SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) started Tuesday trading flat. The New York-based company, a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, today announced that is has met all primary endpoints in its Phase 2 trial of SLS009 (tambiciclib), a highly selective CDK9 inhibitor, in relapsed/refractory acute myeloid leukemia (r/r AML).
The Phase 2 clinical trial of SLS009 is an open-label, single-arm, multi-center study designed to evaluate the safety, tolerability, and efficacy of SLS009 in combination with venetoclax and azacitidine at two dose levels, 45 mg and 60 mg.
In the 60 mg dose cohort, patients were treated with either a 60-mg dose once per week or a 30-mg dose two times per week. The trial was expanded to include ASXL1-mutated AML patients as well as patients with myelodysplasia-related cytogenetic abnormalities other than ASXL1 mutations.
The target response rate for this Phase 2 trial, at the optimal dose level, was at least 20% and a target median survival of at least three months. The primary endpoint for the trial was overall response rate, and key secondary endpoints included overall survival, safety, and tolerability.
The trial met all endpoints, demonstrating strong efficacy and favorable safety and tolerability with robust anti-tumor activity.
SLS shares slipped two cents, or 1%, to $1.96.
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