The latest progress and research results of domestic clinical trials of vorasidenib-VORANIGO

Vorasidenib (trade name: Voranigo) is an oral IDH1/2 dual inhibitor, mainly used to treat IDH mutant low-grade glioma. The drug has been approved by the FDA in the United States and has launched a multi-center phase III bridging study in China.

In August of 2024, Vorasidenib was approved by the FDA in the United States. For the treatment of IDH1 or IDH2 mutated 2 grade astroglioma or oligodendroglioma patients 12 years old and above. The approval was based on results from the INDIGO study, which showed that Vorasidenib significantly extended patients’ progression-free survival (PFS) and time to next intervention (TTNI).

In China, Vorasidenib’s phase III bridging study has been launched in August 2024 to evaluate its efficacy and safety in Asian populations. The study, led by Academician Jiang Tao, plans to enroll 58 patients in 17 hospitals (including 15 hospitals in mainland China and 2 hospitals in Taiwan, China). The study has an open-label safety introduction phase and a randomized double-blind phase. The primary endpoint is PFS, and secondary endpoints include overall survival (OS), overall response rate (ORR), etc.

In addition, Vorasidenib is more efficient at entering the central nervous system than other IDH inhibitors, such as ivosidenib. This gives it potential in combination immunotherapy and provides new ideas for future research directions.

In general, Vorasidenib shows positive clinical prospects in the treatment of IDH mutant low-grade glioma, and its clinical studies in China are expected to provide new treatment options for patients.

Reference materials:https://www.drugs.com/