A global, randomized, double-blinded, Phase 3 trial of vorasidenib vs placebo in patients with grade 2 glioma with an IDH1/2 mutation (INDIGO): updated efficacy and safety

Timothy Cloughesy, MD, reviews updated findings from the global, randomized, double-blind phase 3 INDIGO trial evaluating vorasidenib vs placebo in patients with IDH1/2-mutant grade 2 glioma following surgery. With a median follow-up of 41.6 months, vorasidenib demonstrated sustained clinical benefit, substantially extending progression-free survival and delaying the need for subsequent intervention, including radiation, chemotherapy, or surgery. Cloughesy highlights that median progression-free survival reached 44.1 months by blinded independent review, while 74.2% of patients had not required additional treatment at 48 months. The updated analysis also showed deeper tumor shrinkage and improving response trends over time, supporting a durable and continuous treatment effect. Safety findings remained consistent with prior reports, with no new safety signals observed during extended follow-up. These results reinforce vorasidenib as a tolerable targeted therapy option for patients with IDH-mutant grade 2 glioma and may inform long-term treatment sequencing in this setting for oncology teams and neuro-oncology care.