Dr Vojnic on Vorasidenib in Grade 2 IDH1/2-Mutated Glioma

“The IDH inhibitor vorasidenib was approved [by the FDA] based on [data from] the INDIGO trial. This was a phase 3 clinical trial where patients [with grade 2 IDH-mutant glioma] were randomly assigned to receive vorasidenib or placebo.”

Morana Vojnic, MD, MBA, the director of neuro-oncology at Rutgers Cancer Institute and the system leader for neuro oncology at RWJBarnabas Health, discussed the IDH1/2 inhibitor vorasidenib (Voranigo) for the treatment of patients with glioma.

Vorasidenib was approved by the FDA in August 2024 for the treatment of adult and pediatric patients 12 years and older with grade 2 astrocytoma or oligodendroglioma with a susceptible IDH1 or IDH2 mutation following surgery, including biopsy subtotal resection, or gross total resection Vojnic said. The approval was supported by data from the phase 3 INDIGO trial (NCT04164901), she added. Patients with residual or recurrent grade 2 IDH-mutant glioma were randomly assigned to receive vorasidenib (n = 168) or matching placebo (n = 163), she noted. The HR for progression-free survival was 0.39 in favor of the investigational arm (95% CI, 0.27-0.56; P < .0001) and the median time to next treatment in the investigational and placebo arms was not reached and 17.8 months, respectively.

Notably, at 24 months, more than 50% of patients who received vorasidenib remained progression free, Vojnic said. In terms of safety, vorasidenib was tolerable. The primary adverse effect observed was an elevated liver function test, she added. Notably, the agent is orally administered once a day and patients are monitored via blood testing, she noted.

Findings from a subgroup analysis showed that the benefit with vorasidenib vs placebo was present across key subgroups, Vojnic noted. Even high-risk patients above the age of 40 years old derived benefit from the agent, she added. Patients with residual disease greater than 2 cm in largest tumor diameter also benefited from treatment with vorasidenib, she concluded.