Sellas Life Sciences Group (SLS) said Tuesday that it has met all primary endpoints in its mid-stage trial of SLS009, a CDK9 inhibitor, in patients with relapsed or refractory acute myeloid leukemia.
The mid-stage clinical trial of SLS009 is a study designed to evaluate the safety, tolerability, and efficacy of SLS009 in combination with venetoclax and azacitidine at two dose levels of 45 and 60 milligrams.
CDK9 is a cancer target whose activity has been shown to correlate negatively with overall survival in several cancer types.
The trial met its primary endpoint of overall response rate of at least 20%, as well as key secondary endpoints of overall survival, safety, and tolerability with strong anti-tumor activity, the company said.
Sellas said it now plans to advance SLS009 into a randomized trial that will expand into the newly diagnosed AML populations, potentially supporting a New Drug Application. Trial preparation is underway, with enrollment expected to begin by Q1.
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