INDIGO Trial Shows Potential of Vorasidenib in Low-Grade Glioma

Katherine B. Peters, MD, PhD, neuro-oncologist at Duke Cancer Center, discusses the findings from the phase 3 INDIGO trial (NCT04164901) which were presented at the 2023 ASCO annual meeting.

The study evaluated treatment with vorasidenib (AG-881), an IDH1/2 inhibitor, in patients with low-grade glioma.

According to a presentation of the study during the 2023 ASCO Annual Meeting and simultaneously published in the New England Journal of Medicine, the median independently assessed imaging-based progression-free survival was 27.7 months among patients treated with vorasidenib (95% CI, 17.0-not estimated) vs 11.1 months (95% CI, 11.0-13.7) for those given placebo (HR, 0.39; 95% CI, 0.27-0.56; P <.001).

These findings provide potential to change the treatment paradigm for patients with this type of glioma by allowing vorasidenib to become the first targeted therapy for low-grade glioma.

Transcription:

0:08 | What's exciting is this is a development that we haven't seen in over 20 years, and what we found is that when we looked at our patients that received vorasidenib in comparison with the placebo, those patients had a much improved prognosis, such that their progression-free survival was extended to 27.7 months compared with 11 months, which is a very large, statistically significant difference. For our patients with low-grade glioma, the approach we use is usually a watch and wait, and then if the tumor starts to grow or progresses, we have to go to more aggressive treatments such as surgery, radiation, and chemotherapy. This is challenging because those patients are in the young adult years, and those can cause a lot of significant toxicities.

1:01 | One of the key secondary end points was time to the next intervention. What we found is that patients that received the vorasidenib had a significant extended time to delay the next intervention, whereas patients that received just the placebo, they had to have an extra intervention by 17.8 months. What our data shows is we haven't even reached that median value for those patients. So this can be a durable therapy that can slow progression and slow the chance of your patients having to go to those more aggressive therapies which are more surgery, radiation, and chemotherapy.