Publications and Presentations
Published data and presentations from medical conferences for Karyopharm’s investigational drug candidates
This page is intended to provide scientific information to scientific research professionals. XPOVIO (selinexor) has only been approved by the United States Food and Drug Administration (FDA) for the following indications:
• In combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody.
• For the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from follicular lymphoma, after at least 2 lines of systemic therapy.
Conditional Marketing Authorization from the European Commission granted on March 29, 2021: NEXPOVIO is indicated in combination with dexamethasone for the treatment of multiple myeloma in adult patients who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, two immunomodulatory agents and an anti-CD38 monoclonal antibody, and who have demonstrated disease progression on the last therapy.
On May 26, 2021 the UK’s Medicines & Healthcare Products Regulatory Agency (MHRA) granted conditional marketing authorization for NEXPOVIO® (selinexor), in combination with dexamethasone for the treatment of multiple myeloma in adult patients who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, two immunomodulatory agents, and an anti-CD38 monoclonal antibody, and who have demonstrated disease progression on the last therapy.
Karyopharm’s other drug candidates, including selinexor in additional indications, are investigational medicines and have not been approved by FDA, Health Canada, the European Medicines Agency (EMA), nor any other regulatory agency.
Multiple Myeloma
- Efficacy and safety of once weekly selinexor 40 mg versus 60 mg with pomalidomide and dexamethasone in relapsed and/or refractory multiple myeloma
- Once-per-week selinexor, bortezomib, and dexamethasone versus twice-per-week bortezomib and dexamethasone in patients with multiple myeloma (BOSTON): a randomised, open-label, Phase 3 trial
- Oral Selinexor-Dexamethasone for Triple-Class Refractory Multiple Myeloma
- Selinexor, daratumumab, and dexamethasone in patients with relapsed or refractory multiple myeloma
- Selective Inhibition of Nuclear Export With Oral Selinexor for Treatment of Relapsed or Refractory Multiple Myeloma
- Selinexor plus low-dose bortezomib and dexamethasone for patients with relapsed or refractory multiple myeloma
- Consensus Recommendations for the Clinical Management of Patients with Multiple Myeloma Treated With Selinexor
- Selinexor-based regimens for the treatment of myeloma refractory to chimeric antigen receptor T cell therapy
- Overall survival of patients with triple-class refractory multiple myeloma treated with selinexor plus dexamethasone vs standard of care in MAMMOTH
- Overall survival with oral selinexor plus low dose dexamethasone versus real-world therapy in triple-class-refractory multiple myeloma
- SVD in Prev Tx MM BOSTON PI Naive EHA 2023
- A Phase 3 Randomized, Open-label Trial of Selinexor, Pomalidomide, and Dexamethasone Versus Elotuzumab, Pomalidomide, and Dexamethasone in Patients with Relapsed or Refractory Multiple Myeloma
- Effectiveness of anti-B-cell maturation antigen (BCMA)-targeting therapy after selinexor treatment
- Efficacy And Safety Of 40 Mg Vs 60 Mg Of Once Weekly Selinexor In Combination With Pomalidomide And Dexamethasone In Relapsed And/or Refractory Multiple Myeloma (EHA 2023, presented on 6/9/2023)
- Efficacy and safety of 40 mg vs 60 mg once weekly selinexor in combination with pomalidomide and dexamethasone in relapsed and/or refractory multiple myeloma (ASCO 2023)
- Effectiveness of anti-B-cell maturation antigen (BCMA)-targeting therapy after selinexor Treatment (ASCO 2023)
- Weekly Selinexor, Bortezomib, and Dexamethasone (SVd) Versus Twice Weekly Bortezomib and Dexamethasone (Vd) in Patients with Multiple Myeloma (MM) After 1-3 Prior Therapies: Initial Results of the Phase 3 BOSTON Study
- Selinexor, Daratumumab, and Dexamethasone in Patients with Relapsed/Refractory Multiple Myeloma (MM)
- Once Weekly Selinexor, Carfilzomib, and Dexamethasone (XKd) in Heavily Pretreated Multiple Myeloma
- Oral Selinexor, Pomalidomide, and Dexamethasone (XPd) at Recommended Phase 2 Dose in Relapsed Refractory Multiple Myeloma
- Selinexor, Lenalidomide, and Dexamethasone (SRd) for Patients with Relapsed/Refractory and Newly Diagnosed Multiple Myeloma
- Selinexor-Containing Regimens for the Treatment of Patients with Multiple Myeloma Refractory to Chimeric Antigen Receptor T-Cell (CAR-T) Therapy
- Results of the Pivotal STORM Study (Part 2): Deep and Durable Responses with Oral Selinexor plus Low Dose Dexamethasone in Patients with Penta-Exposed and Triple Class Refractory MM
- Overall Survival of Triple Class Refractory, Penta-Exposed Multiple Myeloma (MM) Patients Treated With Selinexor Plus Dexamethasone or Conventional Care: A Combined Analysis of the STORM and Mammoth Studies
- Selinexor Combined with Low Dose Bortezomib and Dexamethasone (SVd) Induces a High Response Rate in Patients with Relapsed or Refractory Multiple Myeloma (MM)
- Improved Overall Survival (OS) with Oral Selinexor Plus Low Dose Dexamethasone (Sd) in Patients with Triple Class Refractory Multiple Myeloma (TCR-MM) Compared to FLATIRON – Real World Evidence
- Effect of Prior Treatment with Proteasome Inhibitors on the Efficacy and Safety of Once-Weekly Selienxor, Bortezomib, and Dexamethasone in Comparison with Twice Weekly Bortezomib and Dexamethasone in Relapsed or Refractory Multiple Myeloma: Subgroup Analysis From the BOSTON Study
- Once Weekly Selinexor, Bortezomib, and Dexamethasone in Relapsed or Refractory Multiple Myeloma: Age and Frailty Subgroup Analyses From the Phase 3 BOSTON Study
- Impact of Prior Therapies on the Safety and Efficacy of Once-Weekly Selinexor, Bortezomib, and Dexamethasone Compared With Twice-Weekly Bortezomib and Dexamethasone in Relapsed or Refractory Multiple Myeloma: Results from the BOSTON Study
- Once Weekly Selinexor, Bortezomib, and Dexamethasone (SVd) Versus Twice Weekly Bortezomib and Dexamethasone (Vd) in Relapsed or Refractory Multiple Myeloma: High-Risk Cytogenetic Risk Planned Subgroup Analyses from the Phase 3 BOSTON Study
Diffuse Large B-cell Lymphoma (DLBCL)
- Selinexor in patients with relapsed or refractory diffuse large B-cell lymphoma (SADAL): a single-arm, multinational, multicentre, open-label, phase 2 trial
- Selective inhibition of nuclear export with selinexor in patients with non-Hodgkin lymphoma
- Promising activity of selinexor in the treatment of a patient with refractory diffuse large B-cell lymphoma and central nervous system involvement
- A Phase 2b Study of Selinexor in Patients with Relapsed / Refractory Diffuse Large B-Cell Lymphoma: SADAL Trial
- Survival Among Patients with Relapsed/Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL) Treated with Single Agent Selinexor in the SADAL Study
- Effect of Prior Therapy on the Efficacy and Safety of Oral Selinexor in Patients With Relapsed/Refractory (R/R) Diffuse Large B-cell Lymphoma (DLBCL): A Post-hoc Analysis of the SADAL Study
- Effect of Age on the Efficacy and Safety of Single Agent Oral Selinexor in Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL): Subset Analysis from the SADAL Pivotal Phase 2b Study
- Selinexor Efficacy and Safety are Independent of Renal Function in Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL): A Post-Hoc Analysis From the Pivotal Phase 2b SADAL Study
Other Hematologic Malignancies
- Safety and activity of selinexor in patients with myelodysplastic syndromes or oligoblastic acute myeloid leukaemia refractory to hypomethylating agents: a single-centre, single-arm, phase 2 trial
- A phase I study of selinexor in combination with high-dose cytarabine and mitoxantrone for remission induction in patients with acute myeloid leukemia
- A phase 1 clinical trial of single-agent selinexor in acute myeloid leukemia
- MPN 2024 SENTRY Ph 1 presentation
- SOHO 2024 Follow up data from ESSENTIAL Trial
- Selinexor plus ruxolitinib impact on symptom burden in patients with myelofibrosis and potential mechanism of action via inhibition of NF-κB and activation of p53 pathways
- Selinexor Plus Ruxolitinib in JAK Inhibitor (JAKi)-Naïve Patients With Myelofibrosis: Long-Term Follow-up From XPORT-MF-034 Suggestive of Disease Modification
- A Global, Phase 3, Randomized, Double-blind Study to Evaluate Safety and Efficacy of Selinexor, an XPO1 Inhibitor, in Combination With Ruxolitinib in JAK-Inhibitor-Naïve Myelofibrosis (XPORT-MF-034)
- A Phase 2 Study to Evaluate the Efficacy and Safety of Selinexor Monotherapy in Patients With JAK-Inhibitor-Naïve Myelofibrosis and Moderate Thrombocytopenia (XPORT-MF-044)
- Selienexor plus Ruxolitinib in JAKi Naive MF_Longterm Follow up Data XPORT-MF-034
- Activity of Selinexor as a Single Agent and Synergistic Activity in Vitro
- Selinexor (SEL) plus Ruxolitinib (RUX) in JAK Inhibitor (JAKi) Treatment-Naïve Patients with Myelofibrosis: Updated results from XPORT-MF-034 (EHA 2023, presented on 6/9/2023)
- Selinexor plus ruxolitinib in JAK inhibitor treatment-naïve patients with myelofibrosis: Updated results from XPORT-MF-034 (ASCO 2023, presented on 6/5/2023)
- Updated results from Phase 1 study (XPORT-MF-034) of selinexor in combination with ruxolitinib in patients with treament naïve myelofibrosis (AACR 2023, presented on 4/18/2023)
- Results from Phase 1 study (XPORT-MF-034) of selinexor in combination with ruxolitinib in patients with treatment naïve myelofibrosis (ASH 2022)
- Initial results from Phase 1 dose escalation study (XPORT-MF-034) of selinexor in combination with ruxolitinib in patients with treatment naïve myelofibrosis (ASCO 2022)
- A Phase II Study to Evaluate the Efficacy and Safety of Selinexor in Patients with Myelofibrosis Refractory or Intolerant to JAK1/2 Inhibitors (ESSENTIAL study)
- Frontline Selinexor and Chemotherapy is Highly Active in Older Adults with Acute Myeloid Leukemia (AML)
- Selinexor, a First-in-Class XPO1 Inhibitor, Is Efficacious and Tolerable in Patients with Myelodysplastic Syndromes (MDS) Refractory to Hypomethylating Agents
- Phase I Trial of the Selective Inhibitor of Nuclear Export, SELINEXOR, in Relapsed Childhood Leukemia
- Selinexor in Combination with Cladribine, Cytarabine and G-CSF for Relapsed or Refractory AML
- A Phase I/II study of Selinexor (SEL) with Sorafenib in Patients with Relapsed and/or Refractory FLT3- mutated Acute Myeloid Leukemia (AML)
- A Randomized, Open-Label, Phase 2 Study of Selinexor Versus Physician’s Choice (PC) in Older Patients with Relapsed or Refractory Acute Myeloid Leukemia (AML)
Solid Tumors
- Long-term follow-up of efficacy and safety of selinexor maintenance treatment in patients with TP53wt advanced or recurrent endometrial cancer: A subgroup analysis of the SIENDO study
- SIENDO Phase 3 Study, Oral Selinexor as Maintenance Therapy After First-Line Chemotherapy for Advanced or Recurrent Endometrial Cancer
- Phase 2 Study of the Exportin 1 Inhibitor Selinexor in Patients with Recurrent Gynecological Malignancies
- First-in-Class, First-in-Human Phase I Study of Selinexor, a Selective Inhibitor of Nuclear Export, in Patients With Advanced Solid Tumors
- Phase IB Study of Selinexor, a First-in-Class Inhibitor of Nuclear Export, in Patients With Advanced Refractory Bone or Soft Tissue Sarcoma
- Follow-up data from SIENDO Phase 3 with expanded Q-TWIST analysis at IGCS 2024
- ASCO 2024_Long-term Follow-up of Selinexor Maintenance for Patients with TP53wt Advance or Recurrenet Endometrial Cancer in Phase 3 SIENDO Study
- Phase 3 dose selection for selinexor in TP53wt endometrial cancer
- Long-term follow up of selinexor maintenance for patients with TP53wt advanced or recurrent endometrial cancer from Phase 3 SIENDO study
- TPwt status can predict sensitivity to XPO1 inhibitors in patient derived cancer models
- ENGOT-EN20/GOG-3083/XPORT-EC-042 A phase 3, randomized, placebo-controlled, double-blind, multicenter trial of selinexor in maintenance therapy after systemic therapy for patients (PTS) with p53 wild-type, advanced or recurrent endometrial carcinoma (ASCO 2023, presented on 6/5/2023)
- SEAL: Phase 3, Randomized, Double Blind, Cross-Over, Study of Selinexor versus Placebo in Advanced Unresectable DeDifferentiated Liposarcoma (DDLS)
- SIENDO/ENGOT-EN5: A randomized phase 3 trial of maintenance with selinexor/placebo after combination chemotherapy in patients with advanced or recurrent endometrial cancer
- Final Results of the KING trial: Phase 2 Study of Efficacy, Safety, and Intratumoral Pharmacokinetics of Selinexor (KPT-330) Monotherapy in Recurrent Glioblastoma
- Phase 2 Results of Selinexor in Advanced DeDifferentiated (DDLS) Liposarcoma (SEAL) Study: A Phase 2/3, Randomized, Double Blind, Placebo Controlled Cross-Over Study
- Results of a Phase II Trial of Selinexor, in Patients with Gynaecological Cancers
- Phase 1b study to evaluate the safety of selinexor in combination with pembrolizumab in patients with advanced malignancies – The melanoma experience
- Selinexor in combination with carboplatin and paclitaxel in patients with advanced or metastatic solid tumors: Results of an open label, single-center, multi-arm phase 1b study
- Randomized Phase III Study of Maintenance Selinexor vs Placebo in Endometrial Cancer (ENGOT-EN5/GOG-3055/SIENDO): Impact of Subgroup Analysis and Molecular Classification
- SGO: Prospective double-blind, randomized phase III ENGOTEN5/ GOG-3055/SIENDO study of oral selinexor/placebo as maintenance therapy after first-line chemotherapy for advanced or recurrent endometrial cancer
- ESMO: Prospective double-blind, randomized phase III ENGOTEN5/ GOG-3055/SIENDO study of oral selinexor/placebo as maintenance therapy after first-line chemotherapy for advanced or recurrent endometrial cancer
Mechanism of Action
- The Past, Present, and Future of CRM1/XPO1 inhibitors
- Inhibiting cancer cell hallmark features through nuclear export inhibition
- The nuclear export protein XPO1-from biology to targeted therapy
- Nuclear transport inhibition in acute myeloid leukemia: recent advances and future perspectives
- Clinical Implications of Targeting XPO1-mediated Nuclear Export in Multiple Myeloma
Eltanexor and KPT-9274
- Phase 2 Survival and Safety of Eltanexor Monotherapy in Relapsed/Refractory Myelodysplastic Syndromes (17th International Congress on MDS, presented on 05/03/2023)
- Updated Efficacy of Eltanexor Monotherapy in Patients with Higher Risk Myelodysplastic Syndrome Primary Refractory to Hypomethylating Agents
- Eltanexor (KPT-8602), a Second Generation Selective Inhibitor of Nuclear Export (SINE) Compound, in Patients with Metastatic Castration Resistant Prostate Cancer (mCRPC)
- Eltanexor (KPT-8602), a Second-Generation Selective Inhibitor of Nuclear Export (SINE) Compound, in Patients with Refractory Multiple Myeloma
- A First in Human Phase 1 Study of KPT-9274, a First in Class Dual Inhibitor of PAK4 and NAMPT, in Patients with Advanced Solid Malignancies or NHL
- PAK4 Inhibition Improves PD-1 Blockade Immunotherapy