SELLAS Life Sciences announced positive Phase 2 trial data for SLS009 (tambiciclib), a CDK9 inhibitor, in relapsed/refractory acute myeloid leukemia (r/r AML). The trial showed promising median overall survival (mOS) and overall response rates (ORR), exceeding expectations and historical benchmarks. The study focused on patients with r/r AML, particularly those with AML-myelodysplasia-related changes (AML-MRC) and those who had relapsed or were refractory to venetoclax-based regimens.
This news is particularly encouraging for AML patients who have limited treatment options after failing venetoclax-based therapies. The demonstrated efficacy of SLS009 in this heavily pre-treated population, especially those with complex genetic profiles like ASXL1, RUNX1, and TP53 mutations, suggests a potential new therapeutic avenue. The positive results offer a glimmer of hope for improved outcomes in a patient population with historically poor prognoses and limited effective therapies. This advancement could significantly alter the treatment landscape for r/r AML.
Cohort 3 of the trial included 14 patients with r/r AML previously treated with venetoclax-based therapies. The mOS was 8.8 months for all patients and 8.9 months for the AML-MRC subgroup. Notably, the ORR reached 46% in all evaluable patients and 67% in the AML-MRC group, significantly exceeding the targeted 20% ORR. These positive responses were observed across different genetic mutations, including ASXL1, RUNX1, and TP53, and even in patients with adverse karyotypes. Furthermore, the treatment was well-tolerated with no new safety signals detected.
The promising Phase 2 data for SLS009 suggest a potential breakthrough in r/r AML treatment. The ongoing expansion cohorts focusing on specific genetic mutations will provide further insights into the drug’s efficacy and optimal use. These findings could lead to a new standard of care for patients who have exhausted other treatment options, potentially improving survival rates and quality of life for this challenging disease.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
