 | 0 | 4 (9) | 7 (20) |
| Median time to response, months | − | − | 1.2 | − | − | 3.0 | 3.0 |
| Progression-free survival | |||||||
| Events, n (%) | 3 (100) | 3 (100) | 10 (83) | 3 (100) | 4 (100) | 41 (95) | 27 (77) |
| Median (95% CI), months | 3.0 (1.2 to 5.3) |
2.6 (0.7 to 5.4) |
2.0 (1.0 to 4.1) |
3.0 (1.7 to 3.0) |
1.2 (0.7 to 1.9) |
2.9 (2.4 to 3.0) |
3.0 (2.2 to 5.8) |
| Overall survival | |||||||
| Death, n (%) | 3 (100) | 2 (67) | 12 (100) | 3 (100) | 4 (100) | 31 (72) | 25 (71) |
| Median (95% CI), months | 5.3 (3.0 to 11.1) |
9.7 (4.0 to NA) |
6.4 (1.1 to 12.8) |
5.9 (3.8 to 22.2) |
1.7 (0.7 to 6.8) |
11.5 (7.2 to 15.9) |
9.4 (4.6 to 16.4) |
Response and PFS data are based on irRECIST.
BOR, best overall response; irRECIST, immune-related Response Evaluation Criteria in Solid Tumors; NA, not applicable; NSCLC, non-small cell lung cancer; ORR, objective response rate; PFS, progression-free survival; TCID50, 50% tissue culture infectious dose.