SELLAS Announces Topline Data From Phase 2a Study of SLS009 In Relapsed/Refractory Acute Myeloid Leukemia And Provides Steering Committee Update on Phase 3 REGAL Study
SELLAS Announces Topline Data From Phase 2a Study of SLS009 In Relapsed/Refractory Acute Myeloid Leukemia And Provides Steering Committee Update on Phase 3 REGAL Study
SELLAS 公佈了復發/難治性急性髓系白血病 SLS009 2a 期研究的主要數據，並提供了指導委員會關於 REGAL 3 期研究的最新情況
- Phase 3 REGAL Study of GPS in AML: Enrollment Completed; Steering Committee Guided Interim Analysis Imminent; IDMC Now Scheduled in Late April -
- Phase 2a study of SLS009 in r/r AML: 50% Response Rate in the Selected Optimal Dose of 30 mg BIW Exceeding the Targeted 20%; 100% Response Rate in Patients with Identified Biomarkers to Date -
- Median OS Has Not Been Reached in the Phase 2a Study of SLS009; First CR Patient Continues on Study and Remains Leukemia-Free 9 Months Since Enrollment –
- SLS009 Exhibits Strong Anti-Leukemic Activity in ~70% of Patients with a Favorable Safety Profile at All Dose Levels -
- 反洗錢中全科醫生的第三階段REGAL研究：招生工作已完成；指導委員會指導的中期分析迫在眉睫；IDMC現定於4月下旬進行-
- SLS009 在 r/r 急性髓細胞白血病中的 2a 期研究：在所選最佳劑量 30 mg BIW 中，反應率爲 50%，超過目標 20%；迄今爲止，已確定生物標誌物的患者的反應率爲 100%-
- SLS009 的 2a 期研究尚未達到中位操作系統；首位 CR 患者繼續研究，自入組 9 個月後仍保持無白血病狀態 —
- SLS009 在大約 70% 的患者中表現出強大的抗白血病活性，在所有劑量水平下均具有良好的安全性-