Core Insights - SELLAS Life Sciences Group, Inc. announced promising clinical data for SLS009, a CDK9 inhibitor, in combination with azacitidine and venetoclax for treating relapsed or refractory acute myeloid leukemia with myelodysplastic syndrome-related changes [1][3] Group 1: Clinical Study Details - The Phase 2 study involved 35 evaluable patients with a median age of 69, where 98% had ELN adverse-risk AML, with common mutations including ASXL1, RUNX1, TP53, and SRSF2 [2] - The overall response rate for SLS009 in combination with AZA/VEN was 46%, with 29% achieving complete response (CR) or CR with incomplete blood count recovery (CRi) [3] - Patients with ASXL1 and TP53 mutations had response rates of 48% and 57%, respectively, with median overall survival (mOS) significantly exceeding the expected 2.6 months [3] Group 2: Safety and Tolerability - No dose-limiting toxicities (DLTs) or treatment-related deaths were reported, indicating that the combination therapy was well tolerated [3][5] - The combination therapy demonstrated a median overall survival of 8.9 months in the least pretreated cohort, with a 58% response rate in patients with one prior line of therapy [5] Group 3: Future Plans and Implications - The company plans to expand the study to evaluate SLS009 plus AZA/VEN in newly diagnosed AML with high-risk features in Q1 2026 [5] - The results suggest that SLS009 may effectively overcome resistance to venetoclax-based regimens by targeting MCL-1, a key resistance mechanism in AML [4]

Core Insights - SELLAS Life Sciences Group, Inc. announced preclinical efficacy of SLS009 (tambiciclib) in ASXL1 mutated colorectal cancer, highlighting its potential as a targeted therapy [1][2] - The presentation at the 2025 ASCO Annual Meeting emphasized the selective targeting of ASXL1-driven tumors, suggesting ASXL1 mutation status could serve as a biomarker for treatment response [2][3] 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 [4][5] - The company is also developing GPS, a product licensed from Sloan Kettering Cancer Center, aimed at addressing a broad spectrum of hematologic malignancies and solid tumors [5] Clinical Study Details - SLS009 is currently undergoing a Phase 2 open-label, single-arm, multi-center study to evaluate its safety, tolerability, and efficacy in combination with venetoclax and azacitidine for AML patients with ASXL1 mutations [3] - Initial clinical safety and efficacy data are available, and the study aims to identify biomarkers for patient selection [3] Efficacy Data - In a panel of ASXL1 mutant cell lines, 50% showed an IC50 <100 nM, indicating strong anti-proliferative activity, compared to 0% in ASXL1 wild-type lines [4] - Among cell lines with ASXL1 frameshift mutations, 75% responded with IC50 <100 nM, demonstrating a steep dose-response curve [4]

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]