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A.6 INDIGO: a global, randomized, double-blinded, Phase 3 study of vorasidenib versus placebo in patients with grade 2 glioma with an IDH1/2 mutation (mIDH1/2)

Published online by Cambridge University Press:  24 May 2024

JR Perry
Affiliation:
(Toronto)*
IK Mellinghoff
Affiliation:
(New York City)
M van den Bent
Affiliation:
(Rotterdam)
DT Blumenthal
Affiliation:
(Tel Aviv)
M Touat
Affiliation:
(Paris)
KB Peters
Affiliation:
(Durham)
J Clarke
Affiliation:
(San Francisco)
J Mendez
Affiliation:
(Salt Lake City)
S Yust-Katz
Affiliation:
(Tel Aviv)
W Mason
Affiliation:
(Toronto)
F Ducray
Affiliation:
(Lyon)
Y Umemura
Affiliation:
(Phoenix)
B Nabors
Affiliation:
(Birmingham)
M Holdhoff
Affiliation:
(Baltimore)
AF Hottinger
Affiliation:
(Lausanne)
Y Arakawa
Affiliation:
(Kyoto)
J Sepúlveda
Affiliation:
(Madrid)
W Wick
Affiliation:
(Heidelberg)
R Soffietti
Affiliation:
(Turin)
P Giglio
Affiliation:
(Columbus)
M de la Fuente
Affiliation:
(Miami)
E Maher
Affiliation:
(Dallas)
BM Ellingson
Affiliation:
(Los Angeles)
A Bottomley
Affiliation:
(Overijse)
D Zhao
Affiliation:
(Boston)
SS Pandya
Affiliation:
(Boston)
AE Tron
Affiliation:
(Boston)
L Steelman
Affiliation:
(Boston)
I Hassan
Affiliation:
(Boston)
PY Wen
Affiliation:
(Boston)
TF Cloughesy
Affiliation:
(Los Angeles)
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Abstract

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Background: We evaluated vorasidenib (VOR), a dual inhibitor of mIDH1/2, in patients with mIDH1/2 glioma (Phase 3; NCT04164901). Methods: Patients with residual/recurrent grade 2 mIDH1/2 oligodendroglioma or astrocytoma were enrolled (age ≥12; Karnofsky Performance Score ≥80; measurable non-enhancing disease; surgery as only prior treatment; not in immediate need of chemoradiotherapy). Patients were stratified by 1p19q status and baseline tumor size and randomized 1:1 to VOR 40 mg or placebo (PBO) daily in 28-day cycles. Endpoints included imaging-based progression-free survival (PFS), time to next intervention (TTNI), tumor growth rate (TGR), health-related quality of life (HRQoL), neurocognition and seizure activity. Results: 331 patients were randomized (VOR, 168; PBO, 163). The median age was 40.0 years. 172 and 159 patients had histologically confirmed oligodendroglioma and astrocytoma, respectively. Treatment with VOR significantly improved PFS and TTNI. Median PFS: VOR, 27.7 mos; PBO, 11.1 mos (P=0.000000067). Median TTNI: VOR, not reached; PBO, 17.8 mos (P=0.000000019). Treatment with VOR resulted in shrinkage of tumor volume. Post-treatment TGR: VOR, -2.5% (95% CI: -4.7, -0.2); PBO, 13.9% (95% CI: 11.1, 16.8). HRQoL and neurocognition were preserved and seizure control was maintained. VOR had a manageable safety profile. Conclusions: VOR was effective in mIDH1/2 diffuse glioma not in immediate need of chemoradiotherapy.

Type
Abstracts
Copyright
© The Author(s), 2024. Published by Cambridge University Press on behalf of Canadian Neurological Sciences Federation