Karyopharm presents Phase 2 myeloma data

— Oral Selinexor Achieves 25.4% Overall Response Rate and DOR of 4.4 Months in Overall Study Population —

— Median Survival of 8.6 Months in All Patients; Median Survival of Responders not yet Reached —

— New Drug Application Submitted to FDA; On Track to Submit MAA in Q1 2019 —

Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a clinical-stage pharmaceutical company, today announced that clinical data from the Phase 2b STORM study evaluating the Company’s lead, oral Selective Inhibitor of Nuclear Export (SINE) compound selinexor in heavily pretreated patients with refractory multiple myeloma, has been selected for oral presentation at the Society of Hematologic Oncology (SOHO) 2018 Annual Meeting, taking place September 12-15, 2018 in Houston.

“The clinical results from the STORM study further support selinexor’s potential role in advancing the treatment options available to patients with refractory multiple myeloma. In addition to the 25.4% overall response rate (ORR), including two patients who achieved stringent complete responses (sCRs) with minimum residual disease (MRD) negativity, patients treated with oral selinexor and dexamethasone (dex; Sd) also achieved median duration of response (DOR) of 4.4 months and median overall survival (OS) of 8.6 months,” said Sundar Jagannath, MD, Director of the Multiple Myeloma Program, Professor of Medicine (Hematology and Medical Oncology) at Tisch Cancer Institute at Mount Sinai School of Medicine, and principal investigator of the STORM study. “The importance of achieving MRD negativity and extending overall survival rates in this heavily pretreated patient population is very encouraging. Notably, patients with any response to Sd, including minimal, partial, very good partial and complete responses, experienced significantly prolonged OS compared to patients who did not respond, and the median OS had not yet been reached in this population.”

“Despite recent advances in myeloma treatment, an increasing number of patients will require additional therapeutic options for this progressive and fatal disease,” said Sharon Shacham, PhD, Founder, President and Chief Scientific Officer of Karyopharm. “The 27.3% ORR observed in patients who had previously received Darzalex® in combination regimens is particularly compelling as these patients are especially difficult to treat. Additionally, we are increasingly encouraged by the improvement in overall survival demonstrated in patients who had a response of stable disease or better. We look forward to presenting additional data from what is covered in the abstract at the SOHO 2018 Annual Meeting in mid-September. Finally, we remain tremendously excited by the recent submission of our first New Drug Application to the U.S. Food and Drug Administration seeking accelerated approved for selinexor in patients with penta-refractory myeloma, and we look forward to submitting a Marketing Authorization Application (MAA) with the EMA in the first quarter of 2019.”

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