On May 16, 2018 Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a clinical-stage pharmaceutical company, reported that four posters will be presented at the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2018 Annual Meeting taking place June 1-5, 2018 in Chicago (Press release, Karyopharm, MAY 16, 2018, View Source [SID1234526706]). Among the poster presentations will be results from the Company’s Phase 2 SEAL study evaluating selinexor, its lead, oral SINE compound, in patients with advanced de-differentiated liposarcoma. The remaining posters will highlight clinical and preclinical data from ongoing investigator-sponsored trials evaluating selinexor in combination with other anti-cancer agents.
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"Dedifferentiated liposarcoma is a rare and aggressive form of the disease that is resistant to both standard chemotherapy and radiation, and most patients who progress following surgery ultimately succumb to this difficult to treat cancer," said Sharon Shacham, PhD, MBA, President and Chief Scientific Officer of Karyopharm. "We previously reported positive top-line data from the Phase 2 SEAL study in September 2017, including oral selinexor’s demonstration of superiority over placebo for the study’s primary endpoint of progression-free survival (PFS), with a hazard ratio of 0.60, representing a 40% reduction in the risk of progression or death. The Phase 3 portion of the SEAL study is currently ongoing with top-line data expected by the end of 2019. We look forward to presenting the more detailed results from the Phase 2 portion of the SEAL study at ASCO (Free ASCO Whitepaper) this year."
Details for the ASCO (Free ASCO Whitepaper) 2018 selinexor presentations are as follows:
Company-sponsored Trials
Title: Phase 2 results of selinexor in advanced de-differentiated (DDLS) liposarcoma (SEAL) study: A phase 2/3, randomized, double blind, placebo controlled cross-over study
Lead author:Mrinal Gounder, Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College
Poster Board #: 257
Abstract #: 11512
Poster Discussion Session: Sarcoma
Date and Time:Saturday, June 2, 2018; 8:00 AM – 11:30 AM CT; Discussion from 3:00 PM – 4:15PM
Location: Hall A
Investigator-sponsored Trials
Title: Phase 1 study of selinexor plus mitoxantrone, etoposide, and cytarabine in acute myeloid leukemia
Lead author:Bhavana Bhatnagar, Ohio State University Comprehensive Cancer Center
Poster Board #: 108
Abstract: 7048
Poster Session: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant
Date and Time:Monday, June 4, 2018; 8:00 AM – 11:30 AM CT
Location: Hall A
Title: Phase 1b study of selinexor, a first in class selective inhibitor of nuclear export (SINE) compound, in combination with doxorubicin in patients (pts) with locally advanced or metastatic soft tissue sarcoma (STS)
Lead author: Eoghan Ruadh Malone, Princess Margaret Cancer Centre
Poster Board #: 307
Abstract: 11562
Poster Session: Sarcoma
Date and Time:Saturday, June 2, 2018; 8:00 AM – 11:30 AM CT
Location: Hall A
Title: Profiling the immune checkpoint pathway in acute myeloid leukemia
Lead author:Paola Dama, University of Chicago
Poster Board #: 75
Abstract: 7015
Poster Discussion Session: Hematologic Malignancies – Leukemia, Myelodysplastic Syndromes, and Allotransplant
Date and Time:Monday, June 4, 2018; 8:00 AM – 11:30 AM CT; Discussion from 11:30 AM – 12:45 PM CT
Location: Hall A
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.