Baseline patient characteristics
| Study 001 (n=43) | Study 012 (n=16) | Full analysis set (N=59) | |
| Sex | |||
| Male | 14 (32.6) | 1 (6.3) | 15 (25.4) |
| Female | 29 (67.4) | 15 (93.8) | 44 (74.6) |
| Age, median (IQR), years | 56.0 (49.0–64.0) | 57.6 (44.0–63.6) | 56.0 (48.3–64.0) |
| <65 | 33 (76.7) | 13 (81.3) | 46 (78.0) |
| ≥65 | 10 (23.3) | 3 (18.8) | 13 (22.0) |
| Geographic region | |||
| North America | 23 (53.5) | 16 (100) | 39 (66.1) |
| Europe | 13 (30.2) | 0 | 13 (22.0) |
| Asia Pacific | 7 (16.3) | 0 | 7 (11.9) |
| Time since first diagnosis, median (range), months | 34.2 (5.4–125.5) | 31.5 (9.4–80.5) | 34.2 (5.4–125.5) |
| No of prior anti-cancer therapies | |||
| 1 | 14 (32.6) | 6 (37.5) | 20 (33.9) |
| 2 | 13 (30.2) | 2 (12.5) | 15 (25.4) |
| ≥3 | 16 (37.2) | 8 (50.0) | 24 (40.7) |
| Type of previous anti-cancer therapy for metastatic or locally advanced disease | |||
| Cytotoxic therapy | 43 (100) | 16 (100) | 59 (100) |
| Monoclonal antibodies | 27 (62.8) | 6 (37.5) | 33 (55.9) |
| Immunotherapy other than anti-PD-(L)1* | 3 (7.0) | 1 (6.3) | 4 (6.8) |
| ECOG performance status | |||
| 0 | 21 (48.8) | 8 (50) | 29 (49.2) |
| 1 | 22 (51.2) | 8 (50) | 30 (50.8) |
| Primary tumor type | |||
| Cervical | 25 (58.1) | 8 (50.0) | 33 (55.9) |
| SCCHN | 14 (32.6) | 1 (6.3) | 15 (25.4) |
| Anal | 4 (9.3) | 2 (12.5) | 6 (10.2) |
| Rectal SCC | 0 | 2 (12.5) | 2 (3.4) |
| Vaginal | 0 | 1 (6.3) | 1 (1.7) |
| Vulvar | 0 | 1 (6.3) | 1 (1.7) |
| Neuroendocrine cervical | 0 | 1 (6.3) | 1 (1.7) |
| Primary HPV status at screening† | |||
| Positive | 36 (83.7) | 16 (100) | 52 (88.1) |
| Negative | 3 (7.0) | 0 | 3 (5.1) |
| Unknown | 4 (9.3) | 0 | 4 (6.8) |
Data are n (%), unless otherwise specified.
*All four patients received adoptive T-cell transfer.
†In the dose-escalation cohort, when tissue was available, HPV status was determined by PCR using the cobas 4800 HPV test (Roche Molecular Systems). In the dose-expansion cohort, HPV status was determined by RNA sequencing or the investigators.
ECOG, Eastern Cooperative Oncology Group; HPV, human papillomavirus; IQR, interquartile range; PD-1, programmed cell death protein 1; PD-L1, programmed cell death ligand 1; SCC, squamous cell carcinoma; SCCHN, SCC of the head and neck.