Tembiciclib Azacitidine Venetoclax AML Treatment
Tambiciclib Shows Promise in Relapsed/Refractory AML, Paving Way for First-Line Therapy Studies
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SELLAS life Sciences Group announces positive Phase 2 trial results for tambiciclib in combination with venetoclax and azacitidine, highlighting potential for earlier intervention in acute myeloid leukemia (AML).
[City, State] - [Date] - SELLAS Life Sciences Group, Inc. today announced promising results from a Phase 2 clinical trial investigating tambiciclib (formerly SLS009) in combination with venetoclax and azacitidine for patients with relapsed/refractory acute myeloid leukemia (AML). The trial met its primary endpoints,demonstrating the potential of tambiciclib to offer important clinical benefit,particularly when administered earlier in the disease course.
Tambiciclib: A New Frontier in AML Treatment
Dragan Cicic, MD, chief development officer of SELLAS, emphasized the strategic importance of early intervention.”We believe earlier intervention with tambiciclib may offer greater clinical benefit before patients’ bone marrow reserve is depleted by disease or prior therapies, and before the disease evolves into more resistant and aggressive forms,” Cicic stated in a news release. He further noted that data from other recent clinical trials suggest meaningful differences in response rates between newly diagnosed and relapsed/refractory patients, reinforcing the value of this approach.The company’s ongoing collaboration with a leading cancer center is generating critical insights into genomics, proteomics, and transcriptomics. These advancements are expected to refine patient selection and enhance SELLAS’ precision medicine strategy, ultimately unlocking the full potential of tambiciclib as the company prepares for pivotal development.
Phase 2 Trial Design and Patient Population
The open-label, multicenter Phase 2 trial was designed to evaluate the safety, tolerability, and efficacy of tambiciclib at doses of 45 mg or 60 mg when used in combination with venetoclax and azacitidine. In the 60 mg cohort, patients received tambiciclib either as a single 60-mg dose once weekly or as a 30-mg dose twice weekly. The trial was afterward expanded to include patients with Asxl1-mutated AML, as well as those with myelodysplasia-related cytogenetic abnormalities beyond Asxl1 mutations.
Key endpoints of the study included the incidence of dose-limiting toxicities (DLTs), adverse effects, pharmacokinetic profiles, overall response rate (ORR), duration of response, progression-free survival (PFS), and overall survival (OS).
The trial enrolled and treated 54 patients with relapsed/refractory AML who had previously progressed on venetoclax-based therapies. Of these, 47 patients had AML with myelodysplasia-related changes (AML MR), and 23 patients had Asxl1-mutated disease. Among those with AML MR, 17 patients had the M4/M5 AML subtype. all patients had adverse-risk cytogenetics, with the exception of one patient who had intermediate-risk cytogenetics. The median age of the patients was 69 years, and they had received a median of two prior lines of therapy.
Safety and Efficacy Findings
Regarding safety, the addition of tambiciclib to the venetoclax and azacitidine regimen did not result in increased toxicities compared to venetoclax plus azacitidine alone. This finding is crucial for the tolerability and potential widespread adoption of this combination therapy.
“We believe these data strongly support the potential of tambiciclib to meaningfully extend life in patients with otherwise limited options,and we look forward to sharing these findings in more detail in the future,” concluded Stergiou in the news release.
The positive outcomes of this Phase 2 trial provide a strong foundation for advancing tambiciclib into first-line therapy studies, offering a potential new treatment avenue for a broader AML patient population.
References
- SELLAS meets all primary endpoints in phase 2 trial of SLS009 in r/r AML and receives FDA guidance to advance into first-line therapy study. News release. SELLAS Life Sciences Group, Inc. July 15, 2025. Accessed July 15, 2025.
- Study of SLS009 (formerly GFH009) a potent highly selective CDK9 inhibitor in patients with hematologic malignancies. ClinicalTrials.gov. Updated September 19, 2024. Accessed July 15