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SLS009 is associated with an improvement in survival among patients with relapsed/refractory acute myeloid leukemia.
Median overall survival of all patients in the cohort was 8.8 months, while those with AML-myelodysplasia-related changed had a median overall survival of 8.9 months.
SLS009 (tambiciclib) has been found to be associated with an improvement in survival among patients with relapsed/refractory acute myeloid leukemia (r/r AML).
The findings were shared in a news release from late-stage clinical biopharmaceutical company SELLAS Life Sciences Group, Inc., announcing data from cohort 3 of an ongoing phase 2 trial of SLS009. The treatment was described as a highly selective CDK9 inhibitor.
The median overall survival of all patients in cohort 3 was 8.8 months, and the median overall survival in patients with AML-myelodysplasia-related changes (AML-MRC) was 8.9 months.
“The remarkable results from cohort 3 of the ongoing phase 2 trial reinforce the potential of SLS009 to transform outcomes for these heavily pretreated [patients with AML],” said Dr. Angelos Stergiou, president and CEO of SELLAS, in the news release. “Not only have we observed unprecedented survival benefits, but the high response rate underscores the therapy’s efficacy profile.”
The data, as Stergiou outlined, show that patients whose disease was relapsed or refractory to Venclexta (venetoclax)-based regimens patients and who received 30 milligrams twice a week achieved a median overall survival of 8.8 months, surpassing the historical benchmark of 2.5 months.
Additionally, the therapy demonstrated a 67% objective response rate in patients with AML-MRC and 46% in all evaluable patients.
“With responses seen across different genetic mutations, this approach could be transformational for many underserved patients. We are continuing to explore SLS009's potential in expansion cohorts to further validate its potential to address critical unmet medical needs,” Stergiou said.
Additionally, three of four patients with myelomonocytic AML responded to treatment. Four of six patients with mutations ASXL1 responded, three of five patients with RUNX1 mutations responded and one of three patients with TP53 responded, as well as one of three patients with adverse karyotypes.
In the trial, 14 patients with relapsed and refractory AML whose disease had previously failed on Venclexta-based therapies were enrolled and received treatment with SLS009 and Venclexta/azacitidine in cohort 3. Ten of 14 patients had AML-MRC.
The median age of patients was 71, the median number of prior failed therapies was one, 13 of 14 patients were evaluable for efficacy and all patients had adverse risk cytogenetics.
SLS009, the news release noted, was found to be well-tolerated, with no new safety signals observed. The phase 2 trial continues in expansion cohorts 4 and 5, among patients with AML-myelodysplasia-related changes (AML-MRC) with ASXL1 mutation and mutations and cytogenic changes other than ASXL1, respectively.
Relapsed: when cancer returns after a period of improvement.
Refractory: when cancer does not respond to treatment.
Overall survival: the time a patient lives, regardless of disease status.
Objective response rate: patients who responded partially or completely to treatment.
The trial is currently recruiting and is being held at 21 sites across the United States and China, according to its listing on clinicaltrials.gov. The trial has an estimated primary completion date of June 30, 2025, and an estimated study completion date of Dec. 31, 2025, according to the listing.
The phase 2 trial, according to the news release, is an open-label, single-arm study evaluating the safety, tolerability and efficacy of SLS009 in combination with Venclexta and azacitidine at 45 and 60 milligram dose levels, with the 60 milligram dose being administered either once a week or as 30 milligrams twice a week.
In 2023, the U.S. Food and Drug Administration granted Fast Track designation to SLS009 for the treatment of patients with relapsed or refractory peripheral T-cell lymphomas.
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