Co-primary Endpoint Changed to Absolute Total Symptom Score (Abs-TSS) from Total Symptom Score Improvement of ≥ 50% (TSS50) Following Alignment with the FDA 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 Company to Host a Conference Call Today at 8:00 a.m. ET Featuring Drs.
Raajit Rampal and John Mascarenhas NEWTON, Mass. , Oct. 31, 2024 /PRNewswire/ -- Karyopharm Therapeutics Inc.
(Nasdaq: KPTI ), a commercial-stage pharmaceutical company pioneering novel cancer therapies, today announced that, following feedback from the U.S. Food and Drug Administration (FDA), the Company will be replacing TSS50, one of the co-primary endpoints in the Phase 3 SENTRY Trial (NCT04562389) with Abs-TSS.
Abs-TSS measures the average improvement in patient symptom scores over 24 weeks relative to the patient's baseline symptom score. "There remains a tremendous unmet need in myelofibrosis, as less than half of patients achieve SVR35 with each of the approved JAK inhibitors and many patients eventually stop responding to these treatments," said Dr. Raajit Rampal, Director of the Center for Hematologic Malignancies and Director of the Myelo.