SELLAS Life Sciences Group (NASDAQ: SLS) has announced positive results from Cohort 3 of its Phase 2 trial of SLS009 (tambiciclib) in relapsed/refractory acute myeloid leukemia (r/r AML). The trial showed remarkable survival benefits with a median Overall Survival (mOS) of 8.8 months in patients relapsed or refractory to venetoclax-based regimens, significantly exceeding the historical benchmark of 2.5 months.
The study enrolled 14 r/r AML patients, with 71% having AML-MRC. Key findings include an Overall Response Rate (ORR) of 67% in AML-MRC patients and 46% in all evaluable patients, surpassing the targeted 20% ORR. Notable response rates were observed across different genetic mutations: 67% in ASXL1, 60% in RUNX1, and 33% in TP53 patients.
The trial continues with expansion cohorts 4 and 5, focusing on AML-MRC patients with various mutations. Full data and FDA regulatory path feedback are expected in 1H 2025.
No comments:
Post a Comment
Note: Only a member of this blog may post a comment.