other material
confidence high
sentiment positive
materiality 0.75
Karyopharm changes co-primary endpoint for Phase 3 SENTRY trial to Abs-TSS; increases sample size to 350
Karyopharm Therapeutics Inc.
- Co-primary endpoint changed from TSS50 to Abs-TSS following FDA alignment; SVR35 remains co-primary.
- Phase 1 Selinexor+ruxolitinib data showed 79% SVR35 (n=14) and 18.5-point average Abs-TSS improvement (n=9) at week 24.
- Total sample size increased to ~350 patients to improve statistical power; top-line data still expected in 2H 2025.
- Safety profile remains consistent with no new signals; change supported by key investigators and MPN Research Foundation.