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Karyopharm Announces Phase 3 SIENDO Study Meets Primary Endpoint with Statistically Significant Increase in Progression-Free Survival in Patients with Advanced or Recurrent Endometrial Cancer
- Selinexor Demonstrates Statistically Significant 50% Improvement in Median Progression-Free Survival Compared to Placebo (Hazard Ratio of 0.70; p=0.0486) -
About this update from Karyopharm Therapeutics Inc.
[{"type":"text","content":"- Selinexor Demonstrates Statistically Significant 50% Improvement in Median Progression-Free Survival Compared to Placebo (Hazard Ratio of 0.70; p=0.0486) -\n - Patients with Wild-Type p53, a Pre-Specified Subgroup, Achieved a Statistically Significant Improvement in Median PFS (HR=0.38, p=0.0006) -\n - Selinexor was Well Tolerated with No New Safety Signals Identified, and a Low Discontinuation Rate of 10.5% Due to Adverse Events -\n - Company Plans to Submit Supplemental New Drug Application to the FDA and Submit Detailed Results for Presentation at Upcoming Medical Meetings, Both in 1H 2022 -\n - Management to Host Conference Call Today in Conjunction with Fourth Quarter and Year End 2021 Financial Results at 8:30 am ET -\n\n\nNEWTON, Mass., Feb. 8, 2022 /PRNewswire/ -- Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, today announced positive top-line results from the Phase 3 Selinexor In ENDOmetrial Cancer (SIENDO/ENGOT-EN5/GOG-3055) study (n=263) evaluating the efficacy and safety of front-line maintenance therapy using selinexor, an oral medication, in patients with advanced or recurrent endometrial cancer. The SIENDO study met its primary endpoint of a statistically significant improvement in median progression-free survival (PFS) compared to placebo. Selinexor-treated patients had a median PFS 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 (p=0.0486), 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. \nKaryopharm will work with investigators and the U.S. Food and Drug Administration (FDA) to complete a full evaluation of the SIENDO data. The preliminary data identified a pre-specified subgroup (wild-type p53, known as \"the guardian of the genome\"1) which achieved a statistically significant reduction in the risk of disease progression or death (curren...