Extended INDIGO follow-up shows vorasidenib continues to delay progression and defer intervention in IDH-mutant glioma
touchONCOLOGY coverage of ASCO 2026
→ Abstract 2010: Cloughesy TF, van den Bent MJ, Blumenthal DT, et al. 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. Presented at: ASCO, Chicago, IL, USA. May 29 to June 2, 2026.
Extended follow-up from the phase 3 INDIGO trial presented at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago provides further evidence that vorasidenib may offer durable disease control in patients with grade 2 glioma harboring isocitrate dehydrogenase 1/2 mutations, reinforcing earlier findings that led to its regulatory approvals. Presenting the updated analysis, Dr Timothy Cloughesy (University of California, Los Angeles, CA, USA) reported that with more than three years of follow-up, the oral dual mutant IDH1/2 inhibitor continued to demonstrate prolonged progression-free survival and delayed need for subsequent intervention. In the article below, we provide a details analysis of the latest INDIGO data and Dr Cloughesy’s expert perspective on what the longer-term efficacy and safety findings could mean for the evolving treatment landscape in IDH-mutant glioma.
Grade 2 isocitrate dehydrogenase (IDH)-mutant gliomas are diffuse, slowly progressive malignant brain tumours associated with a poor long-term prognosis. “Historically, many patients with Grade 2 IDH-mutant gliomas faced a poor long-term prognosis and managed their disease with a ‘watch and wait’ strategy due to the limited availability of targeted treatment options. These results provide valuable evidence for the glioma community on how long-term treatment with vorasidenib can delay disease progression, extend the time to next intervention and improve patient responses over time”, commented Dr Cloughesy.
The global, randomized, double-blind, placebo-controlled INDIGO trial (NCT04164901) enrolled 331 patients with residual or recurrent grade 2 oligodendroglioma or astrocytoma carrying an IDH1/2 mutation. Eligible patients had undergone surgery as their only prior treatment, had measurable non-enhancing disease, a Karnofsky performance score of at least 80, and no immediate requirement for chemoradiotherapy. Participants were randomized 1:1 to vorasidenib 40 mg once daily in 28-day cycles or placebo, with crossover to vorasidenib permitted after study unblinding.
At the January 17, 2025 data cutoff, 168 patients had been assigned to vorasidenib and 163 to placebo. Median age was 40.0 years (range: 16–71), with 172 oligodendrogliomas and 159 astrocytomas represented. Among those randomized to vorasidenib, 98 of 168 patients (58.3%) remained on treatment at a median follow-up of 41.6 months (95% CI: 40.5, 42.7). Updated efficacy findings showed median prograsion-free survival (PFS) per investigator of 49.9 months (95% CI: 39.6, NE), while median time to next intervention (TTNI) remained not estimable (95% CI: 52.0 months, NE). At 42 months, 59.2% (95% CI: 49.9, 67.4) of patients remained progression-free, and 75.1% (95% CI: 67.4, 81.2) had not required chemoradiotherapy or surgery. The objective response rate per investigator was 31.5% (95% CI: 24.6, 39.2), and median overall survival had not yet been reached. The safety profile remained consistent with previous analyses, with no new safety signals observed.
Investigators concluded that the updated data support the robustness of earlier PFS and TTNI findings and confirm a durable and sustained treatment benefit with long-term vorasidenib in this molecularly defined glioma population.
This content has been developed independently by Touch Medical Media for touchONCOLOGY. Views expressed are the speaker’s own and do not necessarily reflect the views of Touch Medical Media. This article was created by the editorial team utilizing AI as an editorial tool (ChatGPT 5.5 [Large language model]. https://chat.openai.com/chat.) The content was developed and edited by human editors. No funding was received in the publication of this article.
Cite: INDIGO: Follow-up data supports sustained benefit of vorasidenib in IDH-mutant grade 2 glioma. touchONCOLOGY. 22nd June 2026.
Editor: Sophie Nickelson
