Oral Selinexor as an Investigational Anti-cancer Agent
Selinexor is an investigational medicine and has not been approved by The United States Food and Drug Administration (USFDA), Health Canada, the European Medicines Agency (EMA), nor any other regulatory agency.
Selinexor is an oral, first-in-class, reversible, potent, selective inhibitor of nuclear export (SINE) that specifically blocks XPO1. It is being evaluated in multiple Phase 2 and 3 clinical trials in patients with relapsed or refractory hematological and solid tumor malignancies. Our SINE compounds were the first oral XPO1 inhibitors in clinical development.
In May 2018 we reported top-line data for the Phase 2b STORM clinical trial evaluating selinexor and low-dose dexamethasone in patients with heavily pretreated multiple myeloma. To learn more about the STORM study, please visit clinicaltrials.gov
Selinexor has been granted Orphan Drug Designation in both the United States and the European Union in multiple myeloma and Fast Track designation by the Food and Drug Administration (FDA) for the patient population evaluated in the STORM study.
We are also conducting a pivotal randomized Phase 3 study, known as the BOSTON (Bortezomib, Selinexor and dexamethasone) study which is evaluating once weekly selinexor and low-dose dexamethasone in combination with Velcade® (bortezomib) (SVd), compared to Velcade and low-dose dexamethasone (Vd) in patients with multiple myeloma who have had one to three prior lines of therapy.
To learn more about the BOSTON study please visit clinicaltrials.gov
The BOSTON study is supported by data from the ongoing Phase 1b/2 STOMP (Selinexor and Backbone Treatments of Multiple Myeloma Patients) study evaluating selinexor and low-dose dex in combination with one of several standard approved therapies, including Revlimid® (lenalidomide), Pomalyst® (pomalidomide), Velcade® (bortezomib), Kyprolis® (carfilzomib), or Darzalex® (daratumumab), in patients with relapsed or refractory multiple myeloma. To learn more about the STOMPstudy please visit clinicaltrials.gov
In DLBCL, the SADAL (Selinexor Against Diffuse Aggressive Lymphoma) study, an open-label Phase 2b clinical trial, continues to enroll patients with relapsed or refractory DLBCL, either de novo or transformed from a more indolent NHL such as follicular lymphoma, after two to five prior lines of therapy. To learn more about the SADAL study, please visit clinicaltrials.gov
Selinexor is also being evaluated in certain solid tumor indications. The Phase 3 portion of the SEAL (Selinexor in Advanced Liposarcoma) study is currently underway. The SEAL study is a randomized, multicenter, double-blind, placebo-controlled trial evaluating selinexor in patients with advanced unresectable dedifferentiated liposarcoma. To learn more about the SEAL study please visit clinicaltrials.gov
Lastly, selinexor is being investigated in the Phase 3 SIENDO (Maintenance with Selinexor after Chemotherapy in Advanced or Recurrent Endometrial Cancer) study, an investigator-sponsored trial evaluating once weekly selinexor as a maintenance therapy versus placebo in patients with endometrial cancer after first- or second-line chemotherapy. To learn more about the SIENDO study, please visit clinicaltrials.gov
Velcade® is a registered trademark of Takeda Pharmaceutical Company Limited
Revlimid® and Pomalyst® are registered trademarks of Celgene Corporation
Kyprolis® is a registered trademark of Onyx Pharmaceuticals, Inc.
Darzalex® is a registered trademark of Janssen Biotech, Inc.