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INDIGO trial: Major and secondary outcomes

Major efficacy outcome: Progression-free survival (PFS) was significantly improved in patients treated with VORANIGO®¹

Patients treated with VORANIGO had a 61% reduced risk of disease progression or death versus the placebo group.

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

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

Progression-free survival in the INDIGO trial graph

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
Hazard ratio (95% CI)^b	0.39 (0.27-0.56)
P value^c	P<0.0001

^aThe 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.²

^bStratified Cox proportional hazard model, stratified by 1p19q status and baseline tumor size.¹

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

Secondary outcome: Time to next intervention (TTNI) was significantly improved in patients treated with VORANIGO¹

TTNI was the time from randomization to the initiation of the first subsequent anticancer therapy or death from any cause.

Median TTNI for patients treated with VORANIGO was not reached versus 17.8 months for the placebo group.

Kaplan-Meier Curve for TTNI in the INDIGO trial²

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 (95% CI)	NR	17.8
Hazard ratio (95% CI)	0.26 (0.15-0.43)
P value	P<0.0001

Review the safety results for VORANIGO from the INDIGO trial

HR, hazard ratio; 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

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.

INDIGO trial: Major and secondary outcomes

Major efficacy outcome: Progression-free survival (PFS) was significantly improved in patients treated with VORANIGO®1

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

PFS in patients with mIDH glioma1

Secondary outcome: Time to next intervention (TTNI) was significantly improved in patients treated with VORANIGO1