Table 3.
Prior treatment data with comparison between Vaccine vs. Placebo in the ITT and PT cohorts, and in the 3-arm analysis (TLPLDC vs TLPLDC + G vs placebo)
| Category | Intention to treat analysis | Three-arm analysis | ||||||
|---|---|---|---|---|---|---|---|---|
| Vaccine (%) | Placebo (%) | p-value | TLPLDC (%) | TLPLDC + G (%) | Placebo (%) | p-value | ||
| Wide local excision | ||||||||
| Yes | 100 (97.1) | 40 (97.6) | 0.876 | 46 (97.9) | 54 (96.4) | 40 (97.6) | 0.895 | |
| No | 3 (2.9) | 1 (2.4) | 1 (2.1) | 2 (3.6) | 1 (2.4) | |||
| Lymph node surgery | ||||||||
| SLNB | 17 (16.5) | 6 (14.6) | 0.077 | 7 (14.9) | 10 (17.9) | 6 (14.6) | 0.267 | |
| LND | 39 (37.9) | 9 (22.0) | 17 (36.2) | 22 (39.3) | 9 (22.0) | |||
| SLNB and LND | 20 (19.4) | 16 (39.0) | 11 (23.4) | 9 (16.1) | 16 (39.0) | |||
| None | 27 (26.2) | 10 (24.4) | 12 (25.5) | 15 (26.8) | 10 (24.4) | |||
| Immunotherapy | ||||||||
| Yes | 41 (39.8) | 15 (36.6) | 0.721 | 19 (40.4) | 22 (39.3) | 15 (36.6) | 0.931 | |
| No | 62 (60.2) | 26 (63.4) | 28 (59.6) | 34 (60.7) | 26 (63.4) | |||
| Checkpoint inhibitor | ||||||||
| Yes | 34 (33.0) | 9 (22.0) | 0.191 | 16 (34.0) | 18 (32.1) | 9 (22.0) | 0.416 | |
| No | 69 (67.0) | 32 (78.0) | 31 (66.0) | 38 (67.9) | 32 (78.0) | |||
| Chemotherapy | ||||||||
| Yes | 7 (6.8) | 1 (2.4) | 0.303 | 2 (4.3) | 5 (8.9) | 1 (2.4) | 0.346 | |
| No | 96 (93.2) | 40 (97.6) | 45 (95.7) | 51 (91.1) | 40 (97.6) | |||
| Radiation therapy | ||||||||
| Yes | 26 (25.2) | 11 (26.8) | 0.844 | 14 (29.8) | 12 (21.4) | 11 (26.8) | 0.615 | |
| No | 77 (74.8) | 30 (73.2) | 33 (70.2) | 44 (78.2) | 30 (73.2) | |||