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Karyopharm's Phase 3 SENTRY Trial in Myelofibrosis Met First Co-Primary Endpoint, Demonstrating Statistically Significant Improvement in Spleen Volume Reduction
– While Similar Symptom Improvement Was Observed Across the Two Arms Relative to Baseline, SENTRY Did Not Meet its Second Co-Primary Endpoint of Abs-TSS – –
About this update from Karyopharm Therapeutics Inc.
[{"type":"text","content":"– While Similar Symptom Improvement Was Observed Across the Two Arms Relative to Baseline, SENTRY Did Not Meet its Second Co-Primary Endpoint of Abs-TSS – – SENTRY Demonstrated a Rapid and Near Doubling of Patients Achieving SVR35 at Week 24, versus Ruxolitinib –– Promising Overall Survival Signal with >50% Reduction of Risk of Death versus Ruxolitinib –– Evidence of Potential Disease Modification with More Patients Achieving ≥20% Reductions in VAF as Early as Week 24 versus Ruxolitinib –– No New Safety Signals Identified –– Karyopharm will Meet with the FDA to Discuss the Totality of the Data and Potential sNDA Filing – – Conference Call Scheduled for Today at 8:00 a.m. ET –NEWTON, Mass., March 24, 2026 /PRNewswire/ -- Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, today reported topline results from its Phase 3 SENTRY trial, a randomized, double-blind, placebo-controlled trial of 60 mg selinexor in combination with ruxolitinib in frontline myelofibrosis (n=353). The trial met the first co-primary endpoint, demonstrating statistically significant improvement in spleen volume reduction of 35% or more (SVR35) for patients treated with the combination of selinexor plus ruxolitinib, with rapid, deep and sustained spleen volume reduction rates seen in the combination arm. The mean change in absolute total symptom score (Abs-TSS) at week 24 relative to baseline was comparable across the two arms with similar symptom improvement relative to baseline; the difference across the two arms was not statistically significant. Importantly, the topline results suggest a promising signal in overall survival (OS) for the combination arm.Spleen Volume: 50% of patients who received the combination of selinexor plus ruxolitinib achieved a statistically significant improvement in SVR35 at week 24 compared to 28% of patients who received ruxolitinib alone (one-sided p100 x 109/L. Patients were randomized 2-to-1 to the selinexor arm. The co-primary endpoints for this trial are spleen volume reduction ≥ 35% (SVR35) at week 24 and the average change in absolute total symptom score (Abs-TSS) over 24 weeks relative to baseline.About MyelofibrosisMyelofibrosis is a rare blood cancer that affects approximately 20,000 patients in the United States and 17,000 patients in the European U...