Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, today announced that sixteen abstracts have been selected for virtual presentation, including one oral presentation, at the upcoming 2021 American Society of Clinical Oncology (ASCO) Annual Meeting taking place June 4, 2021
NEWTON, Mass., May 19, 2021 /PRNewswire/ -- Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, today announced that sixteen abstracts have been selected for virtual presentation, including one oral presentation, at the upcoming 2021 American Society of Clinical Oncology (ASCO) Annual Meeting taking place June 4-8, 2021. Key abstracts to be presented at the meeting will feature clinical data for XPOVIO® (selinexor), the Company’s first in class, oral Selective Inhibitor of Nuclear Export (SINE) compound, including: (i) multiple new subgroup analyses from the pivotal Phase 3 BOSTON study, including data results evaluating XPOVIO treatment for patients over the age of 65 years old and patients with RAS-mutated multiple myeloma; (ii) updated data from the Pomalyst® (pomalidomide) and Kyprolis® (carfilzomib) arms of the Phase 1b/2 STOMP study evaluating XPOVIO in combination with backbone therapies in patients with relapsed or refractory multiple myeloma; (iii) new results from a Phase 1 study evaluating the combination of XPOVIO and pembrolizumab in advanced RAS mutant and RAS wild type colorectal cancer; (iv) results from gene set enrichment analyses identifying molecular predictors of response to XPOVIO from the Phase 2/3 SEAL study in patients with dedifferentiated liposarcoma (DDLS); and (v) updated overall survival (OS) data from a Phase 1/2 study evaluating oral eltanexor, the Company’s second generation SINE compound, in patients with hypomethylating-agent refractory myelodysplastic syndrome (MDS). “We are honored to be sharing this broad set of clinical data with the medical and scientific community this year at ASCO, where we will be highlighting several important new datasets, including new subgroup analyses from both the BOSTON and STOMP studies in patients with relapsed or refractory multiple myeloma where we believe XPOVIO will become an important backbone therapy,” said Sharon Shacham, PhD, MBA, Chief Scientific Officer of Karyopharm. “Additionally, we are pleased to see data from our growing pipeline of solid tumor studies, which will include new data from an ongoing combination study of XPOVIO and pembrolizumab in patients with advanced colorectal cancer as well as the discovery of certain molecular predictors of response to XPOVIO in patients with dedifferentiated liposarcoma, a difficult to treat cancer due to its resistance to chemotherapy and radiation. The data presented this year continue to demonstrate the broad clinical utility of XPO1 inhibition across a growing range of cancer types.” Select Abstracts Featuring XPOVIO® (selinexor) in Multiple Myeloma 1. Title: Survival Among Older Patients with Previously Treated Multiple Myeloma Treated with Selinexor, Bortezomib, and Dexamethasone (XVd) in the BOSTON study Presenter: Thierry Facon, University Hospital 2. Title: Effects of Weekly Selinexor, Bortezomib, Dexamethasone (XVd) Versus Standard Twice Weekly bortezomib and dexamethasone (Vd) on RAS-mutated previously treated multiple myeloma (MM) Presenter: Christopher J. Walker, Karyopharm Therapeutics Inc. 3. Title: Effects of Refractory Status to Lenalidomide on Safety and Efficacy of Selinexor, Bortezomib, and Dexamethasone (XVd) Versus Bortezomib and Dexamethasone (Vd) in Patients with Previously Treated Multiple Myeloma Presenter: Xavier Leleu, CHU de Poitiers, Hôpital La Mileterie 4. Title: Oral Selinexor, Pomalidomide, and Dexamethasone (XPd) at Recommended Phase 2 Dose in Relapsed Refractory Multiple Myeloma (MM) Presenter: Darrell White, QEII Health Sciences Center, Dalhousie University 5. Title: Once Weekly Selinexor, Carfilzomib, and Dexamethasone (XKd) in Carfilzomib Nonrefractory Multiple Myeloma (MM) Patients Presenter: Cristina Gasparetto, Duke University Cancer Center 6. Title: Selinexor Containing Regimens in Patients with Multiple Myeloma (MM) Previously Treated with anti-CD38 Monoclonal Antibodies (aCD38 mAbs) Presenter: Cristina Gasparetto, Duke University Cancer Center Select Abstracts Featuring XPOVIO (selinexor) in Solid Tumors 7. Title: Molecular Predictors of Response to Selinexor in Advanced Unresectable De-differentiated Liposarcoma (DDLS) Presenter: Christopher J. Walker, Karyopharm Therapeutics Inc. 8. Title: Open-Label Phase 1 Study Evaluating the Tolerability and Anti-Tumor Activity of Selinexor and Pembrolizumab in Colorectal Cancer Presenter: Talia Golan, Oncology Department Center Sheba Medical Center at Tel Hashomer 9. Title: Selinexor in Combination with Weekly Paclitaxel in Patients with Advanced or Metastatic Solid Tumors: Results of an Open Label, Single-Center, Multi-arm Phase 1b Study Presenter: Shannon Westin, The University of Texas MD Anderson Cancer Center Abstracts Featuring Eltanexor in MDS 10. Title: Updated Overall Survival of Eltanexor for the Treatment of Patients with Hypomethylating Agent Refractory Myelodysplastic Syndrome Presenter: Sangmin Lee, Weill Cornell Medical College Additional Abstracts to be Presented 11. Title: A Randomized, Open-label, Phase 3 Study of Low-dose Selinexor and Lenalidomide (Len) Versus Len Maintenance Post Autologous Stem Cell Transplant (ASCT) for Newly Diagnosed Multiple Myeloma (NDMM): ALLG MM23: Sealand Presenter: Hang Quach, St. Vincent Hospital 12. Title: U.S. Budget Impact (BI) Model for Selinexor, Bortezomib, and Dexamethasone (XVd) for the Treatment of Patients with Previously Treated Multiple Myeloma (MM) Presenter: Mike Dolph, McGill University 13. Title: SIENDO/ENGOT-EN5/GOG-3055: A Randomized Phase 3 Trial of Maintenance Selinexor Versus Placebo After Combination Platinum-based Chemotherapy in Advanced or Recurrent Endometrial Cancer Presenter: Ignace Vergote, BGOG and University Hospitals Leuven, Leuven Cancer Institute 14. Title: A Phase 1/2 Study of Selinexor in Combination with Standard of Care Therapy for Newly Diagnosed or Recurrent Glioblastoma Presenter: Yazmin Odia, Miami Cancer Institute, Baptist Health South Florida (BHSF) 15. Title: Digital Measurement of Functional Status of Patients with Glioblastoma Presenter: Yasaman Demastani, Karyopharm Therapeutics Inc. 16. Title: A Phase 1b/2 Study of Selinexor in Combination with Imatinib in Patients with Advanced Gastrointestinal Presenter: Cesar Serrano, West Virginia University School of Medicine Neurology & Neurosurgery About XPOVIO® (selinexor) XPOVIO is a first-in-class, oral Selective Inhibitor of Nuclear Export (SINE) compound. XPOVIO functions by selectively binding to and inhibiting the nuclear export protein exportin 1 (XPO1, also called CRM1). XPOVIO blocks the nuclear export of tumor suppressor, growth regulatory and anti-inflammatory proteins, leading to accumulation of these proteins in the nucleus and enhancing their anti-cancer activity in the cell. The forced nuclear retention of these proteins can counteract a multitude of the oncogenic pathways that, unchecked, allow cancer cells with severe DNA damage to continue to grow and divide in an unrestrained fashion. Karyopharm received accelerated U.S. Food and Drug Administration (FDA) approval of XPOVIO in July 2019 in combination with dexamethasone for the treatment of adult patients with relapsed refractory multiple myeloma (RRMM) 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. NEXPOVIO® (selinexor) has also been granted conditional marketing authorization for adult patients with heavily pretreated multiple myeloma by the European Commission. Karyopharm’s supplemental New Drug Application (sNDA) requesting an expansion of its indication to include the treatment for patients with multiple myeloma after at least one prior therapy was approved by the FDA on December 18, 2020. In June 2020, Karyopharm received accelerated FDA approval of XPOVIO for its second indication in 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. Selinexor is also being evaluated in several other mid-and later-phase clinical trials across multiple cancer indications, including as a potential backbone therapy in combination with approved myeloma therapies (STOMP) and 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 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. For more information about Karyopharm’s products or clinical trials, please contact the Medical Information department at: Tel: +1 (888) 209-9326 XPOVIO® (selinexor) is a prescription medicine approved:
SELECT IMPORTANT SAFETY INFORMATION Warnings and Precautions
Adverse Reactions
Use In Specific Populations For additional product information, including full prescribing information, please visit www.XPOVIO.com. To report SUSPECTED ADVERSE REACTIONS, contact Karyopharm Therapeutics Inc. at 1–888–209–9326 or FDA at 1–800–FDA–1088 or www.fda.gov/medwatch. About Eltanexor (KPT-8602) Eltanexor (KPT-8602) is a second generation oral SINE compound, which is currently being investigated in clinical trials. Eltanexor functions by binding to and inhibiting the nuclear export protein XPO1 (also called CRM1), leading to the accumulation of tumor suppressor proteins in the cell nucleus. Eltanexor has demonstrated minimal brain penetration in animals, which has been associated with reduced toxicities in preclinical studies while maintaining potent anti-tumor effects. About Karyopharm Therapeutics Karyopharm Therapeutics Inc. (NASDAQ: KPTI) is a commercial-stage pharmaceutical company pioneering novel cancer therapies and dedicated to the discovery, development, and commercialization of first-in-class drugs directed against nuclear export for the treatment of cancer and other diseases. Karyopharm’s Selective Inhibitor of Nuclear Export (SINE) compounds function by binding with and inhibiting the nuclear export protein XPO1 (or CRM1). Karyopharm’s lead compound, XPOVIO® (selinexor), is approved in the U.S. in multiple hematologic malignancy indications, including in combination with Velcade® (bortezomib) and dexamethasone for the treatment of adult patients with multiple myeloma after at least one prior therapy, in combination with dexamethasone for the treatment of adult patients with heavily pretreated multiple myeloma and as a monotherapy for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma. NEXPOVIO® (selinexor) has also been granted conditional marketing authorization in combination with dexamethasone for adult patients with heavily pretreated multiple myeloma by the European Commission. In addition to single-agent and combination activity against a variety of human cancers, SINE compounds have also shown biological activity in models of neurodegeneration, inflammation, autoimmune disease, certain viruses and wound-healing. Karyopharm has several investigational programs in clinical or preclinical development. For more information, please visit www.karyopharm.com. Forward-Looking Statements This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Such forward-looking statements include those regarding Karyopharm’s expectations and plans relating to XPOVIO for the treatment of patients with relapsed or refractory multiple myeloma or certain solid tumors; the expected design of the Company’s clinical trials; and the therapeutic potential of and potential clinical development plans for Karyopharm’s drug candidates, especially selinexor. Such statements are subject to numerous important factors, risks and uncertainties, many of which are beyond Karyopharm’s control, that may cause actual events or results to differ materially from Karyopharm’s current expectations. For example, there can be no guarantee that any of Karyopharm’s drug candidates, including selinexor, will successfully complete necessary clinical development phases or that development of any of Karyopharm’s drug candidates will continue. Further, there can be no guarantee that any positive developments in the development or commercialization of Karyopharm’s drug candidate portfolio will result in stock price appreciation. Management’s expectations and, therefore, any forward-looking statements in this press release could also be affected by risks and uncertainties relating to a number of other factors, including the following: the risk that the COVID-19 pandemic could disrupt Karyopharm’s business more severely than it currently anticipates, including by negatively impacting sales of XPOVIO, interrupting or delaying research and development efforts, impacting the ability to procure sufficient supply for the development and commercialization of selinexor or other product candidates, delaying ongoing or planned clinical trials, impeding the execution of business plans, planned regulatory milestones and timelines, or inconveniencing patients; the adoption of XPOVIO in the commercial marketplace, the timing and costs involved in commercializing XPOVIO or any of Karyopharm’s drug candidates that receive regulatory approval; the ability to retain regulatory approval of XPOVIO or any of Karyopharm’s drug candidates that receive regulatory approval; Karyopharm’s results of clinical trials and preclinical studies, including subsequent analysis of existing data and new data received from ongoing and future studies; the content and timing of decisions made by the U.S. Food and Drug Administration and other regulatory authorities, investigational review boards at clinical trial sites and publication review bodies, including with respect to the need for additional clinical studies; the ability of Karyopharm or its third party collaborators or successors in interest to fully perform their respective obligations under the applicable agreement and the potential future financial implications of such agreement; Karyopharm’s ability to obtain and maintain requisite regulatory approvals and to enroll patients in its clinical trials; unplanned cash requirements and expenditures; development or regulatory approval of drug candidates by Karyopharm’s competitors for products or product candidates in which Karyopharm is currently commercializing or developing; and Karyopharm’s ability to obtain, maintain and enforce patent and other intellectual property protection for any of its products or product candidates. These and other risks are described under the caption “Risk Factors” in Karyopharm’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2021, which was filed with the Securities and Exchange Commission (SEC) on May 4, 2021, and in other filings that Karyopharm may make with the SEC in the future. Any forward-looking statements contained in this press release speak only as of the date hereof, and, except as required by law, Karyopharm expressly disclaims any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise. XPOVIO®(selinexor) is a registered trademark of Karyopharm Therapeutics Inc. Any other trademarks referred to in this presentation are the property of their respective owners. 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Company Codes: NASDAQ-NMS:KPTI |