====== IDH-mutant glioma treatment ======
In a [[double-blind]], phase 3 [[trial]], Mellinghoff et al. randomly assigned patients with residual or recurrent [[grade 2 glioma]] IDH-mutant glioma who had undergone no previous treatment other than surgery to receive either oral [[vorasidenib]] (40 mg once daily) or matched [[placebo]] in 28-day cycles. The primary end point was [[imaging]]-based [[progression-free survival]] according to blinded assessment by an independent [[review]] [[committee]]. The key secondary end point was the time to the next anticancer intervention. [[Crossover]] to vorasidenib from placebo was permitted on confirmation of imaging-based disease progression. Safety was also assessed.

A total of 331 patients were assigned to receive vorasidenib (168 patients) or placebo (163 patients). At a median follow-up of 14.2 months, 226 patients (68.3%) were continuing to receive vorasidenib or placebo. 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). The time to the next intervention was significantly improved in the vorasidenib group as compared with the placebo group (hazard ratio, 0.26; 95% CI, 0.15 to 0.43; P<0.001). Adverse events of grade 3 or higher occurred in 22.8% of the patients who received vorasidenib and in 13.5% of those who received placebo. An increased alanine aminotransferase level of grade 3 or higher occurred in 9.6% of the patients who received vorasidenib and in no patients who received placebo

In patients with grade 2 [[IDH-mutant glioma]], vorasidenib significantly improved [[progression-free survival]] and delayed the time to the next [[intervention]]. (Funded by Servier; INDIGO ClinicalTrials.gov number, NCT04164901.).
((Mellinghoff IK, van den Bent MJ, Blumenthal DT, Touat M, Peters KB, Clarke J, Mendez J, Yust-Katz S, Welsh L, Mason WP, Ducray F, Umemura Y, Nabors B, Holdhoff M, Hottinger AF, Arakawa Y, Sepulveda JM, Wick W, Soffietti R, Perry JR, Giglio P, de la Fuente M, Maher EA, Schoenfeld S, Zhao D, Pandya SS, Steelman L, Hassan I, Wen PY, Cloughesy TF. Vorasidenib in IDH1- or IDH2-Mutant Low-Grade Glioma. N Engl J Med. 2023 Jun 4. doi: 10.1056/NEJMoa2304194. Epub ahead of print. PMID: 37272516.))