Meet Steven
Steven was a real patient from the INDIGO trial
At age 33, Steven, a firefighter, experienced a partial seizure. He had no prior symptoms. He was taken to the hospital and diagnosed with a Grade 2 oligodendroglioma with IDH mutation. He underwent surgical resection and qualified to enrol in the double-blind, multicentre, Phase 3 INDIGO clinical trial.
Steven has not experienced radiographic or clinical disease progression or unacceptable toxicity. He remains on treatment with VORANIGO® and maintains regular follow-ups with his healthcare team.
Actual patient. May not be representative of the general population.
The INDIGO trial
A randomized, multicentre, double-blind, placebo-controlled Phase 3 trial assessing the efficacy and safety of VORANIGO® in patients with residual or recurrent Grade 2 IDH1/2-mutated oligodendroglioma or astrocytoma.1,2
Select inclusion criteria
- ≥ 12 years of age
- Weight ≥ 40 kg
- Grade 2 astrocytoma or oligodendroglioma with an IDH1 R132 mutation or IDH2 R172 mutation
- Prior surgery (gross total resection, subtotal resection, or biopsy) for glioma
- Not in need of immediate chemotherapy or radiotherapy per investigator assessment
Select exclusion criteria
- Prior anti-cancer treatment, including chemotherapy or radiation therapy
Randomization was stratified by:
- Local 1p19q status (co-deleted or not co-deleted)
- Baseline tumour size (diameter ≥ 2 cm or < 2 cm)
Treatment until radiographic disease progression or unacceptable toxicity
Primary endpoint:
- PFS as evaluated by a BIRC according to modified RANO-LGG criteria
Select secondary endpoints:
- TTNI: time from randomization to the initiation of first subsequent anticancer therapy or death due to any cause
- TGR: on-treatment percentage change in tumour volume every 6 months
- HRQoL
- OS
Adapted from the VORANIGO® Product Monograph.
Baseline patient and tumour characteristics in INDIGO trial†,2
Characteristic | VORANIGO® (n=168) | |
|---|---|---|
Age (years) median (range) | 40.5 (21–71) | |
Age categories, n (%) | ||
16 or 17 years | 0 | |
18 to 39 years | 76 (45.2) | |
40 to 64 years | 90 (53.6) | |
≥ 65 years | 2 (1.2) | |
Sex, n (%) | ||
Male | 101 (60.1) | |
Female | 67 (39.9) | |
Geographic region, n (%) | ||
North America | 86 (51.2) | |
Western Europe | 57 (33.9) | |
Israel | 25 (14.9) | |
KPS score, n (%)‡ | ||
100 | 90 (53.6) | |
90–80 | 77 (45.8) | |
Location of tumour at initial diagnosis, n (%)§ | ||
Frontal | 107 (63.7) | |
Non-frontal | 61 (36.3) | |
Time from initial diagnosis to randomization, years | ||
Mean | 3.3±2.4 | |
Median (range) | 2.9 (1.0–19.5) | |
Number of previous surgeries for glioma, n (%) | ||
1 | 126 (75.0) | |
≥ 2 | 42 (25.0) | |
Time from last surgery for glioma to randomization, years¶ | ||
Mean | 2.7±1.1 | |
Median (range) | 2.5 (0.2–5.2) | |
Histologic subtype, n (%) | ||
Oligodendroglioma | 88 (52.4) | |
Astrocytoma | 80 (47.6) | |
IDH mutation status, n (%) | ||
IDH1-positive** | 163 (97.0) | |
R132C | 8 (4.8) | |
R132G | 5 (3.0) | |
R132H | 146 (86.9) | |
R132L | 2 (1.2) | |
R132S | 2 (1.2) | |
IDH2-positive | 5 (3.0) | |
R172K | 3 (1.8) | |
R172W | 0 | |
R172G | 2 (1.2) | |
Chromosome 1p/19q co-deletion status, n (%)†† | ||
Co-deleted | 88 (52.4) | |
Not co-deleted | 80 (47.6) | |
Longest diameter of tumour, n (%)†† | ||
≥ 2 | 139 (82.7) | |
< 2 | 29 (17.3) | |
Patient profile
Meet Sophie‡‡
- 43 years of age
- Teacher
- Married, mother of a girl
Medical history1,3
- Two years ago, Sophie was taken to the ER because of a seizure.
- She presented with headaches and vision changes.
- Her doctor ordered an MRI, which revealed a non-enhancing lesion compatible with adult-type diffuse glioma, and Sophie underwent gross total surgical resection.
- Pathology results confirmed a diagnosis of Grade 2 astrocytoma with an IDH1 mutation.
Think about VORANIGO® for your patients
VORANIGO® resources
VORANIGO® information leaflet
An overview of VORANIGO® in the treatment of IDH1/2-mutant glioma, including efficacy and safety data, as well as dosing and administration information.
QD: once daily; R: randomization; PFS: progression-free survival; BIRC: blinded independent review committee; RANO-LGG: Response Assessment in Neuro-Oncology for Low-Grade Glioma; TTNI: time to next intervention; TGR: tumour growth rate; HRQoL: health-related quality of life; OS: overall survival; KPS: Karnofsky Performance Scale; ER: emergency room; MRI: magnetic resonance imaging; SD: standard deviation
*Crossover to receive VORANIGO® was allowed after centrally confirmed radiographic disease progression.
†Plus–minus values are means ± SD.
‡KPS scores range from 0 to 100, with lower scores indicating greater disability. One patient (0.6%) in the vorasidenib group met the eligibility criteria (score of ≥ 80) during screening but had a score of 70 on Day 1 of the first cycle.
§Frontal tumour location included frontal, frontoparietal, and frontotemporal locations, and non-frontal tumour location included all other locations.
¶One patient in the vorasidenib group underwent biopsy during pre-screening to obtain tumour tissue for testing of IDH mutation status, which was allowed by the protocol.
**Two patients in the placebo group had CDKN2A homozygous deletion.
††Data are reported on the basis of the electronic case-report forms, rather than from information in the interactive Web-response system.
‡‡Fictitious patient profile. May not be representative of all patients.
References:
- VORANIGO® Product Monograph. Servier Canada. August 27, 2024.
- Mellinghoff IK et al. Vorasidenib in IDH1- or IDH2-mutant low-grade glioma. N Engl J Med. 2023;389(7):589–601.
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