SELLAS Life Sciences Announced Sunday, SLS009 In Combination With AZA/VEN Achieved 46% Overall Response Rate Across All Cohorts, 58% Overall Response Rate In Patients With One Prior Line Of Therapy In AML-MR Study

SELLAS Life Sciences Group, Inc. (NASDAQ:SLS) ("SELLAS'' or the "Company"), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, today announced that clinical data from its ongoing Phase 2 study of SLS009, a highly selective CDK9 inhibitor, in combination with azacitidine (AZA) and venetoclax (VEN) for the treatment of patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) with myelodysplastic syndrome-related changes (AML-MR) after prior VEN-based treatment were presented today at the 67th American Society of Hematology (ASH) Annual Meeting and Exposition, being held December 6 - 9, 2025, in Orlando, Florida.

 

• SLS009 in combination with AZA/VEN achieved a 46% overall response rate across all cohorts, a 58% overall response rate in patients with one prior line of therapy, and encouraging survival outcomes in heavily-pretreated AML-MR following prior VEN-based treatment
  
   
• Median overall survival (mOS) of 8.9 months in the least pretreated patient cohort; across all cohorts, mOS was not yet reached in patients with one prior line of therapy vs historical benchmark of approximately 2.5 months
  
   
• SLS009 30 mg IV twice weekly added to AZA/VEN was safe and feasible, with no dose-limiting toxicities (DLTs) observed
  
   
• Study expansion to evaluate SLS009 plus AZA/VEN in newly diagnosed AML with high-risk features is planned for Q1 2026