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SELLAS Announces Positive Topline Data from GFH009 Phase 1 Dose-Escalation Trial in Acute Myeloid Leukemia Cohort Supporting Advancement to Phase 2 Clinical Study
- 72 Acute Myeloid Leukemia and Lymphoma High-Risk Advanced Patients Enrolled: 94% Alive at Last Assessment Indicating Favorable Survival Benefit - -
About this update from Sellas Life Sciences Group, Inc.
[{"type":"text","content":"- 72 Acute Myeloid Leukemia and Lymphoma High-Risk Advanced Patients Enrolled: 94% Alive at Last Assessment Indicating Favorable Survival Benefit - - Long-Term Complete Remission and Significant Bone Marrow Blast Reductions in Acute Myeloid Leukemia: Durable Complete Remission with No Minimal Residual Disease Continues > 6 Months vs. Historic Median Survival of 2.5 Months in AML Patient; 77% Bone Marrow Blast Elimination in Highest Dose - - Decrease in MCL1 and MYC Biomarkers Observed in 97% of Patients - - No Dose Limiting Toxicity or Significant Safety Issues at any Dose Level - NEW YORK, May 04, 2023 (GLOBE NEWSWIRE) -- 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 positive topline data for the cohort of patients with acute myeloid leukemia (AML) from its Phase 1 dose-escalation trial in relapsed/refractory (r/r) myeloid malignancies for GFH009, its CDK9 inhibitor. Dose escalation continues in the lymphoma cohort with the last dose level of 75 mg weekly. Clinical activity observed in the lymphoma group will be announced after completion of the last dose level and is expected by the end of the second quarter or early third quarter of 2023. In the cohort of patients with AML, GFH009 treatment showed evidence of anti-tumor activity increasing with higher doses and no significant safety issues, including at the highest dose levels. The recommended Phase 2 dose (RP2D) for AML has been established and submitted to the U.S. Food and Drug Administration (FDA). SELLAS plans to commence a Phase 2a trial with GFH009 in combination with venetoclax and azacitidine (aza/ven) in patients with AML during the second quarter of 2023 with topline data expected by the end of the year. “We are thrilled to share promising signs of safety and clinical activity for GFH009 that support advancement into the Phase 2 clinical study in patients with AML, in parallel to completing the Phase 1 lymphoma cohort dose escalation,” said Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS. “These data include results from patients with difficult to treat advanced heavily pretreated blood cancers, which highlight the significant unmet need of patients that ...