INDIGO
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.
331 patients. PFS 27.7 vs 11.1 months (HR 0.39); time to next intervention HR 0.26. NEJM 2023; FDA approval August 2024. Long-term OS impact and effect on malignant transformation pending.
- Median 27.7 vs 11.1 months with Vorasidenib compared with Placebo; about 16.6 months longer for half the group.
- A median is a midpoint: half the people did better than this and half did worse, so it is not a prediction for any one person.
- Put another way, the treated group had about 61 percent lower chance of the event at any given time (hazard ratio 0.39, likely range 0.27 to 0.56).
- This is a surrogate endpoint: it measures the cancer being controlled or absent on scans and tests, which often, but not always, translates into living longer.
- These results apply to the people the trial enrolled: Residual or recurrent grade 2 IDH-mutant astrocytoma or oligodendroglioma after surgery, no prior RT/chemo: vorasidenib vs placebo. People in a different situation may not see the same effect.
- The trial selected people by a biomarker (IDH); the result should not be assumed for people whose cancer does not have it.
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 participants enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Progression-free survival (BIRC)primary | Vorasidenib | 168 | 27.7 months | 0.39 (0.27–0.56) | <0.001 | link |
| Placebo | 163 | 11.1 months |
Pages like this
not linked directly; found by shared links- Key paperINDIGO: vorasidenib, the first targeted drug for IDH-mutant low-grade glioma
Shares Vorasidenib, IDH1 / IDH2, The brain: barrier and sanctuary, Glioma & glioblastoma.
- InstitutionDuke Cancer Institute
Shares IDH1 / IDH2, The brain: barrier and sanctuary, Glioma & glioblastoma.
- PersonAndreas von Deimling
Shares IDH1 / IDH2, Glioma & glioblastoma.
- InstitutionUniversity of Florida Health Cancer Center
Shares The brain: barrier and sanctuary, Glioma & glioblastoma.
- TrialACT IV
Shares The brain: barrier and sanctuary, Glioma & glioblastoma.
- CollectionNational Brain Tumor Society (NBTS)
Shares Vorasidenib, Glioma & glioblastoma.
- CompanyServier
Shares Vorasidenib, The brain: barrier and sanctuary, Glioma & glioblastoma.
- IdeaDeliver drugs and cells to the brain through the nose
Shares The brain: barrier and sanctuary, Glioma & glioblastoma.