Karyopharm Therapeutics’s Leukemia Treatment Does Not Reach Statistical Significance

Karyopharm Therapeutics (KPTI), a clinical-stage pharmaceutical company, disclosed results of a planned interim analysis of the Phase 2 SOPRA study evaluating single agent selinexor in relapsed/refractory acute myeloid leukemia (AML). The company determined in concert with the study’s independent Data Safety Monitoring Board (DSMB) that SOPRA will not reach statistical significance for overall survival (OS), the study’s primary endpoint.

However, since selinexor-treated patients that achieved a complete response (CR) showed a substantial OS benefit as compared with the physician’s choice (PC) arm, Karyopharm and the DSMB agreed that patients would be permitted to continue on the selinexor arm or the PC arm, as applicable, following discussion between the patient and their treating physician. The company plans to continue clinical development of selinexor in AML through investigator sponsored trials in multiple combination regimens, including with chemotherapy, given encouraging data to date across these settings.