Karyopharm : Phase 3 Study Of Selinexor Meets Primary Endpoint In Recurrent Endometrial Cancer

(RTTNews) - Karyopharm Therapeutics Inc. (KPTI) said that phase 3 SIENDO study, which evaluated the efficacy and safety of front-line maintenance therapy using selinexor, an oral medication, met primary endpoint with statistically significant increase in progression-free survival in patients with advanced or recurrent endometrial cancer.

Selinexor-treated patients had a median progression-free survival of 5.7 months compared to 3.8 months for patients on placebo, representing an improvement of 50%, with a hazard ratio (HR) of 0.70, representing a 30% reduction in the risk of disease progression or death.

Selinexor demonstrated a sustained and long-term improvement as seen at 12 months with a 37% increase in probability that selinexor-treated patients will be in remission compared to patients on no treatment, or today's standard of "watch and wait."

In this study, selinexor was well tolerated with no new safety signals identified, and a low discontinuation rate of 10.5% due to adverse events.

The company plans to submit a supplemental New Drug Application to the U.S. FDA during the first half of 2022. The company also plans to submit the detailed results from the study for presentation at upcoming medical meetings in the first half of 2022.