On November 1, 2017 Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a clinical-stage pharmaceutical company, reported that 14 abstracts have been selected for presentation, including three oral presentations, at the upcoming American Society of Hematology (ASH) (Free ASH Whitepaper) 2017 annual meeting being held December 9-12, 2017 in Atlanta (Press release, Karyopharm, NOV 1, 2017, View Source [SID1234521436]). Four key abstracts being presented at the meeting will feature clinical data from Karyopharm’s ongoing Phase 1b/2 STOMP study evaluating selinexor, the Company’s lead, novel, oral SINE compound, in combination with backbone therapies for the treatment of patients with heavily pretreated multiple myeloma (MM). The four STOMP presentations will include updated data from the arms evaluating selinexor in combination with Velcade (bortezomib) and low-dose dexamethasone (SVd), selinexor in combination with Pomalyst (pomalidomide) and low-dose dexamethasone (SPd), and selinexor in combination with Revlimid (lenalidomide) and low-dose dexamethasone (SRd), and preliminary data from the arm evaluating selinexor in combination with Darzalex (daratumumab) and low-dose dexamethasone (SDd).
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“Despite several treatment advances for myeloma patients, there is a need for treatments with novel mechanisms, and many patients favor orally administered medicines,” said Sharon Shacham, PhD, MBA, President and Chief Scientific Officer of Karyopharm. “Previously reported data from the ongoing Phase 1b/2 STOMP study showed promising response rates in patients with heavily pretreated myeloma when oral selinexor is combined with Velcade (“SVd”) or Pomalyst (“SPd”). We are very pleased to provide updated data for selinexor in combination with these agents, new data for selinexor in combination with Revlimid (“SRd”), and early results from the new Darzalex (“SDd”) combination arm at ASH (Free ASH Whitepaper) this year. We believe these data support the potential of selinexor as a backbone therapy with commonly used agents for multiple myeloma. Moreover, we believe the new data continue to support our ongoing Phase 3 BOSTON study of SVd in myeloma.”
Details for the ASH (Free ASH Whitepaper) 2017 presentations are as follows:
Phase 1b/2 STOMP Study Data Presentations
Title: Selinexor in combination with weekly low dose bortezomib and dexamethasone (SVd) induces a high response rate with durable responses in patients with refractory multiple myeloma (MM)
Presenter: Nizar Bahlis, Southern Alberta Cancer Research Institute, Calgary, Alberta
Abstract Number/Publication ID: 3135
Session: 653. Myeloma: Therapy, excluding Transplantation: Poster II
Date and Time:Sunday, December 10, 2017; 6:00-8:00 PM ET
Location: Georgia World Congress Center, Building A, Level 1, Hall A2
Title: Selinexor in Combination with Pomalidomide and Low Dose Dexamethasone in a Relapsed / Refractory Multiple Myeloma Patient Population with Prior Proteasome Inhibitor and Lenalidomide Exposure
Presenter:Christine Chen, Princess Margaret Cancer Center, Toronto, Ontario
Abstract Number/Publication ID: 3136
Session: 653. Myeloma: Therapy, excluding Transplantation: Poster II
Date and Time:Sunday, December 10, 2017; 6:00-8:00 PM ET
Location: Georgia World Congress Center, Building A, Level 1, Hall A2
Title: A Phase Ib/II Trial of Selinexor Combined with Lenalidomide and Low Dose Dexamethasone in Patients with Relapsed / Refractory Multiple Myeloma
Presenter:Darrell White, Dalhousie University and QEII Health Sciences Center, Halifax; Nova Scotia
Abstract Number/Publication ID: 1861
Session: 653. Myeloma: Therapy, excluding Transplantation: Poster I
Date and Time:Saturday, December 9, 2017; 5:30-7:30 PM ET
Location: Georgia World Congress Center, Building A, Level 1, Hall A2
Title: A Phase 1b Study to Assess the Combination of Selinexor and Daratumumab in Patients with Relapsed/Refractory Multiple Myeloma Previously Exposed to Proteasome Inhibitors (PI) and Immunomodulatory Drugs (IMiDs)
Presenter:Cristina Gasparetto, Duke University Cancer Center, Durham, North Carolina
Abstract Number/Publication ID: 3100
Session: 653. Myeloma: Therapy, excluding Transplantation: Poster II
Date and Time:Sunday, December 10, 2017; 6:00-8:00 PM ET
Location: Georgia World Congress Center, Building A, Level 1, Hall A2
Investigator-sponsored Study Oral Presentations
Title: Selinexor in Combination with Cladribine, Cytarabine and G-CSF for Relapsed or Refractory AML
Presenter:Geoffrey Uy, Washington University School of Medicine in St. Louis
Abstract Number/Publication ID: 816
Session: 616. Acute Myeloid Leukemia: Novel Therapy, excluding Transplantation: Novel Targeted and Immune-based Approaches in the Treatment of AML; Monday, December 11, 2017 from 4:30-6:00 PM ET
Date and Time:Monday, December 11, 2017 at 5:45 PM ET
Location: Georgia World Congress Center, Building B, Level 5, Murphy BR 1-2
Investigator-sponsored Study Poster Presentations
Title: Selinexor maintenance is feasible and tolerable after allogeneic stem cell transplant (allo-SCT) for patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS)
Presenter:Hongtao Liu, University of Chicago Medical Center
Abstract Number/Publication ID: 3312
Session: 732. Clinical Allogeneic Transplantation: Results: Poster II
Date and Time:Sunday, December 10, 2017 from 6:00-8:00 PM ET
Location: Georgia World Congress Center, Building A, Level 1, Hall A2
Title: A Phase I/II study of Selinexor (SEL) with Sorafenib in Patients (pts) with Relapsed and/or Refractory (R/R) FLT3 mutated Acute Myeloid Leukemia (AML)
Presenter: Naval Daver, University of Texas MD Anderson Cancer Center
Abstract Number/Publication ID: 1344
Session: 616. Acute Myeloid Leukemia: Novel Therapy, excluding Transplantation: Poster I
Date and Time:Saturday, December 9, 2017 from 5:30-7:30 PM ET
Location: Georgia World Congress Center, Building A, Level 1, Hall A2
Title: Phase I/II Study of Liposomal Doxorubicin (DOX) in Combination with Selinexor (SEL) and Dexamethasone (Dex) for Relapsed and Refractory Multiple Myeloma (RRMM)
Presenter:Rachid Baz, H. Lee Moffitt Cancer Center and Research Institute
Abstract Number/Publication ID: 3095
Session: 653. Myeloma: Therapy, excluding Transplantation: Poster II
Date and Time:Sunday, December 10, 2017 from 6:00-8:00 PM ET
Location: Georgia World Congress Center, Building A, Level 1, Hall A2
Preclinical Oral Presentations
Title: Non-cytotoxic Low Doses of Selinexor Promote the Differentiation of AML Cells Harboring Mutant-NPM1 into Monocytes
Presenter: Saunthararajah Yogen, Cleveland Clinic
Abstract Number/Publication ID: 105742
Session: 603. Oncogenes and Tumor Suppressors: Nuclear Export and Metabolic Regulation; Monday, December 11, 2017, 6:15-7:45 PM ET
Date and Time:Monday, December 11, 2017 at 6:30 PM ET
Location: Georgia World Congress Center, Building C, Level 1, C101 Auditorium
Title: PAK4 Inhibition Impacts Growth and Survival, and Increases Sensitivity to DNA-Damaging Agents in Waldenstrom Macroglobulinemia
Presenter:Li Na, Dana Farber Cancer Institute
Abstract Number/Publication ID: 102879
Session: 622. Lymphoma Biology—Non-Genetic Studies: Novel Mechanisms Implicated in Lymphoma Biology; Monday, December 11, 2017, 10:30AM – 12:00 PM ET
Date and Time:Monday, December 11, 2017 at 11:45 AM ET
Location: Georgia World Congress Center, Building C, Level 1, C101 Auditorium
Preclinical Poster Presentations
Title: XPO1 Inhibitor Selinexor Overcomes Ibrutinib Resistance in Mantle Cell Lymphoma (MCL) via Nuclear Retention of IκB
Presenter:Mei Ming, University of Chicago
Abstract Number/Publication ID: 104320
Session: 605. Molecular Pharmacology, Drug Resistance-Lymphoid and Other Diseases
Date and Time:Monday, December 11, 2017; 6:00-8:00 PM ET
Location: Georgia World Congress Center, Building A, Level 1, Hall A2
Title: XPO1 Inhibition Synergizes with BCR Inhibition, Blocks Tumor Growth and Prolongs Survival in a Bioluminescent Animal Model of Primary Central Nervous System Lymphoma
Presenter:Marta Crespo, Hall d’Hebron, Barcelona
Abstract Number/Publication ID: 107008
Session: 625. Lymphoma: Pre-Clinical-Chemotherapy and Biologic Agents
Date and Time:Sunday, December 10, 2017; 6:00-8:00 PM ET
Location: Georgia World Congress Center, Building A, Level 1, Hall A2
Title: Eltanexor (KPT-8602), a Second-Generation Selective Inhibitor of Nuclear Export (SINE) Compound, in Patients with Refractory Multiple Myeloma
Presenter:Robert Frank Cornell, Vanderbilt University Medical Center
Abstract Number/Publication ID: 107422
Session: 653. Myeloma: Therapy, excluding Transplantation: Poster II
Date and Time:Sunday, December 10, 2017; 6:00-8:00 PM ET
Location: Georgia World Congress Center, Building A, Level 1, Hall A2
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 2,200 patients have been treated with selinexor, and it is currently being evaluated in several 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), in combination with low-dose dexamethasone (STORM) and backbone therapies (STOMP), and in diffuse large B-cell lymphoma (SADAL), and liposarcoma (SEAL), 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.