On September 20, 2018 Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a clinical-stage pharmaceutical company, reported two oral presentations and one poster presentation highlighting previously reported clinical data relating to selinexor, the Company’s lead, oral Selective Inhibitor of Nuclear Export (SINE) compound at the 21st Annual Meeting of the Chinese Society of Clinical Oncology (CSCO) 2018 taking place September 19-23, 2018 in Xiamen, China (Press release, Karyopharm, SEP 20, 2018, View Source [SID1234529501]).
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"Given our recently executed strategic alliance with Antengene Corporation to develop selinexor in China, we are honored to share these key results from the STORM, STOMP and SADAL studies with the medical oncology community this year at CSCO," said Sharon Shacham, PhD, Founder, President and Chief Scientific Officer of Karyopharm. "The CSCO annual meeting is among the most prestigious oncology conferences in China and presenting these important data further our goal of advancing selinexor in this important market and across the globe."
Details for the presentations at CSCO:
Oral presentations
Title: Phase 2b Results of the STORM Study: Oral Selinexor plus Low Dose Dexamethasone (Sd) in Patients with Penta-Refractory Myeloma (penta-MM)
Date and Time: Friday, September 21, 2018, from 16:42 to 16:50
Title: Single Agent Oral Plus Selinexor Exhibits Durable Responses in Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL) of Both GCB and Non-GCB Subtypes: The Phase 2b SADAL Study
Date and Time: Saturday, September 22, 2018 from 8:45 to 8:55
ePoster presentation
Title: Selinexor Plus Low-Dose Bortezomib and Dexamethasone (SVd) Induces a High Response Rate in Patients with Relapsed or Refractory Multiple Myeloma (RRMM)
Date and Time:Thursday, September 20 – Sunday, September 23, 2018
About Selinexor
Selinexor 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 2,600 patients have been treated with selinexor. In April and September 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 has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA), 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), as a potential backbone therapy in combination with approved therapies (STOMP), 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 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.