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Karyopharm Announces Dosing of First Patient in a Phase 1/2 Study of Selinexor in Combination with Standard of Care Therapy for Patients with Newly Diagnosed or Recurrent Glioblastoma
NEWTON, Mass., June 09, 2020 (GLOBE NEWSWIRE) -- Karyopharm Therapeutics Inc. (Nasdaq:KPTI), an innovation-driven pharmaceutical company, today announced
About this update from Karyopharm Therapeutics Inc.
[{"type":"text","content":"NEWTON, Mass., June 09, 2020 (GLOBE NEWSWIRE) -- Karyopharm Therapeutics Inc. (Nasdaq:KPTI), an innovation-driven pharmaceutical company, today announced dosing of the first patient in a Phase 1/2 clinical study evaluating oral selinexor in combination with standard of care therapy in patients with newly diagnosed or recurrent glioblastoma (GBM). This global study is expected to enroll approximately 400 patients at clinical sites in the U.S., Europe, and Israel.\n Selinexor is an oral selective inhibitor of nuclear export (SINE) compound which blocks the cellular protein XPO1, whose function includes playing a key role in regulating the activity of tumor suppressor proteins and other oncoproteins relevant in cancer cell biology. XPO1 may be an important, novel target in the treatment of patients with GBM as it is frequently overexpressed in both GBM and in high-grade gliomas, and the degree of XPO1 over-expression correlates with higher tumor grade and poor overall patient survival. Nonclinical studies indicate that selinexor has potent anti-GBM activity as monotherapy and is synergistic when combining with radiation, temozolomide and lomustine. Additionally, in previous clinical studies (KING study/NCT01986348), selinexor has demonstrated that it crosses the blood-brain barrier with adequate intra-tumoral penetration and single-agent efficacy with durable response and disease stabilization in heavily pretreated GBM patients further supporting the rationale for clinical development of selinexor to treat patients with brain cancers. The randomized, multi-center, Phase 1/2 study (XPORT-GBM-029/NCT04421378) will be conducted in two phases: a Phase 1 dose finding study followed by a Phase 2 randomized efficacy exploration study, designed to independently evaluate three different combination regimens in three treatment arms in patients with newly diagnosed GBM (Arms A and B) or with recurrent GBM (Arm C). Arms A and B will investigate selinexor in combination with radiation therapy with or without the addition of temozolomide, while Arm C will evaluate the combination of selinexor and lomustine. The primary endpoints in the study are progression-free survival in patients with newly diagnosed GBM and overall survival (OS) in patients with recurrent GBM. Yazmín Odia, M.D., Chief of Neuro-Oncology at Miami Cancer Institute, Baptist Heal...