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
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
Karyopharm Therapeutics宣佈，根據FDA的反饋，公司將用Abs-TSS替換第3階段SENTRY試驗中的兩個共同主要終點之一TSS50
- 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.
- Co-primary Endpoint已由總症狀評分（Abs-TSS）更改爲根據與FDA的對齊情況≥ 50%症狀改善的TSS50。
- Abs-TSS衡量患者症狀評分在24周內相對於基線症狀評分的平均改善。
- 脾臟體積反應率≥35%（SVR35）仍然是共同一級終點。
- Selinexor與Ruxolitinib聯合用藥的第1期試驗顯示Abs-TSS和SVR35有望改善，增強了對第3期SENTRY試驗的信懇智能。
- 積極增加SENTRY試驗的總樣本數量至約350名患者，進一步提高統計功效；預計2025年下半年公佈首要數據。
譯文內容由第三人軟體翻譯。
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