- Co-primary Endpoint Changed to Absolute Total Symptom Score (Abs-TSS) from Total Symptom Score Improvement of ≥ 50% (TSS50) Following Alignment with the FDA.
- Abs-TSS measures the average improvement in patient symptom scores over 24 weeks relative to the patient's baseline symptom score.
- Spleen Volume Response Rate ≥ 35% (SVR35) Remains a Co-primary Endpoint.
- Promising Improvement in Abs-TSS and SVR35 from Phase 1 Trial of Selinexor in Combination with Ruxolitinib Adds Confidence in Phase 3 SENTRY Trial.
- Proactively Increasing Total Sample Size of the SENTRY Trial to Approximately 350 Patients to Further Increase the Statistical Powering; Expected Top-line Data Read-out Remains in 2H 2025.
Karyopharm Therapeutics Announced That, Following FDA Feedback, The Company Will Be Replacing TSS50, One Of The Co-primary Endpoints In The Phase 3 SENTRY Trial With Abs-TSS
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