TABLE 2.
ORR
| Parameter | Efficacy Population (N = 50) | ||
|---|---|---|---|
| RANO-HGGa | RANO-LGGb | Combined HGG/LGGc | |
| ORR, No. (%) [95% CI] | 10 (20.0) [10.0 to 33.7] | 13 (26.0) [14.6 to 40.3] | 15 (30.0) [17.9 to 44.7] |
| CR | 1 (2.0) | 0 | 1 (2.0) |
| PR | 9 (18.0) | 6 (12.0) | 9 (18.0) |
| MR | NA | 7 (14.0) | 5 (10.0) |
| SD | 10 (20.0) | 8 (16.0) | 7 (14.0) |
| NE | 8 (16.0)d | 11 (22.0)e | 11 (22.0) |
| PD | 18 (36.0) | 14 (28.0) | 13 (26.0) |
| NA | 4 (8.0)f | 4 (8.0)f | 4 (8.0)f |
| DCR, No. (%) [95% CI] | 20 (40.0) [26.4 to 54.8] | 21 (42.0) [28.2 to 56.8] | 22 (44.0) [30.0 to 58.7] |
Abbreviations: BICR, blind independent central review; CR, complete response; DCR, disease control rate (CR + PR + SD); HGG, high-grade glioma; LGG, low-grade glioma; MR, minor response; MRI, magnetic resonance imaging; NA, not applicable; NE, not evaluable; ORR, overall response rate; PD, progressive disease; PR, partial response; RANO, response assessment in neuro-oncology; SD, stable disease.
Integrated RANO-HGG criteria assessment by dual-reader BICR.
Integrated RANO-LGG criteria assessment by dual-reader BICR.
Incorporates the best response by RANO-HGG or RANO-LGG criteria for each patient.
Five overall radiographic SD accompanied by increase in corticosteroids; three overall radiographic PD accompanied by decrease in corticosteroids.
Eight overall radiographic SD accompanied by increase in corticosteroids; three overall radiographic PD accompanied by decrease in corticosteroids.
Three patients did not have on-treatment monotherapy MRIs available for BICR; one patient censored before first on-treatment MRI.