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The investigational drug tinostamustine (EDO-S101) will soon be added as a treatment arm in the Phase 2/3 GBM AGILE trial—a global, adaptive study designed to accelerate development of new therapies for glioblastoma. The GBM AGILE trial tests multiple therapies simultaneously against a shared control group and provides a potential pathway to FDA approval. Tinostamustine is a first-in-class compound that combines bifunctional alkylating activity with pan-HDAC inhibition, two mechanisms that may work together to attack glioblastoma cells more effectively. MD Anderson recently completed a small Phase 1 study of the drug in newly diagnosed, MGMT-unmethylated glioblastoma, but the results have not yet been published. In GBM AGILE, the drug will be evaluated in both newly diagnosed and recurrent glioblastoma patients. Activation of this trial arm is expected after regulatory submissions are approved, and we will be closely following for further updates.