Oral Selinexor as an Anti-cancer Agent
Selinexor (KPT-330) is a first in class SINE™ XPO1 antagonist, being evaluated in multiple later stage clinical trials in patients with relapsed and/or refractory hematological and solid tumor malignancies. Our SINE™ compounds were the first oral XPO1 inhibitors in clinical development.
To date, selinexor has been administered to more than 1900 patients across company-sponsored and investigator-sponsored clinical trials. Evidence of single-agent anti-cancer activity has been observed in many patients and selinexor has been sufficiently well-tolerated to allow several of these patients to remain on therapy for prolonged periods. Over 20 patients have remained on study for over 12 months, with the longest patients on study for over 24 months.
In May 2015, we initiated a Phase 2b clinical trial evaluating selinexor and low-dose dexamethasone, or low-dose dex, in patients with heavily pretreated multiple myeloma. The Selinexor Treatment of Refractory Myeloma, or STORM, study is a single-arm study evaluating the treatment of relapsed/refractory MM.
In addition to the STORM study, we initiated the Phase 1b/2 STOMP (Selinexor and Backbone Treatments of Multiple Myeloma Patients) study to evaluate selinexor in combination with existing therapies across the broader population in multiple myeloma.
We continue to enroll our Phase 2 study of selinexor in patients 60 years of age or older with relapsed or refractory AML patients who are ineligible for standard intensive chemotherapy and/or transplantation. In Selinexor in Older Patient with Relapsed/Refractory AML, or SOPRA, study we are evaluating approximately 170 patients who have AML that has relapsed after, or was refractory to, first line therapy.
In DLBCL, the Selinexor Against Diffuse Aggressive Lymphoma, or SADAL study, a two-arm, open-label Phase 2b clinical trial, continues to enroll patients that have relapsed and/or refractory DLBCL, either de novo or transformed from a more indolent NHL such as follicular lymphoma, after two to five lines of therapy with at least 14 weeks since the last systemic anti-DLBCL therapy.
We intend to initiate a pivotal randomized Phase 3 study, known as the BOSTON (Bortezomib, Selinexor and dexamethasone) study in early 2017 which will evaluate selinexor in combination with bortezomib (Velcade®) and low-dose dexamethasone (SVd) compared to bortezomib and low-dose dexamethasone (Vd) in patients with multiple myeloma who have had one to three prior lines of therapy.
In addition, selinexor is being investigated in four Phase 2 clinical trials in solid tumors: the SIGN study in gynecological malignancies, the KING study in glioblastoma, and the STARRS study in head & neck squamous cell carcinoma.
In January 2016 we initiated a new Phase 2/3 clinical trial with oral selinexor. SEAL (Selinexor in Advanced Liposarcoma) is a randomized, multicenter, double-blind, placebo-controlled study of patients diagnosed with advanced unresectable dedifferentiated liposarcoma.