Servier says its next IDH inhibitor has passed PhIII, but no regulatory timeline yet

Servier’s IDH inhibitor vorasidenib has passed its Phase III trial in low-grade glioma, the company announced Tuesday morning. However, it left its regulatory timeline up in the air.

Susan Pandya

The drug met the primary endpoint of progression-free survival as well as a secondary endpoint of time to next intervention, Servier said. But when asked for more details in an interview with Endpoints News, Servier’s VP of clinical development Susan Pandya declined to comment.

Vorasidenib targets tumors with either the IDH 1 or 2 mutations. The former is found in more than 70% of grade 2 and 3 gliomas, according to a 2009 NEJM paper. The latter is less common, and Pandya estimated that around 6-8% of people who have low-grade gliomas have an IDH2 mutation.

Servier acquired the drug alongside Tibsovo, an approved IDH1 inhibitor for AML and bile duct cancer, when it bought Agios’ cancer portfolio in 2020. The FDA recently approved a Tibsovo competitor in Rigel Pharmaceuticals’ Rezlidhia.

The INDIGO trial enrolled over 300 patients who have undergone surgery as their only other treatment and randomized them to receive either vorasidenib or placebo.

Servier said the safety profile was similar to what it had previously published on vorasidenib, but didn’t give additional details. In a Phase I trial, the drug caused elevated liver enzyme levels, which can lead to liver toxicity. Patients also had nausea and headaches in that trial.

Notably, Servier didn’t set a regulatory timeline for when it would file for FDA approval. In the press release, Servier said, “Due to the accelerated enrollment and interim efficacy analysis outcome, the INDIGO clinical trial is well ahead of schedule. Servier is working to determine filing timelines and adapt the vorasidenib supply capacity.”

When asked about the press release, Pandya said that it in part had to do with enrolling the study over the Covid-19 pandemic, adding that the study hit the pre-specified number of events for progression-free survival ahead of what Servier estimated. “I can’t really speak to exactly what our regulatory timeline will look like,” she said.

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