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AnHeart Therapeutics Gets FDA Clearance to Study Safusidenib in IDH1-Mutant Glioma Patients

NEW YORK – AnHeart Therapeutics on Thursday said that the US Food and Drug Administration accepted its investigational new drug application to begin a Phase II trial of safusidenib involving patients with IDH1-mutant glioma.

In a Phase I trial of safusidenib, the objective response rate was 33 percent in patients with non-enhancing glioma and 17 percent in patients with enhancing glioma. In the new Phase II trial, investigators will evaluate safusidenib's safety, efficacy, and pharmacokinetics in patients with grade II/III glioma according to the World Health Organization's classification and who harbor IDH1-mutant tumors. In the first stage of the trial, researchers will explore five dosing regimens, and in the second, dose-expansion stage, they will evaluate a selected dosing regimen in patients with WHO grade III IDH1-mutant glioma. Researchers will track patients' overall response rate and adverse events on safusidenib.

AnHeart is also developing its ROS1 tyrosine kinase inhibitor taletrectinib as a first- and second-line treatment for patients with ROS1-positive non-small cell lung cancer. The New York-based company began a Phase II trial of the drug last year to evaluate efficacy and safety in patients with brain metastases. It is also conducting an ongoing basket trial of the drug in NTRK-positive solid tumors. AnHeart's pipeline additionally includes an IDH1 inhibitor and an AXL inhibitor.