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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 公布了复发/难治性急性髓系白血病 SLS009 2a 期研究的主要数据,并提供了指导委员会关于 REGAL 3 期研究的最新情况
Benzinga ·  03/26 07:37
  • 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 -
  • 反洗钱中全科医生的第三阶段REGAL研究:招生工作已完成;指导委员会指导的中期分析迫在眉睫;IDMC现定于4月下旬进行-
  • SLS009 在 r/r 急性髓细胞白血病中的 2a 期研究:在所选最佳剂量 30 mg BIW 中,反应率为 50%,超过目标 20%;迄今为止,已确定生物标志物的患者的反应率为 100%-
  • SLS009 的 2a 期研究尚未达到中位操作系统;首位 CR 患者继续研究,自入组 9 个月后仍保持无白血病状态 —
  • SLS009 在大约 70% 的患者中表现出强大的抗白血病活性,在所有剂量水平下均具有良好的安全性-
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