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Safusidenib is an investigational oral drug that crosses the blood-brain barrier and targets IDH1 mutations. The randomized, placebo-controlled Phase 3 SIGMA trial (NCT05303519) is now at the stage where they are evaluating the drug as maintenance therapy for patients with high-risk, IDH1-mutant astrocytoma following radiation and temozolomide. An exploratory cohort is also studying patients with grade 3 IDH1-mutant oligodendroglioma who have not yet received radiation or chemotherapy. The trial began enrolling in 2023, initially at sites in the United States, Australia, China, Canada and Japan. Now, new sites have been added across Europe.
Earlier this year, updated results from a separate Phase 2 study of safusidenib for previously untreated grade 2 IDH1-mutant glioma were encouraging, with a 52% confirmed response rate and 79% of patients remaining progression-free at three years. However, the Phase 3 SIGMA trial is still active and has not yet reported results.