Clinical data overview
VORANIGO® improved progression-free survival vs. placebo*,1
61% risk reduction in radiographic disease progression or death from any cause with VORANIGO® vs. placebo HR (95% CI):‡ 0.39 (0.27, 0.56); p=0.000000067§
Number of events: 47/168 for VORANIGO® and 88/163 for placebo.
K-M curve for progression free survival in the INDIGO trial
Adapted from the VORANIGO® Product Monograph.
VORANIGO® delayed the time to next intervention (secondary endpoint) vs. placebo*,1,2
74% risk reduction of death from any cause or receiving the next intervention with VORANIGO® vs. placebo HR (95% CI):‡ 0.26 (0.15, 0.43); p=0.000000019¶
Number of events: 19/168 for VORANIGO® and 58/163 for placebo.
K-M curve for the time to next intervention in the INDIGO trial
Likelihood of being alive and not receiving a next treatment intervention by 24 months2
83.4% with VORANIGO® | 27.0% with placebo |
|---|---|
95% CI: 74.0, 89.6 | 95% CI: 7.9, 50.8 |
Adapted from the VORANIGO® Product Monograph.
Demonstrated an excellent safety profile1
Serious AEs occurred in 0.6% (1/167) of patients who received VORANIGO®.
- The most common serious AE was ALT increased (0.6%).
AEs reported in ≥ 1% of patients receiving VORANIGO® with a difference between arms of ≥ 2% compared with placebo in the INDIGO trial
System organ class** | VORANIGO® | |
|---|---|---|
Metabolism and nutrition disorders | ||
Decreased appetite | 9 (5.4) | |
Gastrointestinal disorders | ||
Diarrhea†† | 20 (12.0) | |
Abdominal pain‡‡ | 13 (7.8) | |
Gastrointestinal reflux disease§§ | 7 (4.2) | |
General disorders | ||
Fatigue¶¶ | 39 (23.4) | |
Investigations | ||
ALT increased | 61 (36.5) | |
AST increased | 41 (24.6) | |
GGT increased | 22 (13.2) | |
Blood alkaline phosphatase increased | 6 (3.6) | |
Adapted from the VORANIGO® Product Monograph.
Discontinuation rates
5 out of 167 patients discontinued treatment with VORANIGO®.
- The most common AE leading to permanent discontinuation was ALT increased (3%).
Adapted from the VORANIGO® Product Monograph.
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.
PFS: progression-free survival; CI: confidence interval; NE: not estimable; HR: hazard ratio; K-M: Kaplan-Meier; AE: adverse event; ALT: alanine transaminase; AST: alanine aminotransferase; GGT: gamma-glutamyl transferase
*The efficacy analyses were based on all patients who were randomized.
†The 95% CI for the median was calculated using the Brookmeyer and Crowley method.
‡Estimated with Cox proportional hazard model adjusted by the following stratification factors: 1p19q status and baseline tumour size.
§Based on one-sided stratified log-rank test compared to the pre-specified α of 0.000359 (one-sided).
¶Based on one-sided stratified log-rank test compared to the pre-specified α of 0.00000048 (one-sided).
**AEs are listed according to MedDRA version 25.1 system organ class.
††Includes diarrhea, feces soft, and frequent bowel movements.
‡‡Includes abdominal pain, abdominal pain upper, and abdominal discomfort.
§§Includes gastroesophageal reflux disease, gastritis, and dyspepsia.
¶¶Includes fatigue and asthenia.
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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