SELLAS Announces Positive Overall Survival in Cohort 3 from the Ongoing Phase 2 Trial of SLS009 in r/r AML

Core Insights - SELLAS Life Sciences Group, Inc. announced promising results from Cohort 3 of the Phase 2 trial for SLS009, a CDK9 inhibitor, showing a median overall survival (mOS) of 8.9 months in patients with AML-MRC and 8.8 months in all relapsed or refractory patients, significantly surpassing the historical benchmark of 2.5 months [1][2] - The overall response rate (ORR) achieved was 67% in AML-MRC patients and 46% in all evaluable patients, exceeding the targeted ORR of 20% [1][2] Company Overview - SELLAS is a late-stage clinical biopharmaceutical company focused on developing novel therapies for various cancer indications, with SLS009 being a key candidate [7] - The company aims to address critical unmet medical needs in heavily pretreated AML patients, particularly those with adverse genetic mutations [2][7] Trial Details - The ongoing Phase 2 trial is an open-label, single-arm, multi-center study evaluating the safety, tolerability, and efficacy of SLS009 in combination with venetoclax and azacitidine [6] - The trial has expanded to include additional cohorts targeting specific mutations, including ASXL1, to further validate the therapy's potential [6] Patient Characteristics - In Cohort 3, 14 patients were treated, with 71% having AML-MRC and a median age of 71 years [5] - The cohort included patients with various mutations, with a median of 1 prior failed therapy [5] Efficacy Results - The mOS for all patients in Cohort 3 was 8.8 months, with a 67% ORR in AML-MRC patients and 46% in all evaluable patients [5] - Specific mutation responses included 75% in myelomonocytic AML, 67% in ASXL1, 60% in RUNX1, and 33% in TP53 [5] Safety Profile - SLS009 was well-tolerated with no new safety signals observed, indicating a favorable safety profile in the patient population [5]