Voranigo (vorasidenib)

Pseudotime trajectory inference revealed a multifurcating developmental model from an Astrocytic-like origin, with GCL tumors gaining preferential access to proliferative and mesenchymal endpoints. A reorganized immune microenvironment and candidate therapeutic axes including CDK4/6 - E2F , MYC / BET , KIF11 , and NOTCH, potentially combinable with vorasidenib as an epigenomic backbone provide a translationally actionable framework for intercepting GCL progression in IDH-mutant glioma.

P3, N=408, Recruiting, Alliance for Clinical Trials in Oncology | Not yet recruiting --> Recruiting | Initiation date: Oct 2025 --> Jul 2026

This case highlights the potential clinical relevance of IDH-directed therapy in IDH2-mutant cholangiocarcinoma and demonstrates feasibility in an immunosuppressed post-transplant setting. These findings are hypothesis-generating and support further evaluation of IDH inhibition in this population.

P1, N=24, Not yet recruiting, Megan Mantica

P1, N=20, Recruiting, Institut de Recherches Internationales Servier (I.R.I.S.) | Not yet recruiting --> Recruiting | Trial completion date: Jul 2026 --> Nov 2026 | Trial primary completion date: Jul 2026 --> Nov 2026

P3, N=57, Active, not recruiting, Servier | Trial primary completion date: Oct 2025 --> May 2026

The recent INDIGO trial, which demonstrated efficacy of the IDH1/2 inhibitor vorasidenib in residual grade 2 IDH-mutant glioma, has further increased the importance of preoperative imaging assessment of IDH mutation status...Third, we discuss the implications of cIMPACT-NOW Updates 8-11 for neuroradiologic diagnosis. In the WHO CNS5 era, imaging plays a central role in supporting integrated diagnosis and prioritizing appropriate molecular testing.

P1, N=28, Completed, Institut de Recherches Internationales Servier (I.R.I.S.) | Recruiting --> Completed

The IDH-mutant inhibitor vorasidenib has been demonstrated to prolong progression-free survival in grade 2 IDH-mutant glioma; however, there is a lack of evidence in patients younger than 18...Craniopharyngioma is a rare CNS tumor in the AYA population, and BRAFV600E mutations in papillary craniopharyngioma represent a targetable alteration. Solutions to improving the care of AYA should include appropriate representation in clinical trials and specialized care by experienced clinicians.

In conclusion, vorasidenib was generally safe and well tolerated, and plasma exposures were generally similar between Japanese and non-Asian participants following single oral 10- and 50-mg vorasidenib doses. These results enabled vorasidenib clinical development in Japan and supported inclusion of Japanese sites in subsequent vorasidenib clinical trials without dose adjustments.

P=N/A, N=90, Recruiting, Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

The striking reductions in tumor 2HG and tCho levels early following initiation of targeted therapy using an IDH inhibitor suggest that MRS may provide an important tool for monitoring treatment response of lower-grade gliomas.