Karyopharm Therapeutics (NASDAQ:KPTI) dosed the first patient in a Phase 1/2 clinical study evaluating oral selinexor in patients with newly diagnosed or recurrent glioblastoma (GBM).
This global study is expected to enroll some 400 patients and will consist of a Phase 1 dose finding study, followed by a Phase 2 efficacy exploration study. The Phase 2 portion will evaluate three different regimens: selinexor in combination with radiation therapy, with or without the addition of temozolomide, and selinexor in combination with lomustine.
The study’s primary endpoints are progression-free survival in patients with newly diagnosed GBM and overall survival in patients with recurrent GBM.
“While selinexor has been most extensively studied in patients with hematologic malignancies, there is increasing evidence that selinexor may also play an important role in the treatment of a variety of solid tumors, including patients with GBM,” Sharon Shacham, Karyopharm’s president and CSO, said in a statement.
“We now look forward to assessing selinexor’s activity in combination with currently used standard of care treatments where we hope it will prove to be synergistic and even more effective,” she added.
