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Association details:
| Biomarker: | IDH2 mutation |
|---|---|
| Cancer: | Glioma |
| Drug: | vorasidenib (S95032) (IDH1 inhibitor, IDH2 inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
Servier Receives Regulatory Filing Acceptances from FDA and EMA for Vorasidenib in the Treatment of IDH-Mutant Diffuse Glioma
Published date:
02/20/2024
Excerpt:
...FDA filing acceptance and priority review for a New Drug Application (NDA) for vorasidenib, as well as the EMA granting accelerated assessment for the vorasidenib Marketing Authorization Application (MAA). This innovative targeted therapy is an oral, selective, highly brain-penetrant dual inhibitor of mutant isocitrate dehydrogenase 1 and 2 (IDH1/2) enzymes for the treatment of IDH-mutant diffuse glioma.
Source:
Title:
498O - INDIGO: A randomized, double-blinded, phase III study of vorasidenib versus placebo in IDH1 or IDH2 low-grade glioma
Published date:
10/16/2023
Excerpt:
In the first randomized phase 3 study of a targeted therapy in grade 2 mIDH1/2 glioma, VOR significantly improved PFS by BIRC compared with PBO, with a manageable safety profile. Findings show the clinical benefit of VOR in pts for whom chemotherapy and radiotherapy are being delayed.
Trial ID:
Source:
Title:
Vorasidenib in IDH1- or IDH2-Mutant Low-Grade Glioma
Published date:
06/04/2023
Excerpt:
In a double-blind, phase 3 trial, we randomly assigned patients with residual or recurrent grade 2 IDH-mutant glioma....Progression-free survival was significantly improved in the vorasidenib group as compared with the placebo group (median progression-free survival, 27.7 months vs. 11.1 months; hazard ratio for disease progression or death, 0.39; 95% confidence interval [CI], 0.27 to 0.56; P<0.001)....In patients with grade 2 IDH-mutant glioma, vorasidenib significantly improved progression-free survival and delayed the time to the next intervention.
DOI:
10.1056/NEJMoa2304194
Trial ID:
Source:
Title:
Servier’s Pivotal Phase 3 INDIGO Trial Investigating vorasidenib in IDH-Mutant Low-Grade Glioma Meets Primary Endpoint of Progression-Free Survival (PFS) and Key Secondary Endpoint of Time to Next Intervention (TTNI)
Published date:
03/14/2023
Excerpt:
Servier, a global pharmaceutical group, announced today that the Phase 3 INDIGO clinical trial investigating vorasidenib in monotherapy for patients with residual or recurrent IDH mutant low-grade glioma met its primary endpoint of progression free survival (PFS) and the key secondary endpoint of time to next intervention (TTNI). The results of the prespecified interim analysis were both statistically significant and clinically meaningful.
Trial ID:
Source:
Title:
Study of Orally Administered AG-881 in Patients With Advanced Solid Tumors, Including Gliomas, With an IDH1 and/or IDH2 Mutation
Excerpt:
...- Patient must have histologically or cytologically confirmed solid tumor, including glioma, with documented IDH1 and/or IDH2 gene-mutation....
Trial ID:
Source:
Title:
Vorasidenib Expanded Access Program
Excerpt:
...- Have IDH-mutant oligodendroglioma or astrocytoma per WHO 2021 criteria, with the IDH1 or IDH2 gene mutation confirmed by tissue-based diagnosis....
Trial ID:
More C2 evidence
Source:
Title:
Study of Vorasidenib (AG-881) in Participants With Residual or Recurrent Grade 2 Glioma With an IDH1 or IDH2 Mutation (INDIGO)
Excerpt:
...- Have confirmed IDH1 (IDH1 R132H/C/G/S/L mutation variants tested) or IDH2 (IDH2 R172K/M/W/S/G mutation variants tested) gene mutation status disease by central laboratory testing during the Prescreening period and available 1p19q status by local testing (eg, fluorescence in situ hybridization [FISH], comparative genomic hybridization [CGH] array, sequencing) using an accredited laboratory....
Trial ID:
Less C2 evidence
Source:
Title:
Safety and Efficacy of Vorasidenib in Recurrent or Progressive Glioma
Published date:
06/29/2021
Excerpt:
Vorasidenib was well tolerated and showed preliminary antitumor activity in patients with recurrent or progressive nonenhancing mIDH LGG.
Trial ID:
Source:
Title:
Vorasidenib, a dual inhibitor of mutant IDH1/2, in recurrent or progressive glioma; Results of a first-in-human Phase I trial
Published date:
06/02/2021
Excerpt:
...patients with mutant IDH1/2 (mIDH1/2) solid tumors, including 52 patients with glioma...in patients with nonenhancing glioma was 18% (one partial response, three minor responses). The median progression-free survival was 36.8 months [95% confidence interval (CI), 11.2-40.8] for patients with nonenhancing glioma and 3.6 months (95% CI, 1.8-6.5) for patients with enhancing glioma. Exploratory evaluation of tumor volumes in patients with nonenhancing glioma showed sustained tumor shrinkage in multiple patients. Vorasidenib was well tolerated and showed preliminary antitumor activity in patients with recurrent or progressive nonenhancing mIDH LGG.
DOI:
10.1158/1078-0432.CCR-21-0611
Trial ID:
