SELLAS Reports Positive Survival and Response Data from Phase 2 SLS009 Trial in r/r AML

SELLAS Life Sciences Group, Inc., a company focused on developing innovative cancer therapies, has reported new data from the expansion cohorts in its Phase 2 clinical trial of SLS009. SLS009 is a highly selective CDK9 inhibitor being tested in patients with relapsed or refractory acute myeloid leukemia (r/r AML). CEO Angelos Stergiou expressed optimism about the potential of SLS009 to improve outcomes for AML patients who have undergone extensive prior treatments.

In the third cohort of the trial, patients receiving a dosing regimen of 30 mg twice weekly who had relapsed or were refractory to venetoclax-based treatments had a median overall survival (mOS) that has not yet been reached but has surpassed 7.7 months. This is a significant improvement over the historically expected mOS of around 2.5 months for this patient population. Additionally, the overall response rate (ORR) to date in expansion cohorts involving patients with AML-myelodysplasia-related changes (AML-MRC) has been 56%. This response rate exceeds the pre-specified target of 33%, showcasing the efficacy of SLS009.

As of the data cutoff on December 4, 2024, 14 patients were enrolled in each of Cohorts 3, 4, and 5, with nine patients evaluable for efficacy analysis. The mOS in Cohort 3 has exceeded 7.7 months, highlighting a marked improvement in survival for these patients. In Cohorts 4 and 5, which included patients with AML-MRC and either ASXL1 mutations or other cytogenic changes, the ORR was 56% in the nine evaluable patients.

The safety profile of SLS009 remains favorable, with no new safety concerns observed. The trial includes both safety and efficacy evaluations, along with efforts to identify biomarkers to better target the patient population for future studies.

The Phase 2 trial is an open-label, single-arm, multi-center study assessing the combination of SLS009 with venetoclax and azacitidine at two dosage levels, 45 mg and 60 mg. Patients in the 60 mg cohort were randomized to receive either a 60 mg dose once weekly or a 30 mg dose twice weekly. The trial has been expanded to include cohorts with specific genetic profiles, such as ASXL1 mutations and other myelodysplasia-related abnormalities.

SELLAS Life Sciences Group is dedicated to developing advanced therapeutics for a variety of cancer indications. Their lead product, GPS, targets the WT1 protein and is being explored both as a monotherapy and in combination with other treatments for various hematologic malignancies and solid tumors. SLS009, formerly known as GFH009, is a small molecule CDK9 inhibitor with reduced toxicity and increased potency compared to other similar inhibitors, showing high response rates in AML patients with poor prognostic factors.

For more details on the study, you can visit the clinical trial registry with identifier NCT04588922. SELLAS Life Sciences Group continues to advance in the field of oncology, providing new hope for patients with challenging cancer diagnoses.