- SELLAS Life Sciences Group Inc (NASDAQ:SLS) announced results from its ongoing dose-escalating Phase 1 study of GFH009 in patients with relapsed and/or refractory (r/r) hematologic malignancies.
- One patient treated with GFH009 in the 30 mg once-per-week cohort achieved a confirmed complete response (CR), which is the first CR reported in acute myeloid leukemia (AML) with any CDK9 inhibitor monotherapy.
- No minimal residual disease (MRD) was detected in this CR patient, and full neutrophil, platelet, and red blood cell recovery were reported.
- Related: SELLAS Life Sciences Shares Tumble As Acute Myeloid Leukemia Trial Will Longer Than Anticipated.
- Anti-cancer effects were also observed at multiple doses in the r/r AML and r/r lymphoma treatment groups.
- Neutrophil counts improved in most patients from both groups while on treatment. Dose-limiting toxicities have not been identified at any levels studied, and the maximum tolerated dose has not yet been reached.
- Apparent efficacy was noted without significant toxicities at multiple doses ranging from 9-30 mg.
- Stable disease (SD) was maintained in certain patients for more than eight months, and one patient still on treatment has maintained SD for more than a year.
- Initial pharmacodynamics (PD) studies have shown evident reductions in two known biomarkers of CDK9 activity, MCLâ€1, and MYC.
- Price Action: SLS shares are down 4.40% at 2.39 on the last check Tuesday.
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