On May 17, 2018 Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a clinical-stage pharmaceutical company, reported that three posters highlighting clinical data from the ongoing Phase 1b/2 STOMP study will be presented at the upcoming European Hematology Association (EHA) (Free EHA Whitepaper) 2018 Annual Meeting taking place June 14-17, 2018 in Stockholm, Sweden (Press release, Karyopharm, MAY 17, 2018, View Source [SID1234526769]). These three poster presentations will feature updated data from the STOMP arms evaluating selinexor, the Company’s lead, novel, oral SINE compound, and dexamethasone in combination with standard approved therapies, Velcade, Pomalyst or Darzalex in patients with heavily pretreated multiple myeloma.
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"Following our positive results for selinexor in the STORM study in patients with penta-refractory multiple myeloma, we are pleased to be presenting updated results of selinexor combinations in earlier lines of myeloma treatment," said Sharon Shacham, PhD, MBA, President and Chief Scientific Officer of Karyopharm. "In the previously reported Phase 1b/2 STOMP study results, selinexor has shown robust anti-myeloma activity and a manageable safety profile in patients with relapsed or refractory myeloma after at least one prior therapy. The STOMP results not only provide the underlying clinical rationale for the ongoing pivotal Phase 3 BOSTON study evaluating selinexor in combination with once weekly Velcade, but also provide supportive data for selinexor as a potential new backbone therapy in combination with approved myeloma therapies, often with synergistic activity. We look forward to sharing these updated STOMP results from the Velcade, Pomalyst and Darzalex arms with the medical community at EHA (Free EHA Whitepaper) this year."
Details for the EHA (Free EHA Whitepaper) 2018 presentations are as follows:
Title: Selinexor combined with pomalidomide and low dose dexamethasone (SPd) in a relapsed/refractory multiple myeloma patient population
Presenter:Christine Chen, University of Toronto, Princess Margaret Cancer Center
Final Abstract Code: PF586
Topic/Session Title: Myeloma and other monoclonal gammopathies – Clinical
Date and Time:Friday, June 15, 2018; 17:30 – 19:00 CEST
Location: Poster area
Title: Selinexor combined with low dose bortezomib and dexamethasone (SVd) induces a high response rate in patients with relapsed or refractory multiple myeloma (MM)
Lead author: Nizar Bahlis, Southern Alberta Cancer Research Institute
Final Abstract Code: PS1322
Topic/Session Title: Myeloma and other monoclonal gammopathies – Clinical
Date and Time: Saturday, June 16, 2018; 17:30 – 19:00 CEST
Location: Poster area
Title: A Phase 1b study using the combination of selinexor, daratumumab, and dexamethasone in multiple myeloma patients previously exposed to proteasome inhibitors and immunomodulatory drugs
Lead author:Cristina Gasparetto, Duke University
Final Abstract Code: PS1329
Topic/Session Title: Myeloma and other monoclonal gammopathies – Clinical
Date and Time: Saturday, June 16, 2018; 17:30 – 19:00 CEST
Location: Poster area
About Selinexor
Selinexor (KPT-330) is a first-in-class, oral Selective Inhibitor of Nuclear Export / SINE compound. Selinexor functions by binding with and inhibiting the nuclear export protein XPO1 (also called CRM1), leading to the accumulation of tumor suppressor proteins in the cell nucleus. This reinitiates and amplifies their tumor suppressor function and is believed to lead to the selective induction of apoptosis in cancer cells, while largely sparing normal cells. To date, over 2,400 patients have been treated with selinexor. In April 2018, Karyopharm reported positive top-line data from the Phase 2b STORM study evaluating selinexor in combination with low-dose dexamethasone in patients with penta-refractory multiple myeloma. Selinexor has been granted Orphan Drug Designation in multiple myeloma and Fast Track designation for the patient population evaluated in the STORM study. Karyopharm plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) during the second half of 2018, with a request for accelerated approval for oral selinexor as a new treatment for patients with penta-refractory multiple myeloma. The Company also plans to submit a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in early 2019 with a request for conditional approval. Selinexor is also being evaluated in several other mid- and later-phase clinical trials across multiple cancer indications, including in multiple myeloma in a pivotal, randomized Phase 3 study in combination with Velcade (bortezomib) and low-dose dexamethasone (BOSTON) and as a potential backbone therapy in combination with approved therapies (STOMP), and in diffuse large B-cell lymphoma (SADAL), liposarcoma (SEAL), and an investigator-sponsored study in endometrial cancer (SIENDO), among others. Additional Phase 1, Phase 2 and Phase 3 studies are ongoing or currently planned, including multiple studies in combination with one or more approved therapies in a variety of tumor types to further inform Karyopharm’s clinical development priorities for selinexor. Additional clinical trial information for selinexor is available at www.clinicaltrials.gov.