GlobeNewswire·Mar 12, 2026, 8:35 AM ET

SELLAS Life Sciences Announces Enrollment of First Patient in Newly Diagnosed First-Line AML Trial of SLS009

SELLAS Life Sciences enrolled the first patient in its randomized Phase 2 trial (NCT04588922) for SLS009 (tambiciclib) in newly diagnosed first-line acute myeloid leukemia (AML) patients.
The study plans to enroll approximately 80 patients across two cohorts: those unlikely to benefit from standard venetoclax/azacitidine therapy based on molecular profiling & patients showing early resistance after two treatment cycles.
The trial will utilize SELLAS' predictive biomarker & AI-assisted precision medicine models to target specific molecular subgroups.
Topline data for the study is expected in Q4 2026.
This advancement follows positive Phase 2 results in relapsed/refractory AML, which showed a 33% overall response rate (ORR) overall & 40% ORR at the 30mg BIW dose.
Specific subgroups in the completed trial demonstrated an ORR of 44% in AML with myelodysplasia-related changes & 50% in ASXL1-mutated AML-MR.
Median overall survival was 8.8 months for patients treated with 30mg BIW compared to 2.4 months with best available therapy.
FDA guidance previously recommended advancing SLS009 into a study including newly diagnosed AML patients eligible for venetoclax & azacitidine therapy.
SLS009 is a selective CDK9 inhibitor with reduced toxicity & increased potency compared to other CDK9 inhibitors.