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VORANIGO® was approved based on results from the INDIGO trial

INDIGO was a phase 3, randomized, multicenter, double-blind, placebo-controlled trial for patients with Grade 2 mIDH glioma: astrocytoma or oligodendroglioma (N=331)^1,2

Treatment continued until radiographic disease progression or unacceptable toxicity.¹

Tumor assessments were performed every 12 weeks.¹

^aIDH1 or IDH2 mutation status was prospectively determined by the Life Technologies Corporation Oncomine Dx Target Test.¹

^bRandomization was stratified by local 1p19q status (codeleted or non-codeleted) and baseline tumor size (diameter ≥2 cm or <2 cm).¹

Major and secondary outcomes

Major efficacy outcome¹:

Progression-free survival (PFS)—progression was evaluated by a blinded independent review committee (BIRC) per modified Response Assessment in Neuro-Oncology for Low Grade Glioma (RANO-LGG) criteria.^c

See VORANIGO PFS results

Secondary outcome¹:

Time to next intervention (TTNI)—the time from randomization to the initiation of the first subsequent anticancer therapy or death due to any cause.

See VORANIGO TTNI results

^cThe RANO criteria for LGGs define progressive disease as either a radiographic disease response (a ≥25% increase in the sum of perpendicular diameters of T2-weighted or T2-weighted fluid-attenuated inversion recovery hyperintense non-enhancing lesions), or the presence of a new lesion as a newly measurable or increased enhancement.³

Baseline demographics and disease characteristics

Selected baseline patient and glioma characteristics³

Demographic and disease characteristics	VORANIGO (n=168)	Placebo (n=163)
Demographics
Age
Median years (range)	40.5 (21-71)	39 (16-65)
Age distribution, %
16 or 17 years	0	0.6
18 to 39 years	45.2	53.4
40 to 64 years	53.6	45.4
≥65 years	1.2	0.6
Male sex, %	60.1	52.8
Disease characteristics
Histologic subtype, %
Oligodendroglioma (1p/19q-codeleted)	52.4	51.5
Astrocytoma (1p/19q-non-codeleted)	47.6	48.5
Number of previous surgeries for glioma, %
1	75.0	82.2
≥2	25.0	17.8
IDH mutation status, %
IDH1-positive^d	97.0	93.3
R132H	86.9	84.7
R132C	4.8	4.3
R132G	3.0	0.6
R132L	1.2	2.5
R132S	1.2	1.2
IDH2-positive	3.0	6.7
R172K	1.8	6.1
R172G	1.2	0
R172W	0	0.6

In the VORANIGO arm, 14% of patients had biopsy, 48% had sub-total resection, and 51% had gross-total resection.¹

^dTwo patients in the placebo group had CDKN2A homozygous deletion.³

Review the efficacy results for VORANIGO from the INDIGO trial

mIDH, mutant isocitrate dehydrogenase; mIDH1/2, mutant IDH1 or mutant IDH2.

References: 1. Voranigo. Package insert. Servier Pharmaceuticals LLC; 2024. 2. Data on file. Servier Pharmaceuticals LLC. 3. 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

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.

VORANIGO® was approved based on results from the INDIGO trial

INDIGO was a phase 3, randomized, multicenter, double-blind, placebo-controlled trial for patients with Grade 2 mIDH glioma: astrocytoma or oligodendroglioma (N=331)1,2

Major and secondary outcomes

Major efficacy outcome1:

Secondary outcome1: