Karyopharm: Positive Top-Line Phase 2b Data for B-Cell Lymphoma Study at ASH

— 29.6% Overall Response Rate Including 9.6% Complete Response Rate —

— Amongst the Patients with Complete or Partial Response, Median Duration of Response was 9.2 Months and Median Overall Survival was 29.7 months —

— Company Plans to Submit New Drug Application to the FDA in the First Half of 2019 —

Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a clinical-stage pharmaceutical company, today reported positive top-line results from the Phase 2b SADAL (Selinexor Against Diffuse Aggressive Lymphoma) study evaluating selinexor, the Company’s first-in-class, oral Selective Inhibitor of Nuclear Export (SINE) compound, in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after at least two prior multi-agent therapies and who are ineligible for transplantation, including high dose chemotherapy with stem cell rescue. The data were highlighted in a poster presentation at the American Society of Hematology (ASH) 2018 Annual Meeting in San Diego. For the SADAL study’s primary endpoint, single-agent selinexor achieved a 29.6% overall response rate (ORR), which included a 9.6% complete response (CR) rate in patients with heavily pretreated relapsed or refractory DLBCL. Key secondary endpoints included a median duration of response (DOR, in the responding patients) of 9.2 months and median overall survival (OS, across the entire study) of 9.1 months.

Selinexor recently received Fast Track designation from the FDA for the patient population evaluated in the SADAL study. Karyopharm plans to submit a New Drug Application (NDA) to the FDA during the first half of 2019, with a request for accelerated approval for oral single-agent selinexor as a new treatment for patients with relapsed or refractory DLBCL.

https://www.marketscreener.com/KARYOPHARM-THERAPEUTICS-I-14825950/news/Karyopharm-Reports-Positive-Top-Line-Phase-2b-SADAL-Data-for-Selinexor-in-Patients-with-Diffuse-Larg-27692960/