Summary of tumor response and survival data
| Study 001 (n=43) | Study 012 (n=16) | Full analysis set (N=59) | |
| Confirmed BOR, n (%) | |||
| CR | 3 (7.0) | 2 (12.5) | 5 (8.5) |
| PR | 9 (20.9) | 4 (25.0) | 13 (22.0) |
| SD | 6 (14.0) | 2 (12.5) | 8 (13.6) |
| PD | 20 (46.5) | 7 (43.8) | 27 (45.8) |
| Not evaluable | 5 (11.6) | 1 (6.3) | 6 (10.2) |
| Delayed PR* | 3 (7.0) | 0 | 3 (5.1) |
| Confirmed ORR, n (%; 95% CI) | 12 (27.9; 15.3 to 43.7) | 6 (37.5; 15.2 to 64.6) | 18 (30.5; 19.2 to 43.9) |
| Disease control, n (%; 95% CI)† | 18 (41.9; 27.0 to 57.9) | 8 (50.0; 24.7 to 75.3) | 26 (44.1; 31.2 to 57.6) |
| Total clinical response rate, n (%; 95% CI)‡ | 15 (34.9; 21.0 to 50.9) | 6 (37.5; 15.2 to 64.6)§ | 21 (35.6; 23.6 to 49.1)§ |
| Duration of response, median, months (95% CI) | 19.1 (4.2 to 27.4) | NR (4.2 to NR) | 19.1 (9.6 to 27.4) |
| KM-estimated PFS, median, months (95% CI) | 2.8 (1.4 to 4.6) | 3.3 (1.4 to NR) | 2.8 (1.4 to 5.5) |
| KM-estimated PFS rate, % (95% CI) | |||
| 6 months | 31.0 (17.8 to 45.0) | 43.8 (19.8 to 65.6) | 34.2 (22.4 to 46.4) |
| 12 months | 26.2 (14.1 to 40.0) | 29.2 (9.6 to 52.3) | 27.0 (16.3 to 38.9) |
| 18 months | 23.3 (11.8 to 37.0) | – | 24.3 (13.8 to 36.4) |
| KM-estimated OS, median, months (95% CI) | 16.2 (7.1 to NR) | NR (3.7 to NR) | NR (8.6 to NR) |
| KM-estimated OS rate, % (95% CI) | |||
| 6 months | 73.7 (57.5 to 84.5) | 72.1 (41.5 to 88.6) | 73.1 (59.4 to 82.9) |
| 12 months | 56.5 (40.1 to 70.0) | 72.1 (41.5 to 88.6) | 58.8 (44.3 to 70.8) |
| 18 months | 48.8 (32.8 to 63.0) | – | 51.4 (36.5 to 64.3) |
Data are according to investigator-assessed RECIST V.1.1.
*Due to confirmed PD before onset of response, these patients did not meet response criteria by RECIST V.1.1.
†CR plus PR plus SD.
‡ORR per RECIST V.1.1 plus delayed PR after initial disease progression.
§One additional patient with a vulvar tumor had an unconfirmed CR.
BOR, best overall response; CR, complete response; HPV, human papillomavirus; KM, Kaplan-Meier; NR, not reached; OS, overall survival; PD, progressive disease; PFS, progression-free survival; PR, partial response; RECIST, Response Evaluation Criteria in Solid Tumors; SD, stable disease.