Updated results from the phase 2 J201 study show that safusidenib continues to demonstrate promising long-term activity in patients with treatment-naive grade 2 IDH1-mutant glioma. After a median follow-up of 38.8 months, the drug achieved a confirmed overall response rate of 51.9%, while 79.1% of patients remained free from disease progression at 36 months. The median progression-free survival has not yet been reached, and the treatment maintained a manageable safety profile.
Based on these encouraging findings, Nuvation Bio is launching two new clinical trials. The phase 3 G307 trial will evaluate safusidenib against placebo in newly diagnosed, treatment-naive grade 2 IDH1-mutant glioma patients outside the United States, where vorasidenib is not widely available. The primary goal is progression-free survival. Meanwhile, the U.S.-based phase 2 G209 trial will test safusidenib in patients with grade 2 or 3 IDH1-mutant glioma whose disease has progressed after prior treatment with vorasidenib, with overall response rate as the primary endpoint.