In This Article:
- Presentation at ASH will Feature Results from the Phase 2a Trial of SLS009 in Relapsed/Refractory Acute Myeloid Leukemia After Venetoclax Failure –
- 50% Response Rate at the Selected Dose Level of 30 mg Twice a Week (BIW) –
- 45 mg (Safety Dose) Once a Week of SLS009 Showed a Median Overall Survival (OS) of 5.5 Months vs. <2.5 Months with Standard of Care; 60 mg Once a Week and 30 mg BIW Median OS Not Reached -
NEW YORK, Nov. 05, 2024 (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 that data from its Phase 2a trial of SLS009, a highly selective CDK9 inhibitor, in relapsed/refractory acute myeloid leukemia (r/r AML) will be presented at the 66th American Society of Hematology (ASH) Annual Meeting & Exposition, which is being held on December 7 –10, 2024, in San Diego, California.
“We are excited to have SLS009 featured at the 2024 ASH meeting and are pleased with the very promising safety and efficacy results from the Phase 2a trial in r/r AML,” said Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS. “Treatment with SLS009 in combination with azacitidine and venetoclax was well tolerated and led to a 50% response rate in the selected optimal dose. Clinical activity was even higher in patients with AML-myelodysplasia-related changes (AML-MRC) and in particular those with ASXL1 mutations, suggesting that this subset of patients may exhibit preferential sensitivity to SLS009. These findings contribute to the growing evidence supporting the potential of SLS009 to address unmet needs in difficult-to-treat populations, and future development efforts will focus on further exploring its impact in patients with AML-MRC.”
Poster presentation details:
| Title: |
| Phase 2a Study of SLS009, a Highly Selective CDK9 Inhibitor, In Combination with Azacitidine and Venetoclax for Relapsed/Refractory Acute Myeloid Leukemia After Prior Venetoclax Treatment |
|
|
|
|
| Session Date and Time: |
| Sunday, December 8, 2024, 6:00 PM - 8:00 PM PST |
|
|
|
|
| Session Title: |
| Acute Myeloid Leukemias: Investigational Drug and Cellular Therapies: Poster II |
|
|
|
|
| Location: |
| San Diego Convention Center, Halls G-H |
|
|
|
|
| Lead Author: |
| Joshua F. Zeidner, MD, University of North Carolina, Lineberger Comprehensive Cancer Center, Chapel Hill, NC |
|
|
|
|
| Abstract Number: |
| 2877 |
|
|
|
|
The study enrolled 30 patients across three dosing levels (DLs) of SLS009:45 mg IV QW, DL2: 60 mg IV QW, and DL3: 30 mg IV BIW. SLS009 was well-tolerated across the DLs tested with no dose-limiting toxicities (DLTs) observed. Among 29 evaluable pts, 16 (55%) had ≥50% reduction in bone marrow (BM) blasts compared to baseline (DL1: 60%; DL2: 33%; DL3: 80%). Nine (31%) patients achieved an overall response (i.e., CR+CRi+MLFS), including 5 (17%) who achieved CR/CRi. The response rates per dose level were 10% in DL1, 33% in DL2, and 50% in DL3. All 9 responders had AML- Myelodysplasia Related (AML-MR) (9/23 of AMLMR pts responded) and 8/15 pts (53%) with somatic MR mutations responded. Among those with ASXL1 mutations, 5/9 (56%) achieved an overall response. 2/9 (22%) with TP53 mutations achieved a response including one patient with concomitant TP53 and ASXL1 mutation who had an ongoing response at data cut-off. Fifteen patients were still alive at the time of the data cutoff and the median OS for the trial has not been reached.