Table 1.
Baseline characteristics (Full analysis set)
| Variable | Infigratinib (N = 26) |
|---|---|
| Age, years | |
| Median (range) | 55 (20–76) |
| Sex, n (%) | |
| Male | 16 (61.5) |
| Female | 10 (38.5) |
| Race, n (%) | |
| Caucasian | 26 (100) |
| ECOG performance status, n (%) | |
| 0 | 6 (23.1) |
| 1 | 12 (46.2) |
| 2 | 8 (30.8) |
| Histology, n (%)a | |
| Glioblastoma | 19 (73.1) |
| Anaplastic astrocytoma | 5 (19.2) |
| Other glioma | 2 (7.7) |
| Measurable disease at baseline, n (%) | 22 (84.6) |
| IDH1/IDH2 status, n (%) | |
| IDH1 mutation (R132H) | 2 (7.7) |
| FGFR1 status, n (%)b | |
| Amplification | 1 (3.8) |
| Fusion (ARHGEF18) | 1 (3.8) |
| Mutation | 3 (11.5) |
| K656E | 2 (7.7) |
| N546K | 1 (3.8) |
| FGFR3 status, n (%)bc | |
| Amplification | 11 (42.3) |
| Fusion (TACC3) | 10 (38.5) |
| Mutation | 2 (7.7) |
| K650E | 1 (3.8) |
| S249C | 1 (3.8) |
| Prior treatment, n (%) | |
| Radiotherapy | 26 (100.0) |
| Anti-neoplastic therapy | 25 (96.2) |
| Temozolomide | 23 (88.5) |
| Bevacizumab | 10 (38.5) |
| Other | 1 (3.8) |
| Prior anti-neoplastic regimens, n (%) | |
| 0 | 1 (3.8) |
| 1 | 11 (42.3) |
| 2 | 9 (34.6) |
| ≥3 | 5 (19.2) |
a
Both diagnoses of “glioma” were subsequently clarified post-hoc as glioblastoma and one of “anaplastic astrocytoma” would be currently defined as a molecular glioblastoma (IDH-wild type, TERT-mutant diffuse astrocytoma; Supplementary Fig. S6 with references therein).
b
FGFR alterations for enrollment by local CLIA-accredited or central laboratory during screening, as reported by the investigator.
c
Three patients had more than 1 FGFR3 alteration.
Abbreviations: CLIA, Clinical Laboratory Improvement Amendments; ECOG, Eastern Cooperative Oncology Group; FGFR, fibroblast growth factor receptor; IDH, isocitrate dehydrogenase.