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Karyopharm Announces Favorable Change in Co-Primary Endpoint for Pivotal Phase 3 SENTRY Trial in Myelofibrosis
Karyopharm Therapeutics (Nasdaq: KPTI)announced a change in co-primary endpoint for its Phase 3 SENTRY Trial in myelofibrosis, replacing TSS50 with Absolute Total Symptom Score (Abs-TSS) following FDA feedback. The trial's sample size will increase to approximately 350 patients, with top-line data expected in 2H 2025.
Phase 1 trial data showed promising results with 79% of patients achieving SVR35 and an average Abs-TSS improvement of 18.5 points at week 24 when combining selinexor with ruxolitinib, compared to historical data showing less than 50% SVR35 achievement with JAK inhibitor monotherapy.
Karyopharm Therapeutics (Nasdaq: KPTI)announced a change in co-primary endpoint for its Phase 3 SENTRY Trial in myelofibrosis, replacing TSS50 with Absolute Total Symptom Score (Abs-TSS) following FDA feedback. The trial's sample size will increase to approximately 350 patients, with top-line data expected in 2H 2025.
Phase 1 trial data showed promising results with 79% of patients achieving SVR35 and an average Abs-TSS improvement of 18.5 points at week 24 when combining selinexor with ruxolitinib, compared to historical data showing less than 50% SVR35 achievement with JAK inhibitor monotherapy.
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