Initial Patient Enrolled in Phase 2a Clinical Trial of GFH009 for Acute Myeloid Leukemia, Announced by SELLAS
Friday, June 23, 2023
SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) has recently commenced a Phase 2a clinical trial to evaluate the efficacy of its novel CDK9 inhibitor, GFH009, in combination with venetoclax and azacitidine (aza/ven) for the treatment of relapsed/refractory acute myeloid leukemia (AML). This open-label, single-arm, multicenter study aims to assess the safety, tolerability, and effectiveness of GFH009 at two different dose levels in conjunction with aza/ven. Approximately 20 AML patients who did not respond or stopped responding to venetoclax-based therapies will be enrolled in the trial, with top-line results expected in the fourth quarter of this year.
The primary objectives of the Phase 2a study include evaluating the composite complete response rate (CRc) and duration of response (DOR), while secondary endpoints encompass event-free survival (EFS), overall survival (OS), and pharmacokinetic (PK) and pharmacodynamic (PD) assessments. SELLAS aims to determine the safety and efficacy of GFH009 in combination with aza/ven, with the potential to improve venetoclax effectiveness and overcome resistance, differentiating it from other CDK9 inhibitors in development. The company anticipates strong synergy between GFH009 and venetoclax, leading to improved patient response rates.
Promising data from a Phase 1 study in AML patients provided the foundation for initiating the Phase 2a trial. The Phase 1 results demonstrated a favorable safety profile of GFH009 and early signs of efficacy, with a durable complete remission observed in one patient who had previously failed aza/ven therapy. This complete remission, lasting over six months, represents a significant achievement as the first reported complete remission for a CDK9 inhibitor in AML. SELLAS plans to present the full Phase 1 AML data at a major medical conference in the fourth quarter of 2023.
GFH009 functions by suppressing MCL1 expression, targeting different mechanisms of action compared to venetoclax. Since AML patients possess heterogeneous cancer cells that rely on various proteins for survival, the combination of GFH009 and venetoclax can effectively target cells dependent on BCL2, MCL1, or both simultaneously. By including azacitidine in the treatment regimen, the trial seeks to enhance the pro-apoptotic effect, potentially increasing response rates in relapsed/refractory AML patients.
SELLAS has engaged in expert panel discussions with hematology-oncology specialists to gain valuable insights into the potential of GFH009 in addressing the unmet medical needs of relapsed and refractory AML patients. The initiation of the Phase 2a study represents a significant milestone in the development of GFH009 as a potential therapeutic option for this challenging form of leukemia.
