Significant improvement seen in progression-free survival and in time to next intervention for vorasidenib versus placebo
By Elana Gotkine HealthDay Reporter
TUESDAY, June 6, 2023 (HealthDay News) — Vorasidenib significantly improves progression-free survival among patients with grade 2 isocitrate dehydrogenase (IDH)-mutant glioma, according to a study published online June 4 in the New England Journal of Medicine to coincide with the annual meeting of the American Society of Clinical Oncology, held from June 2 to 6 in Chicago.
Ingo K. Mellinghoff, M.D., from the Memorial Sloan Kettering Cancer Center in New York City, and colleagues randomly assigned patients with residual or recurrent grade 2 IDH-mutant glioma who had undergone no previous treatment other than surgery to receive either oral vorasidenib or matched placebo (168 and 163 patients, respectively). The primary end point was imaging-based progression-free survival.
The researchers found that 226 patients (68.3 percent) were continuing to receive vorasidenib or placebo at a median follow-up of 14.2 months. Progression-free survival was significantly improved with vorasidenib versus placebo (27.7 versus 11.1 months; hazard ratio for disease progression or death, 0.39). Compared with the placebo group, the vorasidenib group had significantly improved time to next intervention (hazard ratio, 0.26). Adverse events of grade 3 or higher occurred in 22.8 and 13.5 percent of those who received vorasidenib and placebo, respectively.
“Our study shows that targeting IDH mutations with vorasidenib significantly delays tumor growth and the need for more toxic therapies,” Mellinghoff said in a statement. “This is clinically meaningful because patients diagnosed with grade 2 glioma with IDH mutations are typically young, otherwise healthy individuals. The results of this trial offer a chance to change the treatment paradigm for this type of glioma and could bring the first new targeted therapy for low-grade glioma.”
The study was funded by Servier, the developer of vorasidenib.
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