SELLAS' Phase 2 Study Of SLS009 In Acute Myeloid Leukemia Meets All Primary Goals

(RTTNews) - SELLAS Life Sciences Group, Inc. (SLS) Tuesday said that its Phase 2 trial of SLS009 in patients with relapsed/refractory acute myeloid leukemia (r/r AML) met all primary goals.

The Phase 2 study was designed to evaluate SLS009 in combination with venetoclax and azacitidine. The primary endpoint for the trial was overall response rate (ORR). The study exceeded target ORR of 20% with 44% response rate in patients with Acute Myeloid Leukemia-Myelodysplasia-Related Changes (AML MR). Median Overall Survival (mOS) was 8.9 Months, which surpassed the historical median of 2.4 months.

The FDA has recommended SELLAS to include newly diagnosed, first-line AML patients in a study, that may support a New Drug Application. The company plans to initiate the study by the first quarter of 2026.