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INDIGO trial: Efficacy of VORANIGO® versus placebo in Grade 2 mIDH1/2 glioma

Major efficacy outcome: Progression-free survival (PFS)

VORANIGO demonstrated a significant improvement in PFS versus placebo1

In the INDIGO trial, VORANIGO gave patients with mIDH glioma more time without disease progression versus placebo.

Kaplan-Meier Curve for PFS per BIRC in the INDIGO trial1

Progression-free survival in the INDIGO trial graph Progression-free survival in the INDIGO trial graph
VORANIGO—proven to delay progression in patients with Grade 2 mIDH glioma1

PFS in patients with mIDH glioma1

Efficacy parameter VORANIGO (40 mg daily)(n=168) Placebo
(n=163)
Major efficacy outcome
PFS
Number of events, n (%)    
Progressive disease 47 (28) 88 (54)
Death 0 0
HR (95% CI)a 0.39 (0.27-0.56)
P valueb P<0.0001

aStratified Cox proportional hazard model, stratified by 1p/19q-codeletion status and baseline tumor size.1

bBased on one-sided stratified log-rank test compared to the pre-specified α of 0.000359 (one-sided).1

Download the INDIGO Trial Summary Flashcard for a convenient summary of the INDIGO trial design and PFS results

Secondary outcome: Time to next intervention (TTNI)

VORANIGO provided more time before subsequent therapy was necessary compared with placebo in the INDIGO trial1,2

TTNI was significantly improved in patients taking VORANIGO1,2

Median TTNI for patients treated with VORANIGO was not reached versus 17.8 months with placebo. The majority of patients in the VORANIGO arm did not require another anticancer treatment, including surgery, chemotherapy, or radiotherapy.

Kaplan-Meier Curve for TTNI in the INDIGO trial2

Time to next intervention in the INDIGO trial graph Time to next intervention in the INDIGO trial graph

TTNI in patients with mIDH glioma1

Efficacy parameter VORANIGO (40 mg daily)
(n=168)
Placebo
(n=163)
Secondary outcome
TTNI
Median TTNI, months NR 17.8
HR (95% CI) 0.26 (0.15-0.43)
P value P<0.0001
VORANIGO helps give your patients with mIDH glioma more time before requiring another therapy.1

BIRC, blinded independent review committee; HR, hazard ratio; mIDH1/2, mutant isocitrate dehydrogenase-1 or mutant isocitrate dehydrogenase-2; NR, not reached.

References: 1. Voranigo. Package insert. Servier Pharmaceuticals LLC; 2024. 2. Mellinghoff IK, van den Bent MJ, Blumenthal DT, et al. Vorasidenib in IDH1- or IDH2-mutant low-grade glioma. N Engl J Med. 2023;389(7):589-601. doi:10.1056/NEJMoa2304194

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INDICATION

VORANIGO (40 mg tablets) is indicated for the treatment of adult and pediatric patients 12 years and older with Grade 2 astrocytoma or oligodendroglioma with a susceptible isocitrate dehydrogenase-1 (IDH1) or isocitrate dehydrogenase-2 (IDH2) mutation following surgery including biopsy, sub-total resection, or gross total resection.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Hepatotoxicity: VORANIGO can cause hepatic transaminase elevations, which can lead to hepatic failure, hepatic necrosis, and autoimmune hepatitis. Monitor liver laboratory tests (AST, ALT, GGT, total bilirubin, and alkaline phosphatase) prior to the start of VORANIGO, every 2 weeks during the first 2 months of treatment, then monthly for the first 2 years of treatment, and as clinically indicated, with more frequent testing in patients who develop transaminase elevations. Reduce the dose, withhold, or permanently discontinue VORANIGO based on severity.

Embryo-Fetal Toxicity: Based on findings from animal studies, VORANIGO can cause fetal harm when administered to a pregnant woman. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to use effective nonhormonal contraception during treatment with VORANIGO and for 3 months after the last dose, since VORANIGO can render some hormonal contraceptives ineffective. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with VORANIGO and for 3 months after the last dose.

ADVERSE REACTIONS

The most common (≥15%) adverse reactions included fatigue, headache, COVID-19, musculoskeletal pain, diarrhea, nausea, and seizure. Grade 3 or 4 (≥2%) laboratory abnormalities were ALT increased, AST increased, GGT increased, and neutrophils decreased.

DRUG INTERACTIONS

Avoid concomitant use of VORANIGO with strong and moderate CYP1A2 inhibitors. Avoid concomitant use with moderate CYP1A2 inducers and smoking tobacco. Avoid concomitant use with CYP3A substrates, where a minimal concentration change can reduce efficacy. If concomitant use of hormonal contraception cannot be avoided, use nonhormonal contraception methods.

LACTATION

Advise women not to breastfeed during VORANIGO treatment and for 2 months after the last dose.

IMPAIRED FERTILITY

VORANIGO may impair fertility of females and males of reproductive potential.

Please see Full Prescribing Information.

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