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
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
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
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 |