Evaluation of Vorasidenib Plus Temozolomide in IDH1/2-Mutated Glioma
Key Clinical Takeaways
- Vorasidenib (40 mg once daily) plus standard temozolomide was well tolerated in patients with grade IDH1/2-mutated gliomas, with no dose-limiting toxicities reported.
- The combination demonstrated a manageable safety profile, with mostly low-grade, transient liver enzyme elevations and myelosuppression.
- Phase 2 will further evaluate safety and preliminary efficacy in newly diagnosed grade 4 IDH1/2-mutated astrocytoma following radiotherapy.
Macarena De La Fuente, MD, University of Miami, Miami, Florida, discusses results from a phase 1b study that evaluated the safety and tolerability of vorasidenib, a dual IDH1/2 inhibitor, combined with standard-of-care temozolomide in patients with IDH1/2-mutated glioma.
The combination was well tolerated with no dose-limiting toxicities, establishing 40 mg of once daily vorasidenib plus standard temozolomide as the recommended combination dose for phase 2, which will assess safety and preliminary efficacy in newly diagnosed patients with grade 4 IDH1/2-mutated astrocytoma.
These results were presented at the 2025 Society for Neuro-Oncology (SNO) Annual Meeting in Honolulu, Hawaii.
Source:
De La Fuente MI, Cloughesy TF, Touat M, et al. Phase 1B study of vorasidenib in combination with temozolomide in participants with IDH1- or IDH2-mutant glioma. Presented at the SNO Annual Meeting. November 19 - 23, 2025; Honolulu, Hawaii. Abstract CTNI-34.
