Karyopharm to present studies on selinexor anticancer therapies

Karyopharm Therapeutics announced that ten abstracts have been selected for presentation, including three oral presentations, at the upcoming American Society of Hematology 2018 Annual Meeting being held December 1-4, 2018 in San Diego. Four key abstracts to be presented at the meeting will feature clinical data for selinexor, the Company’s first in class, oral SINE compound, from Karyopharm-sponsored trials. The presentations will include: top-line results from the Phase 2b SADAL study in patients with relapsed or refractory diffuse large B-cell lymphoma, additional data from the pivotal Phase 2b STORM study in patients with penta-refractory multiple myeloma, and updated data from the Darzalex and Pomalyst arms of the Phase 1b/2 STOMP study of selinexor in combination with backbone therapies for the treatment of patients with relapsed or refractory multiple myeloma. In addition to top-line data from the SADAL study, this year’s ASH meeting will also feature updated data from the STORM study in an oral presentation. As part of this presentation, data from an independent database of patients with heavily pretreated myeloma will also be presented, further underscoring how poor the prognosis is for patients with penta-refractory multiple myeloma. In October 2018, the U.S. FDA accepted Karyopharm’s New Drug Application for selinexor seeking accelerated approval as a new treatment for patients with penta-refractory multiple myeloma. The FDA has assigned a Priority Review and given an action date of April 6, 2019 under the Prescription Drug User-Fee Act. Other key abstracts at the meeting include data from two arms of the Phase 1b/2 STOMP study. There will be an oral presentation with updated data from the arm evaluating selinexor in combination with Darzalex and low-dose dexamethasone. In previously reported data, the once weekly SDd combination without a proteasome inhibitor or immunomodulatory drug demonstrated high response rates in the patient population as a doublet regimen. Finally, a poster presentation will highlight updated data from the arm evaluating selinexor in combination with Pomalyst and low-dose dexamethasone. In data reported previously from these arms, selinexor demonstrated evidence of synergistic anti-myeloma activity when combined with these standard approved therapies.

https://thefly.com/landingPageNews.php?id=2815649