SELLAS Life Sciences Group has announced encouraging data from its Phase 2 clinical trial of SLS009, an investigational drug for relapsed or refractory acute myeloid leukemia (r/r AML). The open-label, single-arm, multi-center study is evaluating the safety, tolerability, and efficacy of SLS009 in combination with venetoclax and azacitidine.
The latest results indicate a median overall survival (mOS) exceeding 7.7 months in the 30 mg BIW cohort, a significant improvement over the historically expected mOS of approximately 2.5 months for similar patients. Furthermore, the overall response rate (ORR) in two expansion cohorts for patients with AML with myelodysplasia-related changes (AML MRC) reached 56%, exceeding the pre-specified target response rate of 33%.
Trial Design and Patient Population
The Phase 2 trial includes two dose levels of SLS009: 45 mg and 60 mg. Patients in the 60 mg cohort were randomized to receive either 60 mg weekly or 30 mg biweekly. As of December 4, 2024, 14 patients were enrolled in Cohort 3, with an additional 14 across Cohorts 4 and 5, of whom 9 were evaluable at the time of analysis. The study aims to identify biomarkers for the target patient population to optimize future trials.
Clinical Significance
SELLAS emphasizes the rapid enrollment in the expansion cohorts, highlighting the urgent need for new treatments for r/r AML patients. The results suggest that SLS009 has the potential to become a valuable therapeutic option for patients with limited alternatives. The drug has been well-tolerated, with no new safety concerns reported as the trial progresses.
Financial Position and Future Development
SELLAS is also developing its lead product candidate, GPS, alongside SLS009. With a current ratio of 2.26 and minimal debt-to-equity of 0.04, the company appears to have adequate financial flexibility to continue its clinical programs. Recent developments include the FDA granting Rare Pediatric Disease Designation to both GPS for pediatric AML and SLS009 for pediatric acute lymphoblastic leukemia.
