Table 1.
Baseline Characteristics
| Characteristics*,† | Olutasidenib (N = 26) |
|---|---|
| Age in years | |
| Median (IQR) | 45 (40‒49) |
| By category | |
| 18–40 | 7 (27%) |
| 41–59 | 16 (62%) |
| ≥60 | 3 (12%) |
| Sex‡ | |
| Female | 9 (35%) |
| Male | 17 (65%) |
| Race | |
| White | 25 (96%) |
| Not reported | 1 (4%) |
| Ethnicity | |
| Hispanic | 2 (8%) |
| Non-Hispanic | 22 (85%) |
| Not reported | 2 (8%) |
| ECOG performance status | |
| 0 | 10 (38%) |
| 1 | 13 (50%) |
| 2 | 3 (12%) |
| Grade at initial diagnosis | |
| II | 7 (27%) |
| III | 14 (54%) |
| IV | 3 (12%) |
| Unknown/NA | 2 (8%) |
| IDH1 mutation subtype | |
| R132H | 22 (85%) |
| R132L | 2 (8%) |
| R132C | 1 (4%) |
| R132G | 1 (4%) |
| Baseline steroid use | |
| Yes | 5 (19%) |
| No | 21 (81%) |
| Median (IQR) years since initial diagnosis | 6 (4-11) |
| Median (IQR) years since last recurrence | 0.3 (0.1-3.1) |
| Prior therapies** | |
| Surgery only | 2 (8%) |
| Systemic therapy and surgery | 24 (92%) |
| Radiation | 26 (100%) |
| Median (IQR) number of prior surgeries | 2 (1‒2) |
| Median (IQR) years since last surgery | 1.8 (0.5–2.7) |
| Median (IQR) years since last radiation | 1.9 (0.9–6.4) |
| Median (IQR) number prior regimens§ | 2 (1‒3) |
| Number of prior regimens§ | |
| 1 | 7 (27%) |
| 2 | 6 (23%) |
| 3 | 7 (27%) |
| >3 | 4 (15%) |
| Glioma diagnosis | |
| Diffuse astrocytoma, IDH mutant | 1 (4%) |
| Anaplastic astrocytoma, IDH mutant*** | 12 (46%) |
| Oligodendroglioma, IDH mutant | 4 (15%) |
| Anaplastic oligodendroglioma, IDH mutant | 2 (8%) |
| Glioblastoma, IDH mutant | 7 (27%) |
| Tumor type | |
| Enhancing | 23 (88%) |
| Non-enhancing | 3 (12%) |
| Glioma grade at study enrolment (per WHO)**** | |
| II | 4 (15%) |
| III | 15 (58%) |
| IV | 7 (27%) |
*Data are n (%) and median (IQR), unless shown otherwise.
†Percentages may not sum to 100% due to rounding.
‡Sex (as assigned at birth).
§ n = 24.
**All prior antitumor treatments were allowed, except for prior IDH1 inhibitor treatment; the minimum elapsed time from last dose of prior treatment to first dose of olutasidenib was specified by the study protocol.
***Includes one patient with a diagnosis of “anaplastic astrocytoma, NOS”; patient was confirmed to harbor an R132H IDH1 mutation.
****Includes updated tumor grade information for 5 patients with surgery with ~2 months of enrolment.
ECOG, Eastern Cooperative Oncology Group; IQR, interquartile range; NA, not applicable, NOS, not otherwise specified; STD, standard deviation; WHO, World Health Organization.