Is Vorasidenib Monotherapy Effective for Glioma?
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On August 17, 2023, Ingo K. Mellinghoff and colleagues from Memorial Sloan Kettering Cancer Center published the results of the INDIGO Phase III clinical trial in the medical journal "The New England Journal of Medicine." The trial investigated the effectiveness and safety of vorasidenib monotherapy in patients with IDH1/2-mutant recurrent grade 2 glioma.
In this Phase III clinical trial, patients with IDH1/2-mutant recurrent grade 2 glioma (N=331) were randomly assigned to either the vorasidenib group (40mg once daily in 28-day cycles, N=168) or the placebo group (N=163). The primary endpoint was progression-free survival (PFS), and a key secondary endpoint was the time to next treatment (the period before starting another anticancer drug as second-line treatment).
With a median follow-up of 14.2 months, the median progression-free survival was 27.7 months for the vorasidenib group and 11.1 months for the placebo group. The secondary endpoint, time to next treatment, showed significant improvement in the vorasidenib group compared to the placebo group.
The incidence of side effects of Grade 3 or higher was 22.8% in the vorasidenib group and 13.5% in the placebo group. Among Grade 3 or higher side effects, the incidence of elevated ALT (alanine aminotransferase) was 9.6% in the vorasidenib group and was not observed in the placebo group.
Based on the results of the INDIGO trial, Ingo K. Mellinghoff and colleagues stated that vorasidenib monotherapy significantly improved progression-free survival and delayed the time to next treatment in patients with IDH1/2-mutant recurrent grade 2 glioma.
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