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. 2024 Feb 9;42(13):1542–1552. doi: 10.1200/JCO.23.01134

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.

a

Integrated RANO-HGG criteria assessment by dual-reader BICR.

b

Integrated RANO-LGG criteria assessment by dual-reader BICR.

c

Incorporates the best response by RANO-HGG or RANO-LGG criteria for each patient.

d

Five overall radiographic SD accompanied by increase in corticosteroids; three overall radiographic PD accompanied by decrease in corticosteroids.

e

Eight overall radiographic SD accompanied by increase in corticosteroids; three overall radiographic PD accompanied by decrease in corticosteroids.

f

Three patients did not have on-treatment monotherapy MRIs available for BICR; one patient censored before first on-treatment MRI.