Sellas Life Sciences称SLS 009（Tambiciclib）的II期试验符合复发性/难治性急性骨髓性白血病的所有主要终点

2025-07-15 19:47

The Trial Exceeded Target Overall Response Rate (ORR) of 20%, with 44% Response Rate Among Patients with Acute Myeloid Leukemia-Myelodysplasia-Related Changes (AML MR) Treated at Optimal Dose of 30 mg Twice a Week (BIW) and 50% in AML MR with Myelomonocytic/Myelomonoblastic (M4/M5) Subtype
Median Overall Survival (mOS) of 8.9 Months in Patients with AML MR and 8.8 mOS in Relapsed or Refractory to Venetoclax-Based Regimens at 30 mg BIW Dose Level Surpasses the Historical Benchmark of 2.4 Months.
FDA Recommends Advancement towards a Trial Including Newly Diagnosed First-Line AML Patient Cohorts That May Support a New Drug Application; Trial Preparation Underway with Enrollment Expected to Begin by Q1 2026