SELLAS Life Sciences (SLS) Group announced that data from its Phase 2a trial of SLS009, a highly selective CDK9 inhibitor, in relapsed/refractory acute myeloid leukemia will be presented at the 66th American Society of Hematology Annual Meeting & Exposition, which is being held on December 7 -10, 2024, in San Diego, California. The study enrolled 30 patients across three dosing levels 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 observed. Among 29 evaluable pts, 16 had greater than or equal to50% reduction in bone marrow blasts compared to baseline. Nine patients achieved an overall response, including 5 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 and 8/15 pts with somatic MR mutations responded. Among those with ASXL1 mutations, 5/9 achieved an overall response. 2/9 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.
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