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Association details:
Biomarker:IDH1 mutation
Cancer:Glioma
Drug:Voranigo (vorasidenib) (IDH1 inhibitor, IDH2 inhibitor)
Direction:Sensitive
Evidence:
Evidence Level:
Sensitive: B - Late Trials
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.
Evidence Level:
Sensitive: B - Late Trials
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:
Evidence Level:
Sensitive: B - Late Trials
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:
Evidence Level:
Sensitive: B - Late Trials
Title:

FDA Grants Fast Track Designation to Vorasidenib in IDH+ Low-Grade Glioma

Published date:
03/16/2023
Excerpt:
Vorasidenib monotherapy received fast track designation from the FDA after prolonging both progression-free survival (PFS) and time to next intervention (TTNI) in patients with residual or recurrent IDH-mutant low-grade glioma whose only prior treatment was surgery, thereby meeting the primary end point and key secondary end point of the phase 3 INDIGO trial (NCT04164901), according to a press release from Servier.
Trial ID:
Evidence Level:
Sensitive: C1 - Off-label
  (Approved for Astrocytoma)
New
Title:

Servier's VORANIGO® (vorasidenib) Tablets Receives FDA Approval as First Targeted Therapy for Grade 2 IDH-mutant Glioma

Excerpt:
Servier...FDA) has approved VORANIGO®, an isocitrate dehydrogenase-1 (IDH1) and isocitrate dehydrogenase-2 (IDH2) inhibitor, indicated for the treatment of adult and pediatric patients 12 years and older with Grade 2 astrocytoma or oligodendroglioma with a susceptible IDH1 or IDH2 mutation following surgery including biopsy, sub-total resection, or gross total resection.
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

ViCToRy: Vorasidenib in Combination With Tumor Specific Peptide Vaccine for Recurrent IDH1 Mutant Lower Grade Gliomas

Excerpt:
...To assess the safety of the PEPIDH1M vaccine in combination vorasidenib in adult patients with progressive IDH1 mutant World Health Organization (WHO) Grade 2-3 gliomas`Describe the efficacy, as measured by progression-free survival (PFS), of the combination of PEPIDH1M vaccine and vorasidenib in adult patients with recurrent IDH1 lower grade glioma...
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Go to data
Title:

Study of Orally Administered AG-881 in Patients With Advanced Solid Tumors, Including Gliomas, With an IDH1 and/or IDH2 Mutation

Excerpt:
...Patients in the dose escalation phase must have disease that has recurred or progressed following standard therapy and/or therapy with an inhibitor of mutant IDH1 and/or IDH2, or that has...
Trial ID:
Less C2 evidence
Evidence Level:
Sensitive: C3 – Early Trials
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:
Evidence Level:
Sensitive: C3 – Early Trials
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: