Table 1. Baseline Demographics and Neuro-Oncology History for Intent-to-Treat Population.
| Characteristic | No. (%) | ||
|---|---|---|---|
| Toca 511 and Toca FC (n = 201) | Standard of care (n = 202) | Total (N = 403) | |
| Age, y | |||
| Median | 57.0 | 56.0 | 56.0 |
| <65 | 155 (77.1) | 164 (81.2) | 319 (79.2) |
| ≥65 | 46 (22.9) | 38 (18.8) | 84 (20.8) |
| Sex | |||
| Male | 125 (62.2) | 127 (62.9) | 252 (62.5) |
| Female | 76 (37.8) | 75 (37.1) | 151 (37.5) |
| Race | |||
| White | 174 (86.6) | 173 (85.6) | 347 (86.1) |
| Karnofsky Performance Status score category | |||
| 70-80 | 64 (31.8) | 66 (32.7) | 130 (32.3) |
| 90-100 | 137 (68.2) | 136 (67.3) | 273 (67.7) |
| Region | |||
| US | 156 (77.6) | 158 (78.2) | 314 (77.9) |
| Non US | 45 (22.4) | 44 (21.8) | 89 (22.1) |
| Tumor histology at study entry from investigator | |||
| Glioblastoma | 171 (85.1) | 183 (90.6) | 354 (87.8) |
| Anaplastic Astrocytoma | 30 (14.9) | 19 (9.4) | 49 (12.2) |
| IDH1 variant status | |||
| Present (variant) | 27 (13.4) | 31 (15.3) | 58 (14.4) |
| Absent (wild type) | 174 (86.6) | 171 (84.7) | 345 (85.6) |
| No. of recurrences | |||
| 1 | 173 (86.1) | 170 (84.2) | 343 (85.1) |
| 2 | 28 (13.9) | 32 (15.8) | 60 (14.9) |
Abbreviations: HGGs, high-grade gliomas; Toca 511, vocimagene amiretrorepvec; Toca FC, flucytosine.