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The first targeted-therapy win in low-grade brain tumours: a pill that more than doubled the time before the tumour grew, delaying radiation and chemotherapy by years.
INDIGO, trial NCT04164901 sponsored by Servier and reported in 2023, delivered the first targeted-therapy win in low-grade brain tumours: the IDH inhibitor vorasidenib more than doubled the time before residual or recurrent grade 2 IDH-mutant glioma grew, delaying radiotherapy and chemotherapy by years. It randomised 331 patients with astrocytoma or oligodendroglioma after surgery and no prior radiotherapy or chemotherapy to vorasidenib or placebo, met its primary progression-free survival endpoint by blinded review with a large effect, sharply reduced the need for the next intervention, and led to FDA approval in August 2024. OnCo links it to IDH1 and IDH2 as targets, the mutant IDH pathway, Ingo K. Mellinghoff, Patrick Y. Wen and the brain as a bottleneck. Its long-term effect on survival and on malignant transformation is pending, which is the open question.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
331 enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Progression-free survival (BIRC)primary | Vorasidenib | 168 | 27.7 months | 0.39 (0.27 to 0.56) | <0.001 | link |
| Placebo | 163 | 11.1 months |
Shares Ingo K. Mellinghoff, Vorasidenib, Servier, Oligodendroglioma, IDH-mutant and 1p/19q-codeleted.
Shares Mutant IDH / 2-hydroxyglutarate, IDH inhibitors, Astrocytoma, IDH-mutant (grades 2 to 4), IDH1 / IDH2.
Shares Vorasidenib, Oligodendroglioma, IDH-mutant and 1p/19q-codeleted, Astrocytoma, IDH-mutant (grades 2 to 4), IDH1 / IDH2.
Shares Vorasidenib, Oligodendroglioma, IDH-mutant and 1p/19q-codeleted, Astrocytoma, IDH-mutant (grades 2 to 4), IDH1 / IDH2.
Shares IDH inhibitors, Servier, Epigenetic drugs (HDAC, DNMT, EZH2, IDH, menin, BET).
Shares Oligodendroglioma, IDH-mutant and 1p/19q-codeleted, Astrocytoma, IDH-mutant (grades 2 to 4), IDH1 / IDH2, Glioma & glioblastoma.
Shares IDH inhibitors, Servier, Epigenetic drugs (HDAC, DNMT, EZH2, IDH, menin, BET).
Shares IDH inhibitors, Servier, IDH1 / IDH2, Epigenetic drugs (HDAC, DNMT, EZH2, IDH, menin, BET).